Actually this is a small start up company. They are trying to get through clinical trials to get their drug on the market. If they give the drug to this kid and he dies anyway (which is unfortunately likely) the drug company will have to stop its clinical trials and prove to the FDA the drug did not kill him. This could take many months and be very expensive. Possibly preventing the company from ever getting its product on the market.
The problem is not the bad drug company but the FDA regs...
But apparently Moch already claimed it was a money issue. If it’s not the money but the regs, doesn’t he have a moral obligation to say that publicly?
Exactly. I spent 14 years in the industry first on generics and then on contract work. This would invalidate any clinical trial they are attempting to execute under current FDA guidelines. It costs billions of dollars to bring a single drug to market (successful or not. Any positive or negative response to the prescribing could have devastating consequences for this small, start up. They would in fact have to spend millions more to prove/dis-prove the drug worked or if the child unfortunately didn’t make it that the drug did in fact not kill him or contribute to it. Not to mention the potential civil suit. I feel for this family but it not simply a matter of giving the child the drug.