2027-07-22 urocolor
Jul 22, 2026 04:34
· 14:29
· English
· Whisper Turbo
· 1 Kaikōrero
Ka ngaro tēnei tāruatanga i roto i 9 rā.
Whakahauhau mo te rokiroki tūturu →
E whakaatu ana anake
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Speaker 1 (2027-07-22 urocolor)
It's the one that you're here if I can find it from a shelf
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Speaker 1 (2027-07-22 urocolor)
life. Yeah, yeah.
0:07
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Speaker 1 (2027-07-22 urocolor)
So from
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Speaker 1 (2027-07-22 urocolor)
the capital point,
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Speaker 1 (2027-07-22 urocolor)
have we told to you the event or what have we got approved
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Speaker 1 (2027-07-22 urocolor)
tonight?
0:16
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Speaker 1 (2027-07-22 urocolor)
Is it 12 months or 24?
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Speaker 1 (2027-07-22 urocolor)
24
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Speaker 1 (2027-07-22 urocolor)
Yeah, it's only an interim mode of control.
0:28
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Speaker 1 (2027-07-22 urocolor)
I believe you're
0:33
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Speaker 1 (2027-07-22 urocolor)
inserted in your IEP to say 12 months ago,
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Speaker 1 (2027-07-22 urocolor)
correct?
0:48
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Speaker 1 (2027-07-22 urocolor)
Andrea,
0:49
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Speaker 1 (2027-07-22 urocolor)
for Vietnam,
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Speaker 1 (2027-07-22 urocolor)
their country's specific requirement is mentioning
0:54
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Speaker 1 (2027-07-22 urocolor)
the shelf life on IP,
0:56
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Speaker 1 (2027-07-22 urocolor)
and so there is no shelf
1:00
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Speaker 1 (2027-07-22 urocolor)
life on the monster or translated IP,
1:03
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Speaker 1 (2027-07-22 urocolor)
but there is the shelf life mentioned on Vietnam's specific IP.
1:13
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Speaker 1 (2027-07-22 urocolor)
It should be 12 months or Vietnam for the day.
1:17
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Speaker 1 (2027-07-22 urocolor)
So do you think we need to change
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Speaker 1 (2027-07-22 urocolor)
the shelf life,
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Speaker 1 (2027-07-22 urocolor)
reduce the shelf life of
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Speaker 1 (2027-07-22 urocolor)
a leukocyte test,
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Speaker 1 (2027-07-22 urocolor)
which is we didn't touch any shelf life for
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Speaker 1 (2027-07-22 urocolor)
the finished product information.
1:34
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Speaker 1 (2027-07-22 urocolor)
So I guess the re -registered duration will be 12
1:38
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Speaker 1 (2027-07-22 urocolor)
months.
1:41
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Speaker 1 (2027-07-22 urocolor)
but if we use muscle muscle,
1:44
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Speaker 1 (2027-07-22 urocolor)
it will impact to the final product.
1:47
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Speaker 1 (2027-07-22 urocolor)
So the free information will be
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Speaker 1 (2027-07-22 urocolor)
applied from the leukocyte headshot.
1:55
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Speaker 1 (2027-07-22 urocolor)
but our registration or label didn't
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Speaker 1 (2027-07-22 urocolor)
exist from this CAPA in remote control,
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Speaker 1 (2027-07-22 urocolor)
except few countries requiring
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Speaker 1 (2027-07-22 urocolor)
registration from this interim action.
2:26
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Speaker 1 (2027-07-22 urocolor)
It sounds like there's an issue with that realty instability.
2:29
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Speaker 1 (2027-07-22 urocolor)
It's calling into question the Red
2:36
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Speaker 1 (2027-07-22 urocolor)
Cause investigation piece of it.
2:42
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Speaker 1 (2027-07-22 urocolor)
Is that correct?
2:43
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Speaker 1 (2027-07-22 urocolor)
So I'm going to take it from the other angle and ask,
2:47
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Speaker 1 (2027-07-22 urocolor)
can they give us an update on the whole Kappa process?
2:51
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Speaker 1 (2027-07-22 urocolor)
Can we just zoom to the chef's life?
2:53
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Speaker 1 (2027-07-22 urocolor)
So let's get the,
2:54
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Speaker 1 (2027-07-22 urocolor)
we're done with the process,
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Speaker 1 (2027-07-22 urocolor)
what's next?
2:56
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Speaker 1 (2027-07-22 urocolor)
And then we'll find out what we need to do from an idea.
3:00
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Speaker 1 (2027-07-22 urocolor)
The ability is not going to be finished after the update.
3:03
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Speaker 1 (2027-07-22 urocolor)
Next point.
3:07
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Speaker 1 (2027-07-22 urocolor)
It was like next March, next year.
3:36
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Speaker 1 (2027-07-22 urocolor)
I can highlight in red.
