Thanks folks.
So as Andy mentions please send your submissions as soon as possible. The address to send the submission is
Caleb Briggs
Center for Drug Evaluation and Research,
Food and Drug Administration,
10903 New Hampshire Avenue,
Building 31, Room 2417,
Silver Spring, MD 20993-0002
or by email to ODAC@fda.hhs.gov
or by fax to (301) 847-8533.