There are many clinical trials where placebo are more effective than the drugs studied. Now placebo has been tested for some treatment. This tells me that there is lot of psychology behind the treatment, particularly through the action in brain. Cannabis based medicine may show effectiveness on other diseases through such mechanism.
It was not just popped, it popped Golden apples on that tree. So don't short this before think it over.
There are way too many potential uses for cannabinoids than I could list here. As an example, pre-clinical data shows that CBD inhibits bone loss in rats. We normally lose bone cells and they are replaced. In Osteoporosis, bone is lost faster than can be replaced. Anything that could slow down bone loss would be welcome. Don't expect Epidiolex to be used in treatment of Osteoporosis though. It will be years before there is definitive data. Physicians will need proof from a clinical trial before prescribing CBD for Osteoporosis. For now, it will be for seizures - which is a huge market by itself.
Yes, I agree but you would agree though that fact that it is an anti inflammatory in the central nervous system and is not specifically for pain would not preclude some from experimenting with it. While Jim lacks the sophistication of a pharmacological scientist, he is on to something to start thinking about how cannabidiol might expand its scope of utility. Whether its opiates or nonsteroidal anti-inflammatory agents, Epidiolex will find new markets after FDA approval.
Sentiment: Strong Buy
Cramer is a pitchman. He knows nothing about this. His ignorance is on display every time he comments. Cannabidiol is an anti inflammatory in the central nervous system. It has potential for use far beyond Dravet, but not for pain specifically. It will not compete with opiates.
Sounds like Epidiolex could be approved sooner than anyone expects. If the company receives a Pediatric Priority Review Voucher from the FDA (likely), the voucher would be worth $350 million (it can be sold) and approval could come in just 90 days. The FDA really wants to approve anything that can curtail the usurping of it's authority by states legalizing medical cannabis. The FDA wants to regain control and Epidiolex is their 1st answer. Sativex will be next.
The general story line regarding FDA approval for Dravet being a novel milestone but one of limited marketability due to the small population of potential users misses the realistic possibility that an eventual FDA approval will effect a kind of broader prescription by Physicians for a host of other ailments. Think about it; once the drug is approved, Physicians, may begin to experiment with it. Epidiolex could have use against migraine headaches or general pain, and could eventually be used for those ailments. This would be kind of a back-door way to bring cannabis-based therapies in competition with Opioid drugs. Jim Cramer sees this potential, but few others recognize this for the huge upside it represents. Look for GWPH to double before FDA approval in the next six months.
Sentiment: Strong Buy
I should add - the DEA will have 6 weeks to weigh in on the schedule question. They won't have any reason to oppose scheduling of cannabidiol separate from cannabis, but I wouldn't be surprised if they did. Doesn't matter though because the FDA can do whatever they want with the schedule. They should decide it doesn't belong on the schedule at all.
You understand there's no treatment currently available, they have orphan drug status, and fast track with the FDA?
Sigh. If the FDA approves Epidiolex, it cannot be schedule 1. If the FDA panel decides to approve, they MUST also decide the schedule question. It could be schedule 4, or not scheduled at all. Schedule 1 is for drugs that have no medical benefit and carry a high risk for abuse. The FDA will not approve a medicine that has no medical use. And CBD has no potential for abuse.
What if DEA does not reschedule to schedule II, GWPH's Epidilex cannot be approved by FDA at all? Or, is there any way to get approved by FDA? Curious to death.