Gives you an idea of timing - GW Pharma Epidiolex Source: https://www.statnews.com/2016/05/16/marijuana-research/
"GW Pharmaceuticals, Epidiolex’s manufacturer, reported in March 2016 that children with Dravet syndrome — an epileptic condition that affects an estimated 1 in 20,000 individuals — had fewer seizures on the drug than children on a placebo in a 120-person, Phase 3 trial. The company plans to release initial results from another Phase 3 trial next month from patients with Lennox-Gastaut syndrome, an even more rare type of childhood epilepsy in which seizures are so severe and unexpected that some sufferers wear helmets with facemasks so they don’t hurt themselves.
GW hopes to ask the FDA to approve Epidiolex next year.
The FDA has shown a willingness to approve drugs related to cannabis that are shown to help patients. In the 1980s, it approved two synthetic drugs — Marinol and Cesamet — that resemble or are identical to THC, a component of marijuana that gives users a high. The drugs, which treat nausea from chemotherapy among other conditions, are listed as Schedule 3 and Schedule 2, respectively.
If the FDA gives the green light to Epidiolex, it would show that the drug has a medical benefit, meaning it cannot remain a Schedule 1 substance. In that case, the DEA could either put the GW drug itself on a new level or move CBD more broadly to a different classification. (The DEA did not comment about how it would schedule Epidiolex if it is approved.)
Alice Mead, head of US professional relations at GW (which is headquartered and makes its drugs in the United Kingdom), said that federal regulations on marijuana created unique challenges for the company, but “it’s not impossible” to conduct trials with cannabis-derived drugs.
“We have probably a hundred research sites licensed by both the DEA and [state agencies],” she said.
Still, the thought of working with the DEA to get an initial trial running was too much for Zynerba Pharmaceuticals, a Pennsylvania-based company developing synthetic cannabinoid treatments for epilepsy and other conditions. For its Phase 1 trial of a CBD gel, it tapped researchers in Australia, said company president Terri Sebree."