GW Phar­ma's cannabis-based drug ap­pears poised for a ground­break­ing FDA ap­proval as in­ter­nal re­view of­fers a clear thumbs up

GW Phar­ma­ceu­ti­cals’ $GW­PH lead drug picked up a clear en­dorse­ment from reg­u­la­tors at the FDA this morn­ing.

In the agency’s in­ter­nal re­view of GW’s Epid­i­olex ahead of an up­com­ing ex­pert pan­el re­view, reg­u­la­tors con­clud­ed that the biotech’s da­ta backed both the ef­fi­ca­cy of the cannabi­noid drug as well as an ac­cept­able safe­ty pro­file — a clear in­di­ca­tion that the drug ap­pears on a straight path to­ward a land­mark ap­proval for Lennox-Gas­taut syn­drome and Dravet syn­drome.

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