"The big question for the Board is to explain why this trial went ahead and was pumped up when they apparently knew the FDA would not recognise the primary endpoint!"
Well I am also very curious why they would have a clinically non-significant (i.e. non commercial) primary endpoint when they surely have worked closely with the FDA in trial design and approval.
I am relatively new to MSB, so I must have missed something very obvious.
Ann: LVAD Trial Results Provide Potential Regulatory Pathway, page-38
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