Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-427

SI was pissed big time and we had references to the CURRENT fda people so it is pretty clear he has been mucked around.

Possibly a change in staff from those of the early days of trial setting up or a change of policy from Washington has led to the problem. Current also implies more changes in the fda make up or appeal likeliehood if no joy.

I think the movie Pretty Woman had the line were corporate maneouvering occurred with just delays to progress being achieved rathet han halts. But the delay gets the desired result and the Senaotrs umming and arring supposedly are hard to prosecute for same.