260602 Touchpoint
Capitoli
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0:31Capitolo 1: I'll just give it a minute to see if anyone else joins. 300s · Speaker 2
I'll just give it a minute to see if anyone else joins. So in the meantime, we have submitted Chagas deficiency round one yesterday, just yesterday. Congratulations. Thank you everyone for your hard work on that. We had a lot of to and fro …
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5:33Capitolo 2: Now we have a concern about this cut up date. 265s · Speaker 2
Now we have a concern about this cut up date. So this is so we have no buffer at all. So that's my concern right now. OK, so if you just go back to that timeline. If we think about this change request, this is for all three of these product…
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10:00
for RSV and then same idea you wait for Shagas which will probably be in July or August let's hope July then you do the same thing and for Rotadino you would be waiting for deficiency round one round about November to do that no so you what…
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13:22
Yes, just for a moment, I will use Korean, sorry for that. I'm going to take a look at it. I'm going to take a look at it. I'm going to take a look at it. I'm going to take a look at it. I'm going to take a look at it. . . . . . . . . . I d…
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15:14Capitolo 5: But it's time for me to really take a long time. 151s · Speaker 3
But it's time for me to really take a long time. It was a week ago. We had a collaboration with a couple of weeks ago. But we had a lot of the changes in the same way. We had a lot of changes in the same way. We had a lot of changes in the …
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17:49
I think I realize this is a shorter version of our regular tracker. Could you just bring up our regular tracker quickly just so that I can show what the consequential impact is going to be here? So you see over here, the yellow line is wher…
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22:58
know about the other documents but if we change the raw material name then maybe some documents can affect it and we have to revise it once again. So, yes, I have a list of, I'm sorry, it is in Korean. So I have a list that is impacted from…
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24:29Capitolo 8: Yes, in fact, so I am on the same. 60s · Speaker 4
Yes, in fact, so I am on the same. uh same opinion so it seems we cannot meet the submission timeline even if we add the dmr update into these maybe five or six days it will be uh yes also and also i ask Yubin who is responsible for IFU and…
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25:30Capitolo 9: To be honest, I agree with DA's suggestion. 65s · Speaker 5
To be honest, I agree with DA's suggestion. Given that this can be handled in advance, we could apply it into the technical documentation draft before the CR release. We accumulated the change part of raw material, which would likely minimi…
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26:39
I understand both Mandy's opinion and Boram's opinion. So I understand both of them. So I think anyway, if we try to put this change into our initial submission, we have to squeeze TO and RA. So we have no choice to squeeze them. So I think…
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27:46Capitolo 11: Thank you. 91s · Speaker 6
Thank you. Yes. So yes, that was so long for that was so long. Yeah. come back to our touchpoints agenda. So we have talked about that, talked about that. And we also have talked about that. Yes, we are all okay with that bio kit was not a …
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29:18Capitolo 12: So I'm in the process now of actually incorporating those three additional competitors into the report. 67s · Speaker 4
So I'm in the process now of actually incorporating those three additional competitors into the report. I've already updated the CPR with the, I've done the searches for the adverse event database searches for the three competitors. I found…
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30:26Capitolo 13: That's good. 65s · Speaker 6
That's good. Thank you for your additional effort on that, Tahid. You're welcome. Thanks. So that's all. So any updates with Chlamydia? No, you won't be surprised. I got some additional questions again this morning, but I have gone back on …
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31:31
Mandy, can we stay for one minute after this meeting? Yes, thank you. Thank you very much, everybody. Thank you, everybody. Bye -bye.