2027-07-22 urocolor

Jul 22, 2026 04:34 · 14:29 · English · Whisper Turbo · 1 স্পিকার

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0:01

S… Speaker 1 (2027-07-22 urocolor)

It's the one that you're here if I can find it from a shelf

0:06

S… Speaker 1 (2027-07-22 urocolor)

life. Yeah, yeah.

0:07

S… Speaker 1 (2027-07-22 urocolor)

So from

0:11

S… Speaker 1 (2027-07-22 urocolor)

the capital point,

0:12

S… Speaker 1 (2027-07-22 urocolor)

have we told to you the event or what have we got approved

0:16

S… Speaker 1 (2027-07-22 urocolor)

tonight?

0:16

S… Speaker 1 (2027-07-22 urocolor)

Is it 12 months or 24?

0:20

S… Speaker 1 (2027-07-22 urocolor)

0:26

S… Speaker 1 (2027-07-22 urocolor)

Yeah, it's only an interim mode of control.

0:28

S… Speaker 1 (2027-07-22 urocolor)

I believe you're

0:33

S… Speaker 1 (2027-07-22 urocolor)

inserted in your IEP to say 12 months ago,

0:35

S… Speaker 1 (2027-07-22 urocolor)

correct?

0:48

S… Speaker 1 (2027-07-22 urocolor)

Andrea,

0:49

S… Speaker 1 (2027-07-22 urocolor)

for Vietnam,

0:50

S… Speaker 1 (2027-07-22 urocolor)

their country's specific requirement is mentioning

0:54

S… Speaker 1 (2027-07-22 urocolor)

the shelf life on IP,

0:56

S… Speaker 1 (2027-07-22 urocolor)

and so there is no shelf

1:00

S… Speaker 1 (2027-07-22 urocolor)

life on the monster or translated IP,

1:03

S… Speaker 1 (2027-07-22 urocolor)

but there is the shelf life mentioned on Vietnam's specific IP.

1:13

S… Speaker 1 (2027-07-22 urocolor)

It should be 12 months or Vietnam for the day.

1:17

S… Speaker 1 (2027-07-22 urocolor)

So do you think we need to change

1:21

S… Speaker 1 (2027-07-22 urocolor)

the shelf life,

1:23

S… Speaker 1 (2027-07-22 urocolor)

reduce the shelf life of

1:27

S… Speaker 1 (2027-07-22 urocolor)

a leukocyte test,

1:28

S… Speaker 1 (2027-07-22 urocolor)

which is we didn't touch any shelf life for

1:32

S… Speaker 1 (2027-07-22 urocolor)

the finished product information.

1:34

S… Speaker 1 (2027-07-22 urocolor)

So I guess the re -registered duration will be 12

1:38

S… Speaker 1 (2027-07-22 urocolor)

months.

1:41

S… Speaker 1 (2027-07-22 urocolor)

but if we use muscle muscle,

1:44

S… Speaker 1 (2027-07-22 urocolor)

it will impact to the final product.

1:47

S… Speaker 1 (2027-07-22 urocolor)

So the free information will be

1:52

S… Speaker 1 (2027-07-22 urocolor)

applied from the leukocyte headshot.

1:55

S… Speaker 1 (2027-07-22 urocolor)

but our registration or label didn't

2:01

S… Speaker 1 (2027-07-22 urocolor)

exist from this CAPA in remote control,

2:04

S… Speaker 1 (2027-07-22 urocolor)

except few countries requiring

2:08

S… Speaker 1 (2027-07-22 urocolor)

registration from this interim action.

2:26

S… Speaker 1 (2027-07-22 urocolor)

It sounds like there's an issue with that realty instability.

2:29

S… Speaker 1 (2027-07-22 urocolor)

It's calling into question the Red

2:36

S… Speaker 1 (2027-07-22 urocolor)

Cause investigation piece of it.

2:42

S… Speaker 1 (2027-07-22 urocolor)

Is that correct?

2:43

S… Speaker 1 (2027-07-22 urocolor)

So I'm going to take it from the other angle and ask,

2:47

S… Speaker 1 (2027-07-22 urocolor)

can they give us an update on the whole Kappa process?

2:51

S… Speaker 1 (2027-07-22 urocolor)

Can we just zoom to the chef's life?

2:53

S… Speaker 1 (2027-07-22 urocolor)

So let's get the,

2:54

S… Speaker 1 (2027-07-22 urocolor)

we're done with the process,

2:56

S… Speaker 1 (2027-07-22 urocolor)

what's next?

2:56

S… Speaker 1 (2027-07-22 urocolor)

And then we'll find out what we need to do from an idea.

3:00

S… Speaker 1 (2027-07-22 urocolor)

The ability is not going to be finished after the update.

3:03

S… Speaker 1 (2027-07-22 urocolor)

Next point.

