MSB to dispute FDA finding in Type A meeting, page-136

I had a hard time seeing how they could reject it for AGVHD...but I have a nearly impossible time seeing how they could reject it for COVID ARDS if the results are there against the placebo, MOA known or unknown.

The suspicion raised earlier on the board that the FDA preferred an initial approval route for Rem-L through the well-powered ARDS RCT was raised, and I think it makes quite a bit of sense, sick kids be damned.

Thinking about it, this is a very easy "out" for the lily-livered POSs at the FDA in relation to approval of their first allogeneic stem cell product. I mean, their hands will be tied, won't they? Huge RCT, pandemic situation (with their own president now diagnosed), and a true overwhelming need where there is NO other effective treatment approved for victims of moderate/severe ARDS.

If they rejected this treatment, due to assays, unknown MOA, or any other beefs, they are dooming thousands of everyday Americans to death and/or bankruptcy, and perpetuating a MASSIVE financial and resource strain on the entire US medical system.

Remember, there is a big difference between MSB's AGVHD BLA, and the ARDS trials:

The results of the ARDS trial WILL be known by EVERYONE, not just in the US, but GLOBALLY, where we are ALL well aware of the deadly nature of COVID ARDS (as opposed to the AGVHD trials, where it was a small trial for a not well-known illness impacting a small number of children the FDA seems comfortable in ignoring).

So yeah, go ahead, FDA - get on your high horse and tell the American public why precisely the same RCT you shockingly just said MSB needed to run for Rem-L in pediatric AGVHD is suddenly not good enough for immediate COVID ARDS approval. See how that goes over...particularly with Trump (who may suddenly find out just WTF empathy and humanity mean through his experience with the illness...).