That other poster also makes a compelling case for why the DMC has not provided efficacy guidance. He claims that the DMC will not do the efficacy analysis until the trial enrollment is complete. The reason being that if significance is hit, then accelerated approval can be requested with the remainder of the enrolled patients serving as a confirmatory trial. The only problem with this thesis is that it requires that NW did not understand that enrollment must be complete for an interim analysis to be done. It is difficult to imagine this type of oversight.
1. You believe that if the crossover group does not perform on par with the test group and shows a statistically significant gap, then the trial should stop.
2. This other individual you mentioned on another message board who has a much larger base of knowledge ... believes otherwise. That the DCVax-L trial designed with cross over in mind will not end early and rather continue till completion.
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