I have gone through the company's language in their 10-Q, looked at the MHRA site, and quizzed two top AI systems at the highest access level. I've maintained those conversations over months, feeding the AI's relevant texts from the regulator, on the subject, and now also the exact language from NWBO.
They initially disagreed. But ultimately the AI's agreed that the measurement date is, January 24, 2024, not March and not December. That makes 150 days June 22nd, 2024. I'm not saying there has not been a halt since, as we don't know. I'm not saying I know anything for sure. I'm just passing along what I believe to be the most accurate analysis of what the measurement date is for the 150 day period, assuming no interim halt. And the AI's, without bias, have indicated the same. A halt is not guaranteed, though shorts would have us believe so. This is likely one of the most analyzed drug trials around. The fact that the relevant regulator has already licensed NWBO commercially to manufacture the drug, pre-approval, and deliver it on a compassionate basis, is a profound difference from MOST drugs in this context. In fact, I've never seen that before. EVER. And certainly not with this complex of a drug. Licensing the manufacturing and compassionate sale of this complex and individualized of a manufacturing process, pre-approval, required immense care and an extremely deep dive by the regulator, prior to marketing approval or even prior to the marketing application being filed. If you think about THAT, THAT is incredible. Why would a drug regulator dedicate such immense resources to ensuring that a drug, not yet approved for commercial sale, but having already finished it's Phase 3 and published the results, to allow it to commercially manufacture for global distribution and for local compassionate use distribution, at full price? That's a strong indicator if I've ever seen one, of a very positive view, regardless of the opinions of screeching shorts, who screech so loud, and so constantly, that you KNOW they know their position is untenable.
So, I would not be surprised if we saw approval earlier than autumn certainly, but I agree with setting the date so far out there, just in case. The regulatory process is unpredictable and you do that to avoid the manipulation by shorts that is virtually always wrong, but capitalizes on fear. I also believe that, as I have said before, in various previous minor misjudgments where the company estimated a likely timeline as near as possible and then there were slight delays, that they should always double the time and maybe more.... and I believe they heard me. I think Les' autumn timeline was given with an abundance of caution, not necessarily because that is what he absolutely expects, but because beating expectations, by a lot, is a far, far better thing than either missing them, even by a few days or weeks, or barely making them.
So I think shorty better keep ready for a sudden change, because I do think anything is possible and that June 22nd is 150 days. We'll have to watch and see. And like I said, we may have already been halted or will yet have a halt, but I also would not be surprised if there was no halt at all. Now let's listen to the screeching of the shorts for the next month, even on weekends and holidays. These guys work so hard to maintain their false notions, it's a dead giveaway of just how fearful they are about success, the more screeching, name calling and insanity from shorty, the deeper the anxiety and fear they are expressing in their own positions.
