USD573M in retained losses and a less than great 2020!. 2021 a year that cannot get worse, page-292

Hi yelrom,

I'm guessing the precedent you refer to is the other drug for GVHD, Jakafi. It is correct that Jakafi was a rather small, open-label trial, but it also had two important differences - it has previously gone through the gold standard trial in another indication, and it was not a totally new class of treatment.

We will probably never know for sure if the FDA guided MSB to conduct an open-label trial or Mesoblast ignored the advice of the FDA

On point 2, I agree that SI had a robust response, I believed him then, I believe him now. But we are not the people who need to be convinced (nor the ODAC either apparently ).

Some of the ODAC questions focused on the points I mentioned and at least to me, they appear to be the sticking point.

I'm not in the same boat as some who claim FDA corruption. Unfair - yes. Corrupt no.

The evidence would indicate you are correct that the FDA had already decided the fate of Ryoncil prior to the ODAC, the question is why?

Trying to make sense of it all, it appears the FDA, quite rightly, put higher weight on proven statistical evidence than on opinion, even if it's expert opinion.