AVANIR PHARMACEUTICALS (AVNR)

[sts66]

Rhe-rho....shades of MNKD FDA troubles appear to be showing here....how nice of them to wait until a week before the PDUFA to inform AVNR of their concerns, the jerks:

http://www.prnewswire.com/news-releases/avanir-pharmaceuticals-announces-preliminary-feedback-from-the-fda-on-avp-825-for-the-acute-treatment-of-migraine-281907091.html

ALISO VIEJO, Calif., Nov. 7, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has issued preliminary written feedback to its New Drug Application (NDA) for AVP-825. AVP-825 is a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally utilizing a novel Breath Powered delivery technology. 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.

The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle to convey early thoughts on possible deficiencies of an application. In the letter, the FDA requested that the company optimize the product-user interface and conduct additional human factor testing. In addition, the FDA commented that the NDA review is not complete and that they may have additional comments regarding the application.