Chilling:

Often in these retail deals, the announcement date and the actual received date (product arrives in stores) are not the same.

More than likely the initial order of the balms have now been received by CVS stores and are physically on the shelves.

The announcement lets the customers who came in looking for it early on, know that CVS now has it in stock for purchase .


In the Vitamin Shoppe deal, the products will not be arriving at those locations until Sept 21 or so. (it is in the press release)

This is very normal news strategy for retailers..

Rifleshaft

Interesting....Big Pharma takes a hit...more to follow......


https://www.cnbc.com/2019/08/26/judge-rules-against-johnson-johnson-in-landmark-opioid-case-in-oklahoma.html

AP17...

I am not worried about the FDA. CVSI is and has been way ahead of the curve and the game with them.

The article Gottlieb wrote is pretty much telling the market that the FDA is going to act and move swiftly.

The commentary from Abernethy and others is based on safety of the CBD product you are selling and the health claims that need to come off of written advertisements whether it be website or labeling or what not.

What I see immediately happening is (this is my opinion )

1. CBD producers are going to have to submit safety data and detailed toxicology reports on the product content including levels of THC not exceeding 0.3. (As in an independent, FDA recognized science company that the FDA is familiar with)

2. They will more than likely place a requirement as to the derivative source of CBD (as in Agricultural Hemp versus marijuana plant based CBD) The hemp bill is specific to agricultural hemp.

3. They will more than likely require traceability of the process and specific information as to the process to which the CBD is made. (This may work much like Certified Organic Farms which are subject to USDA scrutiny) They will probably follow some sort of model the USDA utilizes.

There may be more...but CV Sciences is way ahead of the game......Stuart Tomc and the science department thought this out long ago....

As for Big Pharma....they are not sitting on their hands....although they may be lobbying for stringent regulations with CBD they really are not in a position to defy the legality of the product.
CBD in the retail form is not Epidiolex.

Big Pharma may be surveying the landscape as to who they may want to acquire....and they are probably waiting to make a move based on an FDA ruling or the windfall from states like Ohio and soon California on the legality of CBD.

Money follows money.....CBD will either get clarification from the FDA....or McConnell will amend the Farm Bill or the States will simply make CBD lawful. In any event....something is going to happen....

Thanks Wolf-manjack for your post on Curaleaf.

The response to me by the CEO of the company, in my view is an admission of guilt to exactly what the FDA is concerned about.

This is a letter that NO CBD company wants to get from the FDA. Getting this type of correspondence and the follow up required by Curaleaf puts them on the FDA's radar.

And the FDA's radar is NOT where you want to be.

I have read Abernethy's comments made yesterday.

First it's important to understand that this agency moves very deliberately and is known for its careful but painfully slow decision process.

I see the concerns they have. One being safety of what is being sold out there. She states in her testimony that the FDA did random tests of some CBD products and found a number of variances of THC levels and other components which are not disclosed on the packaging. Not to mention the various claims health claims made, such as what Curaleaf was cited for.

The other concern is that people would believe the claims and rely on "non scientific " data as a substitute for a prescribed drug with exact dosage and a named side effects that would be FDA approved.

The other concerns are the clinical studies that drug companies would put forth in the advancement of CBD and other research may be jeopardized by the easy availability of CBD being everywhere in the market place.

She hints in her testimony that at some point, CBD companies may have to submit certification of safety data to ensure safety of their product. Along with a disclaimer about what CBD does and does not do.


Now it will come down to dosage, strains of hemp and details of exactly what you (your company) are putting in your CBD products.

The FDA may have to require a GRAS report (such as the one CV Sciences has done) or set regulations regarding the CBD derivative (whether Hemp CBD or Marijuana CBD) and the dosage which appears to be set at 0.3 THC which is what the consensus has been.

This is what Duffy MacKay has told them in his testimony. Hemp is an agriculturally approved product. Which was approved with the passing of the Farm Bill.

As I had mentioned in an earlier post, hemp farming does not help the farmers without the ability of CBD as being part of the deal. The amount of money between harvesting hemp for (rope and other commodities) versus CBD and its extraction potential is enormous.

