Replies to post #423413 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

ex, under ORBIS everything including the CRL contract alive or not, and its readiness everything everything could be kept confidential. No 4 days thing here to let anyone know upfront on what they are doing both the sponsor and the regulators.

[biosectinvestor]

They actually have a contract with CRL (CRL steps into Cognate’s position if they dissolve Cognate into CRL, effectively and Cognate still exists I believe, so the contract still is there), the old one has not expired. And it is subject to FDA approval for the new one, not really a huge worry and then lastly they have Flaskworks in process, which likely they would need to figure out if they were going to license out.

I won’t comment on the BLA already in process, but I do not think they need to have a new contract with CRL, I think more likely, and only if the FDA needs more reassurance, they can have an already negotiated contract pending approval that they would NOT have to PR, with a confidential letter of intent or similar structure to confirm only with the FDA that they have what they need ready upon FDA approval.

And of course they have everything else in process via Sawston and Flaskworks.

[Doc logic]

exwannabe,

The interesting issue is the monkey wrench thrown into the gears by FDA. Their ideal candidate is being held back by their own slowness to accept necessary changes to validate effectiveness of immunotherapy effect, a defect in process that they have been well acquainted with for many years. FDA really looks foolish when they want to ask a company to move into hyperdrive when the chains placed on that company by FDA’s own process keeps them in first gear. I think things are being worked out quietly through available channels by asking NWBO to wait while the paperwork and logistics are being finished up on their end. By the way, has anyone actually produced definitive proof that a conceptual on demand agreement is no longer in place with Charles Rivers Labs/Cognate and if one existed and was not completely terminated but no current production is being done that this agreement must be updated rather than just production itself? I don’t remember seeing this if shared. By the way, even you admit that Charles Rivers Labs/Cognate could be worldwide ready very soon as they already have certification in US, Europe and I assume CRL has rest of world certs pretty much in place too. Best wishes.