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Re: fabius post# 29612

Wednesday, 08/30/2017 11:02:21 AM

Wednesday, August 30, 2017 11:02:21 AM

Post# of 38634
It can come at any time but the FDA usually drags things out rather than speed them up. And if they decide to CRL Rexista, it should be a matter that gets heavily debated within the FDA before being implemented as it really should get tentative approval based on the facts. Furthermore, it sure seemed to be what the FDA believed as well based on the ADCO briefing materials. If it gets CRL'ed, it is only because the bad optics of approving an opioid that an ADCOM reacted very negatively to get in the way of the truth. Unfortunately, that is a real possibility. Hopefully there are many in the FDA with courage and common sense and Rexista gets tentative approval for IV. Literally, some people will likely lose their lives if the FDA does not approve it.
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