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Re: Doc328 post# 413823

Thursday, 05/04/2023 12:53:40 PM

Thursday, May 04, 2023 12:53:40 PM

Post# of 462044
I believe you are way off base. I think Top Line data before the end of June 2023. This was a small trial so it should go much faster. No reason they cannot get an NDA filed by the EOY with the FDA accepting the NDA within 60 days and decision could be by July 2024 or sooner.


"assuming the Excellence study had LPLV last week or this week and it clearly succeeds and if Missling can keep to a reasonable timeline, topline will be September 2023, submission April 2024, filing of NDA June 2024 and decision December 2024. They might shave one month off this but could also miss by a month or two to the long side."
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