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Friday, 02/19/2016 10:51:34 AM

Friday, February 19, 2016 10:51:34 AM

Post# of 16911
I am long and strong come hell or high water, but I have to admit that with each day that passes, I get a little less confident. Not based on probuphine's efficacy or safety, just the irrationality of the FDA.

The end points of the trials submitted with the 2013 were pre-agreed upon with the FDA. They met the endpoints, and the FDA changed the rules and required more...without any more justification than "they felt like it." I remember a lot of news headlines calling it a "mugging" or "The FDA is Unreasonable."

I really don't like the vote on the FDA Commissioner is occurring on February 22nd. If he is approved, there is no "heat" on him to approve probuphine or really do anything about the opioid crisis. But he always has an incentive to make big pharma happy.
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