Showing posts with label Avanir STAR Clinical Trial. Show all posts
Showing posts with label Avanir STAR Clinical Trial. Show all posts

8/18/10

Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision.

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Repost of Seeking Alpha Article on AVNR. Avanir has an upcoming FDA recommendation decision date on Oct. 30. We will see if they stick with that actual date for a Spooky Halloween Trade.

By: Sheff Station

Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision.

Jul 30, 2010 2:14 AM | about stocks: AVNR, ALXA, ARNA

In early 2006 AVNR filed a drug application for Zenvia. They had filed a submission for Zenvia with the 30/30 dose combination. Two Phase III studies demonstrated safety & efficacy of Zenvia in PBA as well as 10 clinical trials. Priority review was received from the FDA as they acknowledged it’s a disorder with a high unmet medical need. In late 2006 AVNR received an approvable letter from the FDA.