Cognate is fully licensed and produces commercial product already daily. That is their daily, normal business and they are a fully operational company owned by CRL. I doubt this is an issue.
You can disagree with me. It’s not me asserting it though. NWBO has indicated that is their plan for now. They have a fully licensed and certified contract manufacturer with its own facilities in the US also in tow, so that is part of their plan in their financials if the regulators call for it, but they do not need to have a live commercial production contract at the moment to proceed with accelerated approval application beyond the plan they have apparently. Whether for ultimate commercial production, their plan clearly addresses not the possibilities and ambiguities of the moment.
You don’t have to agree or disagree with me, but if you think their plan makes no sense, and I am merely pointing out their plan, then you have a big disagreement with NWBO. And I would guess they are better informed than any of us.
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