Lots of information in the last few posts. Thanks Dok, gbp, ou, long and others.
I think the insight, that many other catalysts might be held back until Direct or L results at least confirm continuation of the trials, is quite possible. This is because many of those catalysts must be primarily carried forward by outsiders.
The analysis/hypothesis identifying likely cancers treated by direct in phase 1 is also quite reasonable.
Here's an additional thought.
We already know passage of DCVAX-Direct for phase 1 is a given re: safety and determining dosage. As long as there is some sign of efficacy, it will expand immediately therefrom to colorectal in a phase 2 trial.
However, NWBO previously established a precedence in the L trial. That is, the ability to beef up a phase 2 trial mid-stream, and in fact convert it into a phase 3 trial.
I'm just spitballing here, but I think NWBO anticipating the best results in colorectal cancer treatment (probably from their preclinical complete immune responses and other signals in maurine models) and thereby are protecting themselves from public disappointment if the treatment for multiple cancers narrows down to only one type in phase 2.
However….they also left themselves room to convert their phase 2 trial into a phase 3 trial for all solid tumor cancers -- depending upon the response quality and rate.
NWBO clearly planned way ahead to manage FDA and public expectations These expectations must be managed in order to get the best product with the broadest application to market first without losing funding when the burn rate is at its highest.
Remember, the FDA is legislated to demonstrate some flexibility when dealing with orphan drug prospects. It was a brilliant ethical plan by NWBO to move Direct forward for inoperable tumors.
The FDA is not stupid, they know that direct, if wildly successful on inoperable tumors will be applied to operable tumors as well. In fact, technically it already is. "Inoperable" has a broader definition than one might otherwise think.
I do not believe the FDA would hesitate to convert the Phase 2 trial mid-stream if the phase 1 results are very impressive. I also do not believe adding operable tumors to a phase 3 trial would result in a loss of orphan status, as 2 arms could be delineated and/or addressed with some other reasonable arrangement.
I guess what I am saying is that it appears NWBO took great care to leave themselves room for almost any contingency. Furthermore, due to the safety profile and orphan status for Direct, I believe the FDA can accommodate NWBO.
