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.