Post by
thathurt on Nov 20, 2015 8:54am
IMO the FDA was and is supportive of MCNA
...and i believe i posted this earlier but got lost in the shuffle...
..so in AdCom briefing documents the FDA will signal its thinking, sometimes very strongly sometimes less strongly etc.
.. i believe in the MCNA briefing the stated something like they believed "MCNA offers potential benefits....." which was soft but IMO consistent with the AUA/FDA burden of proof standard...
...now i follow a number of biotechs going through the approval process and this am i read news on BMRN upcoming Adcom for their proposed DMD....google it and the FDA crushed BMRN and their drug will not be approved..period...the FDA very strongly stated they failed...they stated safety profile was concerning (ie unapprovable on safety)...article also states FDA drug reviews are known to be harsh...
..MCNA was treated well in FDA briefing documents..
..so what went wrong??? later today i will post actual voting results with member summary comments and again i will point to TST made IMO strategic messaging errors (assuming members were influencable)...and summary is this: a) safety profile was overwhelmingly positive b) no comments on AUA/FDA standard c) no comment on Valstar...
..and lastly re the TST team.. IMO the team performed admirably (the ODonnell and Hatam were great, TST passable) but again the VP simply shouldn't have been the lead...and here is the analogy Tom Brady (VP) is great because Bellichek (COO) is there to strategize in-game so Brady can focus on execution of real time strategy...TST failed to have a Bellichek there (as best i can tell)...this was the SuperBowl for TST..
...anyways when the FDA don't/won't approve your drug candidate they message it very clearly...
..PS re BMRN i suspect the FDA is harsh as following BMRN is SRPT which has more robust data and will likely be approved