RE:RE:Adcom transcript and the art of being outside his confort zoHaving medical experts from different oncology fields is not a bad thing for an advisory committee.
The FDA wants to have objective opinions and analysis and I do believe that experts in a similar field can bring that.
But in the case of NMIBC and for TST adcom day, it turned out to be a huge disadvantage. Because of the caveats of their phase 3 trial and the complexity of NMIBC. Experts panel from the ODAC committe are used to see randomized double-blind trial of over 500 patients for that final phase 3 study. Most of them refused to recognize any proof of efficiency from MCNA in that small single arm trial.
After reading the transcript, I feel like the "No" side simply meant that the data comes from a too weak trial to be recognized as significant. Not that the benefit-risk ratio is not favorable. But I bet the FDA accepts the data from study 301 (given how hard it is to conduct trial on high risks NMIBC patients that are refractory to BCG) ...if not TST would not have received a priority review with that BLA. And no adcom meeting would had been scheduled.
That's why I think that on the specific question : "does MCNA has a favorable benefit-risk profile in patients with CIS-containing disease refractory to BCG therapy", once you accept the numbers from TST phase 3 study, the only possible answer is yes.
M80