cannabisnews.com: GW Pharma Shares Take Hit on Cannabis Trial Delay GW Pharma Shares Take Hit on Cannabis Trial Delay Posted by CN Staff on April 30, 2004 at 17:55:17 PT By Stephen Foley Source: Independent UK Gw Pharmaceuticals, the company developing a painkilling spray from cannabis, has warned that regulatory concerns will delay the launch of the drug for a second time.The UK authorities have demanded more information on how the drug is formulated and on how safe and effective it might be to treat the symptoms of multiple sclerosis and the pain caused by nerve damage. GW's shares lost 25 per cent of their value on the latest delay, ending at 133.5p.Geoffrey Guy, GW's founder and chairman, said there was no prospect of the product, to be called Sativex, being approved by the end of June as promised at the start of this year. At the time of a fund raising and directors' share sales last June, GW was promising the drug would be available on the National Health Service by the end of 2003.Dr Guy said: "We haven't changed our view that the product is approvable, but clearly we got the timing wrong - as have all the people involved."The Medicines and Healthcare Products Regulatory Authority (MHRA) has had a dossier of scientific information on Sativex, including the results of several human trials, for more than a year but has repeatedly expressed dissatisfaction with the data. GW first admitted the authority had demanded extra information in January."Their questions covered all parts of the dossier," said Dr Guy. "In January we had just submitted responses and large numbers of those original issues have been resolved, but they will keep asking questions until they are fully comfortable with this new style of dossier."The Government has been keen to promote a medicinal alternative to smoked cannabis and GW believes it has overcome problems of how to ensure a plant-based drug contains the same amount of active ingredient in each dose, and of ensuring that patients take the right dose.Multiple sclerosis patient groups have long campaigned to be allowed to use a cannabis drug to relieve their symptoms, and GW believes it has trial data which shows Sativex is an effective treatment for muscle stiffness and bladder problems. It has also requested that it be approved for use to relieve neuropathic pain, pain caused by a diseased or damaged nervous system. Dr Guy promised an update on progress next month, which could reveal whether results from the latest human trials, due to complete over the summer, will be needed to satisfy the MHRA. Complete Title: GW Pharma Shares Take a Hit on Cannabis Trial DelaySource: Independent (UK)Author: Stephen FoleyPublished: May 01, 2004Copyright: 2004 Independent Newspapers (UK) Ltd.Contact: letters independent.co.ukWebsite: http://www.independent.co.uk/ Related Articles & Web Site:GW Pharmaceuticalshttp://www.gwpharm.com/UK Testing Medical Marijuana Inhaler http://cannabisnews.com/news/thread18344.shtmlThe Cannabis Conundrumhttp://cannabisnews.com/news/thread18285.shtmlBritish Firm Holds Hope for Users of Medical Pothttp://cannabisnews.com/news/thread18277.shtml Home Comment Email Register Recent Comments Help Comment #12 posted by BGreen on May 01, 2004 at 20:28:16 PT E_Johnson, Try TinyURL.com It's really easy to do and free. You just paste the long URL and submit, and TinyURL.com provides you with a URL that is easy to paste anywhere.http://story.news.yahoo.com/news?tmpl=story&cid=571&ncid=751&e=2&u=/nm/20040430/hl_nm/head_injuries_dcbecomeshttp://tinyurl.com/3durcThe Reverend Bud Green [ Post Comment ] Comment #11 posted by WolfgangWylde on May 01, 2004 at 12:12:04 PT Call me cynical... ...but I'm thinking that the UK gov't is sandbagging GW. [ Post Comment ] Comment #10 posted by FoM on May 01, 2004 at 11:26:21 PT Dr. Russo I just want to say how much I appreciate you. I know how hard it must be as a Doctor. You have a great spirit about you and I just wanted to say it's been a pleasure getting to know you over these last few years here on CNews. [ Post Comment ] Comment #9 posted by Ethan Russo MD on May 01, 2004 at 