I agree completely re TLD which is separate from the issue of manufacturing. The manufacturing likely will ultimately figure into approval, but more likely they will be far along also on a plan of expansion and will be confirming the effectiveness of the Flaskworks system, which I do not so much think changes what they do to manufacture so much as automating it and putting it into a sterile and controlled space. They will clearly still need rigorous procedures, especially if they are processing many more batches of individualized vaccines. But all of that really will be related to expediting approval and proving they will ultimately have the capacity to meet demand. And let’s remember that they already have a process that is way better than the Provenge process that ended up as an approved product that is still approved and made by a successor company. They do not have the issues of that vaccine, and the increased new tool of the Flaskworks process and procedures will likely take it to a whole new level of efficiency and expected potential revenues.
But none of this relates to finalizing TLD. And, I think this is also obvious. If they did not believe that they have an ultimately approvable product, scaling up the compassionate use manufacturing would make no sense. If they announce results that are substantially inconsistent with the past, and indicate a “failed” drug, it is highly unlikely that that compassionate use status would persist. It should give us further confidence that the UK regulatory authority is definitely not on the same page as those who only have negative things to say about DCVax-L and the trial. If they agreed, regulators in Europe have generally been incredibly protective of their citizens. It is in my opinion that such regulators would never allow their citizens to be ripped off with expensive snake oil cures, and that their belief in their designations that allow DCVax-L to be sold in the UK remains quite solid. The UK regulator is likely, in my opinion, the regulator most likely in the world to be more in sync with the FDA’s thoughts on DCVax-L, even if we do not, in the US, have the laws enacted that make compassionate use and right to try rules helpful and sustainable commercial help for these tiny companies with innovative drugs.
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