Probably The Biggest Worry Of All, Though, Comes From The Threat Of Competition.

Man in business <a href=Medical marijuana stocks attire pointing to lighted line chart going up’ /> Based on the clinical results, the efficacy of Epidiolex shouldn’t present an issue for the FDA in granting approval. But what about safety? GW Pharmaceuticals reported that its drug was “generally well tolerated,” but it has also acknowledged some drug-drug interactions. The company’s CEO, Justin Gover, doesn’t think these interactions will present a serious problem for FDA approval . Gover has stressed in the past that Epidiolex doesn’t rely on any other anti-epilepsy drugs to be effective. GW Pharma anticipates, though, that potential interactions with other drugs will be included on the label for Epidiolex, assuming it gains FDA approval. If Epidiolex can generate annual sales somewhere in the ballpark of $800 million to $1 billion, I think a 50% or more jump in GW Pharmaceuticals stock price would be easily justified. Some analysts have projected much higher peak sales estimates for the drug.  My hunch is that most investors who follow GW Pharmaceuticals aren’t overly concerned about Epidiolex failing to win approval. However, there could be some anxiety about how much payers will be willing to loosen their purse strings for the drug. Probably the biggest worry of all, though, comes from the threat of competition. Zogenix ( NASDAQ:ZGNX ) recently announced positive results from a late-stage study of its experimental drug ZX008 in treating Dravet syndrome.

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