260601 PMO alignment

0:00

S… Speaker 3 (260601 PMO alignment )

Very good.

0:01

S… Speaker 1 (260601 PMO alignment )

Thank you.

0:01

S… Speaker 4 (260601 PMO alignment )

We

0:07

S… Speaker 3 (260601 PMO alignment )

are nearly there with the responses.

0:09

S… Speaker 3 (260601 PMO alignment )

Take that as a positive.

0:11

S… Speaker 4 (260601 PMO alignment )

Hi,

0:15

S… Speaker 2 (260601 PMO alignment )

Ellie. Good morning.

0:17

S… Speaker 4 (260601 PMO alignment )

I can

0:22

S… Speaker 3 (260601 PMO alignment )

see your screen.

0:23

S… Speaker 1 (260601 PMO alignment )

Thank you.

0:24

S… Speaker 4 (260601 PMO alignment )

This

0:34

S… Speaker 1 (260601 PMO alignment )

is the agenda for today.

0:36

S… Speaker 4 (260601 PMO alignment )

The

0:41

S… Speaker 1 (260601 PMO alignment )

first product is the RSV.

0:46

S… Speaker 1 (260601 PMO alignment )

I think I already shared for

0:50

S… Speaker 1 (260601 PMO alignment )

this study timeline.

0:51

S… Speaker 1 (260601 PMO alignment )

Maybe the sample will arrive

0:55

S… Speaker 1 (260601 PMO alignment )

at October because the status

1:01

S… Speaker 1 (260601 PMO alignment )

is in IRB now.

1:03

S… Speaker 4 (260601 PMO alignment )

Okay.

1:04

S… Speaker 3 (260601 PMO alignment )

I don't think this one is a problem,

1:08

S… Speaker 3 (260601 PMO alignment )

right? Because we didn't have anything come up as a deficiency.

1:15

S… Speaker 3 (260601 PMO alignment )

This was just pre...

1:16

S… Speaker 3 (260601 PMO alignment )

proactive studies.

1:18

S… Speaker 3 (260601 PMO alignment )

Yes,

1:19

S… Speaker 3 (260601 PMO alignment )

right.

1:21

S… Speaker 1 (260601 PMO alignment )

But in the opening pouch stability is

1:25

S… Speaker 1 (260601 PMO alignment )

from IFU trace metrics.

1:28

S… Speaker 1 (260601 PMO alignment )

But in here actually they are

1:32

S… Speaker 1 (260601 PMO alignment )

experienced at

1:37

S… Speaker 1 (260601 PMO alignment )

twice time.

1:39

S… Speaker 1 (260601 PMO alignment )

First one is starting time at June and second

1:43

S… Speaker 1 (260601 PMO alignment )

time is the ending point on 2028

1:47

S… Speaker 1 (260601 PMO alignment )

March.

1:48

S… Speaker 1 (260601 PMO alignment )

So maybe they will prepare for

1:53

S… Speaker 1 (260601 PMO alignment )

interfering reports on June 2026

1:58

S… Speaker 1 (260601 PMO alignment )

and after endpoint study they will

2:04

S… Speaker 1 (260601 PMO alignment )

we update the final report.

2:08

S… Speaker 1 (260601 PMO alignment )

So in here at this June point is the

2:13

S… Speaker 1 (260601 PMO alignment )

device starting,

2:15

S… Speaker 1 (260601 PMO alignment )

expired starting dates.

2:18

S… Speaker 1 (260601 PMO alignment )

How can I say?

2:22

S… Speaker 1 (260601 PMO alignment )

The starting time.

2:25

S… Speaker 3 (260601 PMO alignment )

For the expirations.

2:28

S… Speaker 1 (260601 PMO alignment )

Oh yes,

2:29

S… Speaker 5 (260601 PMO alignment )

yes, right.

2:30

S… Speaker 5 (260601 PMO alignment )

Yes.

2:31

S… Speaker 1 (260601 PMO alignment )

So this is the starting time and this is the end time.

2:35

S… Speaker 1 (260601 PMO alignment )

So should we notify

2:39

S… Speaker 1 (260601 PMO alignment )

TOE for

2:43

S… Speaker 1 (260601 PMO alignment )

this end time,

2:45

S… Speaker 1 (260601 PMO alignment )

end point?

2:47

S… Speaker 3 (260601 PMO alignment )

Which particular study,

2:50

S… Speaker 1 (260601 PMO alignment )

sorry?

2:50

S… Speaker 1 (260601 PMO alignment )

It's the opening part of stability.

