`
`IND 112621
`
`Neurelis, Inc.
`c/o Pacific Link Consulting, LLC
`Attention: Richard Lowenthal, MS, MSEL
`President, Pacific-Link Consulting
`8195 Run of the Knolls Court
`San Diego, CA 92127
`
`Dear Mr. Lowenthal:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`GRANT FAST TRACK
`
`Please refer to your Investigational New Drug Application (IND) submitted under section 505(i)
`of the Federal Food, Drug, and Cosmetic Act for NRL-1 (diazepam intranasal solution).
`
`We also refer to your October 31, 2016, request for Fast Track designation. We have reviewed
`your request and concluded that it meets the criteria for Fast Track designation. Therefore, we
`are designating as a Fast Track development program the investigation of NRL-1 for the
`management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who
`require intermittent use of diazepam to control bouts of increased seizures. Please note that if the
`clinical development program you pursue does not continue to meet the criteria for Fast Track
`designation, the application will not be reviewed under the Fast Track program.
`
`For further information regarding Fast Track Drug Development Programs, please refer to the
`FDA document "Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and
`Biologics"1. This document may be requested from the Office of Communications, Division of
`Drug Information at 301-796-3400 or 1-888-463-6332.
`
`1 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
`
`Reference ID: 4034029
`
`Neurelis - EX. 2002
`Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`IND 112621
`Page 2
`
`If you have any questions, contact E. Andrew Papanastasiou, Regulatory Project Manager, via
`email at emilios.papanastasiou@fda.hhs.gov or by phone at (301) 796-1930.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Billy Dunn, MD
`Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Reference ID: 4034029
`
`Neurelis - EX. 2002
`Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00451
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`WILLIAM H Dunn
`12/27/2016
`
`Reference ID: 4034029
`
`Neurelis - EX. 2002
`Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00451
`
`