Replies to post #258526 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

I agree as the agreement for cognate to be ready for the volume is gone as far as I know . So we are relying on good will of Cognate . Please correct me if I am wrong

[flipper44]

Who's preparing for commercialization then, AVII, Ex or Merck? No, it is Cognate's responsibility and we are at the end of the clinical trial road. If Cognate is not essentially prepared, it was a scam. The FDA requires commercial manufacturing readiness and completion of phase III to go hand in hand. Everything points to Cognate being ready -- including these old posts I dug up.

Monday, 09/09/19 04:37:10 PM
Re: Jack2479 post# 243386 0
Post # of 258532
Thanks Jack. I missed that very important detail in Cognate's PR.

Since 2002, Cognate has serviced autologous and allogeneic products in various stages of development from preclinical to Phase 3, and most recently in pivotal Phase 3 with FDA pre-approval inspection preparation.

https://www.globenewswire.com/news-release/2019/08/07/1898347/0/en/Caladrius-Biosciences-and-Cognate-BioServices-Establish-Manufacturing-Agreement-for-Phase-3-Confirmatory-Pivotal-Clinical-Trial-of-CLBS14-in-No-option-Refractory-Disabling-Angina.html

flipper44 Member Level Sunday, 09/15/19 08:44:26 PM
Re: flipper44 post# 243437 0
Post # of 258536
Correction:

Cognate prepared for the pre-approval inspection. They do not conduct the inspection, regulators do. We do not know if that's been done, but it is possible it has (It typically takes seven days), because Cognate is already talking about their past pre-approval inspection preparation. Although, typically complete BLA filed first before inspection....who knows with rolling BLA.

Here is an image I found on the process (not specific to Cognate).

Note: Cognate already reached GMP approval for Europe as well by June of this year.

I'd assume we are at least as far as that last star to the bottom right in the process.