2026-07-21 HIV_SYP
Jul 21, 2026 07:03
· 16:38
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· Whisper Turbo
· 3 Altofalantes
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Speaker 2 (2026-07-21 HIV_SYP)
See what we have,
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Speaker 2 (2026-07-21 HIV_SYP)
where we are coming from,
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Speaker 2 (2026-07-21 HIV_SYP)
where that high prevalence statement came from.
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Speaker 2 (2026-07-21 HIV_SYP)
And I actually had sent out another article that he thinks could
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Speaker 2 (2026-07-21 HIV_SYP)
support us removing the high prevalence piece of it.
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Speaker 2 (2026-07-21 HIV_SYP)
So it's still not decided about
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Speaker 2 (2026-07-21 HIV_SYP)
where we can go and how we can progress with it.
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Speaker 2 (2026-07-21 HIV_SYP)
I think it's a little bit we'll work on it.
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Speaker 2 (2026-07-21 HIV_SYP)
The word Greg had out of the timeline that
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Speaker 2 (2026-07-21 HIV_SYP)
I had sent last week to the team.
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Speaker 2 (2026-07-21 HIV_SYP)
was that it would probably take us about three months to update the
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Speaker 2 (2026-07-21 HIV_SYP)
documentation from the tech firm and another three months to get TV approval.
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Speaker 2 (2026-07-21 HIV_SYP)
So you're talking about the end of the year
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Speaker 2 (2026-07-21 HIV_SYP)
until the start of January before we potentially have an updated certification.
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Speaker 2 (2026-07-21 HIV_SYP)
But this is for your intended purpose that we could use if they really are
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Speaker 2 (2026-07-21 HIV_SYP)
not happy of continuing with the high prevalence burden that's
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Speaker 2 (2026-07-21 HIV_SYP)
currently in there.
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Speaker 2 (2026-07-21 HIV_SYP)
So that will put us.
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Speaker 1 (2026-07-21 HIV_SYP)
um quite late until next year and this is a is this class d for my
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Speaker 2 (2026-07-21 HIV_SYP)
name
1:38
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Speaker 1 (2026-07-21 HIV_SYP)
okay okay yeah
2:43
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Speaker 1 (2026-07-21 HIV_SYP)
i think india was the only one pulling
2:47
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Speaker 1 (2026-07-21 HIV_SYP)
that one out so they're also limited countries
2:53
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Speaker 1 (2026-07-21 HIV_SYP)
and we're just getting back to it because it was locked in the sclp way
2:57
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Speaker 1 (2026-07-21 HIV_SYP)
way to move forward
3:22
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Speaker 1 (2026-07-21 HIV_SYP)
so should we build like just like you were doing the
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Speaker 1 (2026-07-21 HIV_SYP)
pre -work so if we block six months on ivy updates
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Speaker 1 (2026-07-21 HIV_SYP)
worst case scenario which is elendria before
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Speaker 1 (2026-07-21 HIV_SYP)
we have certification so january yeah yeah
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Speaker 1 (2026-07-21 HIV_SYP)
this would
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Speaker 1 (2026-07-21 HIV_SYP)
mean if you put between now and january to january
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Speaker 1 (2026-07-21 HIV_SYP)
for ip update with truth suits yes that was my
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Speaker 1 (2026-07-21 HIV_SYP)
question so this is a part of that marketing has some issues with the internet right
3:57
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Speaker 1 (2026-07-21 HIV_SYP)
yeah for them to agree
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Speaker 1 (2026-07-21 HIV_SYP)
basically agree means we might have to update
4:05
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Speaker 1 (2026-07-21 HIV_SYP)
the ipo no no no because if we have dpsd that's no resolution
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Speaker 1 (2026-07-21 HIV_SYP)
we're estimating
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Speaker 1 (2026-07-21 HIV_SYP)
six months
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Speaker 1 (2026-07-21 HIV_SYP)
so what we can't do and then come back to
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Speaker 1 (2026-07-21 HIV_SYP)
the point where we have to go to mark that said there's no option so actually
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Speaker 1 (2026-07-21 HIV_SYP)
definitely needs to be like with 80 people at
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Speaker 1 (2026-07-21 HIV_SYP)
least two months to prepare
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Speaker 1 (2026-07-21 HIV_SYP)
at least two months
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Speaker 2 (2026-07-21 HIV_SYP)
Is Young here?
