Bioelectronics Corp (BIEL)

[User_347763]

The Substantive Interaction communication is typically:

1.an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or
2.an Additional Information (AI) request which places the submission on hold.

Are we sure a question has been asked?
If so, via interactive review the delay would be a matter of days or weeks. If it is an AI request December might be overly optimistic.

The timing of the interview was very unfortunate...would have been much better if he let it to Keith 2 days later