Recommend calling the company and asking them. They know more about the process than we do. We do know the Optina trials have already started a few weeks ago and have less than 10 weeks to go.
This is really going to rock Regeneron's (REGN) boat since 99% of their revenue is reliant on Eylea that appears to be at very high risk if Optina gets approved. Once approved, Optina will make Eylea obsolete overnight and REGN will plunge like you can't believe.
AMPE gave out the following on 2/25: The multicenter trial is designed to evaluate the safety and efficacy of oral Optina™ compared with placebo given over a period of 12 weeks in adult patients with DME. A total of 450 patients are expected to enroll. Patients are randomized to receive one of two oral doses of Optina™ (0.5mg per BMI and 1.0mg per BMI per day) or placebo. After patients have completed 4 weeks of initial treatment, an interim analysis will occur to determine the best dose of Optina™. Following the 12 week active treatment period, there will be a further 4 week washout period to determine regression of treatment effect. The primary endpoint is improvement in visual acuity (VA), defined by responder status, compared to placebo. Secondary endpoints are 1) measurements of changes in VA and central macular thickness (CMT) in treated patients compared to placebo and, 2) safety and tolerability of the two Optina™ doses. Following treatment and washout, patients will be assessed for vision regression and a 12 week open label extension study will be offered to evaluate the duration of effect of the optimal dose.
Taking 16 weeks from 2/25 takes us to the end of the washout period (that is JUNE 21st). Would think we would not get an interim report until the end of 12 weeks and maybe 16 weeks. Then the last part has another 12 week period that will take us into September.
Not to mention Lucentis also. Hopefully AMPE will give us some guidance as to when to expect preliminary results from the Optina trial. If results are good, this stock will be many times higher than it is now.