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Speaker 1 (2026-07-21 HIV_SYP)
It will take two to
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Speaker 1 (2026-07-21 HIV_SYP)
three months to update the internal documents.
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Speaker 1 (2026-07-21 HIV_SYP)
There
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Speaker 1 (2026-07-21 HIV_SYP)
will be more documents to be updated.
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Speaker 2 (2026-07-21 HIV_SYP)
It's not an option.
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Speaker 2 (2026-07-21 HIV_SYP)
So let's put the worst case scenario and see what happens.
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Speaker 1 (2026-07-21 HIV_SYP)
Well, Andrea,
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Speaker 1 (2026-07-21 HIV_SYP)
this is for you to be honest,
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Speaker 1 (2026-07-21 HIV_SYP)
if we're at least in a resubmission to sue for this.
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Speaker 1 (2026-07-21 HIV_SYP)
At the moment,
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Speaker 1 (2026-07-21 HIV_SYP)
I'm speaking for IDK.
5:54
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Speaker 1 (2026-07-21 HIV_SYP)
They have a lot of...
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Speaker 1 (2026-07-21 HIV_SYP)
They have...
6:01
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Speaker 1 (2026-07-21 HIV_SYP)
So when can they put this into the
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Speaker 1 (2026-07-21 HIV_SYP)
works?
6:19
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Speaker 2 (2026-07-21 HIV_SYP)
So Andrea,
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Speaker 2 (2026-07-21 HIV_SYP)
would it be possible,
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Speaker 2 (2026-07-21 HIV_SYP)
because by then the submission team or infrastructure
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Speaker 2 (2026-07-21 HIV_SYP)
would be kind of moving out there with submissions,
6:31
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Speaker 2 (2026-07-21 HIV_SYP)
so would they be able to make some of the work for this?
6:59
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Speaker 1 (2026-07-21 HIV_SYP)
All right.
7:02
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Speaker 2 (2026-07-21 HIV_SYP)
So Andrea,
7:05
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Speaker 2 (2026-07-21 HIV_SYP)
do you think
7:28
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Speaker 3 (2026-07-21 HIV_SYP)
This is not what you change.
7:30
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Speaker 3 (2026-07-21 HIV_SYP)
We put too much in there and we're getting information back there.
7:33
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Speaker 1 (2026-07-21 HIV_SYP)
So here's,
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Speaker 3 (2026-07-21 HIV_SYP)
you know, the impact assessment we've already done.
7:37
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Speaker 3 (2026-07-21 HIV_SYP)
It's making an assumption that we have a change to the IP.
7:38
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Speaker 3 (2026-07-21 HIV_SYP)
And I don't want to come from IPDD to IPDR.
7:40
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Speaker 1 (2026-07-21 HIV_SYP)
No,
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Speaker 1 (2026-07-21 HIV_SYP)
Andrea.
7:42
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Speaker 1 (2026-07-21 HIV_SYP)
So if you're changing the intended purpose,
7:45
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Speaker 1 (2026-07-21 HIV_SYP)
that is what you're doing to the top entry level.
7:58
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Speaker 1 (2026-07-21 HIV_SYP)
One thing is an IP change from IPVC
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Speaker 1 (2026-07-21 HIV_SYP)
to IVDR.
8:02
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Speaker 1 (2026-07-21 HIV_SYP)
This changes as a significant change.
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Speaker 1 (2026-07-21 HIV_SYP)
So if that IVDR,
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Speaker 1 (2026-07-21 HIV_SYP)
IVDR change in the standard purpose,
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Speaker 1 (2026-07-21 HIV_SYP)
most companies say,
8:09
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Speaker 1 (2026-07-21 HIV_SYP)
yeah, that is a change for registration,
8:11
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Speaker 1 (2026-07-21 HIV_SYP)
that's fine.
8:12
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Speaker 1 (2026-07-21 HIV_SYP)
When we're seeing changes and changes when we're doing this
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Speaker 1 (2026-07-21 HIV_SYP)
type of change that we're doing,
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Speaker 1 (2026-07-21 HIV_SYP)
that is completely different.
8:52
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Speaker 1 (2026-07-21 HIV_SYP)
You're putting too much pressure all at the end.
