2026-07-07 Weekly touchpoint

Jul 07, 2026 08:39 · 14:47 · English · Whisper Turbo · 4 Ομιλητές
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0:33
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Are they all persons for this meeting?
0:36
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Let me just have a look.
0:39
S… Speaker 1 (2026-07-07 Weekly touchpoint)
That's probably good enough to proceed.
0:43
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Please go ahead.
0:43
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
0:44
S… Speaker 2 (2026-07-07 Weekly touchpoint)
For RSV,
0:46
S… Speaker 2 (2026-07-07 Weekly touchpoint)
we have four action items to
0:51
S… Speaker 2 (2026-07-07 Weekly touchpoint)
submit the DR2.
0:53
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So TPS document is in final approval.
0:57
S… Speaker 2 (2026-07-07 Weekly touchpoint)
This should be by today.
0:59
S… Speaker 2 (2026-07-07 Weekly touchpoint)
There are three people for approval.
1:02
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So I'm just waiting for...
1:04
S… Speaker 2 (2026-07-07 Weekly touchpoint)
approving now.
1:06
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And RA documents will collaborate today and
1:10
S… Speaker 2 (2026-07-07 Weekly touchpoint)
this one will be finished by tomorrow.
1:14
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And final approval is expected.
1:17
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And final review and submission is the
1:22
S… Speaker 2 (2026-07-07 Weekly touchpoint)
due date is July 10th.
1:23
S… Speaker 2 (2026-07-07 Weekly touchpoint)
There is no issue for RSV.
1:26
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So I can move on to Shaga's products.
1:29
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yes,
1:31
S… Speaker 1 (2026-07-07 Weekly touchpoint)
that's good.
1:31
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
1:33
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But in here,
1:34
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I just want to confirm to Mandy.
1:36
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So should we hold
1:42
S… Speaker 2 (2026-07-07 Weekly touchpoint)
for approving in agile the interfering
1:47
S… Speaker 2 (2026-07-07 Weekly touchpoint)
and cross -reactivity protocol and then report as well?
1:51
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But should we hold?
1:52
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Can we proceed?
1:57
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Yes.
1:57
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So the technical documentation assessment
2:02
S… Speaker 1 (2026-07-07 Weekly touchpoint)
report was issued yesterday.
2:03
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So we've seen that one.
2:05
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So ULIM is just doing a change notification form for me to update the V12
2:09
S… Speaker 1 (2026-07-07 Weekly touchpoint)
so that we can update the ECREP on there.
2:12
S… Speaker 1 (2026-07-07 Weekly touchpoint)
But the assessment for SHADAS is now formally closed.
2:16
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So you can proceed with the other document
2:20
S… Speaker 1 (2026-07-07 Weekly touchpoint)
updates that we will be processing as part of the follow -on project.
2:27
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Can you approve all the study protocol and report in
2:31
S… Speaker 2 (2026-07-07 Weekly touchpoint)
agile now?
2:32
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
2:33
S… Speaker 1 (2026-07-07 Weekly touchpoint)
You can proceed now.
2:34
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
2:34
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
2:35
S… Speaker 1 (2026-07-07 Weekly touchpoint)
And
2:45
S… Speaker 2 (2026-07-07 Weekly touchpoint)
then the second one is the timeline for the follow -up
2:49
S… Speaker 1 (2026-07-07 Weekly touchpoint)
projects.
2:50
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So in here,
2:52
S… Speaker 2 (2026-07-07 Weekly touchpoint)
actually there are some chains.
2:57
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So in DI.
3:00
S… Speaker 2 (2026-07-07 Weekly touchpoint)
We should open the DCRB for
3:05
S… Speaker 2 (2026-07-07 Weekly touchpoint)
updating TI and IFU.
3:07
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So this one will be expected July 21st.
3:11
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And then CROpen will be open
3:15
S… Speaker 2 (2026-07-07 Weekly touchpoint)
and released.
