260608 PMO Alignment

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S… Speaker 1 (260608 PMO Alignment)

Hi.

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S… Speaker 1 (260608 PMO Alignment)

Good morning.

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S… Speaker 1 (260608 PMO Alignment)

Good morning.

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S… Speaker 1 (260608 PMO Alignment)

Thank you.

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S… Speaker 3 (260608 PMO Alignment)

I hope you had a good weekend.

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S… Speaker 1 (260608 PMO Alignment)

Yeah,

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S… Speaker 1 (260608 PMO Alignment)

it was great.

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S… Speaker 1 (260608 PMO Alignment)

I do

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S… Speaker 3 (260608 PMO Alignment)

have some background noise outside my window,

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S… Speaker 3 (260608 PMO Alignment)

so if you can't hear me,

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S… Speaker 3 (260608 PMO Alignment)

just please let me know and I can repeat answers,

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S… Speaker 3 (260608 PMO Alignment)

but I'll go mute so much as possible.

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S… Speaker 1 (260608 PMO Alignment)

Go ahead.

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S… Speaker 3 (260608 PMO Alignment)

I can see your screen.

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S… Speaker 1 (260608 PMO Alignment)

You can.

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S… Speaker 1 (260608 PMO Alignment)

Okay.

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S… Speaker 2 (260608 PMO Alignment)

The first product is RSV.

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S… Speaker 2 (260608 PMO Alignment)

So I already mentioned the RSV in TIMSS,

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S… Speaker 2 (260608 PMO Alignment)

but in here I have a question for more detail.

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S… Speaker 2 (260608 PMO Alignment)

So this study,

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S… Speaker 2 (260608 PMO Alignment)

this study background is we just only

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S… Speaker 2 (260608 PMO Alignment)

studied at 25 degrees and humidity

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S… Speaker 2 (260608 PMO Alignment)

condition or not considered at all.

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S… Speaker 2 (260608 PMO Alignment)

So this temperature and humidity in IFU.

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S… Speaker 2 (260608 PMO Alignment)

These are different.

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S… Speaker 2 (260608 PMO Alignment)

So these conditions which we

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S… Speaker 2 (260608 PMO Alignment)

already studied,

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S… Speaker 2 (260608 PMO Alignment)

they cannot cover fully

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S… Speaker 2 (260608 PMO Alignment)

the IFU.

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S… Speaker 2 (260608 PMO Alignment)

So if the experiments result

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S… Speaker 2 (260608 PMO Alignment)

default from IFU,

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S… Speaker 2 (260608 PMO Alignment)

this is a present IFU,

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S… Speaker 2 (260608 PMO Alignment)

would it be necessary to submit the data

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S… Speaker 2 (260608 PMO Alignment)

to TOV?

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S… Speaker 2 (260608 PMO Alignment)

the experiments data.

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S… Speaker 1 (260608 PMO Alignment)

Are you saying if

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S… Speaker 3 (260608 PMO Alignment)

we come back with less favourable results that does not support

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S… Speaker 3 (260608 PMO Alignment)

our claims?

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S… Speaker 2 (260608 PMO Alignment)

Yes.

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S… Speaker 2 (260608 PMO Alignment)

So this is my concern.

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S… Speaker 1 (260608 PMO Alignment)

Yes,

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S… Speaker 3 (260608 PMO Alignment)

I think we probably would have some sort of obligation.

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S… Speaker 3 (260608 PMO Alignment)

This is a very good example why executive does

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S… Speaker 3 (260608 PMO Alignment)

not really give us permission to go do new studies on this.

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S… Speaker 3 (260608 PMO Alignment)

It's absolutely required because there's always the rest of the data

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S… Speaker 3 (260608 PMO Alignment)

comes back and it's not as good as the original data we did years ago.

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S… Speaker 3 (260608 PMO Alignment)

Any data that we produce,

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S… Speaker 3 (260608 PMO Alignment)

we have to especially

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S… Speaker 3 (260608 PMO Alignment)

If it differs from what we originally claim in our views,

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S… Speaker 3 (260608 PMO Alignment)

we would need to communicate that.

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S… Speaker 3 (260608 PMO Alignment)

I am not 100 % certain what that would look like.

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S… Speaker 3 (260608 PMO Alignment)

We'll have to discuss with Katrina and regulatory affairs,

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S… Speaker 3 (260608 PMO Alignment)

but I'm sure there would be some sort of obligation.

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S… Speaker 3 (260608 PMO Alignment)

Is there any reason to think that we might get something different?

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S… Speaker 1 (260608 PMO Alignment)

There

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S… Speaker 2 (260608 PMO Alignment)

is no idea,

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S… Speaker 2 (260608 PMO Alignment)

but...

