howabout an outcome of Expanded Access approval for ATC from the...

howabout an outcome of Expanded Access approval for ATC from the recent meeting with the FDA?

Isentress got it with phII data
Intelence got it with phII data
Selzentry got it with phII data

when will ATC get it...!
and what will it mean for the sp and partners WHEN it happens?


what's expanded access approval?

see here
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm134331.htm

and below

Additionally, use of therapeutic products still undergoing clinical trials has been achieved through open-label safety protocols and parallel track.
Parallel Track (1992)

The final Public Health Service policy statement on the parallel track mechanism was published in the Federal Register on April 15, 1992. The purpose of the parallel track was to expand the availability of promising investigational drugs to persons with HIV/AIDS and related illnesses who lack satisfactory alternative therapies and cannot participate in controlled clinical trials.