I hope you are right. and agree with all your points. the thing...

I hope you are right. and agree with all your points. the thing that hangs in my thoughts however is the scathing tone of the materials prepared by the FDA for the ODAC review. whoever was behind that write up is definitely no friend of stem cell therapies, citing all the various instances of prior failures in clinical trials. and then there were the seemingly unanswered questions around certain aspects of the MOA. I thought these were answered well by Si but that is my uneducated opinion. and lastly the nature of the various trials and the change in manufacturing approach taking place in the final trial where the numbers of participants were noted as being rather low but the efficacy was better. not sure how that plays out in the statistical analysis.

someone at FDA will need to "eat crow" for the prior analysis in order for the approval to move forward. I hope they are hungry. my own view is that we will see approval with follow up requirements. also we can probably consider the FDA has knowledge of the other trials of Mesoblast product, particularly the COVID-19 trial, and if FDA knows these to be positive they may be more inclined to give a go ahead to the aGVHD use in advance of the others.