@Techinvestor
re "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"."
As I recall the reduction in trial size to 600 was a reflection of the fact that the endpoint was changed to be recurrent HF-MACE which then allowed for the same patient contributing multiple events to the resultant data. So "more people/single event per person" became "less people/multiple events per person".
One thing I never quite understood in the discussion of multiple events is how they control for treatment after someone has an event. In other words, after a patient has an event, won't the treatment they receive compromise the data gathered? For example, if a patient does not have another event, how do they know this desired outcome was not due to the intervening (non msb) treatment they received, as opposed to the MPC-150?
I suppose they might be hoping all the events occur in the controlled group, and the MPC-150 group has no issues at all. However that might be a bit of a long-shot, because we know some of the phase 2 patients in the MPC-150 group required treatment over the 36 months, the number was only zero after the definition of HF-MACE was introduced.
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Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-34
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