11:11:16 PT Head Injury and PTSD Yes, I believe cannabinoids will be used to prevent problems of head injury.Please see:http://gwpharm.co.uk/research_neuroprotection.aspandhttp://gwpharm.co.uk/research_depression.asp [ Post Comment ] Comment #8 posted by E_Johnson on May 01, 2004 at 11:05:08 PT Something I wonder Which teens are are using marijuana to self medicate from various conditions like post traumatic stress or problems from a head injury?Black male teenagers have a really high rate of chronic PTSD. That probably has a lot to do with the prevalence of marijuana in hip hop. It's being played up as a recreation but I believe for a lot of them it's more of a medication.50 Cent grew up on the front lines of the Drug War. He was raised by two drug dealers who were murdered when he was young. He was shot nine times himself a few years ago. He sings about pot in a way that glamorizes it but I think of him as a medical user who just hasn't admitted that he has an illness yet.All of those rap guys seem to be working through some kind of PTSD. It all seems like a bunch of self medication and self therapy to me, the whole rap and hip hop phenomenon. Everything they rap about has to do with trauma. And they smoke pot like crazy.The violence they face is a lot of it connected to the Drug War. The intrusive scrutiny they face from police is from the Drug War.They grow in the War, their lives become dominated by the economics of the War, they get traumatized by the War, and they smoke pot to cope with the trauma.And the War goes on.Repeat cycle.I wonder when this connection will be made officially? I think it's there but people just don't see it through the double haze of prejudice and glamorization combined. [ Post Comment ] Comment #7 posted by E_Johnson on May 01, 2004 at 10:50:19 PT Maybe this will work http://story.news.yahoo.com/news?tmpl=story&cid=571&ncid=751&e=2&u=/nm/20040430/hl_nm/head_injuries_dc [ Post Comment ] Comment #6 posted by FoM on May 01, 2004 at 10:33:23 PT EJ Is This The Article? The url was too long to post and it cut it. If you paste it in the comment section it won't break. I'm not sure how long a url can be for the link section.http://www.reuters.co.uk/newsPackageArticle.jhtml?type=healthNews&storyID=5004711§ion=news [ Post Comment ] Comment #5 posted by E_Johnson on May 01, 2004 at 10:27:37 PT I give up I can't seem to paste that link. It's a story on Reuters.Even minor head injuries in children seem to have long lasting impact, more than previously believed. [ Post Comment ] Comment #4 posted by E_Johnson on May 01, 2004 at 10:26:19 PT Oops here is it It seems like cannabinoids could be helpful in the first response to a head injury in the home. Head injuries in children [ Post Comment ] Comment #3 posted by E_Johnson on May 01, 2004 at 10:23:16 PT Dr. Russo, could cannabinoids help this problem? Children with even minor head injuries seem to develop more problems later than previously believed.Maybe every home first aid kid should include some kind of cannabinoid first response inhaler for a head injury or stroke victim. Head injuries in children [ Post Comment ] Comment #2 posted by Virgil on May 01, 2004 at 07:22:12 PT I can c omment on the regulatory nonsense The process is corrupted. [ Post Comment ] Comment #1 posted by Ethan Russo MD on May 01, 2004 at 05:59:52 PT: Comments I am not able to comment on the regulatory process pertaining to Sativex as I am enjoined from doing so as a consultant to GW Pharmaceuticals. However, I can say that I have read every single page of the submissions to the Medicines and Healthcare Products Regulatory Agency (MHRA-British equivalent of FDA), and remain convinced of the ultimate acceptance of Sativex as well as high THC (Tetranabinex), high CBD (Nabidiolex) and other cannabis based medicine extracts. Research prospects are depicted on pages arrayed on the right on this page:http://gwpharm.co.uk/research_cri.asp In addition to published studies summarizing the GW Phase II results, several additional Phase III studies await publication or are about to be completed. [ Post Comment ] Post Comment