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Wo

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Alias Born 03/20/2015

Wo

Re: mkendra post# 75809

Monday, 05/21/2018 11:27:59 PM

Monday, May 21, 2018 11:27:59 PM

Post# of 128589
Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy

APR 18, 2018

https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-announces-unanimous-positive-result-fda-advisory-committee-meeting

{...FDA Advisory Committees are independent expert panels. Their votes are not binding but are considered by the FDA when deciding whether to approve a new medicine. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the NDA review of the cannabidiol oral solution is June 27, 2018.

{...GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome, which has been assigned a goal date of 27 June 2018 and, if approved, the medicine is expected to be available by prescription in the second half of 2018.

...Bofore Mods Delete this post, I assume its relevance to Canopy Growth because : Approvals of CBD based formulations for specific indications by the FDA can lead to Federal rescheduling of CBD, therefore opening a significant market to Canopy Health Innovations and In turn Canopy Growth.