RE:RE:RE:RE:RE:some more interesting commentary from Adcom:
damn, it will have zero revenue impact and that is part of the beauty... surgery in bladder cancer is if i remember correctly recommended 1st, 2nd, 3rd, 4th, etc. before any other treatment regime even BCG..so you reject surgery and get BCG, it doesn't work you reject surgery again and get BCG again, it doesn't work you reject surgery again and get MCNA..
..the unfit will always get BCG, BCG then MCNA
..the surgery unfit or unwilling was exactly what the alternate indication was.
..everyone wins, and the press is all pats on the back and a round of clap.. Adcom advised in a more relevant context, FDA proved flexible and adaptable to AdCom advise, MCNA is saved, patients are treated, AUA/FDA happy happy.. zero downside only upside
..and PS if MCNA doesn't work like Valstar it won't be used
..like Provenge i don't think it is used much and FDA didn't want to approve but did, and life went on..Provenge was safe but too expensive for questionable benefit
..again bad safety is only unapprovable criteria...only other problem if ODD then monopoly but that isn't an issue either