That is a very pleasant surprise.
So begins a very exciting 6 months or so for shareholders. I've been involved in a few that had an extended wait then big decision day (knocked back). But this seems much more iterative and pointed towards a positive review.
Expect a few bumps along the way with questons/requests for info from the FDA which hopefully the company can satisfy.
Strapping myself in.
Ann: EBR submits final PMA module to the U.S. FDA, page-2
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