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jimmy667

12/09/20 2:52 AM

#337431 RE: biosectinvestor #337428

No I am not. You are conflating the issue of a statistical test by a third party contractor with a judgment or analysis of data by the company or FDA. A third party statistician hired by the Company gives a report to the Company that the trial did not meet its Primary Endpoint. That is a materially adverse event in a Phase 3 trial of a Company's lead drug any "reasonable investor" would think so, that is the test.
Another such material event would be a fatal AE attributed to the drug.