@whyteeMSB have made a lot of announcements since ODAC back in August 2020. And even a lot since Eric Rose comments to the effect that the potency assay had problems in May 2022. If I'm wrong and they get approval somewhere in those announcements either I will have misread something or MSB will have been more conservative than they needed to be. Conservative (and underselling) is not how I think you see Silviu as normally operating.
But to my knowledge - MSB have not said they've received any specific feedback on potency assays from the FDA since they made a submission in lieu of the BLA resubmission - an IND file update, and MSB have not reported much at all - except that there was a FDA site visit - so MSB have been very circumspect with the market about what the FDA has actually said to them.
That means MSB won't be responsible for ramping up expectations unrealistically here, in my opinion, - by posters (traders on this forum) might be.
What matters is the chains of reasoning - in my opinion - no credit for guessing correctly yeah or nay (on a binary outcome - a coin toss has a fifty/fifty chance) -
should only be credit for having the detailed reasons for the yeah or nay. Otherwise there was no analysis even incorrect analysis just incorrect conclusions or correct guesses.
(20min delay)