The FDA will not terminate a study in which ALL patients are living longer. The worse case scenario, if regulators do not allow for a co-endpoint change (due to immune responders recording false PFS (inflammation changes)), they will allow the Company to complete their confirmed "well over 300-patients" count to get to the 348-patient full enrollment count.
Who even knows how many more patients they will need? You don't know. I don't know. No one does. You continue to suspect the enrollment count is like "304-patients". Yet the Company has stated it is "well over 300 patients." To me your 304 guess seems far removed from reality, as it is no where near a number that is well over 300 patients. Let's pretend you revise you guess, and you somehow agree they need another 10-25 patients left to enroll to get to 348-patients. If it's only 10-25 patients does not your "study will be stopped over incomplete enrollment" argument appear lacking? It does to me. You're in fact suggesting that regulators will not be agreeable to have a Phase III trial, where ALL double-blinded patients are living longer than the 2 year norm (per Linda Liau) and is just shy of enrollment completion to continue screening to get the last few patients. Seriously, can you not spot the holes in your argument? Here's one, regulators have let the Company treat patients over the last 9 months. Here's another, a possibly bad PFS (due to inflammatory responses) tied with longer survival means the therapy may be working, only the problem is recording responses for its efficacy is faulty (psPDs in the main arm). The crossover obviously confounds overall survival, and if the vaccine works, it should confound survival as all patients get treatment at some point! Credit for the long-tail survival can't be either "given" or "taken" from the vaccine until the Phase III data is unblinded. How you could possibly see that regulators won't allow screening to complete enrollment of just another 10-25 patients, on a Phase III no less, that has a crossover patients living longer, is not something I will ever understand. Hopefully when you think it through you will see that the study will be not stopped due to an incomplete enrollment, which is just shy of completion. If you still disagree, then eventually you will find your hypotheses over the study being stopped (if regulatory do not agree to a co-endpoint change) and basing their decision to stop the study because a "just shy 348-patient enrollment", will be dead wrong.
The only risk with holding shares at this point is bankruptcy or a bad investigation report or a statistically insignificant study (at some point). As for the investigation, I doubt they will find wrongdoing, even if pricing is high, I imagine it will not be considered more than their other clients. Woodford already suggested he would buy if the report is solid.
