that is fair, can't argue with wanting to know det
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Posted On: 09/30/2020 4:28:22 PM
that is fair, can't argue with wanting to know details as to why the BLA has been held up. I just don't really care about the why as much as the how we move forward and handle obstacles - but that is just me.
As for setting us back to zero, my impression was that Nader brought up the fact this is a rolling review and much of the process has been moving forward as these BLA data issues are resolved. I sounded to me that the FDA is working on this and that it could take less than the worst case scenario estimates. Nader did not really give a timeline but it is clear that the timeline is really up to the FDA and he never has control of their timeline. I actually think the FDA is actually working with us to get this right and that means the review process will take less time.
I do agree the SC covid data has a better chance of some sort of approval first, but I don't think the HIV combo approval is that far off.
As for setting us back to zero, my impression was that Nader brought up the fact this is a rolling review and much of the process has been moving forward as these BLA data issues are resolved. I sounded to me that the FDA is working on this and that it could take less than the worst case scenario estimates. Nader did not really give a timeline but it is clear that the timeline is really up to the FDA and he never has control of their timeline. I actually think the FDA is actually working with us to get this right and that means the review process will take less time.
I do agree the SC covid data has a better chance of some sort of approval first, but I don't think the HIV combo approval is that far off.
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