MSB to dispute FDA finding in Type A meeting, page-290

I think it also worth remembering, that back in 2018 when MSB released the results of the LVAD trial, we saw a similar spectacular decline in the share price, because the primary end-point was not met.

However, in the process the FDA advised MSB that the primary endpoint was not a clinically meaningful outcome and that it was in fact a biomarker. Instead, the FDA pointed to the reduction in gastrointestinal bleeding as a clinically meaningful outcome;

On this guidance, MSB has shifted focus to the reduction in bleeding events.

The point here is, that the FDA is clearly prepared to work with MSB - and this is also clearly the case here for SR-aGVHD. The FDA has recommended an additional trial that the company was already planning on undertaking.

So whilst the CRL may have been a surprise for MSB (and certainly investors) - it was no doubt anticipated and they will now follow the process.

An approval for Ryoncil with a post-approval trial would be a nice short term win here, after the Type A meeting, but I think practically, the adult trial is needed as a pathway for approval - as others here have indicated.

I will continue to hold as we await readouts for C19-ARDS, CLBP and CHF. All of these remain catalysts for the SP and we now have to continue to trust that the company knows what is needed to progress the GVHD approval.

GLTAH.