Sativex, developed mainly to help multiple sclerosis sufferers but
possibly also a treatment for cancer victims and others in severe pain,
is available in Canada and a part of Spain but it has failed so far to
get approval back home in the UK.
GW has come up with yet another batch of clinic trials data which it has
discussed with several European regulators. Meetings have provided
constructive and positive feedback, GW says.
Filings for approval have been made in the UK, Spain, Denmark and the
Netherlands with the UK acting as a central reference point. If the UK
finally says yes after consulting the other three countries the drug
could be launched simultaneously in all four.
Despite, or perhaps because of, the more liberal attitude taken towards
‘recreational’ smoking of cannabis as an illegal drug, GW has had
prolonged difficulties in gaining approval for Sativex to be used on a
legal medicinal basis here. Perhaps roping another three countries into
the equation, especially as Sativex is available under special
arrangement in Catalonia, will tip the balance.
Given the long delays it is best not to hope for too much. GW shares
slipped back 1.75p to 96.75p. They tend to fluctuate widely as hopes are
raised and dashed.
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GW tries again with Sativex
Rodney Hobson, 05/09/06 12:37
You can't blame GM Pharmaceuticals for trying as it makes yet another attempt to get its cannabis-based Sativex past stubborn UK regulators.
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Sativex, developed mainly to help multiple sclerosis sufferers but possibly also a treatment for cancer victims and others in severe pain, is available in Canada and a part of Spain but it has failed so far to get approval back home in the UK.
GW has come up with yet another batch of clinic trials data which it has discussed with several European regulators. Meetings have provided constructive and positive feedback, GW says.
Filings for approval have been made in the UK, Spain, Denmark and the Netherlands with the UK acting as a central reference point. If the UK finally says yes after consulting the other three countries the drug could be launched simultaneously in all four.
Despite, or perhaps because of, the more liberal attitude taken towards ‘recreational’ smoking of cannabis as an illegal drug, GW has had prolonged difficulties in gaining approval for Sativex to be used on a legal medicinal basis here. Perhaps roping another three countries into the equation, especially as Sativex is available under special arrangement in Catalonia, will tip the balance.
Given the long delays it is best not to hope for too much. GW shares slipped back 1.75p to 96.75p. They tend to fluctuate widely as hopes are raised and dashed.
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Hemscott is the UK registered trademark of Hemscott Group Limited.
Prices displayed on Hemscott.com are delayed by at least 15 minutes unless otherwise stated.