2:57

S… Speaker 3 (260601 PMO alignment )

We don't have to actively notify them,

2:59

S… Speaker 3 (260601 PMO alignment )

depending on what the round two questions would look like.

3:03

S… Speaker 3 (260601 PMO alignment )

So if something specifically comes up,

3:05

S… Speaker 3 (260601 PMO alignment )

we will answer that,

3:06

S… Speaker 3 (260601 PMO alignment )

but we don't go and offer more information unless it's not asked

3:10

S… Speaker 3 (260601 PMO alignment )

for. So we're saying that our data for open pouch will only

3:14

S… Speaker 3 (260601 PMO alignment )

be in around 28.

3:17

S… Speaker 3 (260601 PMO alignment )

I can't remember in round one,

3:20

S… Speaker 3 (260601 PMO alignment )

did we get any deficiencies on this?

3:25

S… Speaker 1 (260601 PMO alignment )

No, this is just only from trace metrics,

3:28

S… Speaker 1 (260601 PMO alignment )

IFA trace metrics.

3:29

S… Speaker 3 (260601 PMO alignment )

And in that case,

3:32

S… Speaker 3 (260601 PMO alignment )

if it's not a question from them,

3:34

S… Speaker 3 (260601 PMO alignment )

then we don't need to tell them anything.

3:36

S… Speaker 3 (260601 PMO alignment )

By the time we get the information back,

3:38

S… Speaker 3 (260601 PMO alignment )

it becomes a periodic update of additional data that we did as part

3:43

S… Speaker 3 (260601 PMO alignment )

of ongoing improvement activity.

3:47

S… Speaker 4 (260601 PMO alignment )

Okay.

3:49

S… Speaker 4 (260601 PMO alignment )

Okay,

3:52

S… Speaker 3 (260601 PMO alignment )

thank you.

3:56

S… Speaker 1 (260601 PMO alignment )

For RSV,

3:57

S… Speaker 1 (260601 PMO alignment )

the second agenda is name change.

4:00

S… Speaker 1 (260601 PMO alignment )

So this year is already

4:05

S… Speaker 2 (260601 PMO alignment )

released.

4:05

S… Speaker 1 (260601 PMO alignment )

So we will apply the

4:09

S… Speaker 1 (260601 PMO alignment )

name.

4:09

S… Speaker 3 (260601 PMO alignment )

Is this the one that changed from gold to gold colloid?

4:13

S… Speaker 4 (260601 PMO alignment )

Yes.

4:14

S… Speaker 1 (260601 PMO alignment )

Okay.

4:15

S… Speaker 3 (260601 PMO alignment )

Ellie,

4:16

S… Speaker 1 (260601 PMO alignment )

I'm sorry.

4:16

S… Speaker 3 (260601 PMO alignment )

When I read that email the other day,

4:18

S… Speaker 3 (260601 PMO alignment )

I thought it was a completely different list of things.

4:20

S… Speaker 3 (260601 PMO alignment )

I just saw implementation products.

4:22

S… Speaker 3 (260601 PMO alignment )

I didn't realize that's what it was referring to.

4:26

S… Speaker 2 (260601 PMO alignment )

The point is,

4:28

S… Speaker 2 (260601 PMO alignment )

it seems like there was much deeper

4:32

S… Speaker 2 (260601 PMO alignment )

discussion in the implementation meetings regarding the raw

4:37

S… Speaker 2 (260601 PMO alignment )

material names,

4:38

S… Speaker 2 (260601 PMO alignment )

because from the IVDR perspective,

4:42

S… Speaker 2 (260601 PMO alignment )

for example,

4:43

S… Speaker 2 (260601 PMO alignment )

in case of Rotadino,

4:45

S… Speaker 2 (260601 PMO alignment )

it's a simple typo.

4:48

S… Speaker 2 (260601 PMO alignment )

We just need to update gold to

4:52

S… Speaker 2 (260601 PMO alignment )

gold colloid.

4:53

S… Speaker 2 (260601 PMO alignment )

Is it right,

4:54

S… Speaker 1 (260601 PMO alignment )

Karin?

4:56

S… Speaker 2 (260601 PMO alignment )

as we are willing to

5:00

S… Speaker 1 (260601 PMO alignment )

update mouse heavy gold into mouse heavy gold colloid

5:04

S… Speaker 1 (260601 PMO alignment )

so first i wanted to treat

5:08

S… Speaker 1 (260601 PMO alignment )

that as a correction of typo but they

5:13

S… Speaker 1 (260601 PMO alignment )

we cannot change as just

5:17

S… Speaker 1 (260601 PMO alignment )

for treating as typo because it is

5:22

S… Speaker 1 (260601 PMO alignment )

i mean dmr is related to other

5:27

S… Speaker 1 (260601 PMO alignment )

regulations like in Korea

5:32

S… Speaker 1 (260601 PMO alignment )

regulation or other things.