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S… Speaker 2 (260608 PMO Alignment)

I'm not sure the temperature

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S… Speaker 2 (260608 PMO Alignment)

is,

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S… Speaker 2 (260608 PMO Alignment)

if we do experiments at

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S… Speaker 2 (260608 PMO Alignment)

different, I mean extreme temperature,

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S… Speaker 2 (260608 PMO Alignment)

maybe I think the result can be different

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S… Speaker 2 (260608 PMO Alignment)

from current IFU.

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S… Speaker 2 (260608 PMO Alignment)

So I just suggest,

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S… Speaker 2 (260608 PMO Alignment)

should we submit the protocol for

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S… Speaker 2 (260608 PMO Alignment)

opening part stability in Tier 2?

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S… Speaker 3 (260608 PMO Alignment)

We don't need to submit the protocol unless it was to answer completely independent

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S… Speaker 3 (260608 PMO Alignment)

efficiency,

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S… Speaker 3 (260608 PMO Alignment)

which is not the case,

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S… Speaker 3 (260608 PMO Alignment)

right? So the question didn't come up,

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S… Speaker 3 (260608 PMO Alignment)

so we don't need to submit the protocol.

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S… Speaker 3 (260608 PMO Alignment)

They are also not going to give us any opinion about the protocol because it's

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S… Speaker 3 (260608 PMO Alignment)

not what their role is.

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S… Speaker 3 (260608 PMO Alignment)

Their role is to assess the data we put in front of them and whether that aligns

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S… Speaker 3 (260608 PMO Alignment)

into any of the technical file.

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S… Speaker 3 (260608 PMO Alignment)

whether it aligns with the regulation,

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S… Speaker 3 (260608 PMO Alignment)

whether they still consider our product to be safe and effective.

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S… Speaker 3 (260608 PMO Alignment)

So at the point where we do a study,

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S… Speaker 3 (260608 PMO Alignment)

we get data that is indifferent to the original one,

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S… Speaker 3 (260608 PMO Alignment)

then this questions the safety and efficacy

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S… Speaker 3 (260608 PMO Alignment)

of the device,

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S… Speaker 3 (260608 PMO Alignment)

which is where the regulation comes in.

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S… Speaker 3 (260608 PMO Alignment)

So we should,

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S… Speaker 3 (260608 PMO Alignment)

for all intent,

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S… Speaker 3 (260608 PMO Alignment)

we should get the same results as we did previously.

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S… Speaker 3 (260608 PMO Alignment)

If we get different results,

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S… Speaker 1 (260608 PMO Alignment)

then

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S… Speaker 3 (260608 PMO Alignment)

that's meaningful right if if the device operates

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S… Speaker 3 (260608 PMO Alignment)

or behaves differently under different conditions that is that that has

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S… Speaker 3 (260608 PMO Alignment)

the potential to impact its performance which is why we then have obligation

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S… Speaker 3 (260608 PMO Alignment)

to do something but if nothing has happened but

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S… Speaker 3 (260608 PMO Alignment)

we feel there is a risk yes then i think we

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S… Speaker 3 (260608 PMO Alignment)

need to we need to hold back because we

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S… Speaker 3 (260608 PMO Alignment)

had originally

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S… Speaker 3 (260608 PMO Alignment)

decided to do this as a gap that we saw.

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S… Speaker 3 (260608 PMO Alignment)

We did it preemptively without TUV questioning

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S… Speaker 1 (260608 PMO Alignment)

it.

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S… Speaker 3 (260608 PMO Alignment)

If we think that there is a risk to do it,

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S… Speaker 3 (260608 PMO Alignment)

I would advise that we go back to the CFPT,

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S… Speaker 3 (260608 PMO Alignment)

ask each of them to assess and give their opinion of the risk.

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S… Speaker 1 (260608 PMO Alignment)

we might get different data,

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S… Speaker 1 (260608 PMO Alignment)

because if we were not asked to produce this data,

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S… Speaker 1 (260608 PMO Alignment)

I would imagine executive would say,

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S… Speaker 1 (260608 PMO Alignment)

don't proceed with the study there.

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S… Speaker 1 (260608 PMO Alignment)

If there isn't a requirement by the Notified Party to give them this piece of

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S… Speaker 1 (260608 PMO Alignment)

data we're trying to generate,

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S… Speaker 1 (260608 PMO Alignment)

then we may need to decide that the risk

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S… Speaker 1 (260608 PMO Alignment)

to conduct it is too big.

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S… Speaker 4 (260608 PMO Alignment)

Okay,

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S… Speaker 2 (260608 PMO Alignment)

I see.

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S… Speaker 2 (260608 PMO Alignment)

So that is a good call out.

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S… Speaker 1 (260608 PMO Alignment)

We always have to look for it now that we're in around two.

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S… Speaker 1 (260608 PMO Alignment)

And it hasn't come up as a question even in round two.

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S… Speaker 1 (260608 PMO Alignment)

We should consider whether we want to do this at all if there is any

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S… Speaker 1 (260608 PMO Alignment)

form of a risk that we might get different results.

