I also believe that approval will be granted, as far as the primary end point being missed, I am not so sure about that. Many are speculating that the primary was missed, because TLD was not released. A couple of things give me pause about the primary being missed.
1. We know that the overall mortality was trending at around 23% in the trial, whereas in other trials the mortality in the placebo group was between 30%-33%. What could bring the overall mortality rate down in CYDY's trial when other trials were basically using SOC like our trial. The one plausible conclusion is that maybe the leronlimab arm had an inordinate low mortality rate. I think Dr. Yang's EIND had a mortality of 23% (I think i read that somewhere), keeping in mind that these were people that were at deaths door and probably had exhausted all other treatment options and probably received leronlimab late in the progression of the disease. This probably was not the case during the trial. The only reasonable deduction that makes sense with the overall mortality being low is the Leronlimab effect.
2.I have been investing in biotech for more then a few years, and have never recalled the FDA asking for raw data to be submitted. Is it possible that the results were to good to be true and the FDA asked CYDY to not disclose TLD, until they were able to crunch and validate the numbers, hence the two-three week timeline to report results? NP stated over a month ago that the FDA wanted the raw data, so the PR should not have been a surprise to anyone. He also stated that he would not release results until he had all the data, he learned his lesson from the piecemeal CD10 release.
3. Doesn't make sense to submit bad trial results to three different regulatory agencies. Keep in mind that the company is also trying to get HIV approval in these countries as well and it wouldn't look good to be trying to get approval on less then stellar results that could jeopardize any future filings for approval.
4. Lastly, if Friday after hours comes (72 hour adverse event expiration) and goes and there is not a PR indicating the primary endpoint was missed, I think that we all can be reasonably assured that the primary was not missed and there are other reasons behind the data not being released. If there is any inkling of Nasdaq uplist hold on to your boots, because that will be the clearest signal yet that the data is good.
All IMHO
