Showing posts with label FDA Special Protocol Assessment. Show all posts
Showing posts with label FDA Special Protocol Assessment. Show all posts

9/19/10

Chelsea Therapeutics 2nd Clinical Trial Pending Results

Image representing Seeking Alpha as depicted i...Image via CrunchBase
From Wikinvest: Chelsea Therapeutics (CHTP) traded higher Friday closing at 5.06 +0.94 for a 22% gain. I am showing some caution for Chelsea Therapeutics as this Clinical Trial was previously rejected last September. News from that rejection from Sept. 2009: Chelsea Therapeutics (CHTP) Dives After Trial Did Not Demonstrate Statistically Significant Improvement Versus Placebo. For more information on the 2009 Clinical Trial you can read more about it here: Chelsea Therapeutics Reports Preliminary Phase III Data of Droxidopa for Treatment of Symptomatic Neurogenic Orthostatic Hypotension

The catalyst that pushed Chelsea higher this past Friday was based on an Upgrade of Chelsea pending a 2nd Phase III clinical trial results.

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.