3:16
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So maybe we can submit this interfering
3:21
S… Speaker 2 (2026-07-07 Weekly touchpoint)
and this final report here.
3:28
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And then final review,
3:30
S… Speaker 2 (2026-07-07 Weekly touchpoint)
and maybe we can submit these final reports on
3:35
S… Speaker 2 (2026-07-07 Weekly touchpoint)
September 1st.
3:36
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So that was a little bit delayed,
3:38
S… Speaker 2 (2026-07-07 Weekly touchpoint)
but this is not confirmed one.
3:42
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Maybe that can be changed.
3:44
S… Speaker 2 (2026-07-07 Weekly touchpoint)
It depends on the DCR,
3:47
S… Speaker 2 (2026-07-07 Weekly touchpoint)
BNCR timeline.
3:52
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Okay, let me just,
3:53
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I just want to take a second.
3:55
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I'm just looking through the technical assessment report.
3:57
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I just want to see,
3:58
S… Speaker 1 (2026-07-07 Weekly touchpoint)
because I only sent it through yesterday.
4:00
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I don't know if there's a date that they added something new.
4:05
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I mean, you didn't spot any date that they sent in the
4:09
S… Speaker 1 (2026-07-07 Weekly touchpoint)
TDAR yesterday.
4:10
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Let me just check.
4:11
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Give me a second.
4:12
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I
4:20
S… Speaker 1 (2026-07-07 Weekly touchpoint)
can navigate to the correct one.
4:21
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I
4:31
S… Speaker 1 (2026-07-07 Weekly touchpoint)
found the document and it's just like through clicking.
4:33
S… Speaker 1 (2026-07-07 Weekly touchpoint)
It's normally...
4:36
S… Speaker 1 (2026-07-07 Weekly touchpoint)
something at the end.
4:37
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I just want to make sure that they aligned on the date we had initially suggested
4:42
S… Speaker 1 (2026-07-07 Weekly touchpoint)
to them.
4:43
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay,
4:46
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I'm going to have to look through this a bit.
4:47
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Could you just take a note there that that's okay in principle,
4:50
S… Speaker 1 (2026-07-07 Weekly touchpoint)
but let me just confirm if it aligns with what TV expected,
4:54
S… Speaker 1 (2026-07-07 Weekly touchpoint)
because they would have written it somewhere into the big assessment report.
5:00
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Oh,
5:00
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I see.
5:01
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But in DR2 response,
5:05
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I think you mentioned the submission date
5:09
S… Speaker 2 (2026-07-07 Weekly touchpoint)
is in September,
5:11
S… Speaker 1 (2026-07-07 Weekly touchpoint)
right?
5:13
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Yes.
5:13
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I just want to confirm that the official assessment report that they
5:17
S… Speaker 3 (2026-07-07 Weekly touchpoint)
issued yesterday has the correct expectation
5:22
S… Speaker 3 (2026-07-07 Weekly touchpoint)
for the following project date.
5:23
S… Speaker 3 (2026-07-07 Weekly touchpoint)
But there's a few documents I have to look at that they sent through.
5:27
S… Speaker 3 (2026-07-07 Weekly touchpoint)
So let me confirm that with you.
5:29
S… Speaker 3 (2026-07-07 Weekly touchpoint)
But in principle,
5:30
S… Speaker 3 (2026-07-07 Weekly touchpoint)
that date for me is okay.
5:31
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I just need to confirm the lines of what TV is expecting as well.
5:35
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I see.
5:36
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
5:38
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But note,
5:39
S… Speaker 2 (2026-07-07 Weekly touchpoint)
please note,
5:40
S… Speaker 2 (2026-07-07 Weekly touchpoint)
this is not the final timeline.
5:44
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And then,
5:48
S… Speaker 2 (2026-07-07 Weekly touchpoint)
so in
5:53
S… Speaker 2 (2026-07-07 Weekly touchpoint)
this submission timeline,
5:54
S… Speaker 2 (2026-07-07 Weekly touchpoint)
so should we submit just only interfering
5:58
S… Speaker 2 (2026-07-07 Weekly touchpoint)
and cross -reactivity report only on September 1st?
