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Saturday, 01/02/2016 12:02:45 PM

Saturday, January 02, 2016 12:02:45 PM

Post# of 118421
$RGBP I just wanted to share this article with everyone, as it pertains to the company, most especially the future approval of dCellvax. It appears we may be on the cusp of seeing a very positive shift within the FDA and associated regulatory bodies as specifically pertains to oncoimmune therapies.


This quote speaks volumes as now this regulator has been forced to see things from a very personal standpoint, now realizing the urgency and time sensitivity of approval like never before:

“Rick Pazdur is the most important person in the cancer world,” said Ellen Sigal, the founder and chairwoman of Friends of Cancer Research, an advocacy group. Now that he has watched his wife die of the disease, she said, “you can’t go through something like this and not be changed by it.”

And this:

When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.

“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”

Source: http://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html?_r=0