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Posted On: 09/07/2020 12:19:40 PM
Post# of 148899
I also agree that the FDA's increased interest in our HIV BLA is somewhat mystifying.
Could recent knowledge (internal to the agency) regarding possible imminent EUA COVID approval (also for 700mg I think) be the reason for the sudden urgency uptick in the FDA moving forward with a CYDY BLA?
I'd have to think some form of licencing agreement needs to be in place (or at least in a late stage and even for a different indication) in order for EUA to be granted.
Apologies if this was the obvious implication in your post -I may be a little slow on the uptake.
Could recent knowledge (internal to the agency) regarding possible imminent EUA COVID approval (also for 700mg I think) be the reason for the sudden urgency uptick in the FDA moving forward with a CYDY BLA?
I'd have to think some form of licencing agreement needs to be in place (or at least in a late stage and even for a different indication) in order for EUA to be granted.
Apologies if this was the obvious implication in your post -I may be a little slow on the uptake.
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