As of 14 Sep they have asked questions. That may narrow the timeline to repack the 60 day clock. That would but us at mid-Nov for approval...
——————-
Yes. Additional information is always part of the process.
Paul Knopick
---------- Forwarded message ---------
From: Vapor09 <>
Date: Fri, Sep 14, 2018 at 3:57 PM
Subject: Information Request
To: <info@bielcorp.com>
Hello,
I am a shareholder and would like to know if the FDA has requested any additional information on the Actipatch 510(k) submitted in July.
A simple yes or no will suffice.
Respectfully,