Thursday, December 02, 2021 3:44:51 PM
I don't believe that CRL would do the buyout if they had no assurances that they would be making a substantial part of the DCVax-L to be used worldwide after it was approved. I would also believe that they were able to view the trial data under confidentiality agreement before they finalized the deal.
I cannot say if provisions already exist covering production of the DCVax's with the FlaskWorks device. If I were spending the money CRL did, I would probably want such issues settled prior to finalizing the acquisition. If not, perhaps Cognant represents more than I and others here have given it credit for. I do not know if CRL is incorporating them completely into CRL, or if it's operating somewhat independently.
I would hope that when DCVax-Direct returns to clinical trials it will be manufactured in the FlaskWork device only. That would eliminate any doubt that if would be used in commercial production of the vaccine after approval. The question might be, is DCVax-Direct to be made for trials by contractors, or utilizing in house production. If the FlaskWork device is to be used, I believe in house production should be possible.
Gary
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