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I agree, however i strongly feel the FDA

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gestalt2   Friday, 11/10/17 09:56:44 AM
Re: Inoviorulez post# 18087
Post # of 18226 
I agree, however i strongly feel the FDA does not have every right to do what ever it wants. It is a government entity whose job it is to monitor trials to make sure drugs do what they say they do, side effects are documented and the drug is safe. I realize this means that they have a lot of responsibility but when there is close to a year of setting the trial protocol they should own their agreements. The FDA said 30 patients for the combo and to think they can and without any explanation change this whenever they want is irresponsible. Cytodyn is a small biotech and these changes could mean a important drug never gets to market. I am sure many past drugs went through this and we do not have treatments available due to the finances required to make it happen. I am sure the FDA is aware of this but they are way behind in terms of solving this problem. Pro 140 has been in existence for 7+ years and it is as close to ever to being on the market but at a cost of many years and hundreds of millions to get here. The FDA has to answer to the HIV population as to why a drug that there is absolutely no safety issues for over 7 years and proven efficacy is being jerked around at the last minute by them.

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