of course results matter. effectiveness has not been demonstrated. that's what the trials are for.
But what you say is correct, results aren't the only hurdle. Which is why the fast track designation given to the covid ARDS therapy by the FDA was price sensitive, it lowers one hurdle for that indication.
But if the therapy doesn't have a significant effect, which is what the trials are for, then it doesn't matter what the FDA says as no one will use the product.
Ann: Mesoblast Phase 3 CLBP Trial Completes Enrollment, page-193
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