NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The problem with compassionate use laws in the US is that they can’t charge what it really costs pre-approval. It is why virtually no one is doing it except for drugs already available in some other commercial context or that are not expensive to manufacture by a tiny company. Advocates for consumer consumer protection did not want companies to “profit” or “make money” selling drugs before they are approved. That was also a problem in the UK under their EAMS program. And similarly, the German program has the requirement instead that the drug had to be manufactured locally. Every such program has problems.

The Specials Program was a break from that pattern, but it’s also why the company can’t talk about “revenue”. It is a sensitive topic. So actually, it is not a commercial manufacturing set-up that prevents it. CRL in theory could have continued making it and the company probably could have provided it compassionately, at the expense of shareholders, probably to the tune of tens or hundreds of millions of dollars annually to keep a factory operational to provide a drug at the literal cost of making it.