I have answered these questions many times. I personally believe this company started out with a genuinely novel approach that had a lot of promise thanks to Dr. Liau's remarkable scientific skill in developing the DCVax vaccine. The biggest mistake made was contracting NWBO to prove the vaccine works. NWBO conducted a flawed Phase III trial, in some part due to factors no one could have anticipated, but flawed nonetheless. I believe the turning point in the history of this project was in 2015 when NWBO requested an interim efficacy assessment. The results of the efficacy IA almost certainly led to a futility recommendation on the primary PFS endpoint and also led to the FDA putting a hold on trial enrollment.
This was the most critical juncture in the whole saga. Even though the company was still blinded to the trial specifics, they nevertheless knew about the futility recommendation. At this point, the company could have disclosed this information to shareholders, along with the reason for the FDA hold, and announced they would do the scientifically responsible thing and start the trial over with a proper design. This announcement would have devastated the share price, no question. But it would have been the right thing to do, and, if they had done so, I personally believe we may be talking about an entirely different set of circumstances today.
Instead, they withheld efficacy IA information, including the reason for the FDA hold, from shareholders and carried on as if nothing had happened. This was a profoundly unethical decision, and I think we all know where the buck stops with that one. For the next five years, they plotted how to keep the gravy train rolling. Due to the events in 2015, they knew the FDA would never approve the trial results for marketing and almost certainly had been told as much by the agency itself. So, the plan they developed involved:
- Selling Cognate, in part to eliminate SEC governance scrutiny
- Shifting the entire focus to Britain where they thought they might have an inside advantage and/or political pull
- Starting up a new CDMO - Advent
- Waiting until the very last minute, right before data lock, to announce that even with the knowledge of the 2015 efficacy IA they were post-hoc changing the endpoints on the trial and ditching the trial's own control group and replacing it with poorly matched external groups with no patient-level data, only summary data
- Working behind the scenes to get MHRA approval through political maneuvering
This is just my theory, but I believe it is true, and I believe they have not been honest with shareholders about any of this. In the meantime, they have continued to dilute shareholders to an almost unimaginable degree, all while continuing to pay themselves million-dollar salaries and bonuses. Now they have lost their political connections and are discovering the MHRA has no intention of approving their trial results, either. And that, in a nutshell, is where we are.
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