when the FDA messages "will not approve" you know it...
..so as i stated earlier i follow a number of biotechs in the FDA approval process...
...over the weekend i had a chance to review the documents related to Nov 24 AdCom for BMRN's DMD drug candidate and the differences between FDA briefing documents compared to MCNA are very telling...
..so DMD is a true definition of unmet need (unlike bladder cancer there is not surgery option) you get you are on death watch (only occurs in young boys (DMD = Duschene Muscular Dystrophy)) and the FDA has broken/adapted every one of their rules to help get something to market...
..but the FDA will never approve an unsafe drug no matter what..
so FDA doc for MCNA was 50 pages and basically supported the TST data package, etc..and presented a basic indication yes/no question
..for BMRN drugs the FDA briefing doc was 350 pages of exceptional statistical evisceration of basically everything BMRN presented...the FDA seems so pixxed they didn't even ask the typcial yes/no question (IMO it is to attempt to leave some room open for something, they try that hard to accomodate)
..they basically said a) it is unsafe b) the biokinetics contradict BMRN conclusions c) effectiveness is illusionary..
..i conclude 0% chance of approval
..the BMRN doc's BTW are are interesting read into how dishonest biotechs can be in public reporting (confirmed again by a detailed FDA study years ago on how company's communicate CRL's to public (basically concluded companies receiving CRL's lie through their teeth and commit securities fraud))
compare to MCNA:
a) FDA does their entirely independent stats analysis of data and came to same efficicacy conclusion (more or less, took a different route as they discounted Kaplan method for another) but came to 23% DFS (or whatever it was)
b) FDA supported the safety profile
c) while the MOA still seems somewhat nebulus, the FDA took the proposed MOA as consitent with data...
..so as i stated before if the FDA was unsupportive of MCNA their messaging would have been different, if the FDA was supportive of MCNA their messaging would be as it was...
..PS i also don't think a decision date needs to extended (although if that was the formal message to next come out it would be positive for the shareprice) as i don't think MCNA needs a "label narrowing" it needs a "label clarification" as IMO surgery unfit or surgery unwilling is the current SoP and completely reflected in current data, it just needs to be explicity stated (don't know why but if that gets everyone to the happy dance its all good)