Thanks for your kind and thoughtful reply and while most of the time a HALT, not a partial halt would be a safety issue, it is never kept confidential. The company claimed it had no idea, as I recal and has NEVER explained the reason for it. Plus it wasn’t material to the Federal securities law case, all of that would make ANY safety halt, and a halt is not some casual thing the FDA does just in case, it would make it a very serious securities law and state fraud and FDA law issue regardless of what gentle thoughts the FDA might feel about it.
So it makes no sense to me that a safety issue is the reason. Moreover during the relevant time of the halt, the company was saying there were very few (almost none) safety issues, they literally can’t say that, repeatedly, and not be in jail right now, if there was a long safety halt by regulators that was literally never resolved except by ending the trial. And everyone, including the SEC, the Court, the FDA they all were aware of the halt and likely what they were saying.
Lastly, your supposition on fixing the halt is not actually what happened, what happened is they stopped randomizing patients and it appears they stopped randomizing them to the placebo arm, and ended the trial and THAT it was literally and explicitly said, ended the halt.
The pseudoprogression supposition has no legal basis for being the reason for the partial halt. Plus other immunotherapies have had pseudoprogression and they completed their side compassionate arm long before the end of the halt. And the journal article that Dr. Liau wrote on pseudoprogression and scanning, which likely was long after her research was completed on identifying pseudoprogression, and their adjustment of the trial protocol I believe for pseudoprogression, all happened long before the end of the partial halt as well, which only ended when the trial effectively ended.
It seems the halt had nothing to do with pseudoprogression and as I said, you can’t keep safety halts a secret. The FDA does not impose them secretly and casually, just in case. They impose a halt for important safety issues that have to be addressed immediately, and you don’t get to keep administering the drug, or starting new patients on the trial, and stop the placebo arm, until the issue is sufficiently addressed to lift a safety halt. They are not casual with the safety and lives of the individuals in that trial, and they are not casual about what companies SAY about their trial or rules of consent.
There is no indication that the company updated their consents.
So you’d need to explain why all those things happened as they did and did not adjust to explain the safety issue and why the changes they did make did not affect the partial halt to make that the explanation.
No one does that. So I can’t see it as the reason. Yes, that was a concern for the PFS measure, it was never considered a safety issue because it is not real rapid progression but PSUEDO, which means spurious or sham progression by definition.
If they halted the trial because they thought it was real progression, that would be a failed trial. I believe that clearly no one thought that. It would be a literal futility finding, not a safety halt, not a partial halt. Yet they were able to keep giving the drug. There is not a lot of ambiguity there. Meanwhile they are considered a most promising drug in multiple jurisdictions, in the UK, and then the Germans gave them the Hospital Exemption, not lightly, but after very detailed filings and data being looked at.
None of that makes sense to me and then there is a futility finding, and it makes no sense as a safety issue to me, without the necessity of the history in various forums legally to be different and not without an absolute necessity of disclosure. The suppositions people are making are absolutely covered by 8-K disclosure rules, they are material, as well as in the other forums. There is no getting around those issues. And LP and LG are not fools. The Federal Judge who wrote that 80+ page opinion, is not a fool. Th SEC which was induced by attackers to investigate, multiple times I believe, is no fool. The FDA would not ignore such misbehavior, which is strictly addressed, and hospitals, doctors and institutions would be duty bound to discuss such matters in that previous journal article.
There is no way I can see the partial halt being a “safety” issue. It’s not possible, too many would be involved in a conspiracy of silence that would be highly criminal.
The shorts say it and pretend it is not absurd. They say it because AF says it, and gets away with it because he does not have to reason out why it is absurd. He can create a false notion and keep spinning it.
But longs should not fall for it and keep repeating it because they can’t see through the haze. How does anyone who believes, and still believes in the company, justify what would be very bad behavior if it were true?
I don’t think it explains all the circumstances and fails as a theory for the partial halt. The one thing I do know is also a fact that starts to explain it to me is there are substantially fewer placebo patients, and given the facts up to that moment, from what I can see, it was patently obvious to everyone that delaying access to DCVax-L has a substantially detrimental impact on survival. I think a new regulator in the mix thought that kind of knowing, human experimentation, given their own history, is deeply unethical. And wouldn’t you know it, but use of external data is also justified in a policy basis for “ethical” reasons, when it is unethical to have a placebo arm.
Ethical does not mean they had the data yet to justify an outright approval. That data still needed to be collected, and the pseudoprogression issue meant that it would not be PFS data but survival data. And survival data takes a very long time to collect.
This is all IMHO.
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