Thanks for that info on this other company. A few points:
1) I do not believe any of the FDA’s issues have anything to do with “corruption”.
2) they were given a shot at expanded access in the U.K. and Germany, but the U.K. specials program is an unusual and odd variation on the expanded access programs that typically are not economically feasible and even large drug companies often qualify for them only for the PR value and then subsequently drop participation when no one is looking.
3) This new factory for expanded access has come more than a year after data lock, and it seems unlikely a regulator would allow that to happen knowing that to be the case and not wanting to have some idea of outcome, but we don’t know that for sure. However, the UK is very strict on marketing on a false basis to it’s citizens even cellphone manufacturers get fined for making claims they do not think are justified. So I think it would be a strange circumstance that the primary drug regulator, an agency they clearly take pride in, would facilitate an incredible fraud by licensing a manufacturing plant and the sale of an ineffective drug at this stage of the trial to gravely ill patients for $200,000 approximately, which is not a small sacrifice for patients or their families. Granted, there is reliance on their top doctors, and wouldn’t it be incredible if for the sake of a few patients or more, they allowed a scam to happen that was so small scale yet so exploitative. Imagine what damage that would do to the agency and probably the government and King’s College. Honestly, it seems inconceivable and if someone can show me a recent case where the MHRA has allowed gravely ill patients and their families to be taken advantage of in similar circumstances, so late, a year after data lock, I’d be most appreciative of that information.
I think you made good points, but I do not agree that the FDA is engaged in corruption.
Thanks for your post and for the new info on this other company I did not follow. The US expanded access program, because it is very paternalistic, written by interests who seek to protect patients from exploitation, simply does not work. It presumes that drug companies are so rich and exploitative that they can even benefit from effectively giving away their drug. And the German program has issues with requiring local manufacturing. They all found ways to throw a wrench into the machinery so that they could say they were giving early access politically, without the headache of having to worry that it would actually happen and then they’d have to answer if some patients did not like the result of what is, in many cases, still an early in trial experimental drug.
In this case, the factory was licensed again, a year after data lock. It would be hard for an agency to cover itself if it turned out it were all a giant, many years going, fraud. So I just think it’s unlikely as a factual possibility. It doesn’t mean it’s a guaranteed approval, but I would not have invested if I did not think it were a very likely possibility.
All IMHO above. I have no idea if anything. It’s just personal opinion, not advice, and people should do their own due diligence and reason from that diligence.
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