MSB Trading 2020 - a new dawn, page-695

Welcome, mate.

I was quietly confident that the data and results were good enough that they just COULD NOT be ignored by the AdComm, particularly the improvements in outcome following MSB's modification of its processes. It's really very compelling stuff, and was fully backed up by the clinicians that spoke on behalf of their patients and their actual experience with Rem-L.

I assume it's even possible that the FDA made clear to MSB that they were going to come down on them like a ton of bricks, and that there were good reasons for them to be tough and to be seen to be tough on this, the first application of its type. A bit of regulatory Kabuki theatre.

That being said (and admittedly, I am too biased to probably view things entirely clearly), they went pretty far with that. I really did feel a sense of spite, or vindictiveness in the voices of the FDA panel members, and some fairly craven dissembling in "answering" Dr Sung's question on Jakafi's questionable approval. That in particular just made the FDA reps seem a bit bullying, and unfair--which is not a good look for the FDA in a public hearing. Just acknowledge the similarities and move on, don't try to make the doctor out to be a numpty for even bringing it up. It's utterly relevant to the question of the acceptability of MSB's single-arm trial in this context. Deal with it.

All in all, with the twin hammerings we took this week in both the hearing and our SP, no one can say that MSB was given an easy ride.

It's behind us, though. We are now set up perfectly for a positive COVID ARDS read out. Bring that thing ON!