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Re: Kandle post# 967

Wednesday, 08/12/2015 9:58:34 PM

Wednesday, August 12, 2015 9:58:34 PM

Post# of 3707
Committee approval rate - link

www.njbiz.com/article/20150615/NJBIZ01/306159990/palatin-eager-to-benefit-from-landmark-fda-ruling


Seton Hall University School of Law professor Jordan Paradise agreed.

“If the committee green-lights something, the FDA commissioner can still say no, but that happens almost never,” she said. “A green-light from committee means it’s basically in the bag, but you never know.”

Historically, Paradise said 74 percent of drugs approved by the committee are granted final approval.

And with a history of controversy around female HSDD drugs, Paradise said it was interesting to see a company directly addressing the issues.
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