"The strength of the data isn't the only thing they consider."...

"The strength of the data isn't the only thing they consider."
Yes however that would be why they require a BLA.
They are currently looking at these remarkable results and the quality of the data. No one is questioning the quality of the data. I have not seen any exspert suggest that these results are not remarkable.

"What hinders MSB is the fact that the mechanism doesn't fit (not just my thinking, also the expert panel), and MSCs are still very experimental (as opposed to a beta blocker such as carvedilol which has similar drugs of the same family that are extremely well understood and utilised)."

This is with out doubt a problem however just because a therapy doesn't fit a preexisting hypothesis of disease progression isn't a problem for MSB , it is a problem for others. Many here listened to the presentation, what I believe many including yourself have missed is that those MOAs described by the presenter that explain our remarkable results were not a hypothesis post P3 readout , they were well established before the P3 was designed. The results of the P3 were confirmatory to the proposed mechanisms of action and the results were actually better than expected as shown by the P values.

"So sure, there's always a possibility."
I agree, that would be why reviewing a BLA would be the proper process rather than listening to a bunch of self proclaimed skeptics.

Before we put this before the FDA as a BLA we need reasonable confidents that the application would not be given a CRL on the same issue that we had with GVHD.

SI and team seem to be well on the way to establishing more suitable potency assays for Remestemcell-L , confirmation by FDA will establish requirement for Rex. and having similar MOAs I would think that similar technologies will be used for Rex.

Confirmation in regards to satisfaction of the final potency assay for GVHD is by far the most value adding event for MSB in the near future. I would think it very likely that on opening of trade the SP could be above the historical high.

ASX records are made and could be broken by MSB.
Good luck all.