Yep and I stand 100% by this statement. The problem is not the result - it is even better than a hit onto the roof of the member's stand, the problem is with the trial design. Thanks to MSB not following the FDA guidance and including survival as a co-primary endpoint, the whole Phase III trial will need to be repeated. With slightly smarter trial design MSB would be at $20.
This is why I said I weep when I see these results. Amazing results that can't be used for FDA approval because the primary endpoint (a proxy) failed.
Ann: Rexlemestrocel Reduces Heart Attacks/Strokes/CV Death in CHF, page-375
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