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Saturday, July 02, 2016 10:09:28 AM
That is my suspicion only. Most realize that, but want to be clear about that. I have never seen the beast, I just see the water swirl and the rest seems very likely.
At the same time I recently conceded that the FDA pushing NWBO to go with crossover to get more patients to enroll in their Ph 2/3 was not a plot to undermine the trial: I want to back-off from that concession to a certain extent. It is a known that big pharma has the ability to influence patient enrollment / selection of a given therapy for trial via the large influence it has on physicians and clinicians. Those are the people advising the patients. Some patients and friends and family attempt to learn about every possible treatment, but even then, many feel the need to cross check with their physician. There is competition in these trials and it is possible that NWBO's inability to enroll sufficient patients with the original DCVax-L trial design was to some degree the result of focused efforts by Big Pharma. Not presenting any evidence in that direction, but it is certainly a possibility.
One reason I changed my view on this was recently reading about another Autologous Immunotherapy + Blockade Inhibitor currently having difficulty enrolling patients. Based on what I know about that therapy and trial, this should not be the case. It doesn't make sense. So I wonder if the missing piece to that puzzle is Big Pharma influence. And that makes me wonder if that was part of NWBO's problems enrolling many years ago. If so, could BP have influenced the FDA to influence NWBO into using crossover as the solution... ? I think it is a possibility. It really doesn't make much sense for the FDA to have suggested that solution given that PFS as primary endpoint had risks. Risks that the FDA was fully aware of. Again, this is similar to saying; we think your high wire act is too risky, but you have chosen to go ahead with it, and you are not selling enough tickets, so we strongly suggest that you remove the net so that you can attract a bigger audience.
Recent NWBO News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
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