Replies to post #152712 on Bioelectronics Corp (BIEL)

[Gramps]

That is a big, big hurdle to clear.

[User_347763]

Are we 100% sure that there were no questions within those 60 days?
The starting date is the one registered upon receiving the submission.
The final date is the one when the FDA sends out a letter with questions.
Seems to me Whelan could have waited a few more days with the interview to be sure.
I don't think it's a good idea to ask the company for confirmation...so let's wait and see what happens in the coming days

[Vapor09]

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...


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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: <[e-mail]>


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,