RE:RE:PLI - FDA discussion Aureus wrote: FDA is not about to render an approval decision. At this point, they have to decide what kind of review they will assign to PLI. How complicated can that be? So the extra questioning and possible related delay has to do with PR review vs standard and a possible voucher. In that context, one would hope that this extra questioning means that this is not going to be just a standard 10 months review, otherwise you would think that they would have rendered their decision already. In hoping that they are asking more questions before giving away a Priority review (after all, they have to substantiate why we would be reviewed in 6 months ahead of others), or even better, more questions before giving away a very rare and valuable voucher. Fingers crossed !
Not to sound like a raging pumper, I DO think it is POSSIBLE for the FDA to give an early conditional approval in the case of Pg. They were going through a rolling BLA where they were presumably in contact with the FDA often, PLUS look at what we are dealing with here?? Plasminogen is already produced in all of us, unfortunately in lower amounts in others with noted conditions. This is not some chemical mixture that cures X but also makes you impotent and grow hair where you don't want it - Pg is produced in the human body so extremely safe and tolerable. If there's ever been a candidate for a conditional approval at this stage this is it...
Now I'd agree the likelihood of that hovers somewhere around zero. I'd agree it is puzzling to see a delay in the process to DECIDE what KIND of review they get, particularly again since there was a rolling BLA and you'd think regular contact with FDA about how to file the BLA.