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I think we all must contact our representatives about this. The FDA is spamming junk science in their effort to preserve big pharma interests. It's blatant and in-your-face.
FDA fraud detected. See the link: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150279741
I smell fraud in the relationship between GW Pharma and the FDA. https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150279741
All of you need to see this blatant fraud: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150279741
You may want to read this: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150279741
CLICK TO SEE FDA FRAUD IN REGARDS TO CBD
I was trained to detect fraud. I found fraud at the FDA. Let me point it out below:
Source:
7/25/19 Dr. Amy Abernathy Testimony on CBD
Confirmed: Plus CBD topicals now selling at all Sprouts in El Paso, TX.
You’re conveniently forgetting that CVSI’s news came out shortly before the market closed.
The CBD craze is getting out of hand. The FDA needs to act.
A syringe with a dose of CBD oil is shown in a research laboratory in Fort Collins, Colo., in 2017. (David Zalubowski/AP)
By Scott Gottlieb July 30 at 5:33 PM
Scott Gottlieb, a resident fellow at the American Enterprise Institute, was the 23rd commissioner of the Food and Drug Administration from May 2017 to April 2019. He consults for and invests in biopharmaceutical companies.
Cannabidiol — better known as CBD — is everywhere, from small specialty shops to large national retail chains. It can be found in foods, supplements, drugs, oils, creams, pet foods and more, and sellers purport that the compound treats everything from cancer to depression. Analysts say the market could surpass $20 billion by 2024.
But many of the compound’s expansive benefits are fanciful, and in fact, the sale of much of the product is illegal under current law. The Food and Drug Administration must act to make sure commercial interests don’t strip away any legitimate value that the compound might have.
Much CBD is derived from hemp, the commodity that was legalized in the 2018 farm bill. But the law still prohibits putting the chemical in food or pet food, and the FDA has issued repeated warnings and actions on the blooming CBD industry. In fact, there’s only one legally available purified form of CBD: the drug Epidiolex, approved by the FDA in 2018 to treat seizure disorders.
This doesn’t mean there can’t be a route for CBD to be legally sold in other forms, including as a food ingredient. Nor does it mean that CBD can’t offer potential benefits. But a legal path should be based on a clear and efficient regulatory process and sound science to guide its proper use.
CBD has risks: It can cause damage to the liver at high doses, and it may have a cumulative effect. If you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose. Currently marketed products might also have undeclared ingredients and impurities, including the psychoactive compound found in marijuana, delta-9-tetrahydrocannabinol (THC).
Any path to allow CBD to be added to food products needs to preserve the incentive to study the compound in rigorous clinical trials to prove its therapeutic potential as a medicine. It’s not appropriate or legal to make such claims otherwise.
The conflict in grappling with these illegal products stems from the misperception that the 2018 farm bill fully “legalized” CBD. When Congress passed the bill, it established a category of cannabis from hemp defined by extremely low concentrations of THC. But in doing so, Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to make sure they’re safe and that their claims are valid.
Under current law, CBD is permitted in food or dietary supplements only if the FDA issues a regulation allowing its use. This is a multiyear process subject to notice and comment, requiring a substantial amount of scientific data that the FDA must evaluate.
Given the pressure on the FDA to create a more immediate path for CBD products, this route might simply take too long. But there is a way that the FDA can fulfill its public-health obligations and meet the political demand for these goods: It can approve the sale of some CBD products immediately, while effecting a framework for their safe and proper regulation and a pathway for an enforceable market for these goods.
The FDA could put the onus on manufacturers to bring forward petitions to demonstrate that CBD can be safely added to products such as food. These submissions can take the form of new dietary ingredient notifications or food additive petitions, which would include toxicity studies to evaluate the safety of CBD. These are the same standards any new food ingredients are held to. Congress can help by passing language saying that the FDA doesn’t need to issue a broad regulation on CBD and can instead rely on petitions filed by individual, prospective producers.
In the meantime, the FDA could exercise enforcement discretion to allow CBD to be marketed in food so long as the products meet certain conditions. These criteria can include meeting good manufacturing requirements, demonstrating traceability, adhering to safe levels for the purity and potency of the CBD being added, and demonstrating that CBD is being added to food products only in very low concentrations that are unlikely to pose health risks.
In setting such a policy, the FDA could make clear that any CBD products that remain on the market — subject to a limited period of enforcement discretion — may not make any claims to treat disease. Other claims — for example, that it might help with relaxation — would have to be substantiated with evidence. This framework should also be expressly unique to CBD. Otherwise, there’s a risk it becomes a precedent for food and supplement makers seeking a back door to add other drugs to foods.
The FDA is being pushed by all sides to act quickly. Meanwhile, responsible food makers waiting for regulators to address the legal and safety considerations before launching CBD products are being eclipsed by unscrupulous purveyors. Obligating the industry to do the front end of this scientific work — and sweeping the market o f those who won’t — could advance a safe path and help establish the stable market for hemp-derived CBD envisioned by lawmakers.
That's what I thought too.