6:02
S… Speaker 2 (2026-07-07 Weekly touchpoint)
That is expected?
6:04
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Or the other documents as well?
6:08
S… Speaker 3 (2026-07-07 Weekly touchpoint)
It depends on what they're going to ask for in the following
6:12
S… Speaker 3 (2026-07-07 Weekly touchpoint)
projects.
6:12
S… Speaker 3 (2026-07-07 Weekly touchpoint)
So I would expect the answer is yes,
6:15
S… Speaker 3 (2026-07-07 Weekly touchpoint)
but just put a TBC there and I
6:19
S… Speaker 3 (2026-07-07 Weekly touchpoint)
will have to read through those same documents just to see if
6:23
S… Speaker 3 (2026-07-07 Weekly touchpoint)
they've outlined exactly what they want.
6:25
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I understood.
6:27
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I think official
6:31
S… Speaker 1 (2026-07-07 Weekly touchpoint)
state is September Indian report.
6:36
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So I shared it with you through teams.
6:39
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Just for your reference.
6:41
S… Speaker 3 (2026-07-07 Weekly touchpoint)
There's many,
6:44
S… Speaker 3 (2026-07-07 Weekly touchpoint)
many pages in those reports.
6:46
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Do you know which page that is?
6:47
S… Speaker 3 (2026-07-07 Weekly touchpoint)
And I can jump to that.
6:48
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I do have it open.
6:50
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I'm just scrolling there.
6:52
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I'm like 50 pages.
6:53
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I think page 29.
6:55
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Okay, that's great.
6:55
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yeah.
6:56
S… Speaker 3 (2026-07-07 Weekly touchpoint)
So if they kept it open in September,
6:59
S… Speaker 3 (2026-07-07 Weekly touchpoint)
then we have until the end of September.
7:01
S… Speaker 3 (2026-07-07 Weekly touchpoint)
So that's fantastic.
7:02
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yes.
7:06
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So could we submit?
7:09
S… Speaker 2 (2026-07-07 Weekly touchpoint)
all documents,
7:10
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I mean not
7:14
S… Speaker 2 (2026-07-07 Weekly touchpoint)
just only for that final report,
7:17
S… Speaker 2 (2026-07-07 Weekly touchpoint)
could we submit including the other impacted document
7:21
S… Speaker 1 (2026-07-07 Weekly touchpoint)
as well?
7:23
S… Speaker 2 (2026-07-07 Weekly touchpoint)
in September?
7:24
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Yes,
7:26
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I think it would be good to do everything in one go.
7:28
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I would not want to go to and fro because you would have to explain
7:34
S… Speaker 3 (2026-07-07 Weekly touchpoint)
to them any changes that you've made and submit with
7:38
S… Speaker 3 (2026-07-07 Weekly touchpoint)
that. I'd need to align with them close to the time.
7:42
S… Speaker 3 (2026-07-07 Weekly touchpoint)
If we have...
7:44
S… Speaker 3 (2026-07-07 Weekly touchpoint)
You know,
7:45
S… Speaker 3 (2026-07-07 Weekly touchpoint)
the other changes we're trying to capture with it,
7:47
S… Speaker 3 (2026-07-07 Weekly touchpoint)
if they would need an additional change notification,
7:49
S… Speaker 3 (2026-07-07 Weekly touchpoint)
but it's small administrative corrections we can
7:54
S… Speaker 1 (2026-07-07 Weekly touchpoint)
confirm with them closer to the time.
7:55
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
7:58
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So just to confirm,
8:02
S… Speaker 2 (2026-07-07 Weekly touchpoint)
we will submit all documents in
8:07
S… Speaker 2 (2026-07-07 Weekly touchpoint)
September?
8:08
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yes.
