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Re: Whalatane post# 2051

Wednesday, 11/12/2025 9:23:32 PM

Wednesday, November 12, 2025 9:23:32 PM

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Re: " EU was fine with the first manufacturer at the time of their inspection ...so they may be staying with that Co . Apparently there was only 1 issue FDA flagged"

That is precisely what I am thinking, they most likely want to get approval from the original submission, and regarding their sending the CEO to live there, I think they may want to send Pramod Gupta, Ph.D. (Executive Vice President of Pharmaceutical & Business Operations) as he might be better qualified to make certain that the manufacturer has dotted the i's and crossed the t's necessary for acceptance by the FDA.
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