The fact we are even having a debate about what stage the application is at (despite multiple market announcements) is a blight on the management teams ability to communicate to share holders.
The way I read it is that we are not even under official FDA review yet for MEBsleep, until Fridays announcement I was of the belief that the application had been accepted for review and that we were awaiting "imminent" approval.
Not happy
Ann: FDA Strategy and Regulatory Update, page-119
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