RE:Adcom voting resultsas you evaluate the "no" votes you should be struck by two issues:
a) no not proved (bad study design)
b) better indication would be supportable
and in general c) good safety profile..
...this suggests to me a number of confusions during the AdCom meeting:
a) bad trial design shouldn't support any real positive conclusion on demonstrated safety
but
b) not proved...this has issues related to absolute vs relative, and IMO the absolute carried weight as the relative was not well communicated or explained...
...in absolute terms 301 failed to meet its objectives
...in relative terms 301 met AUA/FDA standards and this should have been the prevailing standard of proof burden...but IMO i suspect it was not likely even considered and it wasn't considered as IMO it wasn't communicated well or at all really..i betcha if you did a post vote and asked whether they considered AUA/FDA guidance they would likely say no and likely no as it was confusing (so IMO it was a messaging failure)..who knows for sure, it could have been all conspriacy and agenda and that but i doubt it
..ps one other thing i believe AdCOM and FDA will approve on a) good safety profile b) no demonstrated incremental benefit...i believe T-Vec was approved on this basis as i don't believe it extended OS (but trial did meet end points)...i bring this up as I believe some members stated they actually needed to see incremental benefit and safety and i don't believe that is the standard (particularly in non 1st line with no alternatives) and that should've been challenged when commented on.
regards