The great Msb short unwind, page-74

Probably,

IMO MSB caught the FDA off guard and they were not prepared to approve any MSC based treatments at that point. They were still drafting MSC potency guidelines at the time MSB were pitching for approval..... as MJC73 mentioned.

So the question now becomes....... if OTAT agree, what % chance is there of full FDA approval? Or will the FDA go against both OTAT and ODAC recommendations and halt stem cell approvals for everyone even longer?

Either case, this is MSB's chance to pull a rabbit out of the hat. Everyone was in shock the first time around when FDA did not approve, remember the comments and conviction from Silviu and Fred at the time, and how convinced the company was and still is that they would not be doing or not require a randomized placebo double blind trial in children.....plenty of people have been throwing shade ever since then, claiming that the FDA have irriversibly demanded another blinded trial in children - and how it absolutely must occur.......and how the product will never, ever be approved without it.....the current share price reflects this in my opinion.... it is reflective of nothing but hope of a possible future, but no approvals of anything are factored in.

Remember the company are STILL saying that Remestemcell is closest to market by a definate margin. They are 100% laser focussed on getting it to market, not on the day trading share price.

I'm willing to bet there will be a massive upside if OTAT agree with the manufacturing and CMC Bar that MSB will set in the field of Allogenic stem cell treatments. The logical follow on sequence will be BLA resubmission for Ryoncil, Phase 3 Covid ARDS trial initiation, and I am sure the lessons learnt from the OTAT in Remestemcell although not directly applicable, the lessons learnt will guide the way for the next gen product manufacturing and provide a less bumpy path to approval when the time comes for them also....

We are approaching the nexus point..... Novartis was simply a potential cash cow, MSB have gotten to the position they are in now, by themselves. The results are still the same, and yes - peer reviewed post HOC data looks even more supporting of approval now than it ded before they went for approval the first time..... 10% survival in the majic cohort that represented the most fatal outcome... Same cohort in MSB trial had over 60% survival ( almost half of the trail participant numbers ). Even if you don't look that deep into post hoc fields - they still achieved the primary end point, and proved it reduced mortality in the entire co-hort......

The shade throwers continue to falsely claim it doesn't work.... read this again 50 times that was released by peer review....
"10% survival in the majic cohort that represented the most fatal outcome... Same cohort in MSB trial had over 60% survival"