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biosectinvestor

12/03/21 12:16 PM

#423648 RE: JRIII #423593

Believe whatever you want. The contract is a clear issue as far as I am concerned. No worries that you’re wrong. Lots if people don’t understand that, I dealt with many of these kinds of issues for many years. Show me the termination agreement, which is material. And yes, Cognate will be producing DCVax Direct as well going forward. Not really the sign of parties that terminated their other existing contract with terms related to commercial production. They simply may not ultimately need it or not need it initially, but it is definitely an ongoing obligation/option. And I doubt they do not have regular communications.

As for the SAP, rejection would also have been a major event. Nothing disclosed. They said they would proceed when all the agencies accepted. And as you know, the FDA accepts with silence. They and any regulatory agency retains the right to assess with final data, however, survival is the most preferred outcome, especially when accomplished with the least side effects. So moving from a surrogate primary for survival to actual ongoing survival, rejection is not likely in my opinion, and it is doubtful to me that the other regulators would accept without the support of their primary regulator, which is the FDA.