5:34

S… Speaker 1 (260601 PMO alignment )

So these ADK CFTs have

5:39

S… Speaker 1 (260601 PMO alignment )

conclusion that we cannot just update DMR

5:44

S… Speaker 1 (260601 PMO alignment )

file without any CRs.

5:46

S… Speaker 4 (260601 PMO alignment )

Yeah,

5:48

S… Speaker 2 (260601 PMO alignment )

so we're just talking about Rotadino now because

5:53

S… Speaker 2 (260601 PMO alignment )

the other two products,

5:54

S… Speaker 2 (260601 PMO alignment )

I think they can be updated through

5:58

S… Speaker 2 (260601 PMO alignment )

the deficiency rounds.

6:00

S… Speaker 2 (260601 PMO alignment )

That's your plan,

6:01

S… Speaker 2 (260601 PMO alignment )

Yukyung, right?

6:01

S… Speaker 4 (260601 PMO alignment )

Yes,

6:05

S… Speaker 1 (260601 PMO alignment )

for RSV and Shackles.

6:06

S… Speaker 2 (260601 PMO alignment )

In case of Rotat,

6:08

S… Speaker 2 (260601 PMO alignment )

this is a bit problematic because it's

6:13

S… Speaker 2 (260601 PMO alignment )

better to update this earlier

6:17

S… Speaker 2 (260601 PMO alignment )

in the phase.

6:18

S… Speaker 2 (260601 PMO alignment )

It's

6:23

S… Speaker 1 (260601 PMO alignment )

better.

6:25

S… Speaker 3 (260601 PMO alignment )

Before implementation,

6:27

S… Speaker 3 (260601 PMO alignment )

before certification.

6:28

S… Speaker 1 (260601 PMO alignment )

No, no,

6:29

S… Speaker 1 (260601 PMO alignment )

no, no. I think what Ellie wants to say

6:33

S… Speaker 1 (260601 PMO alignment )

is right now we have updated the

6:37

S… Speaker 1 (260601 PMO alignment )

DMR file with mouse heavy gold,

6:40

S… Speaker 1 (260601 PMO alignment )

which was originally not included in our file.

6:44

S… Speaker 1 (260601 PMO alignment )

So we had a QI action to update the

6:49

S… Speaker 1 (260601 PMO alignment )

DMR.

6:49

S… Speaker 1 (260601 PMO alignment )

So we are right now have updated version of that.

6:53

S… Speaker 1 (260601 PMO alignment )

uh for the names of critical materials here

6:58

S… Speaker 1 (260601 PMO alignment )

we are aligned to update gold

7:02

S… Speaker 1 (260601 PMO alignment )

into gold colloid so we have to update the dmr

7:06

S… Speaker 1 (260601 PMO alignment )

again so uh so that means

7:11

S… Speaker 1 (260601 PMO alignment )

when if if we want to i

7:16

S… Speaker 1 (260601 PMO alignment )

don't know i will say that again so uh anyway we

7:20

S… Speaker 1 (260601 PMO alignment )

have to update that

7:22

S… Speaker 1 (260601 PMO alignment )

DMR from gold to gold

7:26

S… Speaker 1 (260601 PMO alignment )

colloid,

7:27

S… Speaker 1 (260601 PMO alignment )

but if we do that change in...

7:33

S… Speaker 1 (260601 PMO alignment )

In this week,

7:34

S… Speaker 1 (260601 PMO alignment )

we have to open a CR to have

7:39

S… Speaker 1 (260601 PMO alignment )

some impact assessment of changing

7:43

S… Speaker 1 (260601 PMO alignment )

DMR at this stage.

7:45

S… Speaker 1 (260601 PMO alignment )

So we have to have a DCRB meeting.

7:49

S… Speaker 1 (260601 PMO alignment )

And after open CR,

7:51

S… Speaker 1 (260601 PMO alignment )

we have to release all CRs.

7:54

S… Speaker 1 (260601 PMO alignment )

And after that,

7:55

S… Speaker 1 (260601 PMO alignment )

we can have a change action that allows us

7:59

S… Speaker 1 (260601 PMO alignment )

to update.

