2027-07-22 malaria

Jul 22, 2026 00:39 · 23:25 · English · Whisper Turbo · 3 Sprekers
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0:00
S… Speaker 2 (2027-07-22 malaria)
So maybe if we can understand that and see how we streamline the two conversations
0:04
S… Speaker 2 (2027-07-22 malaria)
together so there is no justification or disconnect.
0:08
S… Speaker 2 (2027-07-22 malaria)
I think that is maybe one of the goals we need to achieve first.
0:26
S… Speaker 1 (2027-07-22 malaria)
prepare some of the record for the pre
0:31
S… Speaker 1 (2027-07-22 malaria)
-app clinical evaluation.
0:32
S… Speaker 1 (2027-07-22 malaria)
And also,
0:35
S… Speaker 1 (2027-07-22 malaria)
as you know,
0:36
S… Speaker 1 (2027-07-22 malaria)
we have some issues for the clinical data,
0:40
S… Speaker 1 (2027-07-22 malaria)
so we open the QI.
0:42
S… Speaker 1 (2027-07-22 malaria)
So we are under the QI investigation now.
0:45
S… Speaker 2 (2027-07-22 malaria)
Okay.
0:46
S… Speaker 1 (2027-07-22 malaria)
Okay.
0:47
S… Speaker 2 (2027-07-22 malaria)
Okay.
0:48
S… Speaker 2 (2027-07-22 malaria)
Okay.
0:48
S… Speaker 2 (2027-07-22 malaria)
So this is too important.
0:50
S… Speaker 2 (2027-07-22 malaria)
They can't just add the QI investment.
0:54
S… Speaker 1 (2027-07-22 malaria)
After receiving the senior leadership decision
0:58
S… Speaker 1 (2027-07-22 malaria)
this month,
1:00
S… Speaker 1 (2027-07-22 malaria)
we can start
1:04
S… Speaker 1 (2027-07-22 malaria)
to initiate the other people.
1:06
S… Speaker 2 (2027-07-22 malaria)
Understood.
2:08
S… Speaker 1 (2027-07-22 malaria)
We will be
2:16
S… Speaker 1 (2027-07-22 malaria)
almost finalized with the E -Ring in the bureaucracy.
2:35
S… Speaker 1 (2027-07-22 malaria)
Yeah.
2:59
S… Speaker 1 (2027-07-22 malaria)
Yeah.
3:00
S… Speaker 1 (2027-07-22 malaria)
Bye.
3:09
S… Speaker 2 (2027-07-22 malaria)
So from an idea perspective,
3:11
S… Speaker 2 (2027-07-22 malaria)
it's a line where we cannot proceed
3:16
S… Speaker 2 (2027-07-22 malaria)
with notifications.
3:18
S… Speaker 2 (2027-07-22 malaria)
So all these activities are quite young.
3:20
S… Speaker 2 (2027-07-22 malaria)
The question is,
3:22
S… Speaker 2 (2027-07-22 malaria)
do have we decided what this strategy is
3:26
S… Speaker 2 (2027-07-22 malaria)
and if there's an action to which we're saying to be,
3:30
S… Speaker 2 (2027-07-22 malaria)
what are we doing to resolve the issue with the clinical
3:34
S… Speaker 2 (2027-07-22 malaria)
sound of this practice?
3:35
S… Speaker 2 (2027-07-22 malaria)
And do we have a status update on
3:39
S… Speaker 1 (2027-07-22 malaria)
that?
3:40
S… Speaker 1 (2027-07-22 malaria)
We prepared the SML deck,
3:43
S… Speaker 1 (2027-07-22 malaria)
but we are still
3:47
S… Speaker 1 (2027-07-22 malaria)
under the discussion.
3:49
S… Speaker 1 (2027-07-22 malaria)
So,
3:50
S… Speaker 1 (2027-07-22 malaria)
for example, we are updating some several options
3:54
S… Speaker 1 (2027-07-22 malaria)
to the senior leadership.
3:55
S… Speaker 1 (2027-07-22 malaria)
For example,
3:56
S… Speaker 1 (2027-07-22 malaria)
we need to get a decision
4:00
S… Speaker 1 (2027-07-22 malaria)
from the marketing perspective,
4:03
S… Speaker 1 (2027-07-22 malaria)
the A -bone product versus the W -Q -Q.
