ANNAPOLIS, Md. , May 30, 2013 a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the U.S. Food and Drug Administration has lifted the clinical hold previously placed on a proposed Phase II study of SparVax , a next generation recombinant anthrax vaccine.
"We are very pleased by the FDA's thorough review of the SparVax stability data and its subsequent decision to allow our clinical trial to proceed," commented Eric I. Richman , President and Chief Executive Officer. "Anthrax has been identified as one of the foremost potential biological threats to the Nation. The U.S. government's requirement for a recombinant anthrax vaccine for the civilian Strategic National Stockpile is an important national security imperative that remains unfilled. Next-generation anthrax vaccines like SparVax( R) , which employ modern vaccine technology, offer the potential for improved convenience, cost-effectiveness, more rapid immunity, and the ability for large scale rapid delivery. We look forward to working in collaboration with BARDA to fulfill this objective."
In a letter to the Company, the FDA acknowledged that PharmAthene had satisfactorily addressed all of the Agency's clinical hold issues and that consequently, the clinical hold had been lifted, effective immediately.
The clinical hold was enacted in August 2012 , prior to the commencement of a proposed Phase II clinical trial of SparVax . In its original notification to the Company, the FDA requested that PharmAthene provide additional stability data for both its engineering and GMP lots of U.S. manufactured Final Drug Product, as well as additional information about the intended stability indicating assays.
Does anyone realize that good old Uncle Sam nudged the FDA to lift the hold with more and more news making headlines about the Syrians using chemical warfare in the battlefield. You watch, the entire process will be hurried up to get our product stockpiled.
If anybody is selling here to lock in a quick profit be sure to reload your guns for a quick re-entry when this thing settles down. We are now in the best of two worlds and be a part of it. The institutions right now are studying the situation and realize what this stock can do once all the clouds clear. I am not a crazy bull but mark my word, no matter what happens today this will be a $3 stock this summer and summer is right around the corner. Uncle Sam will expedite everything to get this product in their inventory should the Syrian crisis blow up as it seems to be doing.
Different candidate - SparVax is for Anthrax (Assad MAY have Saddam's old pile, or so says an ex-Iraqi officer). Bioscavenger is what you're thinking of, and it was not mentioned in the PR until the "about PharmAthene" boilerplate.