I call $18,320,000
Considering that GGBXF is still in the introduction stage of the product life cycle, it is to be expected that GGBXF uses equity financing during this stage. We are still in the process of adding a bunch of stores with a high focus on establishing brand equity. Conversion rates are currently at 80%; if that is maintained, revenues are going to be awesome in the not-too-distant future. Once GGBXF slows down on adding stores, it can focus on growth which will lead us to the next phase of the product life --the growth stage. Once we enter the growth stage, revenues will be much more important than they are today. GGBXF is on a tight timeline, and if they need to use equity financing right now, then I'm all for it. They're late players to the game, so the early spending is a way of playing catch-up. Just keep adding. All buy-in prices right now will be big winners in 10 years. Think long-term my friend.
I was asking myself that same question.
For the high dose used in this study, I as a 75 kg individual would have to consume 205 bottles of Plus CBD gold capsules (60 ct) at once [184,500 mg / (15 mg per capsule X 60)]. At say $75 per bottle, I would have to spend $15,375 on CBD capsules and use all of it in one sitting to reach this dose. I mean, this isn't realistic at all. I know that they disclose in the study that this isn't realistic:
I think some of you will find this comical:
Source: https://www.mdpi.com/1420-3049/24/9/1694/htm
Bamboo is to Pandas as Cannabis is to Humans.
I think I created confusion. Here’s the article I was replying to by providing a study that showed how CBD actually benefits the liver and protects it from injury: https://www.forbes.com/sites/mikeadams/2019/06/18/marijuana-study-finds-cbd-can-cause-liver-damage/#36c293443ffa
There’s an article by Forbes claiming that CBD causes liver damage. Their study is sourced from GW Pharma. GW Pharma also mentioned this at the FDA CBD hearing. The problem with GW’s argument is that they use CBD isolate. CV Sciences uses full spectrum hemp extract. What if the entourage effect plays a role at mitigating damage to the liver? What if it’s GW Pharma’s poor formulation that’s causing the liver damage? This whole liver damage argument from cannabis is laughable; if it were true, then pot heads would be dropping like flies —cause of death: marijuana toxicity in the liver. —You know what? —That doesn’t happen. To date marijuana hasn’t killed anyone, and GW’s junk science (Tobacco science, DDT science) isn’t going to fool me. Marijuana contains CBD, and it doesn’t kill anyone unless a 2 ton bale of it falls on your head. I call the hBhUhLhLhShHhIhT flag on GW. We need our own liver studies on PlusCBD full spectrum hemp extract.
Agreed 100%
CBD is sooooo bad for the liver that it helps protect it from alcohol damage. It seems that this whole liver damage thing is a ploy to hand the whole industry over to big pharma. Be skeptical. There's a lot of money at stake.
See here on PubMed
Is it possible that CBD liver damage only comes from CBD isolate rather than full spectrum hemp extract? Epidiolex is CBD isolate; am I wrong? --That means studies on CBD that showed liver damage probably used this same isolate; am I right? Did any studies on full-spectrum hemp extract show liver damage? Beware of sophisticated ploys to steal the industry.
If CBD caused liver damage, then wouldn't marijuana that contains CBD also cause liver damage? --Isn't it funny that I've never seen a study that showed marijuana causing liver damage.
CBD doesn’t affect drug tests. See link. https://www.wtvy.com/content/news/Experts-prove-CBD-products-dont-affect-drug-test-results--510089181.html
Let me first disclose that I am a long term investor with a sizable cash pile in this stock, and I've been invested here since October, so take that for whatever it's worth. Now, I'll move on to my quick analysis:
“As we move beyond the early adopters, our collective experience tells us that many of the remaining burncenters will follow a more standard process for adopting the RECELL System, including an initial evaluationof the product and advancement through their hospital’s Value Analysis Committee (VAC), before makingthe formal decision to purchase for regular use. This process can often take six months or more tocomplete,” said Erin Liberto, Chief Commercial Officer. “The recent ABA meeting added greatly to theawareness and credibility of the RECELL System within the burn community, and we look forward toconverting this excitement into product evaluations and the Value Analysis Committee approvals requiredfor adoption by additional U.S. burn centers.”
This VAC review process is why I was being realistic and claiming that it would be a few quarters before seeing any hugely significant revenue movement. I know that we all have dreams of obtaining more wealth overnight with Avita stock, but we must be realistic to prevent the spread of false hope that can destabilize the stock. I'm not day trading, and I'll probably be holding for years if Avita doesn't get bought out by then. I believe that Avita will eventually be a multi billion dollar company, and within a few years, I believe it's a 20 bagger for sure (from the current price per share), but burn hospital adoption takes time due to VAC bureaucracies. We will get to the finish line one step at a time. I believe that there is a high probability that the patient ones will reap massive rewards.
I'm glad to see that institutional investors continue to pour in; this is a great sign --especially since we aren't on the NASDAQ yet.
