Heron Therapeutics Inc. (HRTX)

[gfp927z]

APPA's website is the place for basic DD/research on APF-530 (link below). Most of your questions can be answered by just reading the backround info there and some of the past press releases. It isn't that complicated a story -

http://www.appharma.com/




APF-530 is a sustained release version of the already approved CINV drug Granisetron (which is now generic), so it's a 505 b-2 filing and the endpoint for FDA approval is *non-inferiority* to Aloxi, ie - it doesn't have to be 'superior' to Aloxi for approval, just 'equal'.

APF-530 is given by sub-Q /subcutaneous injection (Aloxi is given IV - intravenously), and its effects last for 5 full days.

Once approved, APF-530 and Aloxi will be the only injectable drugs approved for *both* acute onset and delayed onset CINV. Aloxi's sales were over $400 mil last year.