I wonder if SI and MSB are going to consult with the FDA regarding changing the Primary Endpoint to very impressive Mortality result.
The FDA have allowed this with *word disallowed by google and Cardevilol for example.See this quote re changing the Primary Endpoint for *word disallowed by google -
"We don't usually allow you to change the endpoints after you've seen seen the data," said Robert Temple, director of the FDA's office of drug evaluation. But doing so is not unprecedented.
Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-327
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