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S… Speaker 1 (260608 PMO Alignment)

And I think it's because are we talking about accelerated

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S… Speaker 1 (260608 PMO Alignment)

conditions,

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S… Speaker 1 (260608 PMO Alignment)

so more extreme than what we expose the product to?

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S… Speaker 4 (260608 PMO Alignment)

That's

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S… Speaker 1 (260608 PMO Alignment)

now the open pouch.

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S… Speaker 1 (260608 PMO Alignment)

I'm just wondering why there is a feeling that there may be risks we'll get different

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S… Speaker 5 (260608 PMO Alignment)

results.

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S… Speaker 3 (260608 PMO Alignment)

Could you explain your question?

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S… Speaker 3 (260608 PMO Alignment)

I think I can't understand your question well.

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S… Speaker 1 (260608 PMO Alignment)

So I just want to understand there's obviously been

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S… Speaker 1 (260608 PMO Alignment)

discussions about this within the CFD.

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S… Speaker 1 (260608 PMO Alignment)

So which department raised the concern and

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S… Speaker 1 (260608 PMO Alignment)

what is the concern?

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S… Speaker 1 (260608 PMO Alignment)

Is it because the actual open pouch stability is occurring at extreme

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S… Speaker 1 (260608 PMO Alignment)

accelerated conditions and has the potential to give skewed results

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S… Speaker 1 (260608 PMO Alignment)

or what is the actual concern?

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S… Speaker 3 (260608 PMO Alignment)

This is just my concern from

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S… Speaker 3 (260608 PMO Alignment)

my perspective or timeline.

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S… Speaker 1 (260608 PMO Alignment)

Okay, then I think it might be worth just asking,

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S… Speaker 1 (260608 PMO Alignment)

just look into the actual study and see what kind of conditions they're subjecting

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S… Speaker 1 (260608 PMO Alignment)

the device to and ask TPS if

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S… Speaker 1 (260608 PMO Alignment)

they can give an opinion what they feel the risk would be,

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S… Speaker 1 (260608 PMO Alignment)

because that would be the first question that executive asks us.

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S… Speaker 1 (260608 PMO Alignment)

If we have any sort of...

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S… Speaker 1 (260608 PMO Alignment)

feeling that they may be riskier,

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S… Speaker 1 (260608 PMO Alignment)

we have to elevate and make sure that the CFT

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S… Speaker 1 (260608 PMO Alignment)

leadership can make a decision to proceed or not.

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S… Speaker 2 (260608 PMO Alignment)

Okay.

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S… Speaker 4 (260608 PMO Alignment)

I

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S… Speaker 3 (260608 PMO Alignment)

will communicate with TPS later.

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S… Speaker 4 (260608 PMO Alignment)

Okay.

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S… Speaker 3 (260608 PMO Alignment)

Yeah.

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S… Speaker 3 (260608 PMO Alignment)

And then the next one is

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S… Speaker 3 (260608 PMO Alignment)

Hazard Symbol.

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S… Speaker 3 (260608 PMO Alignment)

So maybe you have a meeting in

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S… Speaker 3 (260608 PMO Alignment)

global.

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S… Speaker 3 (260608 PMO Alignment)

with Hazard Symbol and MPT clinical study that will be

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S… Speaker 3 (260608 PMO Alignment)

maybe Tuesday to Thursday,

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S… Speaker 1 (260608 PMO Alignment)

right?

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S… Speaker 2 (260608 PMO Alignment)

Yes,

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S… Speaker 1 (260608 PMO Alignment)

so two different subjects here.

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S… Speaker 1 (260608 PMO Alignment)

Number one, the Hazard Symbol.

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S… Speaker 1 (260608 PMO Alignment)

I have an internal meeting with regulatory leadership

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S… Speaker 1 (260608 PMO Alignment)

on Wednesday afternoon my time.

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S… Speaker 1 (260608 PMO Alignment)

Our initial feeling is

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S… Speaker 1 (260608 PMO Alignment)

We can't change what we're doing.

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S… Speaker 1 (260608 PMO Alignment)

So for RSV,

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S… Speaker 1 (260608 PMO Alignment)

because we've presented this argument and TVA accepted it,

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S… Speaker 1 (260608 PMO Alignment)

we are compliant,

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S… Speaker 1 (260608 PMO Alignment)

so we proceed without the symbol.

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S… Speaker 6 (260608 PMO Alignment)

However,

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S… Speaker 1 (260608 PMO Alignment)

there's a bigger picture.

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S… Speaker 1 (260608 PMO Alignment)

Everything else,

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S… Speaker 1 (260608 PMO Alignment)

right, we've taken in the program a lot of time to discuss

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S… Speaker 1 (260608 PMO Alignment)

with leadership to arrive at the decision that we should be okay to put

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S… Speaker 1 (260608 PMO Alignment)

the hazard symbol on for those folks.

