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Re: Derek0839 post# 28981

Sunday, 07/30/2017 8:11:33 PM

Sunday, July 30, 2017 8:11:33 PM

Post# of 38634
Derek....Under normal circumstances I would agree. Even though the vote did not reflect it, the IV abuse is superior according to the test results and the FDA's own analysis. You are correct in that, the blue dye being used is within FDA generally accepted amounts and therefore should not even be require to do the study.

However,under the current Political environment in DC I would be very surprised if the FDA gave a tentative approval. They should and I think IPCI could put pressure in them to do so. However, Just think of the political outcry from the media if the FDA tentatively approves an opioid that failed miserably with its Adcomm and will be touted in the media as not having proven safe because of lack of safety studies?

we all know how the media is finding any negative issue they can to hammer the new Trump administration. could you imagine the media coverage on this one? just like the hearing itself where the data clearly showed superiority, the panel still voted 19-4 saying its not IV abuse deterrent because 20% of the Oxy can be syringed at 30 seconds. That is what will make the headline. not the rest of the slide which showed Oxy itself can extract 40% at the same time frame.

I hope I am wrong but as much as Opioids are in the news daily, I just don't see it happening.
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