Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-26

I can only go on the announcement of the "reduced" trial numbers made in Jan 16 where MSB clearly stated that they had agreed to a "second confirmatory study ... conducted in parallel in an identical patient population of approximately 600 subjects".

That is not a post marketing study.

BTW - that was not a reduced trial size despite the heading of that announcement - it was in fact increased from one trial of 1,165 patients to two trials of 600 patients each, an increase of 35 patients!!

BTW2 - that is the agreement they reached with FDA - my experience with negotiating with FDA would suggest it would be difficult to negotiate that number down despite RMAT etc - and there is no indication from MSB that they have or intend to try. Don't forget that 600 is a very small Phase 3, as indeed is 1,200.

BTW3 - the Phase 2 results were not all that convincing when you drill down into the data Perin presented (as an example, take a look at the dose-response analysis), and even then the so-called HF-MACE endpoint came out of a post-hoc analysis trying to find something that worked.

BTW4 - despite a fair bit of spin, the LVAD results do not bode well for the CHF trial.