The Myring re-submission went to FDA at some point in December. There are 2 approval time frames: (1) 8 months if no FDA site inspection required or (2) 10 months if FDA site inspection is required. So we should see a result somewhere between August and November, depending whether the timeframe starts from the re-submission date or from the date FDA confirms re-submission has been received (must be within 1 month of re-submission). Also you can't compare Myring and E4 in terms of approval delays. Myring is an extremely complex product. My understanding is that E4 would be more straight forward and there would have been plenty of learnings from the Myring submission. Also worth noting that every other competitor for Myring has had delays, with Amneal eventually getting to market first.
MYX Price at posting:
46.5¢ Sentiment: Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)