CRL or Approval???, page-49

For Rem-L, the FDA also cannot ignore the current public health and political environment, particularly MSB's involvement in the NIH trials and the MIS-C EAP for children, which were both very much undertaken with the FDA's blessing (if not open encouragement).

Of course it could happen, but realistically, the FDA is NOT going to put a black mark against Rem-L for either safety, efficacy, or manufacturing consistency/quality, when the treatment has a VERY GOOD CHANCE of being approved for broader use amongst victims of the pandemic, particularly MIS-C victims.

The only way the prior approval and rejection cases are really applicable, and you can truly compare apples to apples, is to find a case that has (1) similar facts as does Rem-L for AGVHD (safe, urgent, unmet need, maybe some concerns about batch consistency and quality) AND (2) where, as a backdrop, the treatment is simultaneously undergoing FDA-involved/co-designed trials to solve the public health crisis of our age that is raging out of control due to the US Govt's colossal f*ck-up in mismanaging the response to the virus, and where if approved, patients will need to be convinced the treatment is safe and effective.

If any of the studies looking at FDA figures have that fact pattern? With the FDA rejecting the treatment regardless? I would stand up and take notice.

Otherwise, the situation we are in is UNIQUE (one of the few times you can use the word "unique" without doing so incorrectly) and NO prior analysis or review of earlier FDA decisions is going to be of any real help.

This case rises and falls on its own merits, and any numbers about past approvals just aren't up to the job of informing likelihood of success here (even if that information is VERY interesting and reassuring).