Closer to FDA approval in USA for Cannabis Children Epilepsy drug, page-14

Cannepil will not be able to be distributed in the USA till the GW Pharma patents run out.
GW Pharma patents are very strong and broad and give them a monopoly over cannabinoid
epilepsy drugs.
GW Pharma approval will not remove cannabis from the CSA.
They will simply remove their formulation from the CSA.
Cannabis under .3% thc has a strong chance of being removed from the CSA this year.
The rest will not get past judiciary committees on the federal level.
The Democrat party is simply presenting the idea to win midterms later this year.
Cannabidiol isolates are likely to be the most likely target for enforcement by the FDA if cannabis under .3% thc is removed from the CSA. The FDA will decide what is pharmaceutical and what is allowed over the counter.
The big thing on new medical formulations and the timeline to get them approved by the FDA is 1. Is it a new chemical entity and 2. Can it be fast tracked.
The good part about GW Pharma trials is cannabidiol is no longer a new chemical entity.
To be fast tracked though you have to meet and unmet need.
Treatment Resistant Epilepsy is no longer and unmet need.
It generally takes 10 years to get a drug that is not fast tracked and is a new chemical entity through the FDA from start to finish.
Cannepil will have a rough time going into market where Epidiolex already exists because of the patents they have.