Karlchen, I believe you and I are at the same point in our thinking.
I believe that DCVAX-L works and this belief is based on the gold standard of OS for immuno oncology and the 3 and 5 year survival rates based on blinded data that have bee discussed.
I believe that NWBO's quandary is that they can only show clear success if they can report TLD using the revised endpoints (accepted by UK, PEI and EMA); but may be constrained in doing that until fully cleared by FDA. Dr. Liau is pushing for the new end points, per her talk on Friday and NWBO is committed to the new endpoints, because the old endpoints do not let them declare unequivocal success. With the old endpoints, they have a clear success with their secondary of OS, but perhaps a murkier picture with the primary of PFS and thus being denied the home run that they know they have achieved. [Parenthetically, I now believe the rumored trial failure in 2015 based on a supposed interim analysis that was denied by the head of their DMC as having being conducted at all, was probably based on an anticipated murky PFS due to cross over confoundment and incompletely understood or mistaken pseudo progressions. New techniques and knowledge gained since then have led to the revised endpoints.] Absence of a clear cut success on the primary endpoint would again bring up the same debates and attacks and hence the need to wait.
The statisticians are probably proceeding on the basis of the new endpoints and hence the statements by Dr. Liau and the company to that effect. But I suspect that the unblinding and TLD will be held up until this change is cleared with the FDA.
NWBO could take a chance and release results based on the new endpoints. The FDA may not like that. But if the OS results end up being what we all believe they will be, then any ADCOMM will recommend approval and the FDA will then need to make a decision to accept the ADCOMM recommendation or reject it. I believe they will accept it.
The potential problem for NWBO could be the turmoil that will exist while this plays out and the impacts on potential partnership /acquisition discussions. A clear win out of the gate, makes all that smooth sailing.
JMHO.
AI
