UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Emerging Growth Company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section13(a) of the Exchange Act. ☐
| Item 8.01. | Other Events. |
GW Pharmaceuticals plc, along with its U.S. subsidiary Greenwich Biosciences, Inc., announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Epidiolex® (cannabidiol) oral solution CV. The sNDA seeks to expand the Epidiolex label to include the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), a rare genetic condition. A copy of the press release dated February 3, 2020 is attached hereto as Exhibit 99.1 and incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
The exhibits to this Current Report on Form 8-K are as follows:
| INDEX TO EXHIBITS | ||||
| 99.1 |
Press release of GW Pharmaceuticals plc dated February 3, 2020 | |||
| 104 |
Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document). | |||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Date: February 3, 2020 |
GW PHARMACEUTICALS PLC | |||
| By: |
/s/ Douglas B. Snyder | |||
| Name: |
Douglas B. Snyder | |||
| Title: |
Chief Legal Officer | |||