FDA announces new 'proposed' path to market for HIV...

FDA announces new 'proposed' path to market for HIV drugs...
http://www.hivforum.org/index.php?option=com_content&task=view&id=339&Itemid=65

Announced in the presentation by Jeff Murray, the head of the FDA CDER Infectious Diseases unit...
http://www.hivforum.org/index.php?option=com_content&task=view&id=339&Itemid=65

which includes Phi and Phii trials already done by ATC...

and 3 phiii options for approval
a)heavily treatment experienced
requiring 2 wk efficacy, and 24 wk safety in a single arm with dose comparison.
ATC has all this.

b)treatment experienced
24-48 wk non-inferior to approved drug
ATC has all this.

c)naive
48 wks noninferior to gold standard.
not yet...

I'd say this means AVX meeting with the FDA could be very constructive, if not exciting for near term approval in treatment experienced...

could be a good AGM/xmas with AVX/ATC

and...

naive comments about 'significantly more than 1800 pts' for phiii

and naive comments about 'nothing to be gained for AVX from speaking with the FDA on ATC'

are looking a little sick and slanted...