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fred198484

08/28/17 5:45 PM

#29571 RE: mopar44o #29563

That came out the evening of the ADCOM and I doubt the FDA gave them any authoritative feedback right away. One has to think they have had more substantive discussions with the FDA since then. If the FDA relies on the evidence, they will give it a tentative approval for IV and the briefing document seemed to indicate that is what they were shooting for. I am worried the reality might not sync up well with the facts, however. My principal reason for that concern is the Mackie report's saying they would likely get a CRL and would need to refocus on their other drugs. I have to assume he spoke with the company and got some sense of where things are at. I also assume he would like to get a piece of any offering they might do and that he needed to communicate to IPCI investors where things were actually at ahead of any share sale. I could be completely wrong about that but that si my best guess at the moment.