Does time, actions or lack there of create certainty or uncertainty?
Did blowing past the PFS trigger serve to create certainty or uncertainty?
Did continuing on past 233 deaths serve to create certainty or uncertainty?
Did extending time between preparing to lock the data in Nov 2018 to actually locking the database in Oct 2020 serve to create certainty or uncertainty?
Does testing for IDH mutation in the database serve to create certainty or uncertainty?
Did LL foreshadowing data analysis, likely outcome, and future research directions for GBM serve to create certainty or uncertainty?
Does advertising your product (technology or vaccine based upon your beliefs) serve to create certainty or uncertainty?
It is up to you whether or not you are certain of your investment thesis.
I know two things for certain. First, the only rationale explanation ever offered regarding the Halt in use of Placebo during the screening and randomization phase of the trial is that the DSM saw a clinically meaningful difference in death rate between DCVax treated patients and placebo treated patients and called for a halt of the trial. LP refused the halt and the rest is history.
Second, FDA granted Northwest Biotherapeutics and Early Access Program which was employed for a period of time. EAPs are only given to promising therapies that have shown sufficient evidence of both safety and efficacy so as to deem them appropriate for broader use outside the trial. This EAP is still active. It was not taken away from them, although I am not sure why it has not been employed to offset the fees paid to Cognate. They already had sites up and running with it but then stopped. I have a theory which I may share at some time with you and it is consistent with most everything I have put out there. They never needed “Right to Try,” they had been given the right already. They could have restarted today if they wished to do so, except they can’t.
All the other stuff that causes angst and churn IMO was to create FOMO so that retail wouldn’t shoot itself in the foot and kill the plan. I just wish my wife would allow me to take advantage of this opportunity. But like TRYN2, I fear what could happen if I did.
And BTW, those early people who died after getting placebo, never had the opportunity to be forced on to therapy. So, you could never get to 100% treated, only >90%.