8:00

S… Speaker 1 (260601 PMO alignment )

the DMR and after that we can approve

8:04

S… Speaker 1 (260601 PMO alignment )

IFU because IFU have a dependency of DMR

8:09

S… Speaker 1 (260601 PMO alignment )

so that makes our approval chain delays

8:15

S… Speaker 1 (260601 PMO alignment )

about at least two weeks.

8:20

S… Speaker 3 (260601 PMO alignment )

So once again,

8:22

S… Speaker 3 (260601 PMO alignment )

we've got to remember we have multiple opportunities we can do this

8:26

S… Speaker 3 (260601 PMO alignment )

in, right?

8:26

S… Speaker 3 (260601 PMO alignment )

We have now started the approval chain for our

8:30

S… Speaker 3 (260601 PMO alignment )

submission to try and meet 31 July.

8:32

S… Speaker 3 (260601 PMO alignment )

I think we need to be very protective of that approval

8:36

S… Speaker 1 (260601 PMO alignment )

chain.

8:37

S… Speaker 3 (260601 PMO alignment )

Anything like this coming sideways to change now,

8:40

S… Speaker 3 (260601 PMO alignment )

we should block from changing it now.

8:42

S… Speaker 3 (260601 PMO alignment )

That does not mean I'm saying we don't do this before certification.

8:46

S… Speaker 3 (260601 PMO alignment )

We still have time because there's...

8:50

S… Speaker 3 (260601 PMO alignment )

There's at least two deficiency rounds that we always expect and

8:54

S… Speaker 3 (260601 PMO alignment )

we can still make these changes in line with that.

8:57

S… Speaker 3 (260601 PMO alignment )

So my recommendation would still be to proceed with our approval chain

9:01

S… Speaker 3 (260601 PMO alignment )

because we've been delayed many times now and we cannot go back.

9:05

S… Speaker 3 (260601 PMO alignment )

to leadership to tell them it's going to be late again,

9:08

S… Speaker 3 (260601 PMO alignment )

you know, it's not going to reflect well.

9:10

S… Speaker 3 (260601 PMO alignment )

I would prefer if we find a way to go ahead with the

9:14

S… Speaker 3 (260601 PMO alignment )

CRPB,

9:15

S… Speaker 3 (260601 PMO alignment )

get the approvals we require for the change,

9:18

S… Speaker 3 (260601 PMO alignment )

and then when we open everything again for deficiency rounds,

9:21

S… Speaker 3 (260601 PMO alignment )

which will certainly happen,

9:22

S… Speaker 3 (260601 PMO alignment )

then we can reflect that change.

9:25

S… Speaker 3 (260601 PMO alignment )

That means it still happens before certification and you avoid the delay

9:29

S… Speaker 3 (260601 PMO alignment )

that you can potentially get having to do that post -certification.

9:33

S… Speaker 3 (260601 PMO alignment )

prior to implementation work.

9:35

S… Speaker 1 (260601 PMO alignment )

Yes,

9:36

S… Speaker 1 (260601 PMO alignment )

I agree your opinion and I'm fully aligned

9:41

S… Speaker 1 (260601 PMO alignment )

with you.

9:41

S… Speaker 2 (260601 PMO alignment )

The point is

9:48

S… Speaker 2 (260601 PMO alignment )

the implementation.

9:49

S… Speaker 2 (260601 PMO alignment )

I mean,

9:50

S… Speaker 2 (260601 PMO alignment )

Su Min is responsible for implementation products

9:56

S… Speaker 2 (260601 PMO alignment )

and she said Katrina.

10:00

S… Speaker 3 (260601 PMO alignment )

Katrina Patterson.

10:02

S… Speaker 3 (260601 PMO alignment )

she suggested to include this change in submission

10:06

S… Speaker 1 (260601 PMO alignment )

phase.

10:07

S… Speaker 3 (260601 PMO alignment )

Was there a comment?

10:09

S… Speaker 2 (260601 PMO alignment )

But the way I just explained,

10:12

S… Speaker 2 (260601 PMO alignment )

it's still within submission phase.

10:13

S… Speaker 1 (260601 PMO alignment )

Yes.

10:14

S… Speaker 2 (260601 PMO alignment )

I'm just saying it doesn't need to be prior to initial submission.

10:18

S… Speaker 2 (260601 PMO alignment )

Submission phase is anything from that first physical file

10:22

S… Speaker 2 (260601 PMO alignment )

we upload,

10:23

S… Speaker 2 (260601 PMO alignment )

including response one,

10:25

S… Speaker 2 (260601 PMO alignment )

two or more,

10:26

S… Speaker 2 (260601 PMO alignment )

depending on how many questions we get from the notified body.

