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Reata Pharmaceuticals announces FDA filing acceptance and priority review designation for the New Drug Application (NDA) for Omaveloxolone.
Priority review means that the FDA has 6 months to review vs. the standard 10 months giving an action date of November 30th, 2022. Then, the FDA has to communicate whether it accepts, rejects, or needs more data and a subsequent time extension for approval.
The FDA also announced it plans to hold an advisory committee meeting, which is a public, day-long meeting where the drug is reviewed, patients and experts get to make comments, and a voting board gives a recommendation on whether the drug should be approved.
Click here to read the full press release.
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