RE:RE:Anybody read up on Adcomm I did thanks. Clear and concise. There is also some data available that speaks to the differences in the review and approval process for 2nd vs first line treatments. To your concern, I think that the primary end point in that trial has since been deemed irrelevant as it was, in hindsight, so far beyond what the FDA considered a noteworthy result. Why missing the endpoints is continually highlighted in investor presentations is still unusual to me though.
I can't find a real obtsacle at this point. With its closet full of checked boxes and the fact that option 2 in the current line of treatments is death it makes for a very jarring contrast with any opposition to MCNAs approval as a second line therapy. Who would be in opposition than? Maybe the inluence of MCNAs 2nd line very limited competition and maybe a BCG supplier blessed with foresight.