Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-24

@Treed

re "Based on the language used at the time can you be 100% certain the reference was not to a post release Phase 4 trial?"

There has been a bit of chatter about this happening after the approval. I recall the ceo suggesting that as a possibility. Of course, back then, they were also talking about looking closely at surrogate endpoints and indications of overwhelming efficacy, both of which fizzled out to very little.

Anyway, if the intention of the FDA is to allow this second trial to happen after approval, then I'd conclude that the wording of "the language used at the time" is quite misleading.

"This second, confirmatory study will be conducted in parallel with a patient population that has an identical clinical profile; approximately 600 of them using the same primary endpoint"