Quote:
Originally Posted by DJ's left nut
Yeah, but lines like that are never bright line and will slide really quickly. That's why I asked if it's a 'wink/nod' sorta thing. Is there a true black-letter definition of 'end of the line'? That wouldn't seem terribly likely.
Who's really going to call physicians on the carpet for it?
Is this just the FDA protecting themselves if things go completely haywire and this thing goes sideways in a month? "Hey, we told physicians not to go throwing these out all willy nilly until it was tested further. Not our fault they did it any contradiction of federal guidelines..."
It just sounds like a shifting of liability more than a true bright line cut-off.
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Compassionate use exemptions are get out of jail free cards for providers. The drugs they get are in very limited supply, and the manufacturer sees only upside from it because if it works, it's a miracle, and if it fails they were dead anyway.