Based on the wordings in the announcement and the amount of work required to obtain the data, in my opinion the company won’t persue the approval for MEB sleep.
The company has had no luck in the past with the FDA approval process and that is when they had medical veterans as the CEO and leading advisors Duval & Duval taking care of the submission.
Like I have previously posted the only hope the company has is in the non regulated field. The company needs to aggressively target and grow that while doing a complete restructure at the board level to include medical experts.
Ann: US FDA advises further data needed for MEBsleep approval, page-10
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