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Member Info for bigbob0228


Member Since: Mon, 7th Apr 2008

Number of Share Chat Posts (all time): 115
Number of Share Chat Posts (last 30 days): 2

Last Posted: 18 Aug '15


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18 Aug '15


this is now starting to look cheap will start buying at 325pps down to 300p for a nice two year investment.

GL All

6 Aug '15


GW Pharmaceuticals Receives FDA Fast Track and EMA Orphan Designations for Intravenous Cannabidiol in the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)

- FDA Orphan Designation Previously Granted -

LONDON, Aug. 6, 2015 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for a proprietary intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy, or NHIE. In addition, the European Medicines Agency (EMA) has granted orphan designation for the same product to treat perinatal asphyxia, an alternate term that describes the same condition as NHIE, for which GW has already received Orphan Drug Designation from the FDA. There are currently no approved medicines in Europe or the U.S. specifically indicated for NHIE or perinatal asphyxia.

"GW believes that cannabinoids may have a potentially important role in the treatment of high need pediatric neurologic conditions. As a result, we have developed a proprietary intravenous CBD formulation specifically for use in this most vulnerable of patient populations, newborn infants with NHIE. As there are no current treatment options beyond induced hypothermia for the affected newborns, there exists a dramatic need to develop new and effective therapies aimed at preventing acute brain damage and enhancing long-term brain repair," stated Justin Gover, GW's Chief Executive Officer. "GW is now working towards the launch of a clinical development program in this important medical condition towards the end of this year."

NHIE and perinatal asphyxia are forms of acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth (hypoxia). The incidence of these conditions is estimated to be approximately 12,000 to 24,000 cases per year in the United States and EU combined. Of these cases, 35% are expected to die in early life and 30% may suffer from permanent disability. The current standard of care for perinatal asphyxia patients is to induce whole-body hypothermia. This treatment is only available in specialized neonatal intensive care units and must be started within 6 hours of birth. Even if a patient is put into induced hypothermia there is still a significant rate of morbidity and mortality, with a meta-analysis of the available data revealing a 27% death rate. Among the patients who survive, 28% suffer from major neurodevelopment issues and 26% develop Cerebral Palsy.

FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track des


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