4:11
S… Speaker 1 (2027-07-22 malaria)
the kind of decision that we're going to receive.
4:44
S… Speaker 1 (2027-07-22 malaria)
Yes, yes, yes.
5:02
S… Speaker 1 (2027-07-22 malaria)
So it means that we can change
5:07
S… Speaker 3 (2027-07-22 malaria)
the registration.
5:07
S… Speaker 1 (2027-07-22 malaria)
So first,
5:10
S… Speaker 1 (2027-07-22 malaria)
we will decide to how can
5:14
S… Speaker 1 (2027-07-22 malaria)
we handle the clinical study.
5:36
S… Speaker 1 (2027-07-22 malaria)
So,
5:37
S… Speaker 1 (2027-07-22 malaria)
for this case,
5:39
S… Speaker 1 (2027-07-22 malaria)
we might need to change our mind,
5:42
S… Speaker 1 (2027-07-22 malaria)
and we need to discuss with you.
5:47
S… Speaker 2 (2027-07-22 malaria)
So we will have less than 100
5:51
S… Speaker 2 (2027-07-22 malaria)
% for these?
6:09
S… Speaker 2 (2027-07-22 malaria)
because they were
6:14
S… Speaker 2 (2027-07-22 malaria)
able to retest with 200
6:34
S… Speaker 1 (2027-07-22 malaria)
So, during the separation of ECB
6:38
S… Speaker 1 (2027-07-22 malaria)
and WHTQ,
6:40
S… Speaker 1 (2027-07-22 malaria)
we will be aware about the Korean clinical
6:44
S… Speaker 3 (2027-07-22 malaria)
study.
6:45
S… Speaker 1 (2027-07-22 malaria)
So,
6:46
S… Speaker 1 (2027-07-22 malaria)
I think that the first step that we will decide
6:50
S… Speaker 1 (2027-07-22 malaria)
to do better,
6:51
S… Speaker 1 (2027-07-22 malaria)
how can we handle the Korean student division,
6:55
S… Speaker 1 (2027-07-22 malaria)
that means that we need to set the application
6:59
S… Speaker 1 (2027-07-22 malaria)
to that new clinical,
7:00
S… Speaker 1 (2027-07-22 malaria)
additional clinical study and also we
7:05
S… Speaker 1 (2027-07-22 malaria)
need to know how can we communicate.
7:24
S… Speaker 1 (2027-07-22 malaria)
Yeah, yeah.
7:38
S… Speaker 2 (2027-07-22 malaria)
Because we have no way to move forward with change of education in
7:42
S… Speaker 2 (2027-07-22 malaria)
that particular. And I think maybe the outcome is,
7:46
S… Speaker 2 (2027-07-22 malaria)
first two questions that I have,
7:49
S… Speaker 2 (2027-07-22 malaria)
is anyone here on the EU meeting?
7:53
S… Speaker 2 (2027-07-22 malaria)
Is there an XA representative?
7:55
S… Speaker 1 (2027-07-22 malaria)
Yes,
7:56
S… Speaker 1 (2027-07-22 malaria)
I was working
8:00
S… Speaker 1 (2027-07-22 malaria)
for XCV.
8:02
S… Speaker 1 (2027-07-22 malaria)
After that,
8:03
S… Speaker 1 (2027-07-22 malaria)
we sent medical XCV.
8:07
S… Speaker 1 (2027-07-22 malaria)
And Jillian is that.
8:11
S… Speaker 1 (2027-07-22 malaria)
Right,
8:12
S… Speaker 2 (2027-07-22 malaria)
so are you on Jillian?
8:15
S… Speaker 2 (2027-07-22 malaria)
Okay, so this is the connection between what ADP
8:19
S… Speaker 2 (2027-07-22 malaria)
is doing and what Jillian.
8:21
S… Speaker 1 (2027-07-22 malaria)
okay so
8:28
S… Speaker 2 (2027-07-22 malaria)
any
8:41
S… Speaker 2 (2027-07-22 malaria)
questions from the inside to move forward
8:45
S… Speaker 2 (2027-07-22 malaria)
is there any that the 80k team has
8:49
S… Speaker 2 (2027-07-22 malaria)
Now based upon the activities that you're working on.
