That may be Doc, or might not be. But that would not hold-up the final results nor even likely the approval of DCVax for Glioblastoma.
Companies improve their manufacturing and their labels and expand their labels after an initial approval ALL THE TIME.
It would not be a reason for things to have been held up and I do not think the company would have said the things they did, if this were the case, and in fact they were just waiting on other things not discussed broadly and regularly. I think that would be a huge, huge problem.
I get that people on bulletin boards have made these conclusions. Doesn't make sense commercially or for regulatory reasons in the long-run. It would have no purpose.
It may be that SINCE they bought Flaskworks, it is causing a short delay, while they set-up their factory and establish their manufacturing pre-approval. I have discussed the benefits of doing that in a short term context. So that would not be something that is foreign to anything I have said and is in fact consistent with what I have thought. But, it would not have made sense over years, as is discussed here on a regular basis. I think people convolute one thing with another and before you know it, that is the reason for years and years of delays, and I do not for an instant believe that is actually the case. Nor do I believe that just like Car-T, they could not have moved forward with manufacturing in clean rooms and scaled up quite a good bit and met much of the demand, if not all of it for GBM.
The issue in the short to medium term is that there in no reason to NOW build their factory with clean rooms if they can use Flaskworks machines. That is not an issue since 2015, but an issue that they are facing now as they prepare for commercialization and are likely discussing and working out their commercial plans, which had various options, up to this point in time.
For the company NOW, because it OWNS flaskworks and its patents, it makes sense to have it fully available to use in its scale-up and to have those plans as a part of its approval process. It makes things much better, and much easier with regulators and requires far less capital. But I don't agree that in 2015, they were waiting to have Flaskworks as their own company. Nor do I agree with the notion that buying Flaskworks, lock, stock and smoking barrel, was in the cards until it became possible, because the commercial opportunities for Flaskworks appeared more limited than had been anticipated by Dr. Murthy and Corning. I do think NWBO probably would have bought the machinery from the company were it free standing and independent, but buying Flaskworks was a brilliant and incredibly timed opportunity.
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