I am not an expert with regards to the FDA, but I have

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OTCnewbie sjacobs26 #8243
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I am not an expert with regards to the FDA, but I have worked with a lot of people who have worked with them directly. They are always described as helpful, knowledgeable, and serious. In any new situation that is presented to the FDA, I believe that there in learning happening on both sides of the table. I believe this approval process has been a new first for the FDA. They are trying to get this right the first time, and my feeling is that with all of the data they are collecting they will be able to make better decisions about more that just HIV. They know as much about this drug as anybody and obviously see what is coming their way in the future. I think these small delays will pay dividends going forward for other programs. IMO

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