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May 18, 2016: A PIND meeting held between Novus and FDA was successfully. The Agency agreed Daptomycin for Injection to be submitted under 505 (b)(2) NDA pathway and also agreed the waivers of toxicity and clinical studies.
Picture 2: After PIND meeting; FDA headquarter, on May 18, 2016
Current status: Preparation of NDA dossier is in progress.
FDA ETT meeting
FDA agreed to incorporate the continuous spray drying technology into FDA ETT plan and the ETT meeting was held on Sept. 15, 2016.