McConnell is on this as well as Wyden and other people in Congress. He has met with the FDA as recently as two weeks ago and is putting pressure on the agency. Pressure will continue until the FDA comes up with something.

The FDA is going to shake out the shady operators. You can see that coming.

Bottom line is we are going to see one of a number of things occur very shortly...

Either the FDA will agree to a strain of hemp (its source), a GRAS report, (proving your products safety) a dosage of 0.3 THC as an acceptable pathway for retail distribution. Food and beverage hopefully will be included.

States will and are now taking their own action with CBD and will begin writing their own regulations with regard to CBD. A huge market in California is about to unleash CBD in this regard. This is happening already in other states ( I believe OHIO)

McConnell could and may modify and file an amendment to the 2018 Farm Bill with some sort of provision regarding CBD...

CBD is not going to cease being sold.....shady operators will pay the price for unsafe products on the market. There is too much money involved here folks...plain and simple


And finally, the company would not expand to a 45,000 sq. foot processing facility, engage in partnerships with hemp farmers if it did not see the retail blitz that is coming...

Know what you own.

Successful investors have one thing over the amateurs......

its called PATIENCE

Excellent Post TR6767..

I have said this all along....which is why CVSI filed for up-listing to NASDAQ.

I feel the up-listing is eminent. However, sophisticated traders and investment firms stay away from OTC stocks plain and simple..

And your explanation is "spot on" . There is no rhyme or reason to the movement.....or lack there of...

The OTC is Wild West of investing .....plain and simple....

My opinion is it does not take a year to tell us NO......it may be a case of NASDAQ and its time table for CVSI..

Many of you may recall in one of my past posts, that with out the ability for farmers to harvest hemp for the production of CBD, the farm bill and the ability to grow hemp would be basically useless to the farmers..

Senator Wyden has put the pressure on the FDA (recent letter) looking for clarity from the FDA for some sort of established dosage of CBD that can be safely added to foods and beverages.

Douglas MacKay explained rather clearly to the FDA about the consistency of Agricultural Hemp and submitted to the FDA its GRAS finding's as part of his presentation. (This was done after his brief speech)

The most important thing that I see that happened took place yesterday....see below


U.S. Senate Majority Leader Mitch McConnell (R-KY) met with Acting Food and Drug Administration (FDA) Commissioner Dr. Ned Sharpless yesterday. During the meeting, Senator McConnell discussed the importance of hemp production and the need for clarity from FDA on the sale of hemp derived CBD products.

Senator McConnell informed Dr. Sharpless of the positive impact the legalization of hemp is having in Kentucky. He also reminded Dr. Sharpless of some of the ongoing challenges -- such as the need for a regulatory framework for CBD -- he hears about from hemp farmers, processors and manufacturers in the state.

“While the 2018 Farm Bill included my provision to remove hemp, and its derivatives like CBD, from the list of controlled substances, CBD food and dietary supplement products remain in a gray area without clarification from the FDA,” Senator McConnell said. “Congress’ intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the Agency’s enforcement and potential regulatory plans for certain CBD products[color=red][/color]. I appreciate Acting Commissioner Sharpless meeting with me today to discuss this important issue. Like my constituents, I am anxious to know the FDA’s plans to ensure public access to safe CBD products.”

This is what I was hoping to see happen....You now have McConnell involved with this....and you can be assured that the FDA is going to have to move on this very soon....otherwise you may see an amendment added to the 2018 Farm Bill establishing clarity and essentially legalizing CBD (more than likely the agricultural hemp strain ) with some sort of safe milligram dosage along with any health warnings that may be necessary.

Less than one week from the hearing last Friday, Congress has issued a directive to the FDA with respect to clarity on CBD...

The Farm Bill without the ability for farmers to harvest hemp for CBD production is going to be worthless to them.

In my opinion, this is going to move very quickly in some fashion. Either through the FDA making a decision on the separation of the agricultural commodity from the controlled substance, or by virtue of legislation in the form of an amendment to the 2018 Farm Bill itself.

