RE:RE:RE:RE:RE:Here we go again NOtaPOOp--- no need to apologize to Foxx.
It's hard to tell if this amounts to further delay. Roger does indicate at the end of his quote that the central pathology laboratory validation (part of the amendment granteed by HC) will be used for pre-BTD submission. I suspect they already have been tracking down the folks who made it past 450 as either CR or IR to see how they are doing now. Presumably they have been doing this after speaking to FDA in the pre-BTD phone call. If this means we need FDA to sign off on the amendment too...others might know.
What does seem clear to me is that when the time comes for AA submission, we likely will be in a much stronger position as a result of the changes made now to the trial. That's a huge win for us now.