4:07
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Speaker 1 (2027-07-22 urocolor)
So, at what day,
4:09
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Speaker 1 (2027-07-22 urocolor)
what month were you testing?
4:11
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Speaker 1 (2027-07-22 urocolor)
At this time you saw exam.
4:14
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Speaker 1 (2027-07-22 urocolor)
So,
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Speaker 1 (2027-07-22 urocolor)
sometimes the police,
4:16
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Speaker 1 (2027-07-22 urocolor)
it's...
4:17
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Speaker 1 (2027-07-22 urocolor)
Oh,
4:17
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Speaker 1 (2027-07-22 urocolor)
oh.
4:18
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Speaker 1 (2027-07-22 urocolor)
So, when we call
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Speaker 1 (2027-07-22 urocolor)
the vendor.
4:26
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Speaker 1 (2027-07-22 urocolor)
And I think there's no information for
4:30
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Speaker 1 (2027-07-22 urocolor)
the product manufactured in 2025,
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Speaker 1 (2027-07-22 urocolor)
which is the internal control was applied.
4:37
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Speaker 1 (2027-07-22 urocolor)
And we got the failure from 16
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Speaker 1 (2027-07-22 urocolor)
months.
4:55
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Speaker 1 (2027-07-22 urocolor)
So you had to go to the best case scenario.
5:00
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Speaker 1 (2027-07-22 urocolor)
Where are you sure you have all analyzed?
5:03
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Speaker 1 (2027-07-22 urocolor)
What was the length?
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Speaker 1 (2027-07-22 urocolor)
What was the exit?
5:07
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Speaker 1 (2027-07-22 urocolor)
You had to reduce the data from that simulation.
5:10
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Speaker 1 (2027-07-22 urocolor)
Where would we land?
5:11
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Speaker 1 (2027-07-22 urocolor)
Because
5:15
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Speaker 1 (2027-07-22 urocolor)
12 was just the data from the laser on the Leuka side.
5:18
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Speaker 1 (2027-07-22 urocolor)
But if you had to analyze what's happening,
5:21
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Speaker 1 (2027-07-22 urocolor)
when can you guarantee that all analyze what's happening?
5:24
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Speaker 1 (2027-07-22 urocolor)
If it is this question,
5:27
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Speaker 1 (2027-07-22 urocolor)
we will receive the TU,
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Speaker 1 (2027-07-22 urocolor)
and if the product is idealized,
5:35
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Speaker 1 (2027-07-22 urocolor)
I would say over this problem,
5:38
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Speaker 1 (2027-07-22 urocolor)
and that is not a change,
5:41
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Speaker 1 (2027-07-22 urocolor)
but only change to the observatory criteria,
5:46
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Speaker 1 (2027-07-22 urocolor)
and the street,
6:00
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Speaker 1 (2027-07-22 urocolor)
This condition is different to the current
6:05
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Speaker 1 (2027-07-22 urocolor)
test condition.
6:06
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Speaker 1 (2027-07-22 urocolor)
The current test condition is more or harder condition than
6:10
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Speaker 1 (2027-07-22 urocolor)
when we set the CMP line.
6:26
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Speaker 1 (2027-07-22 urocolor)
yeah yeah yeah yeah
6:53
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Speaker 1 (2027-07-22 urocolor)
What are your next
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Speaker 1 (2027-07-22 urocolor)
steps?
7:00
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Speaker 1 (2027-07-22 urocolor)
Now you're at the point where you have realized other analysts have failed at,
7:04
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Speaker 1 (2027-07-22 urocolor)
say, 16 months beyond.
7:06
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Speaker 1 (2027-07-22 urocolor)
What's the next step?
7:26
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Speaker 1 (2027-07-22 urocolor)
So just we have a step forward to the station.
8:11
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Speaker 1 (2027-07-22 urocolor)
The new date is only in September,
8:14
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Speaker 1 (2027-07-22 urocolor)
but based on my experience on Ecosy's
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Speaker 1 (2027-07-22 urocolor)
investigation,
8:19
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Speaker 1 (2027-07-22 urocolor)
it can take more time than our
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Speaker 1 (2027-07-22 urocolor)
new date,
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Speaker 1 (2027-07-22 urocolor)
which is set up based on our API,
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Speaker 1 (2027-07-22 urocolor)
so much more can be done in this time.
8:34
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Speaker 1 (2027-07-22 urocolor)
Keep our data to show the failure
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Speaker 1 (2027-07-22 urocolor)
from the test.
8:40
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Speaker 1 (2027-07-22 urocolor)
So we are not going to lose the test.
8:42
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Speaker 1 (2027-07-22 urocolor)
This test is all we have.
8:44
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Speaker 1 (2027-07-22 urocolor)
OK,
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Speaker 1 (2027-07-22 urocolor)
OK.