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Speaker 1 (2026-07-21 HIV_SYP)
Everything falls under the same place at the end.
9:11
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Speaker 1 (2026-07-21 HIV_SYP)
I know it's too much personal
9:16
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Speaker 1 (2026-07-21 HIV_SYP)
on the signal of people and to the time that they're getting
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Speaker 1 (2026-07-21 HIV_SYP)
very aggressive.
9:20
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Speaker 1 (2026-07-21 HIV_SYP)
Already,
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Speaker 1 (2026-07-21 HIV_SYP)
all of our products are starting to emerge in a multi -place world
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Speaker 1 (2026-07-21 HIV_SYP)
with a lot of companies in school.
9:47
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Speaker 3 (2026-07-21 HIV_SYP)
He hasn't necessarily said that he will go with it just because we're going to be off the market.
9:51
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Speaker 3 (2026-07-21 HIV_SYP)
He's still pushing to help get this.
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Speaker 1 (2026-07-21 HIV_SYP)
I thought you
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Speaker 1 (2026-07-21 HIV_SYP)
had four months on your doc review.
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Speaker 1 (2026-07-21 HIV_SYP)
three months three months three
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Speaker 1 (2026-07-21 HIV_SYP)
months three great things
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Speaker 1 (2026-07-21 HIV_SYP)
and the gaps from Friday.
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Speaker 1 (2026-07-21 HIV_SYP)
The point is,
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Speaker 1 (2026-07-21 HIV_SYP)
if providers prioritise this,
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Speaker 1 (2026-07-21 HIV_SYP)
we could do it in a shorter time for people.
11:26
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Speaker 1 (2026-07-21 HIV_SYP)
You have the knock -on effect on the day of
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Speaker 1 (2026-07-21 HIV_SYP)
this. But these three months,
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Speaker 1 (2026-07-21 HIV_SYP)
in my mind,
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Speaker 1 (2026-07-21 HIV_SYP)
you should be able to put any change through a system in three months.
11:36
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Speaker 1 (2026-07-21 HIV_SYP)
Like, that's a lot,
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Speaker 1 (2026-07-21 HIV_SYP)
right?
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Speaker 1 (2026-07-21 HIV_SYP)
Yes,
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Speaker 1 (2026-07-21 HIV_SYP)
I understand the risk documents won't.
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Speaker 1 (2026-07-21 HIV_SYP)
The desired documents that we should still
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Speaker 1 (2026-07-21 HIV_SYP)
be able to tie them apart.
12:05
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Speaker 1 (2026-07-21 HIV_SYP)
Everything can help me in the emergency, guys.
12:09
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Speaker 1 (2026-07-21 HIV_SYP)
Understand.
12:09
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Speaker 1 (2026-07-21 HIV_SYP)
Understand.
12:10
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Speaker 1 (2026-07-21 HIV_SYP)
Understand.
12:11
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Speaker 1 (2026-07-21 HIV_SYP)
Understand. Understand.
12:11
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Speaker 1 (2026-07-21 HIV_SYP)
I don't understand.
12:12
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Speaker 1 (2026-07-21 HIV_SYP)
I don't understand. But the exercise here is getting up over here.
12:15
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Speaker 1 (2026-07-21 HIV_SYP)
We need to see what it looks like for us.
12:18
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Speaker 1 (2026-07-21 HIV_SYP)
And then we have to go to another level.
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Speaker 1 (2026-07-21 HIV_SYP)
because it's too late
12:52
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Speaker 1 (2026-07-21 HIV_SYP)
So let's do all of this.
12:53
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Speaker 1 (2026-07-21 HIV_SYP)
We've done an escalation slide.
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Speaker 1 (2026-07-21 HIV_SYP)
We have a process for these kind of things we need to then take to the next level.
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Speaker 1 (2026-07-21 HIV_SYP)
We have to stay with a verbal discussion.
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Speaker 1 (2026-07-21 HIV_SYP)
We have to have something up there.
13:03
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Speaker 1 (2026-07-21 HIV_SYP)
Yeah.
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Speaker 1 (2026-07-21 HIV_SYP)
Yeah.
