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Re: WeeZuhl post# 23459

Thursday, 02/09/2017 10:27:57 AM

Thursday, February 09, 2017 10:27:57 AM

Post# of 38634
Weezuhl- You are twisting what I said. The only thing that was conveyed was that there was misinformation and confusion on the boards regarding the manufacturer being listed on the application. IPCI's position is that that they do not need to specify the manufacturer. If Rexista were to be approved with no manufacturer listed on the NDA, a tentative approval would be granted. Not a rejection as was theorized here. They in no way shape or form suggested that their plan was to go to decision date without naming a manufacturer. But they did not suggest they would name one either. I hope this helps clear up any confusion people have on the subject.