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Re: jour_trader post# 410192

Sunday, 10/06/2024 10:11:54 PM

Sunday, October 06, 2024 10:11:54 PM

Post# of 446075
October 21 is the GDUFA date.

Regarding Vyvanse “And we will update you in November…” We may not hear anything by cc mid-November.

“So our PDUFA 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.”


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