The opening statement from Monday CC at this point we can confirm all efficiency data as presented in CTAD are accurate. The objectives and endpoint assessment using appropriate statistical analysis were performed by independent expert team…I would like to emphasize the data is even better than anticipated.
CM is firm on the company’s claims. There are 2 possible scenarios the claims could be right.
Scenario 1: the SAP primary endpoints are defined as odds ratio and the test sequence is 50mg -> pooled. CM was expecting 50mg but pooled results show significance. “Better than expected”. So he presented pooled.
Scenario 2: CM is legally correct and covered by claiming p2 success as most of the issues identified here don’t apply to p2. The public were expecting phase 3 but the trial is p2b/p3.
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