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Just give me $1.50

08/27/24 12:14 PM

#407148 RE: Winechemist #407146

Nasrat - "So our GDUFA date is November. That was very nice of FDA to do that, because they found that our application itself doesn’t have any issues or all the issues we had, we resolved them over the past year. They had a question to the DMF supplier, and instead of saying, take this back and call us back in a year or in six months or whatever, they actually said, we need another month to resolve some issues, which is really very promising. And we will update you in November once we hear – if we hear from FDA and what their verdict is."

And like I said, the original GDUFA date is October 21 and it may still happen by then. But Nasrat is predicting a one month delay pushing us into November.
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Lazarus Elite

08/27/24 1:26 PM

#407161 RE: Winechemist #407146

Emperor and I have stated this many times. You are EXACTLY right, Wine. He speaks very specifically. Tries to give us tidbits if you can read between the lines.