EYEN" from the CEO-"Fortunately, we had taken actions throughout the development of MydCombi to minimize the impact of a potential reclassification by the FDA. We are preparing additional documentation requested by the FDA and look forward to resubmitting our NDA in early 2022 for the FDA’s review."
I have no idea(s) about what extra data they collected on the drug delivery device (their proprietary Optejet), but it is clear that the re-submission timeline now places a new PDUFA date in late 2022 at best. By that time, they should also have in the submission pipeline their pilocarpine studies.
This is now a "wait and see" investment, for sure. I don't have the time to research the specifics of the Genus Medical Technologies, LLC v. FDA, but will be looking at this case as time permits.
