NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Thanks Doc,

Is the device used to make DCVax-Direct similar to the FlaskWork device, or something that the FlaskWork device could replace.

Many years ago IMGN had a product that was generated with the use of oriental mice, they had made a sufficient quantity to run all their planned trials. A cryogenic freezer failed, they lost the supply, and they contracted for new product. After many months of trying, their contractor was unable to duplicate their drug, they took over and once again produced it. This failure caused the drug and a partner for it to be delayed almost two years, as I remember it. Ultimately the drug failed, but much was learned in the process. I'm not sure if they were ever able to synthesize the drug without using the specific oriental mice, but that's what the company went back to.

Frankly, I wish the regulators would get together and provide a path to approval for products drug developers are unable to fund. I would believe that once potential was shown in a Phase 1 or Phase 1/2 a developer should be able to ask for it to be considered. In such a scenario, the regulators would fund the Pivotal Trial, and they would be entitled to a royalty interest in the drugs approved in this manner. At first seed money would be needed, but in time such a program would become self sustaining, even profitable if they so choose. My point is, how many years ago could DCVax-Direct been in Pivotal trials if such a program existed. I believe it could be an even bigger game changer than DCVax-L, but it was forced to wait for the success of DCVax-L to have the funding needed to advance. I suspect that their are many potentially great drugs that never advance for lack of funding. Even BP has a limited number of new drugs they can move into the clinic each year, they take the drugs at the top of their list. A potentially great drug might remain just under the number being brought forward for decades. Imagine if these drugs could be turned over to regulator development and both the company and the regulators profit from those that meet success, that would more than pay for those that fail.

Gary