While it is possible to gain conditional approval through secondary endpoints where the primary fails it is a very high hurdle to cross with the FDA. The wifey runs regulation for over 30 countries at a large US biotech and have discussed other her in detail. It can happen but it’s a very difficult threshold. Her comments point to a poor trial design which obviously many here have pointed out
Ann: Rexlemestrocel Reduces Heart Attacks/Strokes/CV Death in CHF, page-450
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