Ryoncil: ODAC/FDA Meeting Discussion, page-1988

I think the AdCom meeting was more precarious in my eyes because FDA was basically stating MSB did not have measurable CQA's which goes right back to the fundamentals of CFR (basically the law). That would be an easy rejection for FDA if the AdCom had agreed with them. Even now, I don't know how they will backtrack in saying they have approved a product with no valid CQA's. I think they will lean off the AdCom vote as them telling FDA we believe they have sufficient enough CQA's based on the 'known science' which I don't think was reality because none of those ppl were remotely qualified to answer that question after listening to that session. My background is FDA regs and I know when you don't meet a part of their regs, they themselves have basically little room to move.


Anyway, they have to approve now based on efficacy and safety, in the absence of AdCom saying the product can't be produced with reliable effectiveness (which is actually FDA's position still, imo ). And no doubt FDA will work with MSB on how they will validate MSB existing CQA's and also identify new ones in upcoming trials and also in the soon to be approved indication (ie P4 trials).