8:10
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
8:14
S… Speaker 2 (2026-07-07 Weekly touchpoint)
I just prepared for SSP.
8:17
S… Speaker 2 (2026-07-07 Weekly touchpoint)
This is mentioned in working session today.
8:20
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But I think if we can submit all documents
8:24
S… Speaker 2 (2026-07-07 Weekly touchpoint)
in September,
8:26
S… Speaker 2 (2026-07-07 Weekly touchpoint)
maybe there is no issue for SSP.
8:29
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But is there any comments for SSP,
8:34
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yurim?
8:34
S… Speaker 1 (2026-07-07 Weekly touchpoint)
I
8:39
S… Speaker 1 (2026-07-07 Weekly touchpoint)
think it would be okay that
8:43
S… Speaker 1 (2026-07-07 Weekly touchpoint)
it's up to
8:47
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Here we request which document
8:51
S… Speaker 1 (2026-07-07 Weekly touchpoint)
for updates.
8:52
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So I think it'll be okay.
8:55
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
8:56
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Thank you.
8:58
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Thank you for your opinion.
9:00
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So these are all updates for Shagas.
9:03
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Is there any comments for this product?
9:07
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Nothing more
9:11
S… Speaker 3 (2026-07-07 Weekly touchpoint)
from my side.
9:11
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Okay.
9:12
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Thank you.
9:14
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And from today,
9:17
S… Speaker 2 (2026-07-07 Weekly touchpoint)
maybe I can follow for Rotardino and Kula Media as
9:21
S… Speaker 1 (2026-07-07 Weekly touchpoint)
well.
9:23
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So EDDF.
9:24
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So actually,
9:27
S… Speaker 2 (2026-07-07 Weekly touchpoint)
we already had a meeting with Sean,
9:30
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Sidley,
9:30
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Sean, and me,
9:32
S… Speaker 2 (2026-07-07 Weekly touchpoint)
and then Ellie on Monday.
9:36
S… Speaker 2 (2026-07-07 Weekly touchpoint)
But after that meeting,
9:38
S… Speaker 2 (2026-07-07 Weekly touchpoint)
we have discussed in ADK in working session.
9:41
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So I can suggest this timeline.
9:44
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So maybe TPS team.
9:48
S… Speaker 2 (2026-07-07 Weekly touchpoint)
can prepare for drafting,
9:51
S… Speaker 2 (2026-07-07 Weekly touchpoint)
like getting a D numbers from other departments.
9:54
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And then in this week,
9:57
S… Speaker 2 (2026-07-07 Weekly touchpoint)
maybe SIDLi Xion will come ADK site.
10:00
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So they can EDDF creation in this week and
10:04
S… Speaker 2 (2026-07-07 Weekly touchpoint)
then apply the comments by Xion.
10:08
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And then the last week,
10:10
S… Speaker 2 (2026-07-07 Weekly touchpoint)
the EDDF approval after Xion
10:15
S… Speaker 2 (2026-07-07 Weekly touchpoint)
goes back.
10:17
S… Speaker 2 (2026-07-07 Weekly touchpoint)
leave the korea and then we can submit the rota
10:21
S… Speaker 2 (2026-07-07 Weekly touchpoint)
in july 31st is it
10:25
S… Speaker 1 (2026-07-07 Weekly touchpoint)
okay yeah um like i
10:29
S… Speaker 4 (2026-07-07 Weekly touchpoint)
indicated i'll be over the week of the 20th to the 24th so
10:33
S… Speaker 4 (2026-07-07 Weekly touchpoint)
if there's anything that i can help with uh for the
10:37
S… Speaker 4 (2026-07-07 Weekly touchpoint)
e ddf for rota yeah by all means we can do it that week
10:41
S… Speaker 4 (2026-07-07 Weekly touchpoint)
but like there is nothing at the moment uploaded to
10:45
S… Speaker 4 (2026-07-07 Weekly touchpoint)
agile for rota
10:48
S… Speaker 4 (2026-07-07 Weekly touchpoint)
For the DDF.
