Replies to post #423425 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Do not think they absolutely need CRL either, but The existing contract is adequate to meet that precondition, I believe, and would not need to be released in any securities documentation. I’ve outlined previously that to get accelerated approval status, which in previous but not current SEC filings, they indicated they intended to get, they needed manufacturing capacity that would be scalable for purposes of meeting demand if they become the standard of care (soc), which is really the focus of accelerated approvals.

They need a plan. CRL can and was a part of their plan always. In the future, now that they have Flaskworks, he’s, they can slot in better and more profitable options, but for the regulator, they just need to show they have the potential to put necessary resources together to get there. The FDA does not care if Flaskworks is more profitable.

[skitahoe]

I could be wrong, but I believe that much of the value CRL paid for Cognant was based on contract with NWBO. I don't know what else they had to offer, but they certainly were deemed to be worth a lot.

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