On 21 January 2004, GW announced that it expected the regulatory assessment process for Sativex to be completed during the second quarter of 2004.
Whilst the Directors of GW have not altered their expectations that approval of Sativex will be granted, it is now clear that the regulatory process will continue past the end of the second quarter.
GW is continuing its constructive dialogue with the UK regulator, the Medicines and Healthcare products Regulatory Agency (“MHRA”). A significant number of the MHRA’s questions arising from the original submission have been resolved. GW is now working on the advice of the regulatory authority in order to submit further information and clarification in response to the outstanding questions. These responses will be submitted within the current review process.
GW expects to provide a further update at the time of the release of its interim results in June.
Dr Geoffrey Guy, Executive Chairman of GW said, “We continue to make progress towards regulatory approval. GW is actively working with the regulators to provide responses to the outstanding points. We look forward to continuing our positive discussions with the regulators”.
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GW Pharmaceuticals plc
(30/04/04) 020 7067 0700
Dr Geoffrey Guy, Chairman
(Thereafter) 01980 557000
Justin Gover, Managing Director
Weber Shandwick Square Mile
020 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.