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Tuesday, August 29, 2017 2:38:28 PM
"Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options).The options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance."
Why in the world would the FDA limit labeling to resistance to four, or even all five, classes of HAART after agreeing to this trial protocol, as you suggest is "likely"? Your "small market" argument makes sense as is, even if not everyone agrees completely on the final impact of that market. Why are you making such unsubstantiated claims? You lose credibility when you make things up.
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