MSB to dispute FDA finding in Type A meeting, page-599

Hey, @stockrock. I wonder whether at any point, the FDA intimated--or even suggested--to MSB during the discussions that accelerated approval was an easier path (hint, hint, MSB!).

We know that MSB and the FDA have been in pretty close contact throughout the process, as is clear from this history, multiple comments and the somewhat collaborative nature of the process. If that's the case, I am confused why, if the FDA was opposed to full approval (perhaps to the point of even being p*ssed off at MSB for foolishly following this path, as you have indicated you suspect a few times), they didn't, at some point in the process, make clear to MSB that they were going in the wrong direction and risking a CRL if they persisted. Is it just SI being bullheaded? Seems unlikely, but it's possible.

The strength of the negativity in the ODAC briefing notes, however, always seemed to me to have shocked MSB a bit, and taken them by surprise.

If that's true, it would be an indication that as much as they were "collaborating" with the FDA, they were not really that clued in to the FDA's view that there were problems with the application, either with the single-arm trial and/or with the full approval path that MSB had chosen. It seems obtuse for the FDA to harbour such reservations (or even outright anger/disappointment) against MSB's chosen path, when a much easier option is available and would find the FDA's favour, to permit MSB to stupidly, regardless.

None of that makes sense to me.

The only thing that does is that EITHER: (a) MSB misread (due to inexperience, naivete, over-reading into ambiguous messages, etc., etc.) the signals that the FDA was sending; OR, more worryingly, (b) the FDA had an agenda (perhaps to make a clear example to the industry and the public that stem cells were NOT going to get an easy ride) that was not fully disclosed to MSB, and which only really came to light with the issuance of the ODAC briefing packet, with the apotheosis in the CRL.

If it's the latter, let's hope the CRL process is where they make up for hiding their cards with MSB throughout the BLA process.