NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

As for maturation agents and the process of manufacturing. Yes, there is discretion for new formulations of DCVax-L for new trials.

There is maybe even some as they improve patents and seek approvals to change the formulation.

But the formulation at any given time is set in stone. For that version, absent some process for approval. The persons at the factory are not “chefs” and they have no basis to fiddle around with the formulations Willy Nilly.

As I also said, they may in fact use poly iclc in the current manufacture of the drug as a maturation agent, as we both pointed out was possible give the broad patent that covers all kinds of variations for different versions of the vaccine. Whether they do or use other various formulas mentioned in the patent, none of us know. However, that is as a maturation agent and the results of the Phase 3 were derived with whatever formula they were and are using. They don’t get to just experiment every day going forward with any new idea that pops into their head. That is absolutely not how any of this works at all.

However, if it is in that formulation, of course it will be “approved”. But that’s not the issue. You misstated the issue.

The 50% results came when poly iclc was administered directly to patients. Presumably as a drug itself, in those patient’s bloodstreams it did things beyond just the cells that it might have been used to mature if it was used in the formulation of DCVax-L in the main Phase3. The use of adjuvants is in fact to stimulate the immune system directly, not as a maturation agent in a formula happening in the factory, but inside the patient’s body. It likely triggers more than dendritic cell response and triggers other cells to do things that are helpful to what the dendritic cells ultimately do.

So that is not the same thing as what you asked the chatbots and it requires some additional steps that I have said, might come with the approval of DCVax-L, but if the company can’t make Oncovir ready, they can control their own process and they may or may not seek that approval with DCVax-L, that will be a reasonable judgment call for which none of us have enough information to judge, when it happens.