"atc valuable addition for pts"

sounds like a very simple and quick trial required for ATC approval, and ATC will be a "valuable addition for treatment experienced patients"

to see how easy this sort of trial will be for a drug like ATC with strong efficacy, see the results of the phiib and the massive reduction in viral load compared to placebo, as will be required over 1-2 weeks in the coming phiii


February 23, 2011

AIDS Activists Call on Public to Support New FDA HIV Drug Approval Policy

"apricitabine?have recently failed to demonstrate the efficacy necessary for FDA approval even though both drugs would certainly have been a valuable addition for treatment experienced patients.?

That?s where the new guidance comes in. In the proposed trial design, the experimental drug would be given to people on top of their failing regimen for a week or two, just to measure how much it was able to reduce virus on its own. At the end of the initial trial period, people would add a new active background regimen, allowing researchers to assess the longer-term durability and safety of the experimental agent without placing people at undue risk of developing resistance to the new drug.

To sign on in support of these new regulations, click here.


Search: FDA, treatment-experienced, policy, sign-on letter, ATAC


http://www.aidsmeds.com/articles/hiv_fda_letter_1667_19939.shtml