Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-550

My understanding is that the new potency data is generated only from the 001 clinical trial- which removes the confounding variables.

Reg, there is no point me repeating myself - but the 001 clinical trial can't be enough - there weren't enough patients given single doses for the data to give a clear signal assuring that each vial was potent enough.

If you check one of my relatively recent posts (I think I was replying to grainger) there is a link to a question (to Silviu) at ODAC (by an ODAC panelist) - when I read that in context (which I invite you to do for yourself) it seems really clear to me that Silviu was saying back then something that is very inconsistent with him claiming to have another potency assay now.

Read or don't read reg - I leave it to you. Pledge took a look and saw my point (or so he (I presume) said. That doesn't make either of us right though.