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S… Speaker 1 (260608 PMO Alignment)

So what we don't want to do is...

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S… Speaker 1 (260608 PMO Alignment)

create further confusion by coming back and saying but they accepted it for this

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S… Speaker 1 (260608 PMO Alignment)

part although it's good news that they accepted that argument it

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S… Speaker 1 (260608 PMO Alignment)

does not mean that they'll accept that same argument for everything else and we are facing extreme

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S… Speaker 1 (260608 PMO Alignment)

timeline risks in implementation so for now proceed

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S… Speaker 1 (260608 PMO Alignment)

as we have agreed already on friday it stays out nothing that

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S… Speaker 1 (260608 PMO Alignment)

we need to do for rsv also nothing that we need to do for rotodina

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S… Speaker 1 (260608 PMO Alignment)

we proceed with symbol as planned

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S… Speaker 1 (260608 PMO Alignment)

I do have a meeting on Wednesday,

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S… Speaker 2 (260608 PMO Alignment)

though. If that changes,

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S… Speaker 1 (260608 PMO Alignment)

I will let you know straight after that meeting,

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S… Speaker 1 (260608 PMO Alignment)

but I don't suspect anything will change.

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S… Speaker 2 (260608 PMO Alignment)

Then for the MPT,

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S… Speaker 1 (260608 PMO Alignment)

and it's not clinical study,

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S… Speaker 1 (260608 PMO Alignment)

it's about the European population.

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S… Speaker 1 (260608 PMO Alignment)

um i have a meeting set on thursday

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S… Speaker 1 (260608 PMO Alignment)

with the reviewer to discuss this and to see what ways we can

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S… Speaker 1 (260608 PMO Alignment)

we can find forward forward what i would like to

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S… Speaker 1 (260608 PMO Alignment)

do however is we need to we need to um

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S… Speaker 1 (260608 PMO Alignment)

work with tps and subin to see either what

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S… Speaker 1 (260608 PMO Alignment)

kind of timelines would

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S… Speaker 1 (260608 PMO Alignment)

what the timelines would look like to get samples for the original

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S… Speaker 1 (260608 PMO Alignment)

and it's not a clinical study but it's an internal study that

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S… Speaker 1 (260608 PMO Alignment)

we can get stored samples to just test from European population and

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S… Speaker 1 (260608 PMO Alignment)

it really is about the samples needing to come from

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S… Speaker 1 (260608 PMO Alignment)

Europe and it's not about the demographic of the person but more about

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S… Speaker 1 (260608 PMO Alignment)

the fact that that person is in that region because it's

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S… Speaker 1 (260608 PMO Alignment)

related to the strains of

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S… Speaker 1 (260608 PMO Alignment)

RSV that is circulating in Europe.

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S… Speaker 1 (260608 PMO Alignment)

And because we don't have details of

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S… Speaker 1 (260608 PMO Alignment)

the genotypes as we have used for previous deficiencies,

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S… Speaker 1 (260608 PMO Alignment)

this may be the only solution.

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S… Speaker 1 (260608 PMO Alignment)

But to look at that,

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S… Speaker 1 (260608 PMO Alignment)

we need to figure out if that's even possible.

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S… Speaker 1 (260608 PMO Alignment)

So can I please ask that you discuss with the relevant departments

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S… Speaker 1 (260608 PMO Alignment)

if they can see?

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S… Speaker 1 (260608 PMO Alignment)

My idea is...

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S… Speaker 1 (260608 PMO Alignment)

And I'll forward the old email.

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S… Speaker 1 (260608 PMO Alignment)

We actually prepared this in March,

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S… Speaker 1 (260608 PMO Alignment)

but we didn't get permission to proceed with the study,

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S… Speaker 1 (260608 PMO Alignment)

whereas now we won't really have another way but to proceed with it because

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S… Speaker 1 (260608 PMO Alignment)

it's a showstopper in round two.

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S… Speaker 1 (260608 PMO Alignment)

I think the idea was to see if there's a European

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S… Speaker 1 (260608 PMO Alignment)

site that could conduct

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S… Speaker 1 (260608 PMO Alignment)

it for us,

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S… Speaker 1 (260608 PMO Alignment)

like Jena,

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S… Speaker 1 (260608 PMO Alignment)

for example.

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S… Speaker 1 (260608 PMO Alignment)

I don't know if they have testing facilities available.

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S… Speaker 1 (260608 PMO Alignment)

I don't think Galway has testing facilities available.

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S… Speaker 1 (260608 PMO Alignment)

We'll have to find out through tech ops,

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S… Speaker 1 (260608 PMO Alignment)

so please ask tech ops to elevate within their function

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S… Speaker 1 (260608 PMO Alignment)

to Stella to see if they have any ideas on how to do that.

