how are they defining "profit" though? like, a single dollar over the cost of manufacturing? or can companies factor in development costs?
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The problem is - I am told, I’m not a lawyer - is, if a company says, well $150,000 is our cost, we r not making a profit, there’s no entity charged with confirming that. Under expanded access, the confirmation of cost would be done by the FDA. So, who will keep companies honest?
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