Unless of course you have facts which support your comment...

Unless of course you have facts which support your comment relating to the FDA nor accepting anything at all.

Wilba, we have zero atm approved by the FDA. Thats non acceptance, which is fact.

I do concede and agree that CBLP at least we have a definite start point for singular primary & secondary endpoints, which bodes well. But didnt we have this for AGVHD for kids as well?

As for SR-AGVHD well we need that OTAT to be positive, and for the facts to come out that states, here is what FDA wants, which is Phase 3B trials and MSB to raise capital for that to go it alone. what i am really upset about is how the FDA can appoint an ODAC independent council, get a 9-1 in favour vote. Then prior to getting a BLA - they told us the endpoints and we exceeded this...as far as im concerned this is the crux of the issue. THE FDA moves parameters and whats not to say they move it again this time even with a clear OTAT message.