Rumor has it June18-20 window set for FDA meeting but what do I know. Outcome will have to be PR’d.
I too am hopeful Mono Trial will be discussed and given the green light to convert to Pivotal P3. Also anxious to hear Interim efficacy w the increased dosage.
To me BLA acceptance and Mono conversion are the needle movers. If BP looks at the Mono Interim and calculates there is a realistic chance for future approval it won’t matter what the SP is they will be forced to move and pay plenty.
Have to believe things are coming to a head. Can’t keep a lid on the valuation of this science forever.