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Aquestive Therapeutics Announces Completion Of Pre-IND Meeting For AQST-108

Pre-IND Meeting on AQST-108 Completed FDA Confirmed AQST-108 To Be Reviewed Under 505(b)(2) No Additional Clinical Studies Would Be Required Prior to Opening Proposed IND Pivotal Pharmacokinetic (PK) Clinical Trials

Benzinga · 02/06/2020 12:44
  • Pre-IND Meeting on AQST-108 Completed
  • FDA Confirmed AQST-108 To Be Reviewed Under 505(b)(2)
  • No Additional Clinical Studies Would Be Required Prior to Opening Proposed IND
  • Pivotal Pharmacokinetic (PK) Clinical Trials Planned To Be Initiated Before Year End 2020