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WeeZuhl

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Re: wimuskyfisherman post# 23411

Thursday, 02/09/2017 9:13:56 AM

Thursday, February 09, 2017 9:13:56 AM

Post# of 38634
That's good dd, wimusky


I received clarification from IPCI in regards to specifying the manufacturer on Rexista NDA. Their position is they do not need to list a manufacturer to receive tentative approval. However, to receive final approval they need to specify the manufacturer.





I am not aware of anyone else getting IPCI on record as expecting only Tentative Approval this review cycle. Can you tell us with whom you communicated, and was there any mention of the company's expectations of the timeline until Full Approval?

Good post, thanks.



Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)

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