Otonomy Inc. fka OTIC

[BioSpecialist]

Market Cap $105 Million / Cash $150 MILLION / 1 Drug approved / Another one under review by FDA , approval likely in March = STRONG BUY AGGRESSIVEEEEEE $10 easily


sNDA Filing Accepted and PDUFA Action Date Assigned for OTIPRIO® in Acute Otitis Externa (AOE): In July, Otonomy announced that its Supplemental New Drug Application (sNDA) for the approval of OTIPRIO (ciprofloxacin otic suspension) as a treatment for patients with AOE was accepted for filing by the U.S. Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review by the FDA.