Thanks @stockrock
I'm definitely not trying to cover for the FDA, I'm just trying to make sense of this CRL in the context of all the circumstantial evidence, and the FDA decision stinks atm
I'm not too sure on the formalities, but did the FDA has the capacity (legal, processes, mandate) of offering a conditional approval without going through the CRL or do they need to be asked via the CRL?
e.g. ODAC members can only vote on items they were asked to vote on and nothing else.
Likewise, the FDA can only approve on what it was asked for (on the BLA) and nothing else - or do they have wiggle rooms via these discussions
@dplane thoughts?
(BTW I've been through some legal reviews recently and everything is so formal - you know - just answer the question!
It may surprise some, but I don't have a legal background)
MSB to dispute FDA finding in Type A meeting, page-97
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