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S… Speaker 1 (260608 PMO Alignment)

Second option would be to see

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S… Speaker 1 (260608 PMO Alignment)

if we can procure stored European samples and get

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S… Speaker 1 (260608 PMO Alignment)

them delivered to ADK for ADK to conduct that study.

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S… Speaker 1 (260608 PMO Alignment)

And I'm just going to forward that old email from Alex now,

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S… Speaker 1 (260608 PMO Alignment)

just so that you have it.

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S… Speaker 3 (260608 PMO Alignment)

Yeah.

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S… Speaker 1 (260608 PMO Alignment)

Just look forward quickly.

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S… Speaker 1 (260608 PMO Alignment)

We're talking RSV,

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S… Speaker 1 (260608 PMO Alignment)

right?

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S… Speaker 3 (260608 PMO Alignment)

Yeah.

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S… Speaker 3 (260608 PMO Alignment)

I'll

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S… Speaker 1 (260608 PMO Alignment)

send it to all three of you.

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S… Speaker 3 (260608 PMO Alignment)

So

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S… Speaker 1 (260608 PMO Alignment)

it spends a little time to receive.

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S… Speaker 2 (260608 PMO Alignment)

At this point,

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S… Speaker 2 (260608 PMO Alignment)

I just worried about the RSVTR2

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S… Speaker 1 (260608 PMO Alignment)

timeline.

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S… Speaker 2 (260608 PMO Alignment)

After deciding the hazard symbol and

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S… Speaker 2 (260608 PMO Alignment)

NPTN clinical study,

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S… Speaker 2 (260608 PMO Alignment)

maybe they can update the IFU and labelling updates.

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S… Speaker 2 (260608 PMO Alignment)

Then if there's any change for

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S… Speaker 2 (260608 PMO Alignment)

NPTN clinical study,

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S… Speaker 2 (260608 PMO Alignment)

maybe the impacted number of

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S… Speaker 2 (260608 PMO Alignment)

documents is increasing.

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S… Speaker 2 (260608 PMO Alignment)

I think the timeline is longer

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S… Speaker 2 (260608 PMO Alignment)

than maybe June.

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S… Speaker 2 (260608 PMO Alignment)

I expected.

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S… Speaker 2 (260608 PMO Alignment)

So I think the decide for

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S… Speaker 2 (260608 PMO Alignment)

MPT and clinical and hard -of -symbols should be decided

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S… Speaker 2 (260608 PMO Alignment)

as soon as possible.

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S… Speaker 3 (260608 PMO Alignment)

Yes,

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S… Speaker 1 (260608 PMO Alignment)

so I'm hoping then by the end

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S… Speaker 1 (260608 PMO Alignment)

of this week we'll have a decision on that because that meeting is,

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S… Speaker 1 (260608 PMO Alignment)

we're going to have it tomorrow.

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S… Speaker 1 (260608 PMO Alignment)

Let me just check it is now on Thursday afternoon,

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S… Speaker 1 (260608 PMO Alignment)

so on Friday morning I'll have an answer for you.

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S… Speaker 2 (260608 PMO Alignment)

I can update just only MDF.

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S… Speaker 2 (260608 PMO Alignment)

I will tell

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S… Speaker 2 (260608 PMO Alignment)

the owner of MDF to update

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S… Speaker 2 (260608 PMO Alignment)

and then these are after this

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S… Speaker 2 (260608 PMO Alignment)

discussion.

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S… Speaker 1 (260608 PMO Alignment)

I do think we have high risk that we're going

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S… Speaker 1 (260608 PMO Alignment)

to have to change this product to professional use only,

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S… Speaker 1 (260608 PMO Alignment)

which has quite a considerable impact in the IFU.

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S… Speaker 1 (260608 PMO Alignment)

When that very likely happens,

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S… Speaker 1 (260608 PMO Alignment)

I need you to not worry about the proposed

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S… Speaker 1 (260608 PMO Alignment)

deficiency response date of 23.

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S… Speaker 1 (260608 PMO Alignment)

I can then just arrange with TUV how

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S… Speaker 1 (260608 PMO Alignment)

long you think that would take.

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S… Speaker 1 (260608 PMO Alignment)

So what I think would be prudent now is if you create a scenario two for

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S… Speaker 1 (260608 PMO Alignment)

me, scenario two's assumption is we are

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S… Speaker 1 (260608 PMO Alignment)

not successful with the NPT claim and we have to change everything to professional

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S… Speaker 1 (260608 PMO Alignment)

use only.

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S… Speaker 1 (260608 PMO Alignment)

So we need to assess what documents are impacted.

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S… Speaker 1 (260608 PMO Alignment)

We should be able to capture this still under the original

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S… Speaker 1 (260608 PMO Alignment)

submission CR.