10:31

S… Speaker 1 (260601 PMO alignment )

Yeah, so what Mandy says is correct.

10:34

S… Speaker 1 (260601 PMO alignment )

I understand,

10:37

S… Speaker 3 (260601 PMO alignment )

but I think even if

10:41

S… Speaker 3 (260601 PMO alignment )

we don't include it in the initial submission,

10:43

S… Speaker 3 (260601 PMO alignment )

we probably need to progress with the CR

10:48

S… Speaker 3 (260601 PMO alignment )

in parallel.

10:49

S… Speaker 1 (260601 PMO alignment )

Yes, I agree.

10:54

S… Speaker 2 (260601 PMO alignment )

So the idea would be to get everything flowing in the same direction,

10:58

S… Speaker 2 (260601 PMO alignment )

but not necessarily hijacking that initial submission because we've

11:03

S… Speaker 2 (260601 PMO alignment )

moved it so many times.

11:04

S… Speaker 2 (260601 PMO alignment )

We need to be careful of anything that derails it from 31

11:08

S… Speaker 1 (260601 PMO alignment )

July.

11:09

S… Speaker 2 (260601 PMO alignment )

Again, we must protect 31 July,

11:11

S… Speaker 2 (260601 PMO alignment )

but we still have opportunities.

11:13

S… Speaker 2 (260601 PMO alignment )

So I'd say in parallel,

11:15

S… Speaker 2 (260601 PMO alignment )

absolutely go ahead with the CRP board,

11:18

S… Speaker 2 (260601 PMO alignment )

get that CR up and going.

11:22

S… Speaker 2 (260601 PMO alignment )

and ready so that when deficiency round comes you have all

11:27

S… Speaker 2 (260601 PMO alignment )

the administration done prior to the point of actually

11:32

S… Speaker 2 (260601 PMO alignment )

making the change into the file do you know what i mean yes

11:37

S… Speaker 1 (260601 PMO alignment )

So that's my plan and I have

11:41

S… Speaker 1 (260601 PMO alignment )

some concern about that.

11:43

S… Speaker 1 (260601 PMO alignment )

That our CFT

11:47

S… Speaker 1 (260601 PMO alignment )

would have some negative perspective of

11:52

S… Speaker 1 (260601 PMO alignment )

that approach because that means even

11:56

S… Speaker 1 (260601 PMO alignment )

if we know we have to reflect that change

12:00

S… Speaker 1 (260601 PMO alignment )

right now for July 3rd.

12:03

S… Speaker 1 (260601 PMO alignment )

search first,

12:04

S… Speaker 1 (260601 PMO alignment )

our initial submission,

12:06

S… Speaker 1 (260601 PMO alignment )

we have to move on to the old

12:10

S… Speaker 1 (260601 PMO alignment )

version of DMR.

12:14

S… Speaker 1 (260601 PMO alignment )

So what I concern is they

12:18

S… Speaker 1 (260601 PMO alignment )

will not like to have

12:23

S… Speaker 1 (260601 PMO alignment )

a work twice.

12:28

S… Speaker 2 (260601 PMO alignment )

Well, we have to weigh this up,

12:30

S… Speaker 2 (260601 PMO alignment )

right? Yes.

12:31

S… Speaker 2 (260601 PMO alignment )

Having to open something up again later,

12:34

S… Speaker 2 (260601 PMO alignment )

which we will do anyway,

12:36

S… Speaker 2 (260601 PMO alignment )

right?

12:36

S… Speaker 2 (260601 PMO alignment )

I can promise you we're going to open things for the deficiency round.

12:40

S… Speaker 2 (260601 PMO alignment )

It happens every single time versus standing in front of leadership to say we missed

12:44

S… Speaker 2 (260601 PMO alignment )

the deadline again.

12:45

S… Speaker 2 (260601 PMO alignment )

Do you know what I mean?

12:47

S… Speaker 1 (260601 PMO alignment )

Yeah.

12:48

S… Speaker 2 (260601 PMO alignment )

I think they prefer the second one.

12:51

S… Speaker 2 (260601 PMO alignment )

What we can do is maybe,

12:53

S… Speaker 2 (260601 PMO alignment )

could you bring up the timeline for our approval in the Exile,

12:58

S… Speaker 1 (260601 PMO alignment )

the tracker?