9:43
S… Speaker 2 (2027-07-22 malaria)
yeah yeah so i think so i think
9:44
S… Speaker 2 (2027-07-22 malaria)
Whatever is going to be decided,
9:47
S… Speaker 2 (2027-07-22 malaria)
it will impact IDDR.
9:48
S… Speaker 2 (2027-07-22 malaria)
Do we have the green light to move forward with IDDR implementation?
9:52
S… Speaker 2 (2027-07-22 malaria)
Or do we need to go based upon communication with TIP
9:56
S… Speaker 2 (2027-07-22 malaria)
Suite and know what the next steps are going to be?
10:00
S… Speaker 2 (2027-07-22 malaria)
I think for,
10:00
S… Speaker 2 (2027-07-22 malaria)
we can only agree now at this point to the authorized
10:05
S… Speaker 2 (2027-07-22 malaria)
state to be out of our scope,
10:07
S… Speaker 2 (2027-07-22 malaria)
until we have present.
10:10
S… Speaker 2 (2027-07-22 malaria)
I think that this whole thing is supposed
10:14
S… Speaker 2 (2027-07-22 malaria)
to be, if you push on,
10:15
S… Speaker 2 (2027-07-22 malaria)
do you have comment on your line?
10:19
S… Speaker 1 (2027-07-22 malaria)
No.
10:19
S… Speaker 1 (2027-07-22 malaria)
I was waiting for one or two months by August
10:24
S… Speaker 1 (2027-07-22 malaria)
to meet all the structures.
10:27
S… Speaker 1 (2027-07-22 malaria)
Yeah.
10:28
S… Speaker 1 (2027-07-22 malaria)
Yeah.
10:40
S… Speaker 2 (2027-07-22 malaria)
hcb programs here is
11:15
S… Speaker 2 (2027-07-22 malaria)
Yes,
11:16
S… Speaker 2 (2027-07-22 malaria)
absolutely.
11:17
S… Speaker 1 (2027-07-22 malaria)
Any
11:29
S… Speaker 2 (2027-07-22 malaria)
other questions on ATV?
11:31
S… Speaker 2 (2027-07-22 malaria)
What's happening with the current
11:35
S… Speaker 1 (2027-07-22 malaria)
unmarked product?
11:48
S… Speaker 1 (2027-07-22 malaria)
Okay.
11:50
S… Speaker 1 (2027-07-22 malaria)
Okay.
12:09
S… Speaker 1 (2027-07-22 malaria)
I want a very stupid question.
12:11
S… Speaker 1 (2027-07-22 malaria)
Why?
12:12
S… Speaker 1 (2027-07-22 malaria)
How can you?
12:14
S… Speaker 2 (2027-07-22 malaria)
Because it's now a
12:18
S… Speaker 2 (2027-07-22 malaria)
business decision between marketing.
12:20
S… Speaker 2 (2027-07-22 malaria)
So they're looking at what is the business strategy.
12:23
S… Speaker 2 (2027-07-22 malaria)
So they want revenue in the countries
12:27
S… Speaker 2 (2027-07-22 malaria)
that currently have the ACV product made by Align.
12:31
S… Speaker 1 (2027-07-22 malaria)
Now.
12:33
S… Speaker 2 (2027-07-22 malaria)
Should we have to do that because we do not
12:37
S… Speaker 2 (2027-07-22 malaria)
fulfill the sensitivity and specific environment,
12:41
S… Speaker 2 (2027-07-22 malaria)
how could they transition
12:45
S… Speaker 2 (2027-07-22 malaria)
to another product?
12:48
S… Speaker 2 (2027-07-22 malaria)
Or if we have to close clinical work,
12:51
S… Speaker 2 (2027-07-22 malaria)
what would be an impact on the one month?
12:54
S… Speaker 2 (2027-07-22 malaria)
So it's secure and ready.
12:55
S… Speaker 2 (2027-07-22 malaria)
So I think it's more like putting a portfolio discussion
13:00
S… Speaker 1 (2027-07-22 malaria)
rather than just
13:02
S… Speaker 2 (2027-07-22 malaria)
a working stream yeah so it's kind
13:06
S… Speaker 2 (2027-07-22 malaria)
of like kind of like this one
13:20
S… Speaker 2 (2027-07-22 malaria)
this one is is
13:31
S… Speaker 2 (2027-07-22 malaria)
I think that's why that hunts from the movies.
