I agree with you and have always believed similarly. If randomized, the placebo would not be so short at the end of the trial, and crossover does not reduce the randomized patients. Additionally, under law the FDA MUST inform the company of the reason for any halt it imposes and as I said, the reason would be the rule that requires them to halt when a foreign regulator halts a trial, until they can get the halt lifted there.
The only reason the FDA lifted the partial halt was because the issue was moot once’s the enrollment had stopped. Not because of addressing a specific issue that was identified, and the FDA has specific reasons allowed for imposing such a partial halt, and no longer enrolling patients I believe does not resolve those reasons. Not enrolling patients would be a practical reason only for ending the partial halt, because the matter was moot in terms of the foreign regulator, it would not have addressed the “reason” for a partial halt, which is a narrow set of defined kinds of things.
Meanwhile the Germans never lifted theirs and it is still listed, as before, on the website the Germans update, not the company. And we know the Germans updated it for the update to the SAP. It also never listed the partial halt with the relevant regulator for the temporary halt also as the MHRA even when the U.K. was a member of the EU, identifying only Germany. And as I have said, it came after the Germans gave the very difficult to get Hospital Exemption and they never canceled the HE, despite the halt.
Meanwhile the placebo arm is short by a huge percent of the total placebo arm that was supposed to be in the trial, and that seems not random. Could be random, but it seems unlikely to be because of the large percentage not enrolled as random.
I’ve never said I am right, just that I have my theory for the halt. The company did say to a journalist that they did not know the reason for the halt. I believe they said that other times but that such things are not always bad. I have been told this last bit here, I was not a shareholder at that time or it was not a public statement. But, given the allowed reasons for a halt, there are very few that might be viewed as not bad, that might result in a trial ending with fewer placebo patients, that could be formally lifted because a trial ended, and that would not be openly communicated to basically everyone because of practicality and necessity. The ones that exist other than the positive one I know, would in fact necessarily need to be communicated to the company, and would also then require an 8-K.
So I agree with you, and you seem also to agree with me, except that my official stance is that this is all arrived at deductively, I have no special information and I, therefore, of course could be wrong.
However, if the reason was what some had originally insisted, then the ending of recruitment, the short number of patients, and other indicators that would come from that other reason would in fact cause the reason for the partial halt to necessarily become public, for a multitude of practical and legal reasons. But I see no indication of that fact set that would have indicia and fingerprints even if the company chose not to communicate that possible reason, which would not be appropriate either, for many reasons. They would know and they would necessarily need to say so.
So I do not think I am wrong, but if I am, they’d have a lot of explaining to do and there would be serious liability. I just don’t think the bad reason makes sense however, given all the people involved and all the circumstances.
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