InMed Pharmaceuticals Inc (INM)

[lesgetrich]

we are light years away from the FDA accepting cannabis... especilay with Trump and Sessions in house.

Several things need to be pointed out here...

1.) InMed is currently only working on drugs containing CBD and it's variants not THC. CBD is already widely available in the US and regularly shipped across state lines with no interference from the feds. Federal enforcement has so far been focused on CBD products which claim to have a medical purpose or value and have not gone through FDA approval.

2.) Even those who argue that THC and CBD are illegal under US federal law acknowledge that the illegality stems from the fact that it is derived from the cannabis plant. Under this definition, what InMed produces from biosynthesis would not fall under federal controlled substances regulation...

DEA guidance is clear: Cannabidiol is illegal and always has been

There is one path forward for those hoping to challenge the federal government on CBD’s legality. Marijuana is defined in the Controlled Substances Act as a product derived from the cannabis plant, except products derived from its mature stalks—essentially from hemp. This has pushed people to argue that extracts derived from hemp should not be controlled. However, the law is also clear that tetrahydrocannabinols (THC products) are controlled as a Schedule I substance. If a company could extract pure CBD with no detectable amount of THC from a hemp plant, a plain reading of the Controlled Substances Act could provide cover for its legality.

3.) The controlled substances act defines THC and CBD as schedule 1 substances, meaning they have no medicinal value. This will be challenged by GW Pharmaceuticals in 2018 as it applies for approval of its Epidolex formula, which has shown efficacy in combating Dravet's Syndrome and other forms of Epilepsy. The current scheduling of these substances can not be justified if the FDA approves GW's application. The FDA can't ignore the results from GW's clinical trials.

4.) InMed's own clinical trials will lend further evidence against the federal position for keeping THC and CBD on schedule 1. By the time InMed's products are ready for market, we should see a rescheduling of these substances.