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Warpy

(114,595 posts)
1. My guess is that this one might be expedited in Africa
Wed Aug 6, 2014, 07:33 PM
Aug 2014

and produced there if it works in the two aid workers, bypassing the FDA approval process it will have to survive to be marketed in the US or most of the developed world.

The truth is that this drug is so early in the approval process that it has never been given to human beings before, it's only worked in animals.

The last time I've seen drugs early in the approval process circumvent that process and go directly to dying patients was in the later 80s, when big city hospitals were getting slammed with desperately ill people and there was nothing we could do without experimental drugs. Double blind studies were not done but I still shudder when I remember the paperwork.

Once the crisis was over, the FDA rules went back into effect, with double blind studies being done on new drugs.

The real hope for Ebola-Zaire is a vaccine.

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