Ann: Update on Novartis Agreement, page-247

The only thing that we KNOW is contemporaneous (or nearly so) and linked even if tangentially with both NVS' decision today AND any pending MSB announcements is one thing: OTAT.

If OTAT gives MSB the tick for Rem-L, the BLA for AGVHD can be readily resubmitted. As well, that would be a green light for any COVID ARDS--and indeed, all-ARDS--trial to begin, with manufacturing concerns out of the way.

The last time that MSB had an FDA meeting that didn't go well, it announced that to the market right away, where the writing was on the wall that they weren't going to get the FDA to budge on their effort to overturn the CRL.

So here, assuming the OTAT meeting was held (I still doubt it has even occurred yet...), and if the takeaway from the OTAT meeting was bleak--so bleak, in fact, that it was enough for Novartis to step back and say "No thanks MSB, you don't appear able to get the OTAT to agree in the near term, we are moving on.", then it seems to me that MSB would BE ABSOLUTELY REQUIRED to similarly inform the market of that outcome.

If, however, SI is playing it cute, and reckons that they will instead wait to see the minutes from the OTAT meeting that CONFIRM the negative view of OTAT before telling us plebs? Well, that will just be beyond the pale. I'd consider jumping into a class action lawsuit off the back of a decision like that by the board.

That said, I am skeptical that MSB would dump the bad NVS news on us and NOT simultaneously disclose a perceived negative outcome from the OTAT meeting sufficient to convince NVS to walk away.

As we don't know what other negotiations went on behind the scene, it's possible that NVS' notification of their not closing was very terse, something like:

Dear SI, Get stuffed. Signed, Your Not-Very-Good Partner.

Anyway, it's just to wait for OTAT now, and to see whether MSB has cracked that nut...or strung us along like idiots before telling us the bad news of which NVS may have already been aware.