10:50
S… Speaker 1 (2026-07-07 Weekly touchpoint)
So, you know,
10:52
S… Speaker 4 (2026-07-07 Weekly touchpoint)
I'm just conscious.
10:52
S… Speaker 4 (2026-07-07 Weekly touchpoint)
I don't want to wait until the 20th for the
10:57
S… Speaker 4 (2026-07-07 Weekly touchpoint)
TO team to start working on it.
10:59
S… Speaker 4 (2026-07-07 Weekly touchpoint)
Is there any way that they can start working on it in
11:03
S… Speaker 1 (2026-07-07 Weekly touchpoint)
advance of that week?
11:04
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Because before July
11:09
S… Speaker 2 (2026-07-07 Weekly touchpoint)
20th,
11:10
S… Speaker 2 (2026-07-07 Weekly touchpoint)
maybe we should do the Chagas and Rotardino as
11:15
S… Speaker 1 (2026-07-07 Weekly touchpoint)
well.
11:15
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So I think...
11:17
S… Speaker 2 (2026-07-07 Weekly touchpoint)
They can do July 20th to 24th
11:22
S… Speaker 2 (2026-07-07 Weekly touchpoint)
with your comments.
11:24
S… Speaker 1 (2026-07-07 Weekly touchpoint)
That's fine,
11:25
S… Speaker 1 (2026-07-07 Weekly touchpoint)
that's fine.
11:25
S… Speaker 4 (2026-07-07 Weekly touchpoint)
I suppose just be aware
11:30
S… Speaker 4 (2026-07-07 Weekly touchpoint)
that I will be looking,
11:31
S… Speaker 4 (2026-07-07 Weekly touchpoint)
myself and Grace,
11:32
S… Speaker 4 (2026-07-07 Weekly touchpoint)
looking at Chagas and RSV during that week as well
11:36
S… Speaker 4 (2026-07-07 Weekly touchpoint)
to see if there's any potential updates that we need to do to
11:41
S… Speaker 4 (2026-07-07 Weekly touchpoint)
the DTF.
11:41
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay,
11:46
S… Speaker 2 (2026-07-07 Weekly touchpoint)
maybe Eunju will reply to your email.
11:51
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yep.
11:51
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
11:52
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
11:54
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And the owner for EDDF,
11:59
S… Speaker 2 (2026-07-07 Weekly touchpoint)
they have three people.
12:01
S… Speaker 2 (2026-07-07 Weekly touchpoint)
They are the submission part in TPS.
12:05
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So they can be owner.
12:07
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
12:10
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
12:10
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So there is
12:14
S… Speaker 2 (2026-07-07 Weekly touchpoint)
no any issues for Cloud Media.
12:16
S… Speaker 2 (2026-07-07 Weekly touchpoint)
We just waiting for decision.
12:18
S… Speaker 2 (2026-07-07 Weekly touchpoint)
So there is no issue anymore.
12:22
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Do you have any questions?
12:27
S… Speaker 2 (2026-07-07 Weekly touchpoint)
or comments.
12:29
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Nothing
12:33
S… Speaker 3 (2026-07-07 Weekly touchpoint)
for me then.
12:34
S… Speaker 3 (2026-07-07 Weekly touchpoint)
If we're all on track for that,
12:35
S… Speaker 3 (2026-07-07 Weekly touchpoint)
then that's great.
12:36
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Sorry,
12:38
S… Speaker 4 (2026-07-07 Weekly touchpoint)
just one question from me.
12:40
S… Speaker 4 (2026-07-07 Weekly touchpoint)
The submission date for Rosa is what date?
12:43
S… Speaker 3 (2026-07-07 Weekly touchpoint)
End of July.
12:45
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank
12:52
S… Speaker 2 (2026-07-07 Weekly touchpoint)
you so much.
