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     190  0 Kommentare GW Pharmaceuticals and Greenwich Biosciences Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX (cannabidiol) in the Treatment of Seizures Associated with Tuberous Sclerosis Complex - Seite 3

    Important Safety Information
    Important safety information for Epidiolex is available at Epidiolex.com.

    Forward-looking statement
    This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding our goal of bringing Epidiolex to patients with seizures associated with Tuberous Sclerosis Complex (TSC), the potential for Epidiolex to serve as a new treatment option for patients with seizures associated with TSC, the clinical benefits of Epidiolex, and the timing and outcomes of regulatory decisions. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the risks and uncertainties which can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

    Enquiries:

    GW Pharmaceuticals plc  
    Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
       
    U.S. Media Enquiries:
    Sam Brown Inc. Healthcare Communications
     
    Christy Curran
    Mike Beyer
    615 414 8668
    312 961 2502

    ___________________________

    1
    TS Alliance, What is TSC? https://www.tsalliance.org/about-tsc/what-is-tsc/. Accessed April 15, 2019.
    2 NIH Tuberous Sclerosis Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-S .... Accessed November 19, 2019.
    3 TS Alliance Website. https://www.tsalliance.org/. Accessed November 19, 2019.
    4 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157.
    5 Kwan P., Brodie M.J. Early identification of refractory epilepsy. N. Engl. J. Med. 2000;342(5):314–319.
    6 French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3-7.

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    GW Pharmaceuticals and Greenwich Biosciences Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX (cannabidiol) in the Treatment of Seizures Associated with Tuberous Sclerosis Complex - Seite 3 PDUFA date of July 31, 2020CARLSBAD, Calif., March 31, 2020 (GLOBE NEWSWIRE) - GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with its U.S. …

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