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Speaker 1 (2026-07-21 HIV_SYP)
So if
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Speaker 1 (2026-07-21 HIV_SYP)
we start into this one,
13:10
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Speaker 1 (2026-07-21 HIV_SYP)
and then once we're ready,
13:11
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Speaker 1 (2026-07-21 HIV_SYP)
so we need to start from scratch.
13:15
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Speaker 1 (2026-07-21 HIV_SYP)
Yeah.
13:16
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Speaker 1 (2026-07-21 HIV_SYP)
Yeah.
13:17
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Speaker 1 (2026-07-21 HIV_SYP)
I'm just done.
13:39
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Speaker 1 (2026-07-21 HIV_SYP)
So that's not going to impact on
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Speaker 1 (2026-07-21 HIV_SYP)
or the...
14:00
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Speaker 1 (2026-07-21 HIV_SYP)
So for me,
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Speaker 1 (2026-07-21 HIV_SYP)
whether it's pink or blue,
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Speaker 1 (2026-07-21 HIV_SYP)
for them it's an IVDR update.
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Speaker 1 (2026-07-21 HIV_SYP)
We know that it was pink and then they need to
14:09
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Speaker 1 (2026-07-21 HIV_SYP)
change to blue, but that's only what they want.
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Speaker 1 (2026-07-21 HIV_SYP)
They only seem one color.
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Speaker 1 (2026-07-21 HIV_SYP)
So what do we need to do as
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Speaker 1 (2026-07-21 HIV_SYP)
a team?
14:41
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Speaker 1 (2026-07-21 HIV_SYP)
What do we do to elevate this issue?
14:43
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Speaker 1 (2026-07-21 HIV_SYP)
What do we need to do to make leadership aware of this bandwidth issue that we
14:47
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Speaker 1 (2026-07-21 HIV_SYP)
have?
14:47
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Speaker 1 (2026-07-21 HIV_SYP)
And how do we resolve it?
14:49
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Speaker 1 (2026-07-21 HIV_SYP)
Is it a prioritisation issue?
14:51
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Speaker 1 (2026-07-21 HIV_SYP)
Do we have to tell you which one is the one we want to focus on instead of bringing everything
14:56
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Speaker 1 (2026-07-21 HIV_SYP)
together?
14:56
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Speaker 1 (2026-07-21 HIV_SYP)
What are the next steps we do here?
15:03
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Speaker 1 (2026-07-21 HIV_SYP)
I think,
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Speaker 1 (2026-07-21 HIV_SYP)
like we're doing here now,
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Speaker 1 (2026-07-21 HIV_SYP)
for us to really see how much impact this is going to
15:10
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Speaker 1 (2026-07-21 HIV_SYP)
have, we need to know what does this mean if we need to do with
15:14
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Speaker 1 (2026-07-21 HIV_SYP)
this. We're not saying it's going to be done,
15:17
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Speaker 1 (2026-07-21 HIV_SYP)
but let's see what it needs to look like for us.
15:43
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Speaker 1 (2026-07-21 HIV_SYP)
Because I was never going to say,
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Speaker 1 (2026-07-21 HIV_SYP)
oh, we have seen change implications go in that take longer than that,
15:50
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Speaker 1 (2026-07-21 HIV_SYP)
that we anticipate that it's not fair.
15:52
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Speaker 1 (2026-07-21 HIV_SYP)
So let's be honest about the worst case scenario.
15:58
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Speaker 1 (2026-07-21 HIV_SYP)
Let's be conservative.
15:58
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Speaker 1 (2026-07-21 HIV_SYP)
If you don't want to say six,
16:01
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Speaker 1 (2026-07-21 HIV_SYP)
that's fine.
16:01
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Speaker 1 (2026-07-21 HIV_SYP)
Let's go with four.
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Speaker 1 (2026-07-21 HIV_SYP)
Something that is a little bit more realistic.
16:05
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Speaker 1 (2026-07-21 HIV_SYP)
I don't want to overthrow us three months.
16:07
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Speaker 1 (2026-07-21 HIV_SYP)
A lot of times we have not seen three months come in too soon.
16:11
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Speaker 1 (2026-07-21 HIV_SYP)
Fair enough.
16:14
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Speaker 1 (2026-07-21 HIV_SYP)
Then you need to add two months for my team to work and
16:19
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Speaker 1 (2026-07-21 HIV_SYP)
four months for my team to review.
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