14:19
S… Speaker 1 (2027-07-22 malaria)
Yes.
14:20
S… Speaker 1 (2027-07-22 malaria)
Yes.
14:21
S… Speaker 1 (2027-07-22 malaria)
Yes.
14:22
S… Speaker 1 (2027-07-22 malaria)
Yes.
14:23
S… Speaker 1 (2027-07-22 malaria)
Yes. Yes. Yes.
14:55
S… Speaker 1 (2027-07-22 malaria)
update to pbs and rms yeah
15:26
S… Speaker 1 (2027-07-22 malaria)
but you did
15:45
S… Speaker 2 (2027-07-22 malaria)
So what I understand
15:49
S… Speaker 2 (2027-07-22 malaria)
is that
16:03
S… Speaker 2 (2027-07-22 malaria)
They have a big package to look at.
16:07
S… Speaker 2 (2027-07-22 malaria)
But
16:11
S… Speaker 2 (2027-07-22 malaria)
usability
16:15
S… Speaker 2 (2027-07-22 malaria)
is an opportunity that we want to
16:20
S… Speaker 1 (2027-07-22 malaria)
leverage.
16:20
S… Speaker 2 (2027-07-22 malaria)
So one thing,
16:22
S… Speaker 2 (2027-07-22 malaria)
the WHO has part of its expectation is
16:26
S… Speaker 2 (2027-07-22 malaria)
that the way a paint line is interpreted by the user is
16:31
S… Speaker 2 (2027-07-22 malaria)
an issue by the WHO.
16:32
S… Speaker 2 (2027-07-22 malaria)
They see that this needs to be more
16:38
S… Speaker 2 (2027-07-22 malaria)
specifically described in our user guide.
16:42
S… Speaker 2 (2027-07-22 malaria)
That users will know if they see a paint line,
16:45
S… Speaker 2 (2027-07-22 malaria)
it is to be considered as positive.
16:48
S… Speaker 2 (2027-07-22 malaria)
The IDDR user guide does not
16:53
S… Speaker 2 (2027-07-22 malaria)
explain it clearly.
16:54
S… Speaker 2 (2027-07-22 malaria)
Now,
16:56
S… Speaker 2 (2027-07-22 malaria)
if we have an opportunity for us
17:00
S… Speaker 2 (2027-07-22 malaria)
to update the user guide with just
17:05
S… Speaker 2 (2027-07-22 malaria)
information.
17:05
S… Speaker 2 (2027-07-22 malaria)
So I think you had it in the malaria
17:10
S… Speaker 2 (2027-07-22 malaria)
campaign behind this one.
17:15
S… Speaker 2 (2027-07-22 malaria)
This is the IDDR.
17:18
S… Speaker 2 (2027-07-22 malaria)
What they're doing is just to
17:22
S… Speaker 2 (2027-07-22 malaria)
emphasize that anything
17:27
S… Speaker 2 (2027-07-22 malaria)
in line must be incident and positive.
17:30
S… Speaker 1 (2027-07-22 malaria)
Here,
17:31
S… Speaker 2 (2027-07-22 malaria)
no one sees this.
17:34
S… Speaker 2 (2027-07-22 malaria)
So this is just an optical re -identification to
17:39
S… Speaker 2 (2027-07-22 malaria)
make sure that people will understand.
17:42
S… Speaker 2 (2027-07-22 malaria)
better the
17:48
S… Speaker 2 (2027-07-22 malaria)
second thing is
17:52
S… Speaker 2 (2027-07-22 malaria)
in the language
17:55
S… Speaker 2 (2027-07-22 malaria)
They use negative,
17:57
S… Speaker 2 (2027-07-22 malaria)
positive.
17:59
S… Speaker 2 (2027-07-22 malaria)
Here we say reactive,
18:02
S… Speaker 2 (2027-07-22 malaria)
non -reactive.
18:03
S… Speaker 2 (2027-07-22 malaria)
Now, it's just how people understand these terms in English.
18:08
S… Speaker 2 (2027-07-22 malaria)
Now, what the usability study is going to do in
18:12
S… Speaker 2 (2027-07-22 malaria)
August is to do a test to see if they do
18:16
S… Speaker 2 (2027-07-22 malaria)
the simple changes.