12:53
S… Speaker 2 (2026-07-07 Weekly touchpoint)
If you don't have any questions,
12:55
S… Speaker 2 (2026-07-07 Weekly touchpoint)
maybe I can complete this meeting.
13:00
S… Speaker 3 (2026-07-07 Weekly touchpoint)
All right, if nobody has anything else,
13:02
S… Speaker 3 (2026-07-07 Weekly touchpoint)
then that's great.
13:03
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Everything is on track.
13:04
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Once I have any more information about Pramedia,
13:07
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I will let you know.
13:08
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I think I've managed to get an initial meeting just with
13:13
S… Speaker 3 (2026-07-07 Weekly touchpoint)
no limit on Thursday to discuss it.
13:16
S… Speaker 3 (2026-07-07 Weekly touchpoint)
After that point,
13:17
S… Speaker 3 (2026-07-07 Weekly touchpoint)
we will then escalate it one step further.
13:20
S… Speaker 3 (2026-07-07 Weekly touchpoint)
But I do not have a date for that yet.
13:23
S… Speaker 3 (2026-07-07 Weekly touchpoint)
As soon as I have any more information,
13:25
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I will let you know.
13:26
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay,
13:29
S… Speaker 2 (2026-07-07 Weekly touchpoint)
thank you.
13:29
S… Speaker 2 (2026-07-07 Weekly touchpoint)
And when they go to...
13:32
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Could you send an email like regarding the Chagas via
13:36
S… Speaker 1 (2026-07-07 Weekly touchpoint)
email?
13:36
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Because I just want to share in ADK,
13:39
S… Speaker 2 (2026-07-07 Weekly touchpoint)
just regarding the report.
13:41
S… Speaker 3 (2026-07-07 Weekly touchpoint)
For
13:46
S… Speaker 3 (2026-07-07 Weekly touchpoint)
what specifically?
13:47
S… Speaker 3 (2026-07-07 Weekly touchpoint)
About the report that the new approval
13:51
S… Speaker 3 (2026-07-07 Weekly touchpoint)
can proceed?
13:52
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Yeah.
13:52
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Okay.
13:53
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Yes, I can do that.
13:55
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Thank you.
13:56
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Sorry,
13:58
S… Speaker 4 (2026-07-07 Weekly touchpoint)
Mandy. So we think chlamydia might still be in scope.
14:01
S… Speaker 4 (2026-07-07 Weekly touchpoint)
Is that right?
14:03
S… Speaker 1 (2026-07-07 Weekly touchpoint)
No.
14:04
S… Speaker 3 (2026-07-07 Weekly touchpoint)
The decision is
14:08
S… Speaker 3 (2026-07-07 Weekly touchpoint)
out with the
14:13
S… Speaker 3 (2026-07-07 Weekly touchpoint)
executive leadership.
14:14
S… Speaker 3 (2026-07-07 Weekly touchpoint)
So we have escalation slides that are prepared and it
14:18
S… Speaker 3 (2026-07-07 Weekly touchpoint)
is being escalated one step further to the DVPs of each of
14:22
S… Speaker 3 (2026-07-07 Weekly touchpoint)
the different functions who will have to make the final decision about
14:26
S… Speaker 1 (2026-07-07 Weekly touchpoint)
it.
14:26
S… Speaker 3 (2026-07-07 Weekly touchpoint)
What that decision will be.
14:30
S… Speaker 3 (2026-07-07 Weekly touchpoint)
I would not guess to speculate right now.
14:32
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Okay.
14:39
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Thank you very much,
14:40
S… Speaker 1 (2026-07-07 Weekly touchpoint)
everybody.
14:40
S… Speaker 2 (2026-07-07 Weekly touchpoint)
Thank you.
14:41
S… Speaker 3 (2026-07-07 Weekly touchpoint)
Thank you for your time.
14:42
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Thank you.
14:43
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Bye -bye.
14:44
S… Speaker 1 (2026-07-07 Weekly touchpoint)
Bye -bye.

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