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Orphan status unfortunately doesnt mean that the drug works and will be approved, just look at AGEN.My gut was to sell all in the $1.10s pre-market yesterday and buy back in the 90s or lower, but only sold 1/4.Still think there is explosive potential here if trial results are positive with high confidence...GL to longs
Obviously Orphan doesn't guarantee approval, but what if the 184th event shows a clear benefit? Does Orphan status make it easier for FDA to stop the trial for efficacy? Good question for the CC tomorrow.