3:07

S… Speaker 1 (2027-07-22 urocolor)

It was like next March, next year.

3:36

S… Speaker 1 (2027-07-22 urocolor)

I can highlight in red.

4:07

S… Speaker 1 (2027-07-22 urocolor)

So, at what day,

4:09

S… Speaker 1 (2027-07-22 urocolor)

what month were you testing?

4:11

S… Speaker 1 (2027-07-22 urocolor)

At this time you saw exam.

4:14

S… Speaker 1 (2027-07-22 urocolor)

So,

4:14

S… Speaker 1 (2027-07-22 urocolor)

sometimes the police,

4:16

S… Speaker 1 (2027-07-22 urocolor)

it's...

4:17

S… Speaker 1 (2027-07-22 urocolor)

Oh,

4:17

S… Speaker 1 (2027-07-22 urocolor)

oh.

4:18

S… Speaker 1 (2027-07-22 urocolor)

So, when we call

4:22

S… Speaker 1 (2027-07-22 urocolor)

the vendor.

4:26

S… Speaker 1 (2027-07-22 urocolor)

And I think there's no information for

4:30

S… Speaker 1 (2027-07-22 urocolor)

the product manufactured in 2025,

4:33

S… Speaker 1 (2027-07-22 urocolor)

which is the internal control was applied.

4:37

S… Speaker 1 (2027-07-22 urocolor)

And we got the failure from 16

4:43

S… Speaker 1 (2027-07-22 urocolor)

months.

4:55

S… Speaker 1 (2027-07-22 urocolor)

So you had to go to the best case scenario.

5:00

S… Speaker 1 (2027-07-22 urocolor)

Where are you sure you have all analyzed?

5:03

S… Speaker 1 (2027-07-22 urocolor)

What was the length?

5:05

S… Speaker 1 (2027-07-22 urocolor)

What was the exit?

5:07

S… Speaker 1 (2027-07-22 urocolor)

You had to reduce the data from that simulation.

5:10

S… Speaker 1 (2027-07-22 urocolor)

Where would we land?

5:11

S… Speaker 1 (2027-07-22 urocolor)

Because

5:15

S… Speaker 1 (2027-07-22 urocolor)

12 was just the data from the laser on the Leuka side.

5:18

S… Speaker 1 (2027-07-22 urocolor)

But if you had to analyze what's happening,

5:21

S… Speaker 1 (2027-07-22 urocolor)

when can you guarantee that all analyze what's happening?

5:24

S… Speaker 1 (2027-07-22 urocolor)

If it is this question,

5:27

S… Speaker 1 (2027-07-22 urocolor)

we will receive the TU,

5:31

S… Speaker 1 (2027-07-22 urocolor)

and if the product is idealized,

5:35

S… Speaker 1 (2027-07-22 urocolor)

I would say over this problem,

5:38

S… Speaker 1 (2027-07-22 urocolor)

and that is not a change,

5:41

S… Speaker 1 (2027-07-22 urocolor)

but only change to the observatory criteria,

5:46

S… Speaker 1 (2027-07-22 urocolor)

and the street,

6:00

S… Speaker 1 (2027-07-22 urocolor)

This condition is different to the current

6:05

S… Speaker 1 (2027-07-22 urocolor)

test condition.

6:06

S… Speaker 1 (2027-07-22 urocolor)

The current test condition is more or harder condition than

6:10

S… Speaker 1 (2027-07-22 urocolor)

when we set the CMP line.

6:26

S… Speaker 1 (2027-07-22 urocolor)

yeah yeah yeah yeah

6:53

S… Speaker 1 (2027-07-22 urocolor)

What are your next

6:57

S… Speaker 1 (2027-07-22 urocolor)

steps?

7:00

S… Speaker 1 (2027-07-22 urocolor)

Now you're at the point where you have realized other analysts have failed at,

7:04

S… Speaker 1 (2027-07-22 urocolor)

say, 16 months beyond.

7:06

S… Speaker 1 (2027-07-22 urocolor)

What's the next step?

7:26

S… Speaker 1 (2027-07-22 urocolor)

So just we have a step forward to the station.

8:11

S… Speaker 1 (2027-07-22 urocolor)

The new date is only in September,

8:14

S… Speaker 1 (2027-07-22 urocolor)

but based on my experience on Ecosy's

8:19

S… Speaker 1 (2027-07-22 urocolor)

investigation,

8:19

S… Speaker 1 (2027-07-22 urocolor)

it can take more time than our

8:23

S… Speaker 1 (2027-07-22 urocolor)

new date,

8:25

S… Speaker 1 (2027-07-22 urocolor)

which is set up based on our API,

8:28

S… Speaker 1 (2027-07-22 urocolor)

so much more can be done in this time.

