RE:RE:Jp morgan news tmroBecause you don't have any clue what will happen by the end of february doesn't mean everybody doesn't. You certainly have to right to see the FDA decision as a binary event...a 50 % chance for a "yes" / 50 % chance for a "no". And honestly I'm sure of lot of shareholders / big players think exactly like you. Otherwise the SP would clearly be higher by now.
From my point of view, that just proves you (and others) don't understand 1- the FDA briefing document content 2- the purpose of an ADCOM meeting and 3- most importantly, the role of the FDA in regards of a BLA submission. I'm saying this respectfully and humbly. I do admit a high level of scientifc understanding is required to get an accurate portrait of what is the most probable scenario for TST in the coming weeks.
Since the day after the Adcom meeting 2 months ago, people are focusing way too much on the final vote results. The FDA have said it often before : the final vote is not the most important thing for their review team. Arguments used by the panel experts to justify their vote is more significant. Here I'm not saying the panel experts all had weak and crazy arguments for voting no. All of the "no voters" mentionned the caveats of the study design...which are without a doubt major issues. But you see, I believe at this point these arguments worth close to zero to the eyes of the FDA. Why ? Simply because a sponsor doesn't get as far TST currently is (they had their late-cycle conference last month) when the FDA has problems with the phase 3 study design. Clearly the FDA has accepted several months ago the weaknesses of study 301 and decided to look more deeply at the benefit (DFS % and PFS %, etc..).
When you look at the question objectively, does MCNA has a favorable benefit-risk ratio profile for at least one subpopulation, the answer is without a doubt YES. And it's the FDA' role to find that indication, where that benefit-risk ratio is favorable. Whether or not the sponsor applied for a larger indication.
So even if that larger indication if denied, you seriously think the're not going to say yes for at least a narrower indication (clearly the CIS-containing disease subpopulation) ? If you do, please explain me your logic here as it would imply the FDA is 1- not listening the Adcom panel experts (who all recognized the benetfit for that subpopulation during that meeting) and 2- not "listening" is own briefing document.
I guess we'll soon know if I'm a delusional shareholder.
M80