8:47
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Speaker 1 (2027-07-22 urocolor)
So the time we're going to do the investigation,
8:51
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Speaker 1 (2027-07-22 urocolor)
possibly we could get off.
8:55
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Speaker 1 (2027-07-22 urocolor)
So then,
8:57
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Speaker 1 (2027-07-22 urocolor)
from the next year,
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Speaker 1 (2027-07-22 urocolor)
point where you can,
8:59
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Speaker 1 (2027-07-22 urocolor)
what stage are we at?
9:02
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Speaker 1 (2027-07-22 urocolor)
Cement right here or so.
9:07
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Speaker 1 (2027-07-22 urocolor)
So what's the worst thing in the world is failure or things that we just perceived?
9:11
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Speaker 1 (2027-07-22 urocolor)
Well,
9:15
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Speaker 1 (2027-07-22 urocolor)
this is where I was kind of going with it.
9:18
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Speaker 1 (2027-07-22 urocolor)
From either our point of view,
9:19
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Speaker 1 (2027-07-22 urocolor)
this product is selling on -market.
9:21
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Speaker 1 (2027-07-22 urocolor)
They've been used there,
9:23
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Speaker 1 (2027-07-22 urocolor)
they're still surprising,
9:24
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Speaker 1 (2027-07-22 urocolor)
they've done their pre -daction,
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Speaker 1 (2027-07-22 urocolor)
they've registered it into 12 months.
9:27
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Speaker 1 (2027-07-22 urocolor)
Are we passing it 12 months?
9:29
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Speaker 1 (2027-07-22 urocolor)
No, we're not passing it 12 months.
9:31
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Speaker 1 (2027-07-22 urocolor)
So the problem is,
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Speaker 1 (2027-07-22 urocolor)
if it doesn't pass after 24,
9:36
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Speaker 1 (2027-07-22 urocolor)
we will have to officially go out and reduce our day,
9:39
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Speaker 1 (2027-07-22 urocolor)
which we haven't done.
9:40
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Speaker 1 (2027-07-22 urocolor)
Well, we are seeing activities and other
9:45
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Speaker 1 (2027-07-22 urocolor)
analyses indicating more complex issues.
9:47
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Speaker 1 (2027-07-22 urocolor)
So my question would be,
9:49
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Speaker 1 (2027-07-22 urocolor)
you have these scores of 10 and 11.
9:52
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Speaker 1 (2027-07-22 urocolor)
Is that all you have for IBDO?
9:59
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Speaker 1 (2027-07-22 urocolor)
There is a fundamental thing I heard from Chuzan.
10:05
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Speaker 1 (2027-07-22 urocolor)
Chuzan said,
10:06
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Speaker 1 (2027-07-22 urocolor)
the original data set was conducted at
10:10
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Speaker 1 (2027-07-22 urocolor)
room temperature.
10:11
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Speaker 1 (2027-07-22 urocolor)
Yes, I know.
10:12
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Speaker 1 (2027-07-22 urocolor)
Yes, I know.
10:12
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Speaker 1 (2027-07-22 urocolor)
So
10:17
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Speaker 1 (2027-07-22 urocolor)
obviously,
10:18
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Speaker 1 (2027-07-22 urocolor)
we're not going to be able to replicate
10:22
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Speaker 1 (2027-07-22 urocolor)
that.
10:23
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Speaker 1 (2027-07-22 urocolor)
And this is why we're taking these answers.
10:25
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Speaker 1 (2027-07-22 urocolor)
I get that.
10:27
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Speaker 1 (2027-07-22 urocolor)
I guess that.
10:28
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Speaker 1 (2027-07-22 urocolor)
Zero, two, zero,
10:29
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Speaker 1 (2027-07-22 urocolor)
two, zero,
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Speaker 1 (2027-07-22 urocolor)
four. Zero, two, zero, four.
10:31
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Speaker 1 (2027-07-22 urocolor)
Zero, two, zero, four. Zero, zero, four.
10:31
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Speaker 1 (2027-07-22 urocolor)
Zero,
10:32
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Speaker 1 (2027-07-22 urocolor)
zero, four. Zero, zero,
10:33
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Speaker 1 (2027-07-22 urocolor)
four. Zero, zero, zero, zero, zero.
10:34
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Speaker 1 (2027-07-22 urocolor)
Zero, zero, zero, zero, zero.
10:34
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Speaker 1 (2027-07-22 urocolor)
Zero, zero, zero, zero, zero. Zero, zero, zero, zero, zero. Zero,
10:35
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Speaker 1 (2027-07-22 urocolor)
zero,
10:37
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Speaker 1 (2027-07-22 urocolor)
zero, zero,
10:38
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Speaker 1 (2027-07-22 urocolor)
zero, zero, zero, zero, zero,
10:39
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Speaker 1 (2027-07-22 urocolor)
zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero,
10:40
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Speaker 1 (2027-07-22 urocolor)
zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero,
10:41
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Speaker 1 (2027-07-22 urocolor)
so it's only so it's only
10:56
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Speaker 1 (2027-07-22 urocolor)
So you can only go
11:00
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Speaker 1 (2027-07-22 urocolor)
with two.