8:34

S… Speaker 1 (2027-07-22 urocolor)

Keep our data to show the failure

8:39

S… Speaker 1 (2027-07-22 urocolor)

from the test.

8:40

S… Speaker 1 (2027-07-22 urocolor)

So we are not going to lose the test.

8:42

S… Speaker 1 (2027-07-22 urocolor)

This test is all we have.

8:44

S… Speaker 1 (2027-07-22 urocolor)

OK,

8:47

S… Speaker 1 (2027-07-22 urocolor)

OK.

8:47

S… Speaker 1 (2027-07-22 urocolor)

So the time we're going to do the investigation,

8:51

S… Speaker 1 (2027-07-22 urocolor)

possibly we could get off.

8:55

S… Speaker 1 (2027-07-22 urocolor)

So then,

8:57

S… Speaker 1 (2027-07-22 urocolor)

from the next year,

8:58

S… Speaker 1 (2027-07-22 urocolor)

point where you can,

8:59

S… Speaker 1 (2027-07-22 urocolor)

what stage are we at?

9:02

S… Speaker 1 (2027-07-22 urocolor)

Cement right here or so.

9:07

S… 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

S… Speaker 1 (2027-07-22 urocolor)

Well,

9:15

S… Speaker 1 (2027-07-22 urocolor)

this is where I was kind of going with it.

9:18

S… Speaker 1 (2027-07-22 urocolor)

From either our point of view,

9:19

S… Speaker 1 (2027-07-22 urocolor)

this product is selling on -market.

9:21

S… Speaker 1 (2027-07-22 urocolor)

They've been used there,

9:23

S… Speaker 1 (2027-07-22 urocolor)

they're still surprising,

9:24

S… Speaker 1 (2027-07-22 urocolor)

they've done their pre -daction,

9:25

S… Speaker 1 (2027-07-22 urocolor)

they've registered it into 12 months.

9:27

S… Speaker 1 (2027-07-22 urocolor)

Are we passing it 12 months?

9:29

S… Speaker 1 (2027-07-22 urocolor)

No, we're not passing it 12 months.

9:31

S… Speaker 1 (2027-07-22 urocolor)

So the problem is,

9:33

S… Speaker 1 (2027-07-22 urocolor)

if it doesn't pass after 24,

9:36

S… Speaker 1 (2027-07-22 urocolor)

we will have to officially go out and reduce our day,

9:39

S… Speaker 1 (2027-07-22 urocolor)

which we haven't done.

9:40

S… Speaker 1 (2027-07-22 urocolor)

Well, we are seeing activities and other

9:45

S… Speaker 1 (2027-07-22 urocolor)

analyses indicating more complex issues.

9:47

S… Speaker 1 (2027-07-22 urocolor)

So my question would be,

9:49

S… Speaker 1 (2027-07-22 urocolor)

you have these scores of 10 and 11.

9:52

S… Speaker 1 (2027-07-22 urocolor)

Is that all you have for IBDO?

9:59

S… Speaker 1 (2027-07-22 urocolor)

There is a fundamental thing I heard from Chuzan.

10:05

S… Speaker 1 (2027-07-22 urocolor)

Chuzan said,

10:06

S… Speaker 1 (2027-07-22 urocolor)

the original data set was conducted at

10:10

S… Speaker 1 (2027-07-22 urocolor)

room temperature.

10:11

S… Speaker 1 (2027-07-22 urocolor)

Yes, I know.

10:12

S… Speaker 1 (2027-07-22 urocolor)

Yes, I know.

10:12

S… Speaker 1 (2027-07-22 urocolor)

10:17

S… Speaker 1 (2027-07-22 urocolor)

obviously,

10:18

S… Speaker 1 (2027-07-22 urocolor)

we're not going to be able to replicate

10:22

S… Speaker 1 (2027-07-22 urocolor)

that.

10:23

S… Speaker 1 (2027-07-22 urocolor)

And this is why we're taking these answers.

10:25

S… Speaker 1 (2027-07-22 urocolor)

I get that.

10:27

S… Speaker 1 (2027-07-22 urocolor)

I guess that.

10:28

S… Speaker 1 (2027-07-22 urocolor)

Zero, two, zero,

10:29

S… Speaker 1 (2027-07-22 urocolor)

two, zero,

10:30

S… Speaker 1 (2027-07-22 urocolor)

four. Zero, two, zero, four.

10:31

S… Speaker 1 (2027-07-22 urocolor)

Zero, two, zero, four. Zero, zero, four.

10:31

S… Speaker 1 (2027-07-22 urocolor)

Zero,

10:32

S… Speaker 1 (2027-07-22 urocolor)

zero, four. Zero, zero,

10:33

S… Speaker 1 (2027-07-22 urocolor)

four. Zero, zero, zero, zero, zero.

10:34

S… Speaker 1 (2027-07-22 urocolor)

Zero, zero, zero, zero, zero.