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S… Speaker 1 (260608 PMO Alignment)

But there are many documents,

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S… Speaker 1 (260608 PMO Alignment)

that's the intended purpose,

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S… Speaker 1 (260608 PMO Alignment)

that's labelling,

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S… Speaker 1 (260608 PMO Alignment)

possibly risk as well.

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S… Speaker 1 (260608 PMO Alignment)

But we will need each of the CFTs to please go have a

15:41

S… Speaker 1 (260608 PMO Alignment)

look and let us know.

15:44

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um what documents will be impacted so we can start preparing for that then

15:49

S… Speaker 1 (260608 PMO Alignment)

once we know which documents are impacted if you can create another timeline like

15:53

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this and let me know what is a reasonable time for us to have all that

15:57

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completed to return to the notified body for

16:01

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a response um it will not be the 23rd we would

16:05

S… Speaker 1 (260608 PMO Alignment)

not be able to make that change that quickly okay

16:09

S… Speaker 3 (260608 PMO Alignment)

this one right

16:14

S… Speaker 1 (260608 PMO Alignment)

That's the European samples.

16:16

S… Speaker 3 (260608 PMO Alignment)

Oh.

16:17

S… Speaker 1 (260608 PMO Alignment)

So this is,

16:19

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but I think we spoke about two things here,

16:21

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but just look at that last bullet with the green.

16:23

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Obtain biobank specimens stored under

16:27

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relevant conditions and conduct a test at NAP inside Europe.

16:31

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I think we were also talking about near patient settings at

16:35

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that time,

16:36

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but just for the European population.

16:39

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uh question this is the kind of study that we likely need to do

16:44

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to resolve um to resolve that deficiency okay

16:50

S… Speaker 2 (260608 PMO Alignment)

thank you for sending this email um

16:54

S… Speaker 2 (260608 PMO Alignment)

next product is

16:59

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chagas so we already submit to dr1

17:03

S… Speaker 3 (260608 PMO Alignment)

but

17:05

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This is just updates.

17:07

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Maybe we will update the document for name change.

17:11

S… Speaker 2 (260608 PMO Alignment)

Maybe just remaining drafting status

17:15

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because we can have some

17:19

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deficiency about regarding the IFU or

17:23

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some documents.

17:25

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So we will have just draft status

17:29

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documents and in DR2,

17:31

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we will upload documents to agile and approval in

17:36

S… Speaker 2 (260608 PMO Alignment)

that time.

17:37

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And then Flash Assist sample sourcing.

17:41

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At this time,

17:43

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we have a difficult to record

17:47

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sample sourcing for global and ADK

17:52

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both.

17:53

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So I asked you in Teams in the morning.

17:57

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So is there any updates for option one and

18:01

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or two?

18:04

S… Speaker 1 (260608 PMO Alignment)

I've briefly discussed with Alex.

18:06

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I have to wait for American time to discuss with Robert Bruce.

18:10

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The problem is we really have looked everywhere.

18:13

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We can't find samples at the moment,

18:15

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even from the biobank.

18:16

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So this in itself may be a reason to exclude it.

18:19

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I'm just going to have to talk to Robert Bruce to see if there's a

18:23

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reason we can justify it.

18:25

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I think the protocol we submitted in DR,

18:29

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in the deficiency response,

18:31

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it's already named for the rises,

18:32

S… Speaker 1 (260608 PMO Alignment)

right?

18:34

S… Speaker 3 (260608 PMO Alignment)

Yeah.

18:34

S… Speaker 3 (260608 PMO Alignment)

Okay.

18:36

S… Speaker 1 (260608 PMO Alignment)

So we can't just simply exclude it anymore.

18:39

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So I think what we need to do is we need to proceed with everything

18:43

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else.

18:43

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In the protocol,

18:45

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we would probably just need to declare that we were not able to source it at

18:49

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that time, and therefore it was not tested.

18:51

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But it is important that we get the other information because it will be required

18:56

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to close the deficiency round as part of deficiency two when we submit

19:00

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it.

19:01

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we then have to justify why we submitted it with our full arises while

19:05

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we continue looking.

19:06

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I'm hoping what they would then do is accept that we struggled

19:10

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to get it and either accept it as is,

19:13

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maybe we can find another reason that this is not a problem,

19:17

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or suggest that we open up the follow -on project and continue

19:21

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trying to get samples.

19:22

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Even if it's not from the banks,

19:24

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we'll then have to go to regions to collect fresh

19:29

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samples and test those.

19:30

S… Speaker 3 (260608 PMO Alignment)

okay so if yeah

19:34

S… Speaker 2 (260608 PMO Alignment)

that's all for RSV and Chagos yes

19:39

S… Speaker 3 (260608 PMO Alignment)

so

19:45

S… Speaker 1 (260608 PMO Alignment)

if you have any questions let's move

19:49

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on to the Ritalino so I have little

19:53

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things to share so

20:00

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As I said before,

20:01

S… Speaker 2 (260608 PMO Alignment)

we already discussed about the timing

20:07

S… Speaker 2 (260608 PMO Alignment)

to implement our change of material

20:11

S… Speaker 2 (260608 PMO Alignment)

name, which is originally mouse heavy gold to mouse

20:16

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heavy gold colloid.

