The Times (UK) Profiles GW’s Fortunes In The USA Markets & With The FDA

Here’s the introduction to the piece.

 

Twenty years after the Home Office issued a biotechnology start-up with a licence to grow cannabis in southern England, GW Pharmaceuticals is set to launch a potential blockbuster drug.

The British-based, Nasdaq-listed drugs company is hoping to receive approval from the US Food and Drug Administration next month for Epidiolex, a cannabis-based treatment for severe childhood epilepsy. If it is successful, GW is hoping to launch the medicine in Britain and Europe next year.

Justin Gover, chief executive, said that approval would bring recognition that cannabis research was “serious science” and “that this type of medicine and these classes of medicines could become important drugs across a range of other disease areas”. GW is developing a pipeline of cannabis-derived medicines targeting cancer and autism.

Regulatory approval in the United States would mark a significant breakthrough for a company that has overcome several disappointments, including clinical trial setbacks for Sativex, its first product, which treats symptoms related to multiple sclerosis, and scepticism among investors in “earlier days” as it sought to disentangle itself from the wider socio-political debate about cannabis.

Read the full article at

https://www.thetimes.co.uk/article/medical-cannabis-developer-close-to-final-breakthrough-in-fight-with-us-regulator-ttst5hpzb

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