Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-952

I know you hate the acronym OMG.

But, OMG. I am not even talking about any potential mistaken claims in interviews or quotes in newspaper articles here.

You don't think FDA said "we can refile"

My god. We had a trading halt, which clearly was the result of a communication from the FDA, followed by an official company announcement that said:

"U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD)."

Maybe after FDA accepts our resubmission, you might be willing to admit they said "we can refile" and then proceed to answer my question about what led them to change from the prior position of "come back when you have more data"?