The article link posted below was posted yesterday from Time.com

Clearly the pressure is on.

https://time.com/5601977/united-states-government-cbd/

In my post yesterday, I mentioned the amount of profit farmers can make with an industrial or agricultural hemp farm. (Profit per acre)..

Read the article I have posted and in particular points 2, and 3 in the article and you will see why it may move quickly either through Congress filling an amendment to the 2018 Farm Bill (specifically relating to CBD) and or States will start taking the bull by the horns and implementing the commercial use of CBD at the very minimum as supplements and quite possibly in the food supply.

The comment period runs through July 2....The problem the FDA has right now is the genie is out of the bottle. The CBD industry is being driven heavily by public demand, and of lobbying groups like CRN, National Hemp Association, Hemp Roundtable, and the World Health Organization (WHO), just to name a few.

These lobbying groups are very powerful. They are more than likely going to pursue the legislative angle to all this.....

Keep in mind how quickly the tax reform bill was passed in late 2017.....I think they got it all done in less than 60 days....

California is about to do this on its own in July with their AB 228 legislation that is going to overwhelmingly pass the State legislature..

Read the article......as I have always said....this is about money .....tax money....

You may recall that about a month and a half after the Farm Bill passed, Senator Wyden, and Conaway both contacted the FDA looking for clarity on CBD.....

Bottom line: There is WAY too much pressure to say NO to agricultural or industrial hemp based CBD at the .3 THC level.....Not going to happen folks......CBD is mainstream.....companies like Ben and Jerry;s ice cream are sitting on the sidelines ready to go.

Legalization of Hemp with out the ability to harvest for CBD processing is worthless to the farmers....

Read the article....

https://www.agweb.com/article/three-potential-paths-for-farming-hemp/

Lot of panic out there based on trading action Friday and so far today..

I have listened to MacKays presentation a few times...he has laid it all out for them....he explained that the FDA has the regulatory framework in place....

He states...."You have to separate an agricultural commodity from a controlled substance"

Current USDA and FDA regulations currently allow VERIFIABLE HEMP SEED SOURCE. (Seed licensing scheme )

He mentions International's Hemp Supply Scheme advocates verifiable sources of hemp based products for the industry. Hemp can be safely regulated. Current FDA regs allow natural derived ingredients to co-exist as conventional foods and dietary supplements.

This comes down to type of Hemp being used.

Hemp extracts are significantly different from Marjuana.

Key Points

CBD used for the treatment as a drug requires different regulation...(DRUG APPROVAL)

CBD used (hemp extract different from purified CBD) a food ingredient or dietary supplements have approval paradigms in place.

Most importantly he described to the FDA the process of how the CVSI manufacturing of CBD is tracked and verified.

He did an excellent job of explaining high potency CBD "Isolate" and how that cannot be free flowing in the food supply ..

FDA can simply regulate CBD by via verifiable food fiber hemp source. He mentions the difference between Marijuana CBD and Hemp CBD...and there in is what he is speaking to.

Also that the USDA and FDA synchronize the process to differentiate the two
This is the first step in their thinking I would hope.

The FDA has to separate agricultural hemp (and the CBD derived from it) from other sources of CBD (Isolates and from the CBD derived from marijuana.)

Bottom line....(This is my opinion) ....the FDA is going to have to start with the separation of agricultural hemp from the other sources...

The framework is in place of all of this. Either the FDA will act and do this.....or the CRN, and National Hemp Association and other lobbying groups will then turn lawmakers to move on this...and realistically the existing farm bill would only need an amendment to put this in place. One other very important point worth mentioning....Farmers growing hemp WITHOUT the ability for companies to extract CBD from the plant will make only a fraction of revenue per hemp acre versus WITH CBD extracted from their hemp plants. This will get the attention of McConnell and et,al who sponsored the bill.




This is a few days old...(May 30) but worth the read.....Article appears on the TD Ameritrade site.