12:59

S… Speaker 2 (260601 PMO alignment )

Maybe we can see,

13:01

S… Speaker 2 (260601 PMO alignment )

I mean, if we can find a way,

13:03

S… Speaker 2 (260601 PMO alignment )

if you can talk to the CFD to see if we have a two week delay,

13:06

S… Speaker 2 (260601 PMO alignment )

where do we compensate for the two week delay to still make it into 31

13:10

S… Speaker 1 (260601 PMO alignment )

July?

13:11

S… Speaker 1 (260601 PMO alignment )

I think that's really,

13:13

S… Speaker 1 (260601 PMO alignment )

really,

13:14

S… Speaker 1 (260601 PMO alignment )

really difficult and challenging.

13:15

S… Speaker 1 (260601 PMO alignment )

So I think we have to

13:20

S… Speaker 1 (260601 PMO alignment )

reflect that change,

13:21

S… Speaker 1 (260601 PMO alignment )

that deficiency round.

13:23

S… Speaker 1 (260601 PMO alignment )

Yeah.

13:27

S… Speaker 2 (260601 PMO alignment )

I mean, I can see how we'll probably get resistance

13:31

S… Speaker 2 (260601 PMO alignment )

like what you just said,

13:32

S… Speaker 2 (260601 PMO alignment )

but then it's a different version of the BMR.

13:34

S… Speaker 2 (260601 PMO alignment )

Then my advice would be wait before

13:38

S… Speaker 2 (260601 PMO alignment )

you make that change if they're really going to have a problem with that.

13:43

S… Speaker 2 (260601 PMO alignment )

Then we pause with the CR until a point where we have a submission

13:47

S… Speaker 2 (260601 PMO alignment )

-ready file,

13:48

S… Speaker 2 (260601 PMO alignment )

we submit, and then we do the CR.

13:49

S… Speaker 2 (260601 PMO alignment )

Because we're talking about a two -week time,

13:52

S… Speaker 2 (260601 PMO alignment )

and maybe early that would be better,

13:54

S… Speaker 1 (260601 PMO alignment )

right?

13:54

S… Speaker 2 (260601 PMO alignment )

Time the CRB board in line

13:58

S… Speaker 2 (260601 PMO alignment )

with our submission so that that week that we're submitting,

14:01

S… Speaker 2 (260601 PMO alignment )

this is on the agenda for the CRB board.

14:04

S… Speaker 2 (260601 PMO alignment )

Then you have approval for the CR that is raised.

14:07

S… Speaker 2 (260601 PMO alignment )

after we submitted the file.

14:09

S… Speaker 2 (260601 PMO alignment )

Then we don't have QA or DA saying,

14:11

S… Speaker 2 (260601 PMO alignment )

no, now we're using the wrong versions into our submission because it just becomes

14:16

S… Speaker 2 (260601 PMO alignment )

a practical nightmare.

14:17

S… Speaker 2 (260601 PMO alignment )

Because if we're going to start taking that approach,

14:20

S… Speaker 2 (260601 PMO alignment )

we will be one day before submission and somebody will say,

14:24

S… Speaker 2 (260601 PMO alignment )

no, we can't submit because now we've made another change somewhere,

14:26

S… Speaker 2 (260601 PMO alignment )

which isn't ever going to help us get our products in.

14:30

S… Speaker 2 (260601 PMO alignment )

So if we foresee that,

14:32

S… Speaker 2 (260601 PMO alignment )

we'll get resistance from CFD on it.

14:35

S… Speaker 2 (260601 PMO alignment )

Then perhaps look at the timing to see if we can align

14:40

S… Speaker 2 (260601 PMO alignment )

the timing of raising it on the CRB board the

14:44

S… Speaker 2 (260601 PMO alignment )

same week that we're going to submit.

14:46

S… Speaker 2 (260601 PMO alignment )

So we don't have the potential of clashing the penguins there.

14:49

S… Speaker 2 (260601 PMO alignment )

I think that's probably lower risk because it's only going to take two weeks

14:53

S… Speaker 2 (260601 PMO alignment )

to get that CR up then.

14:55

S… Speaker 2 (260601 PMO alignment )

And it's going to be at least four to eight or

14:59

S… Speaker 1 (260601 PMO alignment )

more.

15:00

S… Speaker 1 (260601 PMO alignment )

weeks before we get any response from the notified body for

15:05

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a deficiency.

15:06

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So we have time.

15:07

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So probably in tomorrow's

15:11

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meeting we can compare the two scenarios,

15:15

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including and not including,

15:16

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and then show them how the timeline becomes in

15:22

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these two scenarios.