20:17

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So that's the colloid thing.

20:18

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So I am right now.

20:23

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working with the CRF and the other

20:27

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documents to originate the CR

20:31

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and I will open the CR hopefully

20:35

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tomorrow so this CRB meeting with

20:39

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require is required before the CR

20:43

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open it will be hold tomorrow so

20:48

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it's it's fixed so I will join I will attend

20:52

S… Speaker 2 (260608 PMO Alignment)

the meeting tomorrow afternoon in Korea time so

20:56

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after that I can open a CR and

21:00

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after that I will

21:05

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probably I can release DCR

21:10

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in this Friday so after DCR

21:14

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release I can make a change action and

21:18

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then we can move on to the MDF

21:22

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updates and make everything updated and

21:27

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also maintaining our

21:32

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September 30,

21:34

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July 31st deadline.

21:36

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So this is how we,

21:41

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so I already shared this file with you and this

21:45

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is how we aligned last Thursday.

21:49

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So all of CFTs and I am aligned

21:53

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with this timeline.

21:55

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So right now we are on prep.

21:58

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preparation for the CRB and tomorrow we will have a meeting

22:02

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and we will open and release hopefully

22:07

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in three days and after that we can make

22:11

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action change action that can allow MDF

22:15

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implement and after that by the way IFU

22:20

S… Speaker 2 (260608 PMO Alignment)

who is who which is

22:25

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responsible in QAPC said collaboration

22:29

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even collaboration should be hold

22:34

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after the MDF implements so only

22:38

S… Speaker 2 (260608 PMO Alignment)

for IFU we will move on to the collaborate after the implement other

22:42

S… Speaker 2 (260608 PMO Alignment)

things we can we can move

22:46

S… Speaker 2 (260608 PMO Alignment)

collaboration stays parallel to other

22:50

S… Speaker 2 (260608 PMO Alignment)

things so this color says this color says

22:56

S… Speaker 2 (260608 PMO Alignment)

it is waiting for some dependency documents

23:01

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so after collaboration and we will wait

23:05

S… Speaker 2 (260608 PMO Alignment)

until the previous thing

23:09

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And after that,

23:10

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we can move on to the implement and move on,

23:13

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move on, move on like this.

23:15

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So that we can make

23:19

S… Speaker 2 (260608 PMO Alignment)

this stat.

23:21

S… Speaker 2 (260608 PMO Alignment)

By the way,

23:24

S… Speaker 2 (260608 PMO Alignment)

stat changed

23:29

S… Speaker 2 (260608 PMO Alignment)

its name to td.

23:32

S… Speaker 2 (260608 PMO Alignment)

technical documents so that's the same thing so TD of

23:37

S… Speaker 2 (260608 PMO Alignment)

implement

23:41

S… Speaker 2 (260608 PMO Alignment)

will be targeting on 27th

23:45

S… Speaker 2 (260608 PMO Alignment)

and we will have final review on before

23:50

S… Speaker 2 (260608 PMO Alignment)

the submission so and so

23:54

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a little

24:00

S… Speaker 2 (260608 PMO Alignment)

question so when

24:04

S… Speaker 2 (260608 PMO Alignment)

I

24:06

S… Speaker 2 (260608 PMO Alignment)

see how you young works so uh so

24:10

S… Speaker 2 (260608 PMO Alignment)

it is about the deficiency round we

24:14

S… Speaker 2 (260608 PMO Alignment)

always share the

24:19

S… Speaker 2 (260608 PMO Alignment)

final documents with senior that they can review

24:23

S… Speaker 1 (260608 PMO Alignment)

it.

24:24

S… Speaker 2 (260608 PMO Alignment)

So is the senior review will be

24:28

S… Speaker 2 (260608 PMO Alignment)

included in our initial submission?

24:31

S… Speaker 2 (260608 PMO Alignment)

I am asking right now because my timeline

24:35

S… Speaker 2 (260608 PMO Alignment)

does not include that.

24:37

S… Speaker 1 (260608 PMO Alignment)

You mean for the actual

24:41

S… Speaker 1 (260608 PMO Alignment)

submission?

24:41

S… Speaker 2 (260608 PMO Alignment)

Yes,

24:42

S… Speaker 2 (260608 PMO Alignment)

the initial submission.

24:44

S… Speaker 1 (260608 PMO Alignment)

No, it's just it's just for deficiency rounds.

24:46

S… Speaker 1 (260608 PMO Alignment)

It's submission.

24:51

S… Speaker 1 (260608 PMO Alignment)

We previously had reviews on that,

24:55

S… Speaker 1 (260608 PMO Alignment)

but it was only for deficiency rounds to make sure that we get

24:59

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aligned questions and responses going back.

