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Re: None

Tuesday, 02/20/2024 7:12:25 PM

Tuesday, February 20, 2024 7:12:25 PM

Post# of 232957
((((((((FULL HOLD)))))))) lifted yet?

Once the complete response to all of the clinical hold deficiencies has been received, FDA will review the submission within 30 calendar days and determine whether the applicant’s response to clinical hold satisfactorily addresses the issues.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold


Has the FDA already reviewed the submission or not?

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