To: Jibacoa who wrote (1785 ) 10/8/2007 8:51:52 AM From: Jibacoa Respond to of 3722 AVNR is up 46% in pre-market after news.bigcharts.marketwatch.com AVANIR Granted Special Protocol Assessment (SPA) From FDA for Confirmatory Phase III Trial of Zenvia in Patients With PBA Monday October 8, 8:30 am ET ALISO VIEJO, Calif.--(BUSINESS WIRE)--AVANIR Pharmaceuticals (NASDAQ:AVNR - News) today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of a single confirmatory Phase III clinical trial of Zenvia(TM) (dextromethorphan/quinidine (DM/Q)) for the treatment of patients with pseudobulbar affect (PBA). AVANIR trial 07-AVR-123 "A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients with Amyotrophic Lateral Sclerosis and Multiple Sclerosis" (otherwise known as the "STAR trial") is expected to begin enrolling patients by the end of 2007."We now have a clear path toward gaining regulatory approval for Zenvia in this important indication and continue on track to begin patient enrollment in this trial before 2007 calendar year end," said Randall Kaye, MD, Chief Medical Officer of AVANIR. "We have developed an alternative formulation of Zenvia with a lower dose of the quinidine component than the formulation used in earlier PBA studies. Based on our extensive PK/PD modeling, we expect that the new formulation of Zenvia will demonstrate acceptable safety and tolerability, while continuing to provide significant efficacy." "The STAR trial represents an important milestone for greater than one million Americans thought to suffer from the debilitating episodes of PBA," said Jeffrey Cummings, MD, Executive Vice Chair of the Department of Neurology at the David Geffen School of Medicine at UCLA and lead investigator of the STAR trial. "With no currently approved treatment options available, the STAR trial is an essential step toward making Zenvia available to patients with PBA." Snip AVNR has closed most its Apr 18 UG & has formed a base at the $2 level. If it can get back to the $5 level it would still be a nice gain from present levels.bigcharts.marketwatch.com The stock is now getting off the DT coming from the March 2006 H at the 18.14 level. The Oct 200 H at 38 is a little far away at present.<g>bigcharts.marketwatch.com Bernard