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Posted On: 09/07/2020 2:03:49 PM
Post# of 151702
For HIV, I think the most obvious answer for our change to live FDA meeting is the answer already stated by NP on Aug. 20. Now regarding COVID-19 I do believe we will get our answer for EUA vs P3 for M/M. I subscribe to an opinion that is somewhere in the middle of you, CDiddy, and blafarm. From the sound of it, I think we got some clarification via FDA response on Sept 1, but not sufficient enough to feel confident in resubmitting our BLA, which leads us to the addition of a live Type A, just as NP said would happen, if the team still needed further clarification. Please see below.
Please Review starting at the 1:00min - 1:30min Reference:
https://youtu.be/oxHVoIGDopA
"...FDA has been so busy, that the time frame we want the meeting they can't give us the meeting in that time frame, so they're going to answer our questions. Now once we receive those questions, if our team 100% understands it and they're very comfortable, that we can get those data in that form, then we're done. IF NOT, WE CAN COME BACK STILL AND SAY WE NEED A WEB-EX, TOO JUST TALK and at least be able to see each other and talk."
Please Review starting at the 1:00min - 1:30min Reference:
https://youtu.be/oxHVoIGDopA
"...FDA has been so busy, that the time frame we want the meeting they can't give us the meeting in that time frame, so they're going to answer our questions. Now once we receive those questions, if our team 100% understands it and they're very comfortable, that we can get those data in that form, then we're done. IF NOT, WE CAN COME BACK STILL AND SAY WE NEED A WEB-EX, TOO JUST TALK and at least be able to see each other and talk."
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