MSB 2023 - awaiting for Ryoncil approval, page-15

GvHD is definately important for the company, but I don't think that it is the make or break one shot on goal.

Leading up to BLA in 2020, the share price rose up North of $5, and that was before the PDUFA date, and before any decision had been made.

In my opinion..... the chances of the share price staying where it is today, the day before the next PDUFA date is close to zero.
Chances of going into PDUFA with an SP of below 87 cents, again in my opinion close to zero.

Likelyhood that the CLPB pivotal phase 3 trial repeats both the first phase 3, and the phase 2 dose escalation results I think are very good.

So, we are kind of in a poop sandwich where the top layer is GVHD - which had a CRL already, and will not get another chance if rejected a second time.

The good stuff is the CLBP and CHF and Crohns results which by all indication just needs to repeat exactly what it allready did twice and will be much more approvable than Ryoncil comparatively.

The bottom layer is the " what if " that Ryoncil get's rejected and dropped, and then CLBP miraculously shows different results than the phase 2 and the phase 3 already completed, and the Crohns and CHF results also start showing different results than they have already generated. This is the only scenario where I would question the validity of the results, and consider if the company survives.

The bar maybe high for MSB, but in terms of efficacy, MSB has some of the best results out there as a treatment. Unbeatable in many of the applications. It has always been a matter of time and paying to generate enough results.

They have been careful with their spending, they could have spent a few billion on any of the trials to increase the number of results they had, to backup efficacy, but they are at the leading edge and they will run into barriers, some barriers makeing them re-think things, and invalidating some results in the process, and needing to retest in some areas - as they just found ouw with GvHD, that was thanfully only around 50 children and not hundreds or thousands.