18:18
S… Speaker 2 (2027-07-22 malaria)
Will people understand the results in question?
18:23
S… Speaker 2 (2027-07-22 malaria)
And it's an opportunity,
18:25
S… Speaker 2 (2027-07-22 malaria)
but it would mean we would
18:29
S… Speaker 2 (2027-07-22 malaria)
have to update IBDR,
18:30
S… Speaker 2 (2027-07-22 malaria)
use a guide,
18:32
S… Speaker 2 (2027-07-22 malaria)
to go to TPSU and to
18:36
S… Speaker 2 (2027-07-22 malaria)
do an obtain notification.
18:39
S… Speaker 2 (2027-07-22 malaria)
It would delay,
18:40
S… Speaker 2 (2027-07-22 malaria)
but the question is,
18:42
S… Speaker 2 (2027-07-22 malaria)
what's the value?
18:43
S… Speaker 2 (2027-07-22 malaria)
If we do IBBR with this change,
18:47
S… Speaker 2 (2027-07-22 malaria)
we would block them from their change
18:51
S… Speaker 1 (2027-07-22 malaria)
notification.
18:52
S… Speaker 2 (2027-07-22 malaria)
And so the question is,
18:54
S… Speaker 2 (2027-07-22 malaria)
do we put this in their timeline
18:59
S… Speaker 2 (2027-07-22 malaria)
of this so we don't argue that there's
19:03
S… Speaker 2 (2027-07-22 malaria)
no changes?
19:04
S… Speaker 2 (2027-07-22 malaria)
Or do we make a simple change?
19:07
S… Speaker 2 (2027-07-22 malaria)
and go to IBDR.
19:10
S… Speaker 2 (2027-07-22 malaria)
That's it.
19:11
S… Speaker 2 (2027-07-22 malaria)
Understood?
19:12
S… Speaker 2 (2027-07-22 malaria)
Yeah.
19:13
S… Speaker 1 (2027-07-22 malaria)
That's
19:17
S… Speaker 1 (2027-07-22 malaria)
my question.
19:20
S… Speaker 2 (2027-07-22 malaria)
The usability in itself is doing more
19:25
S… Speaker 2 (2027-07-22 malaria)
than this because I think usability is going to use dummy parts
19:29
S… Speaker 2 (2027-07-22 malaria)
to see.
19:30
S… Speaker 2 (2027-07-22 malaria)
So they're testing this product.
19:33
S… Speaker 1 (2027-07-22 malaria)
Yeah.
19:35
S… Speaker 2 (2027-07-22 malaria)
Yes, yes,
19:36
S… Speaker 1 (2027-07-22 malaria)
yes.
19:38
S… Speaker 1 (2027-07-22 malaria)
The question is,
19:41
S… Speaker 1 (2027-07-22 malaria)
we're going to be ruling out this kind of change into the
19:45
S… Speaker 1 (2027-07-22 malaria)
other malaria series.
19:46
S… Speaker 1 (2027-07-22 malaria)
That is the first one question,
19:48
S… Speaker 1 (2027-07-22 malaria)
and the second one is,
19:49
S… Speaker 1 (2027-07-22 malaria)
so as I understand,
19:52
S… Speaker 1 (2027-07-22 malaria)
what kind of change we should implement for
19:56
S… Speaker 1 (2027-07-22 malaria)
the IP,
19:57
S… Speaker 1 (2027-07-22 malaria)
especially for the IPR.
20:01
S… Speaker 1 (2027-07-22 malaria)
How about,
20:02
S… Speaker 1 (2027-07-22 malaria)
as I understand,
20:03
S… Speaker 1 (2027-07-22 malaria)
yesterday Lucy and Fiona and Malaya,
20:06
S… Speaker 1 (2027-07-22 malaria)
they said they're gonna need some updates,
20:10
S… Speaker 1 (2027-07-22 malaria)
what kind of the information should be correct for the
20:14
S… Speaker 1 (2027-07-22 malaria)
IPR.
20:14
S… Speaker 1 (2027-07-22 malaria)
So I mean,
20:15
S… Speaker 1 (2027-07-22 malaria)
so I thought,
20:16
S… Speaker 1 (2027-07-22 malaria)
you know,
20:17
S… Speaker 1 (2027-07-22 malaria)
we are still not,
20:18
S… Speaker 1 (2027-07-22 malaria)
we don't have any form,
20:20
S… Speaker 1 (2027-07-22 malaria)
you know, description,
20:21
S… Speaker 1 (2027-07-22 malaria)
what kind of changes we should implement.