15:23

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So that visual will tell them a lot of things.

15:29

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Yes, I think that's a good way to show them.

15:31

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And then when you're showing that in the meeting,

15:36

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make sure to emphasise that,

15:39

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I don't know if we want to show somewhere where our original submission date was and

15:43

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where we are already,

15:44

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so that people can understand we cannot move 31 July

15:48

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again.

15:49

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Okay,

15:50

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I will.

15:51

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So,

15:55

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back to Sarah.

16:03

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I think I already explained all

16:07

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for RSV,

16:08

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but additional for the name change for SHAGAS,

16:12

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maybe tomorrow we will discuss about the time

16:18

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for applying for SHAGAS.

16:23

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Actually,

16:23

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as you know,

16:24

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in DR1,

16:26

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there is no any deficiency about the IFU.

16:30

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So I think I just want to start this to apply the

16:35

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name change right away after maybe

16:39

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today or tomorrow.

16:41

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After we send the response back.

16:43

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Yes,

16:44

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yes, right.

16:44

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Because I think there is maybe there is a

16:49

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low risk for revised IFU,

16:53

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but I think that risk is a little bit low.

16:56

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But IFU revision,

17:01

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maybe we'll take a lot of documents should

17:05

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be revised.

17:06

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So I just want to suggest to apply

17:10

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this one right

17:14

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away after submission tier one.

17:17

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Okay, that makes sense to me.

17:18

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Okay.

17:19

S… Speaker 1 (260601 PMO alignment )

Okay.

17:20

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And the other one for Shagas,

17:24

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I hope your submission should be today.

17:34

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So tell me,

17:35

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are we ready with,

17:36

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I think there was changes just about the logo.

17:38

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And then once that's in,

17:40

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I can just talk to Yelam quickly if she can just zip up the folder.

17:43

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I said to her,

17:44

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she doesn't need to stay to upload it.

17:46

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I can upload it as long as I have access to the folder,

17:50

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the zip folder.

17:52

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But we just need that final COO now.

17:57

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Yes,

17:58

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I will maybe remind to Hyunseo,

18:02

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he's the owner of COO.

18:04

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But I think this is a little bit,

18:07

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some questions from ADK.

18:10

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If the COO

18:14

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removed the E .coli in Chagas,

18:17

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maybe how can we do for the other

18:21

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products?

18:22

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The Chagas products?

18:24

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The Rotadina?

18:27

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For example,

18:27

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you're talking or maybe RSV.

18:32

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So RSV,

18:35

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let's not touch that because the question hasn't come up about it.

18:39

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Right.

18:39

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I think it would be prudent to

18:43

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proactively look at what does this look like?

18:45

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Because we seem to be uncovering this time and time again where

18:49

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there isn't appropriate supplier control and then the supply approval

18:53

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procedure is not being followed.

18:56

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I think they need to get ahead of it to make sure that there isn't a scenario like this in Road to

19:00

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Adina.

19:00

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Because I see a lot of arguments

19:05

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being made for the way things were procured during

19:09

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the design verification stage.

19:11

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And we've got to remember these are products that have been on the market for years.

19:15

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So maybe they got away with it for years.

19:17

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But if something is in production and it's in your manufacturing steps.

19:22

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There really is no excuse for items being procured,

19:26

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not being on the approved supply list.

19:28

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But at this point,

19:30

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my concern is about the consistency.

19:34

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And it's

19:38

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a valid concern,

19:39

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but it's a very difficult one.

19:41

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And there are many items like this.

19:44

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If you're going to take some of the 10 previous files submitted with ADK,

19:47

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you're going to find it full of inconsistencies,

19:49

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right?

19:54

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I think often when we've reached an

19:58

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issue like this before,

20:00

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our agreement is going forward let's do it in a consistent way it is

20:04

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difficult to retrospectively go and correct it for all other products right but

20:08

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but you have to you have to think that i would

20:12

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expect for example the qi raise that quality would do an

20:16

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impact assessment and they would look at what other products are impacted

20:20

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what other coos are impacted as part of the qi

20:25

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you would be able to make these corrections,

20:28

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but it's certainly not part of the submission scope,

20:30

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but it would land with supplier quality's obligation after an quality

20:34

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incident is raised.

20:35

S… Speaker 3 (260601 PMO alignment )

Oh,

20:38

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actually,

20:39

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I couldn't think about the QI,

20:42

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but just in my perspective,

20:46

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I just want to suggest just including the equali and.

