I agree thatwe're a little in the dark here because the goal posts keep moving
It takes two to tango in this instance, for a change to happen one party, MSB or the FDA, has to bring it up, ask for it of the other and the other has to agree. I'd suggest the FDA probably has the upper hand if a change is requested by MSB.
Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-41
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