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Wednesday, October 01, 2014 7:31:57 PM
Dr. Garnick said that the DATA was "as compelling Phase II data as he had EVER SEEN"...that is enough for me!
Just so newbies don't get fooled by misleading statements please research the above statement on your own and you will find the above statement was made on July 16 2012...
Frustrated, I strongly disagree with your sentiments. All this talk about July 2012 is baseless and not justified, baed on the facts the FDA made a future decision based on the same data you reference. We know that Garnick made the statement that: "..as compelling Phase II data as he had EVER SEEN" and we also know that Peregrine had to retract results "TEMPORARILY" ... right?
I think you may have missed a very important, other quote by Rob Garnick, made on Jan 6, 2014 ... ALL BASED ON THE SAME DATA FROM HIS PREVIOUS QUOTE.. : ) and guess what? The FDA liked it so much that they agreed. Actually, not only agreed.. but Fast Tracked their Phase III Sunrise trial for NSCLC. Very compelling data to say the least!
Peregrine Pharmaceuticals Receives FDA Fast Track Designation for Its Immunotherapy Bavituximab as a Potential Treatment of Second-Line Non-Small Cell Lung Cancer
Jan 6, 2014
"The fast track designation is a milestone for the SUNRISE trial program and represents a step closer to bringing bavituximab to the market," said Robert Garnick, Ph.D., head of regulatory affairs at Peregrine. "We are very pleased that the FDA has recognized the potential of this novel therapy as a treatment for this serious and devastating type of cancer and look forward to working closely with them to ensure the most efficient review process."
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=817072
... please, any other discrepancies.. just let us know. We are here to set the facts straight and what do you think the FDA used to fast track Phase III Sunrise? Yes... that very same data that Rob Garnick said: "... as compelling Phase II data as he had EVER SEEN."
Be well...
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!
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