2026-07-30 short meeting for rotaadeno

Jul 30, 2026 08:41 · 7:49 · English · Whisper Turbo · 1 කථානායක

මෙම පිටපත කල් ඉකුත් වේ 18 දවස්. ස්ථිර ගබඩාව සඳහා උසස් →

දේශන සූචිය

0:00

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Let's just have a look.

0:00

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Sorry,

0:03

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

my team is acting up.

0:05

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I can't click in there.

0:06

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Can someone just read that message to me quickly?

0:08

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I don't think this meeting is needed.

0:10

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I can only see the title.

0:11

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I don't think this meeting is needed.

0:13

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I spoke with the DATO teams and we agreed how to proceed.

0:17

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Let me know if we still need to meet.

0:18

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Well,

0:21

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

someone needs to explain to us how to proceed.

0:23

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Is there a forum or someone available just

0:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

to explain my concern here?

0:30

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

is I see a lot of things in that list that says requirements not met.

0:34

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Now, it may just be miscommunication,

0:36

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

maybe it's just an internal document

0:40

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

requirements or internal lines that are met,

0:43

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but where I was reading from that initial one,

0:45

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

it seems either there are requirements,

0:47

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

which doesn't make sense because our guys have been through this file back to time.

0:56

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Right before this meeting,

0:58

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we,

0:59

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

TO and DA and also Grace,

1:02

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we get a meeting to

1:06

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

rephrase this.

1:07

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So we align the contents perspective.

1:11

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So we are now revising the document.

1:14

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So we plan to complete our approval until tomorrow.

1:22

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So the email from G1,

1:25

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I wonder if you can just share that screenshot.

1:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I'm sorry,

1:29

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

my team's frozen,

1:30

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

so I can't even see you online.

1:31

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

But it

1:36

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

talks about things like LOD requirements

1:40

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

not met, hook effect requirements not met.

1:43

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Can you just clarify,

1:45

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

is it just...

1:47

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

internal documents that don't align from something historical

1:51

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

or what precise requirement is not

1:55

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

made like what is the metric that is being measured against

1:59

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So,

2:00

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

for example,

2:01

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

LOD study,

2:02

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we only use

2:06

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

one lab device and only perform one replicate

2:11

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

like this.

2:12

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

There are some gaps when comparing the

2:16

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

latest CSI guidelines,

2:18

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but we plan to,

2:19

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

say,

2:20

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

our precision study or other claims

2:24

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

or other data,

2:26

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we can explain this.

2:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

It is acceptable.

2:29

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Like that.

2:31

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

We are now,

2:33

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

yeah,

2:34

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we are now recreating this.

2:36

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

And we do say,

2:39

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

yeah,

2:40

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we are acceptable.

2:41

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah.

2:42

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

In terms of our reports,

2:44

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

like Alex,

2:45

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we would have captured this,

2:47

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

right? We would have written our reports to say we've got this

2:51

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

and not that,

2:51

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but we justify this way or that way.

2:53

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

And won't we justify that with Maldi?

3:02

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Where did we document that evaluation?

3:09

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I'm not sure if we did a formal documentation or anything

3:14

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

to say we did or didn't comply with the CLSI,

3:17

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but I think, as most of these are legacy devices,

3:20

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I think a lot of the study designs originally didn't use CLSI.

3:23

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

We saw that time and time again.

3:26

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

We picked it up time and time again,

3:27

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but I think...

3:29

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

At the time,

3:30

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

that's the studies that were done.

3:31

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So I think obviously if you're assessing now against CLSI or even new CLSI

3:36

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

stuff that's coming out,

3:37

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

there are going to be noticeable deficiencies between the

3:41

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

content and what's in the guidelines.

3:43

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I think as well as the stress that they are guidelines as well,

3:46

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

representing best practice.

3:49

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah, I think all the legacy studies just weren't done with those in mind.

3:54

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I guess that's what we're talking about.

3:57

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

We're just closing that gap because ultimately,

4:00

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I guess with the submission,

4:02

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but we're going to have to be able to send us through the state of the art.

