No, that’s not what u am saying. If they haven’t raised enough of the money, they may not be getting it. Alternatively, the company may be making it available on some other basis. If you’re testing a drug manufacturing process, you’re might be potentially creating a trial patient for the purpose of manufacturing. Additionally, you might not be doing that, you might be making the doses available on a piece by piece basis with other funding to be provided upon some other approval.
The U.K. is trying to make such treatments available through special funding, but that funding may be complex to get, involve red tape and be conditional, for instance, subject to final regulatory approval.
There could be any number of reasons, and assuming the worst at every turn when the company has scaled up, is hiring people and apparently working quite hard on their production prices and has all the necessary licenses, seems like unnecessary stone throwing to me. It would not happen to a larger company, it is easy to throw stones at small bios and try to create fud.
I disagree that my comments did not address your comments fully and this goes further.
I did not give you any specifics on regulatory maximums and did not use that term at all. They cannot market their product. There may be informal ways suggested to not appear to be marketing a drug, and no, it doesn’t have to be something of which we are aware. The point is for it NOT to be transparent because a regulator may fear if people see a lot of other patients flocking to a new treatment that that is, indirectly, a form of marketing.
Maybe you failed Econ 101 or Business 101, but people having careful conversations on the subject are the realists here.
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