MSB 2022 - The road to commercialisation, page-878

Now I'm just guessing, but I'd imagine any sort of approval is not just given out willy-nilly. MSB would have to request it first. And that request would first be directed by guidance that we're waiting on.

However I guess if you think AA guidance is likely, then that whole process could happen quicker than the Rem-l BLA 2-to-6-month process.

I think there should probably be a bit more weight to previous FDA guidance. As pointed out by Joe on the wahoo forums - if a trial fails to meet its primary endpoint, other endpoints are usually taken as thesis generating for future trials.

However the FDA have said that Mace reduction is clinically meaningful, which means it has a clinical benefit. Not to mention the CHF trial therefore produced a clinically meaningful endpoint.

I believe this may guide to full approval as oppose to surrogate endpoints that usually guide to AA.

The above is probably wishful thinking, happy to be corrected.