Replies to post #181935 on Biotech Values

[DewDiligence]

AVNR receives negative “preliminary feedback” from FDA on AVP-825 NDA:

http://finance.yahoo.com/news/avanir-pharmaceuticals-announces-preliminary-feedback-133000097.html

The FDA has raised questions regarding the human factor validation study data submitted as part of the NDA. Human factor testing focuses on the interactions between people and devices. The goal of human factor testing is to evaluate use-related risks and confirm that users can use the device safely and effectively. Although the NDA review is ongoing, Avanir has concluded, at this time, that approval of AVP-825 may be unlikely by the PDUFA date of November, 26, 2014.