260608 PMO Alignment

Relatori

• Speaker 1 0:00
• Speaker 2 0:35
• Speaker 3 0:06
• Speaker 4 5:20
• Speaker 5 6:07
• Speaker 6 8:54

1. 0:00

   Capitolo 1: Hi. Good morning. 300s · Speaker 1

   Hi. Good morning. Good morning. Thank you. I hope you had a good weekend. Yeah, it was great. I do have some background noise outside my window, so if you can't hear me, just please let me know and I can repeat answers, but I'll go mute so …

2. 5:01

   Capitolo 2: because if we were not asked to produce this data, I would imagine executive would say, don't proceed with the study there. 65s · Speaker 1

   because if we were not asked to produce this data, I would imagine executive would say, don't proceed with the study there. If there isn't a requirement by the Notified Party to give them this piece of data we're trying to generate, then we…

3. 6:07

   Capitolo 3: results. Could you explain your question? 91s · Speaker 5

   results. Could you explain your question? I think I can't understand your question well. So I just want to understand there's obviously been discussions about this within the CFD. So which department raised the concern and what is the conce…

4. 7:38

   Capitolo 4: Okay. I will communicate with TPS later. 75s · Speaker 2

   Okay. I will communicate with TPS later. Okay. Yeah. And then the next one is Hazard Symbol. So maybe you have a meeting in global. with Hazard Symbol and MPT clinical study that will be maybe Tuesday to Thursday, right? Yes, so two differe…

5. 8:54

   Capitolo 5: However, there's a bigger picture. 203s · Speaker 6

   However, there's a bigger picture. Everything else, right, we've taken in the program a lot of time to discuss with leadership to arrive at the decision that we should be okay to put the hazard symbol on for those folks. So what we don't wa…

6. 12:18

   Capitolo 6: Yeah. Just look forward quickly. 301s · Speaker 3

   Yeah. Just look forward quickly. We're talking RSV, right? Yeah. I'll send it to all three of you. So it spends a little time to receive. At this point, I just worried about the RSVTR2 timeline. After deciding the hazard symbol and NPTN cli…

7. 17:19

   Capitolo 7: deficiency about regarding the IFU or some documents. 73s · Speaker 2

   deficiency about regarding the IFU or some documents. So we will have just draft status documents and in DR2, we will upload documents to agile and approval in that time. And then Flash Assist sample sourcing. At this time, we have a diffic…

8. 18:34

   Capitolo 8: Yeah. Okay. 60s · Speaker 3

   Yeah. Okay. So we can't just simply exclude it anymore. So I think what we need to do is we need to proceed with everything else. In the protocol, we would probably just need to declare that we were not able to source it at that time, and t…

9. 19:34

   Capitolo 9: that's all for RSV and Chagos yes so if you have any questions let's move on to the Ritalino so I have little things to share so As I said before, we already discussed about the timing to implement our change of material name, which is originally mouse heavy gold to mouse heavy gold colloid. 300s · Speaker 2

   that's all for RSV and Chagos yes so if you have any questions let's move on to the Ritalino so I have little things to share so As I said before, we already discussed about the timing to implement our change of material name, which is orig…

10. 24:35

    Capitolo 10: does not include that. 253s · Speaker 2

    does not include that. You mean for the actual submission? Yes, the initial submission. No, it's just it's just for deficiency rounds. It's submission. We previously had reviews on that, but it was only for deficiency rounds to make sure th…