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Posted On: 09/06/2020 8:02:21 PM
Post# of 149206
You can make a case both ways that this extra review by the fda, which will take 30 days, is a good thing or a bad thing. It does push it further out but it also should solidify the BLA and make it slam dunk approvable. Not sure where I fall yet.
Here’s an extra thought...
What if the reason the fda flip flopped about this type A meeting and went from written to a physical (likely virtual, I don’t recall) meeting is because Cytodyn is moving toward a deal with the UK and the fda realizes it needs to stop f’ing around and start working with us before there’s no vials available in 2020?
For the record I don’t think it’s the case, but the timing is interesting.
Here’s an extra thought...
What if the reason the fda flip flopped about this type A meeting and went from written to a physical (likely virtual, I don’t recall) meeting is because Cytodyn is moving toward a deal with the UK and the fda realizes it needs to stop f’ing around and start working with us before there’s no vials available in 2020?
For the record I don’t think it’s the case, but the timing is interesting.
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