10:34

S… Speaker 1 (2027-07-22 urocolor)

Zero, zero, zero, zero, zero. Zero, zero, zero, zero, zero. Zero,

10:35

S… Speaker 1 (2027-07-22 urocolor)

zero,

10:37

S… Speaker 1 (2027-07-22 urocolor)

zero, zero,

10:38

S… Speaker 1 (2027-07-22 urocolor)

zero, zero, zero, zero, zero,

10:39

S… Speaker 1 (2027-07-22 urocolor)

zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero, zero,

10:40

S… 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

S… Speaker 1 (2027-07-22 urocolor)

so it's only so it's only

10:56

S… Speaker 1 (2027-07-22 urocolor)

So you can only go

11:00

S… Speaker 1 (2027-07-22 urocolor)

with two.

11:23

S… Speaker 1 (2027-07-22 urocolor)

Are your projections?

11:25

S… Speaker 1 (2027-07-22 urocolor)

What is,

11:28

S… Speaker 1 (2027-07-22 urocolor)

do we have even a diagnosis?

11:32

S… Speaker 1 (2027-07-22 urocolor)

What can we do?

11:35

S… Speaker 1 (2027-07-22 urocolor)

How severe will we see the results

11:39

S… Speaker 1 (2027-07-22 urocolor)

coming downstream?

11:40

S… Speaker 1 (2027-07-22 urocolor)

Is there any hypothetical?

12:02

S… Speaker 1 (2027-07-22 urocolor)

Andrea?

12:04

S… Speaker 1 (2027-07-22 urocolor)

Andrea?

12:10

S… Speaker 1 (2027-07-22 urocolor)

Yeah.

12:26

S… Speaker 1 (2027-07-22 urocolor)

At the end of the official field action,

12:27

S… Speaker 1 (2027-07-22 urocolor)

that field action is allowing us to keep them as product at the rigid state

12:32

S… Speaker 1 (2027-07-22 urocolor)

until we implement and show that

12:36

S… Speaker 1 (2027-07-22 urocolor)

we can meet 24 months daily.

12:39

S… Speaker 1 (2027-07-22 urocolor)

We've now had another issue,

12:42

S… Speaker 1 (2027-07-22 urocolor)

because that's the opinion of our mode of control,

12:44

S… Speaker 1 (2027-07-22 urocolor)

which would be another investigation,

12:45

S… Speaker 1 (2027-07-22 urocolor)

could end up on another field action and have different actions that need to be taken.

12:48

S… Speaker 1 (2027-07-22 urocolor)

At that time,

12:49

S… Speaker 1 (2027-07-22 urocolor)

it could be on our own as to what that investigation is going to look like,

12:53

S… Speaker 1 (2027-07-22 urocolor)

what the outcomes are going to be,

12:54

S… Speaker 1 (2027-07-22 urocolor)

or what the next steps are going to be.

12:56

S… Speaker 1 (2027-07-22 urocolor)

So I think from us as a team point of view,

12:59

S… 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

S… 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

S… Speaker 1 (2027-07-22 urocolor)

I'm interested to understand more about the 32

13:10

S… Speaker 1 (2027-07-22 urocolor)

degrees,

13:10

S… Speaker 1 (2027-07-22 urocolor)

why we're testing 32 degrees,

13:12

S… Speaker 1 (2027-07-22 urocolor)

because I see in HHE that the storage temperature only goes up to 30 degrees.

13:15

S… Speaker 1 (2027-07-22 urocolor)

So is this an accelerated?

13:17

S… Speaker 1 (2027-07-22 urocolor)

Or why are we going to be on the storage claims

13:21

S… Speaker 1 (2027-07-22 urocolor)

or in a package insert?

13:23

S… 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

S… Speaker 1 (2027-07-22 urocolor)

do we do for your implementation yeah yeah so

13:32

S… Speaker 1 (2027-07-22 urocolor)

from an idea of your implementation point of view that's

13:37

S… Speaker 1 (2027-07-22 urocolor)

always going to ask what what are we cleaning and what are we certified for do

13:42

S… Speaker 1 (2027-07-22 urocolor)

we do we certified for sorry again and is what

13:46

S… 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

S… Speaker 1 (2027-07-22 urocolor)

all of these issues were yes it

14:03

S… Speaker 1 (2027-07-22 urocolor)

would have been 24 months

14:08

S… Speaker 1 (2027-07-22 urocolor)

in those documentation okay so then what

14:12

S… Speaker 1 (2027-07-22 urocolor)

did we tell tp during that production what was our what was our outcome from

14:16

S… Speaker 1 (2027-07-22 urocolor)

our um impact on qi what

14:20

S… Speaker 1 (2027-07-22 urocolor)

did we say we were going to do

14:23

S… Speaker 1 (2027-07-22 urocolor)

Thank you.

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