LONDON, ENGLAND / ACCESSWIRE / August 22, 2017 / GW Pharmaceuticals (NASDAQ: GWPH) recently announced that a rolling NDA filing for Epidiolex in both Dravet syndrome and Lennox-Gastaut syndrome (LGS) is underway. The pre-clinical module has already been submitted, the clinical module is in process, and the company expects to finish the chemistry, manufacturing, and controls (CMC) section in October. GW anticipates the FDA will grant priority review status, which would enable a June 2018 PDUFA date. In Europe, pre-submission meetings were held with the EMA and the agency agreed that the company can file for approval for Dravet and LGS in a single application. An EMA filing is expected in Q417.

We have reduced our valuation from $3.43bn, or $136.08 per ADS, to $3.14bn, or $124.24 per ADS. This is mainly due to reducing our Sativex estimates, increasing our operating spending estimates, as well as factoring in the NDA submission delay. We now estimate profitability in 2020 (previously 2019) with a total cash burn of around $325m until then. We estimate that GW has enough cash to achieve its goals without additional capital.

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