11:23
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Speaker 1 (2027-07-22 urocolor)
Are your projections?
11:25
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Speaker 1 (2027-07-22 urocolor)
What is,
11:28
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Speaker 1 (2027-07-22 urocolor)
do we have even a diagnosis?
11:32
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Speaker 1 (2027-07-22 urocolor)
What can we do?
11:35
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Speaker 1 (2027-07-22 urocolor)
How severe will we see the results
11:39
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Speaker 1 (2027-07-22 urocolor)
coming downstream?
11:40
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Speaker 1 (2027-07-22 urocolor)
Is there any hypothetical?
12:02
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Speaker 1 (2027-07-22 urocolor)
Andrea?
12:04
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Speaker 1 (2027-07-22 urocolor)
Andrea?
12:10
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Speaker 1 (2027-07-22 urocolor)
Yeah.
12:26
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Speaker 1 (2027-07-22 urocolor)
At the end of the official field action,
12:27
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Speaker 1 (2027-07-22 urocolor)
that field action is allowing us to keep them as product at the rigid state
12:32
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Speaker 1 (2027-07-22 urocolor)
until we implement and show that
12:36
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Speaker 1 (2027-07-22 urocolor)
we can meet 24 months daily.
12:39
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Speaker 1 (2027-07-22 urocolor)
We've now had another issue,
12:42
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Speaker 1 (2027-07-22 urocolor)
because that's the opinion of our mode of control,
12:44
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Speaker 1 (2027-07-22 urocolor)
which would be another investigation,
12:45
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Speaker 1 (2027-07-22 urocolor)
could end up on another field action and have different actions that need to be taken.
12:48
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Speaker 1 (2027-07-22 urocolor)
At that time,
12:49
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Speaker 1 (2027-07-22 urocolor)
it could be on our own as to what that investigation is going to look like,
12:53
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Speaker 1 (2027-07-22 urocolor)
what the outcomes are going to be,
12:54
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Speaker 1 (2027-07-22 urocolor)
or what the next steps are going to be.
12:56
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Speaker 1 (2027-07-22 urocolor)
So I think from us as a team point of view,
12:59
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Speaker 1 (2027-07-22 urocolor)
what we can do is go with what the information is that we have at the moment,
13:01
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Speaker 1 (2027-07-22 urocolor)
which is we have a field action saying there's no issue with this product and we're going to adjust it to 12 months.
13:05
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Speaker 1 (2027-07-22 urocolor)
I'm interested to understand more about the 32
13:10
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Speaker 1 (2027-07-22 urocolor)
degrees,
13:10
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Speaker 1 (2027-07-22 urocolor)
why we're testing 32 degrees,
13:12
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Speaker 1 (2027-07-22 urocolor)
because I see in HHE that the storage temperature only goes up to 30 degrees.
13:15
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Speaker 1 (2027-07-22 urocolor)
So is this an accelerated?
13:17
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Speaker 1 (2027-07-22 urocolor)
Or why are we going to be on the storage claims
13:21
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Speaker 1 (2027-07-22 urocolor)
or in a package insert?
13:23
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Speaker 1 (2027-07-22 urocolor)
um but that's a separate issue to what we're trying to resolve here we're trying to resolve what
13:28
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Speaker 1 (2027-07-22 urocolor)
do we do for your implementation yeah yeah so
13:32
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Speaker 1 (2027-07-22 urocolor)
from an idea of your implementation point of view that's
13:37
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Speaker 1 (2027-07-22 urocolor)
always going to ask what what are we cleaning and what are we certified for do
13:42
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Speaker 1 (2027-07-22 urocolor)
we do we certified for sorry again and is what
13:46
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Speaker 1 (2027-07-22 urocolor)
we're certified in alignment to whatever that connection was that was issued out of this qi
13:59
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Speaker 1 (2027-07-22 urocolor)
all of these issues were yes it
14:03
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Speaker 1 (2027-07-22 urocolor)
would have been 24 months
14:08
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Speaker 1 (2027-07-22 urocolor)
in those documentation okay so then what
14:12
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Speaker 1 (2027-07-22 urocolor)
did we tell tp during that production what was our what was our outcome from
14:16
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Speaker 1 (2027-07-22 urocolor)
our um impact on qi what
14:20
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Speaker 1 (2027-07-22 urocolor)
did we say we were going to do
14:23
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Speaker 1 (2027-07-22 urocolor)
Thank you.
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