4:05

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So what we need is that technical documentation to show that we

4:09

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

can stand over that these products do meet the state of the art.

4:13

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So what Boren was just explaining,

4:15

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I think when I joined,

4:15

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

is just making sure we can close that gap.

4:19

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So we have a certain report that is part

4:23

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

of the submission, right?

4:24

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So that is already argued in there.

4:26

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Okay.

4:27

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah.

4:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah.

4:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

And I think this only becomes,

4:30

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I think, more sort of pressing for devices that are sort of class.

4:35

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

see all the low possibly because all the pasties would have been assessed against the

4:39

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

comms specifications which represents state of the air at that point but

4:44

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

yeah I see what you know I understand what you're saying I think it makes sense to review

4:48

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

against you know best practice guidelines like CLSI it's something we were

4:52

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

sort of asking for the whole way but obviously there's only so much that can be done

4:56

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

with the legacy reports so then I guess

5:00

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

just in terms of moving forward and the submission right so

5:04

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I just spoke with the team a few minutes ago and we've agreed the

5:08

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

content that we're going to do.

5:09

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So we are going to have the design review closed out.

5:12

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

But there should be no reason that we can't go ahead with the submission,

5:16

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

right? So the submission I presume is going to be European time,

5:19

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

is it?

5:21

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Say again,

5:22

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Chris.

5:22

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

The submission tomorrow,

5:24

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I presume,

5:25

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

is going to be European time or,

5:27

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

you know, it's not the 80k time zone,

5:29

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

correct?

5:29

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

No, it'll be 80k because Geelan would be making the submission.

5:32

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Oh, Geelan.

5:34

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah.

5:34

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Okay.

5:35

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Okay.

5:39

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Again,

5:40

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I think that's achievable,

5:41

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but I don't want to.

5:44

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah, I think we can conclude.

5:46

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Can I just ask,

5:49

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

can I just ask Riffy,

5:50

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

this is obviously an internal control document that we've

5:54

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

got going, but it doesn't form part of this machine package itself.

5:58

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

No.

5:59

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

So do we need to time them 100 % align on

6:03

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

if they're still trying to get this internal document at least,

6:06

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

and they do it by tomorrow?

6:09

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

because we are going to submit to what we have now.

6:11

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

We can already submit messages as soon as possible.

6:15

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

It could,

6:16

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

in theory, right,

6:17

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but I guess the preference would be to close out on this,

6:20

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

right, because,

6:21

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

and I get what you're saying,

6:23

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Alex, we have to see the artwork,

6:24

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

but it's just to close that gap in terms of...

6:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

our current products and study design.

6:31

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I'm okay if it only goes tomorrow.

6:33

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

That's fine.

6:34

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

That is our absolute update.

6:35

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

We planned on today because I'm going to leave today.

6:39

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

But you didn't plan to make the submission card for the submission

6:44

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

and credentials for it.

6:45

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah, the approval of Netflix is between EA

6:50

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

and Kila,

6:51

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

so I think we can approve it fast.

7:01

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I'm happy with that.

7:02

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Grace, are you happy with everything about me?

7:04

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Anyone else got any questions

7:08

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

or are we okay to proceed this way?

7:10

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Sounds

7:15

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

like no questions.

7:16

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

You can,

7:17

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

are we all good then?

7:18

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

All

7:26

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

right, so I'm sorry,

7:28

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

my team's at first and can you guys still hear me?

7:30

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Yeah, yeah,

7:31

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

we can hear you.

7:33

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Gosh, we're not going to take issues there.

7:35

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

All right.

7:35

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

I think in that case,

7:36

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

if no one has any more questions,

7:38

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

thanks for finding a way for it,

7:40

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

guys. Thanks.

7:42

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Thank you for your time,

7:43

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

everybody.

7:44

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Thanks,

7:44

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

everyone. Thank you.

7:46

S… Speaker 1 (2026-07-30 short meeting for rotaadeno)

Thanks, everyone.

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