20:52

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we can response why we don't need to mention

20:58

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the approved supplier for E .coli

21:02

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because that is not our animal.

21:05

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Our ideal answer and response would have been simply to

21:09

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add all of these items on this list are

21:15

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from suppliers and the approved suppliers.

21:18

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But because of the discrepancy we found,

21:20

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we couldn't take the easy step.

21:22

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So the best way to avoid further questions

21:27

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was to split them out and say,

21:29

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we're limiting these to the animal origin,

21:32

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and we've described this in the deficiency response to stop

21:37

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them from asking us,

21:38

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but why did you remove it?

21:39

S… Speaker 1 (260601 PMO alignment )

So we proactively told them we removed it because we wanted

21:43

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to separate materials of animal origin,

21:46

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and the ECOLA -1 for these reasons are not considered a material of animal origins.

21:50

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We hope they will accept it.

21:52

S… Speaker 1 (260601 PMO alignment )

There is every chance that they go,

21:54

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OK,

21:55

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that's fine.

21:56

S… Speaker 1 (260601 PMO alignment )

Now show me the separate one because we still need the E.

21:59

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coli one to have a certificate of animal origin.

22:01

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For that reason,

22:03

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I think it's quite important.

22:05

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Did you see that last question I sent in our CFT chat where

22:09

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I highlighted a flowchart from chapter three that I looked at with my

22:13

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team this morning?

22:15

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It appears to show at the top of the flowchart

22:19

S… Speaker 1 (260601 PMO alignment )

that it starts with the acquiring of recombinant T

22:24

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-Cruzy antigen.

22:25

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I'd like to understand more what's happening there.

22:28

S… Speaker 1 (260601 PMO alignment )

Are we buying in the T -Cruzy from

22:33

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a supplier?

22:33

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So that's the first question.

22:35

S… Speaker 1 (260601 PMO alignment )

If the question is yes,

22:37

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do we have them on an approved supplier list?

22:41

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Question A.

22:43

S… Speaker 1 (260601 PMO alignment )

Question B,

22:44

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do they have a certificate of origin for

22:48

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the T -Cruzi?

22:49

S… Speaker 1 (260601 PMO alignment )

On the other hand,

22:52

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the other side of the path

22:56

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could be,

22:57

S… Speaker 1 (260601 PMO alignment )

are we using E.

23:00

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coli to process and refine to get the T -Cruzi in

23:04

S… Speaker 1 (260601 PMO alignment )

-house?

23:04

S… Speaker 3 (260601 PMO alignment )

Give

23:11

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me a second,

23:12

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please, for transport.

23:15

S… Speaker 2 (260601 PMO alignment )

Korean English.

23:16

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Oh,

23:19

S… Speaker 3 (260601 PMO alignment )

I

23:25

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got it.

23:25

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Actually,

23:27

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I got information from

23:31

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research team and QA,

23:35

S… Speaker 2 (260601 PMO alignment )

the Hyunso.

23:35

S… Speaker 2 (260601 PMO alignment )

She replied to me,

23:38

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we buy just only E.

23:41

S… Speaker 2 (260601 PMO alignment )

coli and we are using the

23:45

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E. coli.

23:47

S… Speaker 2 (260601 PMO alignment )

Yes,

23:48

S… Speaker 2 (260601 PMO alignment )

for transformation.

23:49

S… Speaker 2 (260601 PMO alignment )

And now we are,

23:51

S… Speaker 2 (260601 PMO alignment )

we have a transformation spark and

23:55

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then we will give to production team from research team.

23:59

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So they will use this E.

24:02

S… Speaker 2 (260601 PMO alignment )

coli,

24:03

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that recombinant antigen.

24:06

S… Speaker 3 (260601 PMO alignment )

Okay,

24:07

S… Speaker 1 (260601 PMO alignment )

so we do refine it in -house then.

24:13

S… Speaker 1 (260601 PMO alignment )

So that's better for me to know that.

24:16

S… Speaker 1 (260601 PMO alignment )

I think we probably could have explained it better than in chapter three,

24:19

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but that's okay.

24:21

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We weren't queried about it,

24:22

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so let's just leave it alone.

24:24

S… Speaker 1 (260601 PMO alignment )

It's probably just the way it's described.

24:28

S… Speaker 1 (260601 PMO alignment )

We are still,

24:30

S… Speaker 1 (260601 PMO alignment )

we're still at the same point.

24:33

S… Speaker 1 (260601 PMO alignment )

I think where we get stopped dead,

260601 PMO alignment

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