25:02

S… Speaker 1 (260608 PMO Alignment)

It's not for the actual submission document itself.

25:06

S… Speaker 1 (260608 PMO Alignment)

They haven't required that again.

25:08

S… Speaker 1 (260608 PMO Alignment)

So I'm not going to go suggest that because that would definitely

25:12

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be difficult for the submission time.

25:15

S… Speaker 1 (260608 PMO Alignment)

Okay,

25:15

S… Speaker 2 (260608 PMO Alignment)

I am fully aligned with you.

25:19

S… Speaker 1 (260608 PMO Alignment)

As long as ADK remembers not to go and significantly change items

25:23

S… Speaker 1 (260608 PMO Alignment)

that we gave on handover,

25:25

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right?

25:26

S… Speaker 1 (260608 PMO Alignment)

We've had that in the past where things were significantly changed and

25:30

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then it comes up as a deficiency.

25:31

S… Speaker 1 (260608 PMO Alignment)

Okay,

25:32

S… Speaker 2 (260608 PMO Alignment)

so that's great news for me.

25:35

S… Speaker 2 (260608 PMO Alignment)

So that's all news about Rotadinos.

25:39

S… Speaker 2 (260608 PMO Alignment)

So I think we can move on to all

25:43

S… Speaker 2 (260608 PMO Alignment)

of the critical approval.

25:48

S… Speaker 2 (260608 PMO Alignment)

critical things can move on till after

25:53

S… Speaker 2 (260608 PMO Alignment)

the friday so the cr release after the cr release

25:57

S… Speaker 2 (260608 PMO Alignment)

so i will be the originator so i will work hard on this so

26:02

S… Speaker 2 (260608 PMO Alignment)

don't worry about that so so

26:06

S… Speaker 2 (260608 PMO Alignment)

any news for media maybe

26:10

S… Speaker 1 (260608 PMO Alignment)

Now I've had Andrea elevated because they are not coming back

26:14

S… Speaker 1 (260608 PMO Alignment)

to us.

26:14

S… Speaker 1 (260608 PMO Alignment)

What we are going to end up doing if we don't get any of the functional

26:18

S… Speaker 1 (260608 PMO Alignment)

needs to respond is we will add it as an escalation again

26:23

S… Speaker 1 (260608 PMO Alignment)

in the functional steer code,

26:24

S… Speaker 1 (260608 PMO Alignment)

which is...

26:26

S… Speaker 1 (260608 PMO Alignment)

Not too far away.

26:27

S… Speaker 1 (260608 PMO Alignment)

Let me just check.

26:28

S… Speaker 1 (260608 PMO Alignment)

Let me just check.

26:29

S… Speaker 1 (260608 PMO Alignment)

I think it's next week.

26:32

S… Speaker 1 (260608 PMO Alignment)

So the functional steer code is next Wednesday.

26:35

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So by that time,

26:37

S… Speaker 1 (260608 PMO Alignment)

I'm hoping at the latest to have a decision by Friday the 19th,

26:41

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because if we don't get a decision there,

26:43

S… Speaker 1 (260608 PMO Alignment)

we will elevate it to the new project sponsor,

26:46

S… Speaker 1 (260608 PMO Alignment)

which is Autumn's replacement,

26:48

S… Speaker 1 (260608 PMO Alignment)

for him to make a decision then if they can't make a decision

26:53

S… Speaker 1 (260608 PMO Alignment)

prior to that.

26:54

S… Speaker 1 (260608 PMO Alignment)

Okay,

26:55

S… Speaker 2 (260608 PMO Alignment)

so great.

26:56

S… Speaker 2 (260608 PMO Alignment)

So that's everything from us.

26:59

S… Speaker 2 (260608 PMO Alignment)

So any comments from you?

27:01

S… Speaker 1 (260608 PMO Alignment)

No,

27:03

S… Speaker 1 (260608 PMO Alignment)

this is great.

27:03

S… Speaker 1 (260608 PMO Alignment)

Good progress.

27:04

S… Speaker 1 (260608 PMO Alignment)

I'm glad you found a middle ground for Rotatina to get that gold colloid

27:08

S… Speaker 1 (260608 PMO Alignment)

change in.

27:10

S… Speaker 1 (260608 PMO Alignment)

Now we just need to get them resolved.

27:13

S… Speaker 1 (260608 PMO Alignment)

I'll let you know as soon as I have feedback from the notified body,

27:17

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but we've got our call tomorrow anyway.

27:19

S… Speaker 1 (260608 PMO Alignment)

I need to ask though for tomorrow's call.

27:22

S… Speaker 1 (260608 PMO Alignment)

Do you see value in having a call with CFT

27:26

S… Speaker 1 (260608 PMO Alignment)

or would you rather use that time to actually get work done?

260608 PMO Alignment

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