RE:RE:RE:The More I Search, the More Mind-Boggling the Adcom's Decis
rg, their name is irrelevant that is why i didn't and won't post it (AdCom vote was 100% no) it is the narrative that is important and it is this if the FDA wants to bury you (and it is based on science not some malice agenda) they will and they do..they were IMO broadly supportive of MCNA and i base my opinion on previous experiences where they weren't of other therapies and current example and why i name the company BMRN is that IMO the FDA is out to bury them based on the data presented by BMRN for an indication that the FDA is even more supportive of then what MCNA is out to do...
..read the post of Pazdur it is consistent with my understanding of him and the FDA., i believe in 2013 he went into the ASCO Hall of Fame (actually i think it was Person of the Year)
..re. diference between MCNA and BMRN and i will post BMRN on safety:
BRMN is sort of saying on safey, if their candidate causes the early death of a few boys who will die anyways to extend the lives of some other boys, BRMN says approve us...the FDA response is sort like this "go f yourself, you BMRN suffer from god-complex"
MCNA safety profile is exemplary and praised beyond expectation at AdCom
..the FDA was and is supportive of MCNA IMO, AdCom was a bump in the approval process road
regards