2023 The Final Countdown, page-1216

Can't argue with that. Pretty much all of the MSB trials have failed to reach the primary end points and the theoretical mechanism of action has then been massaged to try and fit the post hoc analysis of a cherry picked subgroup to claim "success", but without the validation of a new trial.

If the FDA stick by their comments from the ODAC meeting and the previous recommendations for a new trial, a validated potency assay and "substantial new information" then it doesn't seem possible for a resubmission of the old BLA even with a cobbled together potency assay and some long term survival data to meet the requirements. The potency assay hasn't been tested in a new trial and the original trial wasn't designed to test long term survival (according to the FDA representative at the ODAC meeting). Add to that the problem of convincing the FDA that the two previous failed Osiris RCT results somehow should be overlooked.

So I can imagine there would be complaints from interested parties if the FDA were to change their mind an allow some limited conditional approval without good quality evidence. Some posters here have been banging on about how the FDA previously approved a treatment on the basis of an open label trial and it was less effective than thought. On that basis I would have thought that would be less likely for the FDA to approve Remestemcel, but the arguments from MSB investors aren't particularly known for consistency or logical thought.