Hi Dan,
Nice write-up and I appreciate it. I do disagree with you on the reason for the PARTIAL halt being pseudoprogression and the view it put patients at harm.
Such halts, and I have seen them with other drugs, are conspicuously loud. They are fully disclosed, they are brief in duration (if there is an approvable drug), and everyone is notified including the patients that there is a potential harm here which the company has been charged with investigating, and getting back to the regulator before the halt can even possibly be lifted. There is no continued trial. Patients do not continue to get the drug, if it is determined with enough satisfaction that the drug has caused a harm and the halt is not lifted until the risk has been clearly addressed with the regulator.
Virtually none of that appears to have happened in this case. This was a partial halt, patients that were “accepted”, whatever that means, continued to enroll and get the drug (such that patients who first got the drug, appear to have received their first doses after the partial halt was approved, I believe, and others continued), and it appears the trial at the end was short a significant number of placebo patients that were originally designated to be a necessary part of proving any kind of efficacy.
Also, the company has continued to say there are very few side effects, and virtually no serious events. The company was not unblinded, and has said it was not aware of the reasons for the partial halt, I believe. The lawsuit that was dismissed, if anyone seriously believed the halt was due to harm, all of that failure to disclose and those statements, those would be bad acts at numerous federal and state levels of law. There would be consent issues, for the patients, fraud issues, issues with FDA laws and Securities laws.
We would not be where we are and none of those institutions or doctors would have likely rushed to sign on to that interim study had there been a halt because of harm that was not fully disclosed to them, their patients, to their institutions and to the world.
So I do not think that was THE reason for the partial halt.
I do think pseudoprogression was a possible worry for the validity of the trial result with PFS, since obviously if your primary measure is recurrence and if recurrence was repeatedly misdiagnosed potentially, and that diagnose can’t be undone, then it could be an issue, though survival results, the secondary measure, and the gold standard for which PFS is really just a surrogate measure, was exceptionally good.
I think one regulator who came into the trial later than the others, accepted the trial into their country and then was as the regulator, unblinded and thought this placebo arm is unethical. Just a theory. The reason a company would not be informed would be that under their SAP, as it existed, there would not be enough evidence at that moment of the partial halt, even though, all my opinion, it was viewed as unethical to deny placebo patients access to the drug or delay their access. I think this problem was likely compounded by a conflict of ethical rules and laws between different countries, an unexpected result. And in order to maintain the integrity of the trial and allow a sponsor to fix it, they can’t be inadvertently unblinded. So no reason can be given.
But I think something like that deductively explains far better the potential reason/theory for the partial halt than that a regulator thought patients were being harmed by DCVax. Nowhere is that in the record, not in the federal ruling and case, where it would have been a necessity to disclose that if it were a fact, nowhere. And had it been disclosed to the judge, which it would have had to have been, it would have been clearly described as a material fact in the court opinion. Even the interim review by all of the doctors, the journal article, it would have necessarily had Togo into the details of such an issue. That is not in that article. It would be gross negligence of them all not to have disclosed there.
This is why false narratives become so easy on social media. People introduce theories, traders particularly, to advance their trade hypothesis. And those theories, absent an ability to verify, become “facts” on social media.
My theory on why the halt may have happened is just my theory. But the notion that it was a safety halt, appears to be highly unlikely to me for for many of the reasons stated above and more.
Great post, just wanted to clarify my view on that point since it is so completely different than what has been frequently said here that I think is just absolutely not consistent with the facts. If it were true, I’d unfortunately, be agreeing with ExW and others, and I do not think people understand the gravity of the situation if the halt were due to safety concerns, that apparently were never resolved, until the trial ended. That would be a completely different set of facts, and I would not even be here but would be invested in some other company.
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