OTIC - I'm showing $4.40 netcash remaining as of this latest Q filing. Today's "AVERTS-2" Phase3 was an unexpected surprise because it had previously been cancelled as a partner trial with AVERTS-1 that failed back in August: SAN DIEGO, Aug 30, 2017 "We are greatly disappointed by these results, and surprised by both the higher placebo response and lower OTIVIDEX improvement than observed in our previous trials. I would like to thank the many patients and investigators who participated in our M?ni?re's clinical program," said David A. Weber, Ph.D., president and CEO of Otonomy. "Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial.
These new (out of the blue) results were "conducted in Europe" is the catch as I have no clue how the FDA considers a Europe test?
SAN DIEGO, Nov 08, 2017 Announced Results for the AVERTS Phase 3 Trials for OTIVIDEX in Patients with M?ni?re's Disease: Otonomy announced today that the AVERTS-2 trial, conducted in Europe, achieved its primary endpoint (p value = 0.029) and that OTIVIDEX demonstrated clinically significant treatment benefit for patients with M?ni?re's disease. In August, the company announced negative results from the AVERTS-1 trial conducted in the United States. The company plans to review these results with the U.S. Food and Drug Administration (FDA) and discuss clinical requirements for registration of OTIVIDEX in patients with M?ni?re's disease during the first quarter of 2018.
In conclusion: we still have The Supplemental New Drug Application (sNDA) for OTIPRIO in acute otitis externa (AOE) is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. catalyst that I was basing this investment on + an additional Q1/18 catalyst for today's OTIVIDEX surprise.
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