20:26
S… Speaker 2 (2027-07-22 malaria)
So if they're saying they don't know if that will impact IBDI,
20:31
S… Speaker 2 (2027-07-22 malaria)
it could mean,
20:32
S… Speaker 2 (2027-07-22 malaria)
do we have the decision to do this update?
20:36
S… Speaker 2 (2027-07-22 malaria)
Yes or no?
20:38
S… Speaker 2 (2027-07-22 malaria)
If they say yes,
20:40
S… Speaker 2 (2027-07-22 malaria)
then that's what will be needed to go into the IBDI.
20:44
S… Speaker 2 (2027-07-22 malaria)
If they say no,
20:47
S… Speaker 2 (2027-07-22 malaria)
then we have no change.
20:50
S… Speaker 2 (2027-07-22 malaria)
And then the same line will have
20:54
S… Speaker 2 (2027-07-22 malaria)
to do this.
20:55
S… Speaker 2 (2027-07-22 malaria)
Plus the oxygen information,
20:58
S… Speaker 2 (2027-07-22 malaria)
plus the all that are in that package,
21:02
S… Speaker 2 (2027-07-22 malaria)
and then that would be put out to the
21:06
S… Speaker 2 (2027-07-22 malaria)
paint line implemented.
21:09
S… Speaker 1 (2027-07-22 malaria)
So,
21:10
S… Speaker 1 (2027-07-22 malaria)
for my view,
21:12
S… Speaker 1 (2027-07-22 malaria)
this kind of change,
21:13
S… Speaker 1 (2027-07-22 malaria)
if we receive the yes,
21:15
S… Speaker 1 (2027-07-22 malaria)
we need to update it.
21:17
S… Speaker 2 (2027-07-22 malaria)
So,
21:19
S… Speaker 1 (2027-07-22 malaria)
actually,
21:20
S… Speaker 1 (2027-07-22 malaria)
this kind of change can be also like for
21:24
S… Speaker 1 (2027-07-22 malaria)
the other malaria cities,
21:25
S… Speaker 1 (2027-07-22 malaria)
for example,
21:26
S… Speaker 1 (2027-07-22 malaria)
malaria PM,
21:27
S… Speaker 1 (2027-07-22 malaria)
PPE,
21:29
S… Speaker 1 (2027-07-22 malaria)
etc.
21:31
S… Speaker 1 (2027-07-22 malaria)
Do you think we should be ruling out those changes?
21:34
S… Speaker 2 (2027-07-22 malaria)
Because I think the two that are in the
21:38
S… Speaker 2 (2027-07-22 malaria)
scope of the paint line are only the PFBB and the PAN.
21:41
S… Speaker 2 (2027-07-22 malaria)
We didn't even have downstream changes coming,
21:45
S… Speaker 2 (2027-07-22 malaria)
but we were not told they were in the scope of the paint line.
21:48
S… Speaker 2 (2027-07-22 malaria)
So at the moment,
21:50
S… Speaker 2 (2027-07-22 malaria)
next step is a NPI that's different.
21:53
S… Speaker 2 (2027-07-22 malaria)
That's a bigger change.
21:55
S… Speaker 2 (2027-07-22 malaria)
But PFPD and PAN
22:00
S… Speaker 2 (2027-07-22 malaria)
are not considered in this form.
22:36
S… Speaker 1 (2027-07-22 malaria)
I just received from R .A
22:41
S… Speaker 1 (2027-07-22 malaria)
.S. Kim that we finalized the announcement from
22:45
S… Speaker 1 (2027-07-22 malaria)
Rachel. So if we took off stage.
22:51
S… Speaker 1 (2027-07-22 malaria)
Always fine.
22:54
S… Speaker 1 (2027-07-22 malaria)
All of
22:58
S… Speaker 2 (2027-07-22 malaria)
them.
23:00
S… Speaker 1 (2027-07-22 malaria)
Exactly.
23:09
S… Speaker 1 (2027-07-22 malaria)
Those
23:15
S… Speaker 2 (2027-07-22 malaria)
we have here.

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