The reliance on odds ratio raises the possibility that Missling opened the company up to lawsuits on false claims to public shareholders, regarding ADCS-ADL. If the odds ratios themselves were not primary in the SAP, that's a problem.
But he seems to indicate this is not the case. So what I'm worried about is if odds ratio is primary and the % mean change wasn't met. I.e., not lawsuits but a less successful trial.
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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