In December 2004, GW announced that the Committee on Safety of Medicines (CSM), an advisory body to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), had advised that a further clinical study in Multiple Sclerosis (MS) spasticity would be required prior to the grant of a product licence for Sativex. GW elected to appeal against the CSM’s decision to the Medicines Commission, the senior advisory body to the MHRA.
The Company confirms that this appeal was considered by the Medicines Commission at its meeting in mid May.
GW has yet to be informed of any recommendations made by the Commission to the MHRA, nor has it received any communication from the MHRA since the meeting.
Prior to the meeting, GW was informed that it may take a number of weeks for the MHRA to formally notify the outcome of the meeting to the Company. The Company will issue a further statement as soon it has received notification of the decision by the MHRA.
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GW Pharmaceuticals pl:
Justin Gover, Managing Director
Weber Shandwick SquareMile: + 44 20 7067 0700
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical development and regulatory clearance of the Company's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and the Company's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.