Thanks PGSD. It’s a great answer, and again points to key aspects in the SAP and analysis including the MAIC analysis that was included and certain results that come out in that analysis, like the fact that patients with MORE tumor remaining did better in the DCVax-L trial than in the other comparative trials in which patients had lesser resections of their tumors or the same surgical outcome. Meaning that the more tumor they had, the better they did in comparison to patients in a similar situation in the other trials. This is an elegant address to the cherry picking argument, which was never valid, but came up when critics had nowhere to go. Further older patients did better. Patients in the control arms that had a worse prognosis and should also have had a similar prognosis in the DCVax-L trial, did better in comparison to similar patients in the control arm trials. DCVax-L’s immune response was stronger where there was more tumor remaining and in older patients who likely otherwise had a lesser immune response, because they were older, but with vaccination, managed to elicit a more vigorous reaction to kill tumor tissue.
There are many features of this trial that indicate that the mechanism of action is working. Even the inflamation that causes pseudoprogression actually is proof of the mechanism of action when patients go on to survive longer and in some instances live in the fat tail long-term survival arm and have no recurrence. The fact that recurred patients do so much better also validates that mechanism of action.
There are no doubt persons who want nothing more than to have their other alternative research and treatments left without having to compete against anything new like DCVax-L. Oncology for those who promote TTF/Optune, is a very lucrative endeavor. It is hard not to expect that those doctors would get very wealthy when a mechanism that basic can generate $21,000 a month, indefinitely. That is real cash flow. They have dedicated much energy to validating that technology. We get it. They have interests to protect and bills to pay. But the results here with DCVax-L can’t be ignored and I do not see the FDA ignoring these results at the end of the day and doing anything but some form of approval. That is my opinion, but I do think it is based on solid ground.
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