Replies to post #361828 on NorthWest Biotherapeutics Inc (NWBO)

[Idunno]

Hope CRL buys Advent. Seems like a great idea for the manufacture of this Cancer Vaccine. Interesting, that you seem to be against it. ??? Correct me if I’m wrong in my thinking that you’d oppose such a move (CRL buying Advent).

[X Master]

Kind of like Apple...Unethical as hell.

[ATLnsider]

I disagree Jerry. It was not unethical, it was smart and strategic. But Bears, Shorts and FUDsters characterized it as unethical. They mis-framed the narrative to disparage NWBio and Linda Powers.

Linda Powers understood early on in the DCVax platform development process, that in order to put DCVax-L and DCVax Direct in the best position to be approved by the FDA, MHRA, EMA (PEI) and Health Canada, NWBio would need to prove / show that they had a CDMO, that was GMP licensed, authorized and inspected by the regulatory authorities. This valuable lesson was learned from the Dendreon saga.

Also, when Cognate Bioservices was founded in 2002, the Cell and Gene Therapy CDMO industry was in its infancy. In fact, it was no coincident that the DCVax-L Phase III clinical trial also started in 2002. NWBio needed a FDA licensed GMP facility to produce the DCVax vaccine for each participant in the clinical trial.

Linda Powers started Cognate because there were no other CDMOs in the US or in the world with the know-how, specialized facilities, or other capabilities to manufacture its personalized dendritic cell vaccine on a commercial scale, using the proprietary patented processes developed by NWBio and UCLA.

It was better to build Cognate and Advent from scratch because it also helped to better protect the 100s of DCVax-L and DCVax Direct patents. As you may know, you can not patent human dendritic cells, but you can patent the methods and processes used to make the DCVax vaccines. That is what NWBio did.

If NWBio had outsourced the production of the DCVax vaccine to BPs, or an unfriendly-CDMO, and the shorts had been successful in bankrupting NWBio, the DCVax IP would have been stolen for pennies on the dollar. This would have hurt all NWBO shareholders.

[Kaizenman]

JerryCampbell: "Not necessarily illegal, but certainly unethical."

I am trying to understand how the relationship between Toucan, NWBO, and Advent is "certainly unethical."

There are 3 Legal areas that come to mind when I think about this: Anti-Trust, Monopolies, and company officers' and employees' conflict of interest in regards to a publicly traded company.

Monopoly: Standing cannot be established since there is not even an approved product to sell in the open market place.

Anti-Trust: It is difficult for me to see any manner in which Toucan, NWBO, or Advent is trying to constrain or collude in the manufacturing of DCVax-L. In fact, it appears that all of the efforts in these parties are trying to create and establish an initial manufacturing capability. Now that CRL has an agreement to buy Cognate, it would be much harder for collusion to occur if and when actual approved product can be manufactured.

In terms of conflict of interest, I assume you are talking about LP being an officer of the publicly traded NWBO and and officer of the private Toucan Company. Since there was no established company that could manufacture DCVax-L and new manufacturing capabilities were needed, the question boils down to if NWBO financial obligation associated with any of the Toucan work was more than what it would cost outside of Toucan; and if LP "steered" this to Toucan when either NWBO or another external entity could establish the capability cheaper at the needed quality level from NWBO's perspective.

Given the financial state of NWBO and the fact that this type of manufacturing did not exist on the open market, if find it difficult to see "certainly unethical" behavior.

Please explain. Thank you.