Having said all that, I am happy with this quote: “'We are well ahead of our expectations for the U.S. launch of the RECELL System and are delighted thatsales doubled during this quarter compared to the prior quarter,' said Dr. Mike Perry, Chief ExecutiveOfficer"
Cash receipts from customers for the quarter ended31 March 2019 were A$2,513, an increase of A$1,655 or 193% compared to the prior quarter due to thecommencement of the U.S. national market launch of the RECELL System.
Here's another chunk of strong revenue that will take time to be realized: “COSMOTEC filed on 25 February 2019 a Japan’s Pharmaceuticals and Medical Devices Act (“JPMDA”)application for approval to market the RECELL System in Japan. The JPMDA has accepted the application andreview is expected to take nine months to a year."
Conclusion:
Big things are happening. An additional 5.22% (7/134) of the total amount of burn centers have placed orders this quarter alone bringing total US burn center adoption to 19.44% (26/134). Many more are undergoing VAC review, which could take 6 months or longer. 80.6% (108/134) of the burn centers still haven't place orders. I presume that once the VAC reviews are complete, adoption by these burn centers will accelerate, hence my previous statements about having to wait a few quarters to realize more significant gains. Recell technology is simply too good to ignore, and the word about it is spreading like a wildfire in the US. Due to the huge cost saving advantages and the scarless healing potential of Recell, I believe that these remaining burn centers will soon adopt; otherwise, those centers will adopt a bad reputation for not doing everything in their power to deliver the best possible care to their patients at the lowest possible cost.
We must also consider that FDA approval is still pending for recell's use on children. The cosmetics, vitiligo, diabetic ulcers, and general wound healing segments are yet to be tapped. Japan's market is still in the works, and in the long term, the word will spread worldwide, and customers all over will demand recell.
Considering that sales just started in January in the US, the doubling of sales QoQ in this highly bureaucratic and political arena is music to my ears. I'll be here for 10 years or more if this doesn't get bought out by a bigger fish. Slow and steady wins the race.
Remember, this is like investing in the wheel. People need time to get educated about recell's cost saving and life saving potential. My guts tells me that growth will be exponential over time, and that's already begun.
Someone must need eye surgery to correct blindness, because the price right now is quite a bit higher than the average price 9 months ago. In fact, this is blowing my mutual fund out of the water. I'd much rather have my money here.
Looking back from the long term future, you’ll see that all of these prices were dirt cheap. You’ll be thinking, “Man, I should have just dumped everything into Avita.” The markets Avita’s going after are worth over $30 billion annually —maybe closer to $40. Who knows? Considering that doctors everywhere are acknowledging that Avita’s Recell is a huge leg up from the Standard of Care, I am thinking that we will eventually capture more than 20% of the market share within 3-5 years. —Thinking conservatively. That would probably equate to around $8 billion per year in revenue with around $2 billion in Net Income (hypothetically). That would put us at what, a $20 billion market cap? What is that? —More than 20X the current price? —Of course hypothetically. What if they obtained more than 20% market share? What if it became the latest trend? —The latest thing that’s hip on reality TV? Could we approach 80% market share or more? Anyways, you do the math. Good luck, and have fun.
Vanadium is the closest thing on Earth to Marvel Comic's Adamantium. Nothing comes close to its strength potential. --Except maybe hemp --for some applications.
The gold soft-gels are great! They have 15 mg of CBD each; I buy the 60 ct bottle. I take one of those daily. If I'm stressed, I'll take 3, and it calms me down. --This effect is heightened when taking a 20-30 minute epsom salt bath. I sleep better since I've been using this product. I used to suffer from anxiety, but I haven't felt much anxiety since I started using this product. The most I've taken at once was 55 mg (1 gel tab and 8 gummies), and I felt super-relaxed after about an hour. --Great stuff! It's more expensive to take mega-doses, but as the prices come down over time, that shouldn't be too much of an issue.
Up again! and again. and again. and again.
Big potential here. Earnings apparently to be released within 2 weeks. China is the largest hemp producer in the world with the most patents. Big, big market.
Now this firm has a future!
I expect to double within a year with my new investment here.
Ferro-niobium is inferior to ferro-vanadium. Since prices of vanadium have come down, I don't expect the substitution to last since the high prices of vanadium are what spawned the substitution.
Nice diamond in the rough here. I'm in!
Plus CBD calms dog with tremors!
huge
Thanks! This is huge!
2019 Expo West CVSI Recap:
https://vimeo.com/325321416
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https://wholefoodsmagazine.com/columns/editorial/education-opportunity-highlights-from-expo-west/
Very interesting speeches by Fiona Wood:
https://www.youtube.com/embed/ujqxB-I2rdM
If I was a betting man, I would bet that this upswing is going to continue to possibly $10. --That's realistic if you add the length of the flag pole on the 1 year chart to the inflection point at the end of the bull flag. A breakout to that range is likely considering big approaching catalysts that are CBD industry-changing. CVS fired the shot that was heard around the world, and each one of you should be realizing by now that CVSI is most likely not far behind CURLF at reaching the END CAPS of a MAJOR RETAILER, as Stuart Tomc (CVSI's VP of Human Nutrition) stated in an interview.