BTW, you know FDA requires updated data on all active and recent studies related to drug in condition at the time of the BLA and can ask for the information again during the reply-response phase.
COVID can cause delays, other things can cause delays, so I am not changing my stance on premarket promotion one bit after that lecture. I know now that the BLA is in. Could next week be the response letter? Possibly, yes.
Could there be reason other than something bad for a delay? Plausible
Also, I was told by experts that taking the other path in premarket promotion also comes with the limit of the 6 month coming soon approach, and is thus considered a coming soon campaign (on this side of the isle). But maybe FDA sees an ability to flex there if they so choose while retaining the strict language in the reg. I stand by the combination of those two advertisements in those two locations with a highly suggestive “unbranded” disease ed piece sandwiched between is clearly suggestive of a reassurance from the regulator to do so.
GBM is a rare and orphan disease. I hope it is getting treated as such, for the patients sake, not mine. I can have patience.
News 
Market Data 
Discover 
AI
