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To: workerbee

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...


12 posted on 03/11/2014 6:01:35 PM PDT by montanajoe
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To: montanajoe

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?


15 posted on 03/11/2014 6:08:05 PM PDT by workerbee (The President of the United States is DOMESTIC ENEMY #1!)
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To: montanajoe
eWll said. It mystifies me that people will belabor and demonize the very corporations that they might have to depend on to develop medicines that could save their lives. It is the entitlement mentality on conservative steroids, and a disgrace. This corp owes nothing to nobody, and the risk is tremendous. If you want this kid to get this medicine, go convince the governmental and legal scum who are the real perps here.
17 posted on 03/11/2014 6:11:00 PM PDT by hinckley buzzard
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To: montanajoe

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.


22 posted on 03/11/2014 6:49:44 PM PDT by nurees (Oh...there is a NEW Mexico (Homer Simpson))
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