Sativex Update
30 April 2004 - 5:01PM
UK Regulatory
RNS Number:1780Y
GW Pharmaceuticals PLC
30 April 2004
Embargoed until 0700 30 April 2004
GW Pharmaceuticals plc
("GW" or "the Company")
Sativex(R) Regulatory Update
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".
- Ends -
Enquiries:
GW Pharmaceuticals plc (30/04/04) 020 7067 0700
Dr Geoffrey Guy, Chairman (Thereafter) 01980 557 000
Justin Gover, Managing Director
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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