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Tuesday, March 09, 2021 11:29:45 PM
1) Almost every trial, and particularly as trial options change under FDA guidelines, is slightly different than the last. When you're in new areas, this is increasingly so;
2) This trial lasted longer than most and had more hurdles to overcome than most, including lots of false rumors and scuttlebut, so release of the data alone may be viewed, particularly when coming from an OTC company (major media refuse to cover OTC stocks, but will cover journal articles) as questionable commercial information and the vacuum there will likely be filled by commercial competitors and their handmaidens in the media (and those people, while often having bad motives and being uncredible, very likely would get more attention, seeming on superficial glance to be independent, because their motives are unclear, while a commercial OTC company posting its TLD in a simple press release, particularly if they sound unbelievably good, will get ignored because policy at media companies ignores OTC companies, otherwise known as "penny stocks");
3) This trial SAP changed, which is allowed, and they will likely be the first trial seeking approval using an external data set for placebo comparison, and those things are very unique. They are allowed, and the FDA created new guidance almost custom made for a trial in these circumstances, but that won't stop shorts from making all sorts of arguments, almost like yours, like that it is "unprecedented", etc. This entire trial is unprecedented. It is unique for numerous good reasons. But masters of rhetoric will be more effective against a purely commercial release of TLD rather than an academically reviewed, scientific discussion of the key details and data. Also, academic critics, who are ofen commercial rivals in reality, will have more work cut out for them.
4). There was a partial halt. I doubt they want to spend a lot of time talking about the intricacies and procedures of the trial, as that distracts from the results, and a fully vetted publication will ensure the results are the primary focus and that the circus masters of the internet have a harder time distracting media and others from the results. It may still happen, but with less effect.
So no, I do not see anything bad about this approach. You also said that DI was lying about the journal earlier and I believe in posts previous to the one where I responded and showed you that in fact they had put that in the press release.
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