Maverick,
I really believe that we have failed to accept the importance of what the company has given us, not that they've had nothing to say. I believe that Dr. Bosch's presentation at ASCO was very significant, we've failed to recognize how significant it was.
All the data that Dr. Liau and others have presented has been a powerful indication of the advances being seen from the application of DCVax-L in a few different ways and how the gains seen in Phase 3 can greatly be built on with other therapeutics, there is no denying the clinical benefits being seen. This by itself is probably worthy of approval, but what Dr. Bosch told us was why.
I believe that knowing WHY our DCVax-L works as it does also sets the stage for it's acceptance in being used in other cancers as if it achieves the same thing there, benefits will almost certainly be seen. I don't know that the regulators will go that far in their approval, but I believe that knowing why our vaccine works will give them reason to clearly allow its use off label and they'll support having insurance pay for its use. It may not happen instantly upon approval, but as demand for the vaccine builds in other cancer I believe they'll be supportive while additional trials are being run to achieve label changes.
I know none of this relates to when we'll have approvals, but nonetheless it is important and it's something the company revealed. I believe the company's getting closer to when they can reveal submissions to the regulators, but until they're there they can't say so. I've seen too many cases in the past where what sounded like a minor issue that surfaced during progress toward approval resulted in many months, or years, of additional effort before the product was approved. In every case that I felt a product should be approved, it was, but delays were all too often caused by issues from the regulators. I believe that NWBO is trying to deal with any concerns the regulators may have before calling their submission complete. IE, if the regulators have any requests after reviewing a section of the application, they'd rather resolve it than say, our submission is complete.
In some ways it's like the story of Henry Kissinger with a new staff member who submitted his first report to Kissinger on an issue assigned to him, it came back with a note, "Is this the best you can do". This was repeated a few times, finally the new staff member personally brough the report to Kissinger saying it was the best he could do, Kissinger thanked him and said, good, than I'll read it.
Gary
Bullish
