I don't think they would have gotten any answer fr
Post# of 153903
(Total Views: 707)
Posted On: 09/10/2020 8:31:58 PM
I don't think they would have gotten any answer from the FDA as that meeting was simply to help them with what they needed to resubmit the BLA for HIV combo. That meeting never had anything to do with Covid EUA. It was not the kind of meeting that would have produced an immediate yes or no.
I am not sure why everyone expects an immediate yes or no from the MHRA either. I think this is why some people seem upset. I never expected an immediate answer from that meeting. It was also an exploratory meeting. As we know, reg agencies have a lot to look over and evaluate and discuss and have meetings on top of meetings and get it past this person and that person etc. And even if it is expedited due to Covid, I doubt it happens a day later.
So the idea that they had a meeting Wednesday and got a definitive answer on Thursday is absurd.
I am not sure why everyone expects an immediate yes or no from the MHRA either. I think this is why some people seem upset. I never expected an immediate answer from that meeting. It was also an exploratory meeting. As we know, reg agencies have a lot to look over and evaluate and discuss and have meetings on top of meetings and get it past this person and that person etc. And even if it is expedited due to Covid, I doubt it happens a day later.
So the idea that they had a meeting Wednesday and got a definitive answer on Thursday is absurd.
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