Upcoming CBD Shortage is an Opportunity for Cost-efficient Producers to Expand

8:50 am ET May 30, 2019 (PR Newswire) Print
Few developments have been as game-changing for the cannabis industry as the U.S. Farm Bill. While demand for cannabis will remain strong over the upcoming years, experts are anticipating that the hemp industry will become a new big player in the marketplace. Ever since hemp agriculture was legalized thanks to the U.S. Farm Bill signed December last year, cannabis companies around the world have jumped on the opportunity to get in on ground zero of this sector. Well known Canadian listed companies such as Charlotte's Web Holdings Inc. (OTC:CWBHF) (CSE:CWEB), CV Sciences Inc. (OTC:CVSI), Liberty Health Sciences (OTC:LHSIF) (CSE:LHS), Namaste Technologies (TSXV:N)(OTC:NXTTF), and StillCanna Inc. (CSE:STIL) (OTC:SCNNF) have all been making major moves in the growing hemp market.

Analysts at the Brightfield Group predict CBD will grow from a $600 million sector this year to $22 billion by 2022. With the US Farm Bill in effect, demand for hemp is expected to spike over the upcoming year as cannabis companies switch to sourcing hemp for their CBD.

The Growing Market for Hemp

While interest in hemp-based products has been growing, the current demand is only at a fraction of what it is expected to be. Just as Canadians saw drastic supply shortages after the demand for cannabis spiked post-legalization, so too will the CBD industry. For this reason, companies that can scale up hemp production in a way that's cost-efficient are in the best position to dominate the market when CBD supplies become tight.

One of the first-movers in Europe when it comes to cost-efficient hemp cultivation is an up and coming company called StillCanna Inc. (CSE:STIL) (OTCPK:SCNNF). The company boasts one of the lowest production costs of CBD isolate with a production cost of just $744 per kg. The wholesale price for hemp isolate is currently $6,077 per kg. Their new facility in Poland is expected to bring 2019's production output up to 16,000 kg and in 2020, the Company's output is expected to produce over 40,000 kg of CBD isolate.

Hemp-derived products are quickly becoming mainstream as Dr. Oz and Dr. Gupta spoke about 'The CBD Oil Boom'. Even retail chains that haven't traditionally embraced cannabis products, such as drug store chains and pharmacies, are stocking CBD products now. Walgreens has already announced they will be selling hemp-derived products in over 1,500 stores recently. Another major retailer, CVS, is already selling hemp products at over 800 locations in the U.S.

Charlotte's Web Holdings Inc. is perhaps the biggest player in this market. Producing around 675,000 lbs of hemp in 2018 with more than 700 acres planned in 2019, the company's revenue increased by 74 percent last year. The second largest company in the hemp market, CV Sciences Inc., has also seen significant growth even prior to the US Farm Bill passing. Over the past year, the company's sales have increased by 200 percent and currently holds 11% of the overall hemp market.

Many retail-based cannabis companies have already embraced hemp-products into their line-up with great success. Namaste Technologies is one such example. Unique in the sense that they focus exclusively on online sales, the company owns 24 unique websites and brands, with many of them focusing on hemp products. Even in the medical market, hemp has surged in popularity. Companies that focus mainly on the health sector, such as Liberty Health Sciences, has seen a surge of hemp-product sales based on the reported medical benefits of the plant.

The Rise of Cost-Efficient Producers

StillCanna Inc. (STIL-SCNNF) has also been completing several strategic partnerships to further expand its capacity. They just recently finalized a deal with California-based BioSciences Enterprises for C$36 million, giving them a steady pipeline to sell their European produced CBD into the U.S. market. Richard Parker, President of Biosciences, said that "not a day goes by that our firm isn't looking for a company like StillCanna, but finding a knowledgeable seed to shelf CBD manufacturer in this young industry is extremely rare."

Other major deals that StillCanna signed include a $48 million agreement with one of the biggest CBD retail suppliers in Europe, DragonFly BioSciences. The deal would see StillCanna act as DragonFly's sole processor of CBD, a significant achievement for a company that small.

Further Cannabis Developments

Charlotte's Web Holdings Inc. (OTCQX:CWBHF)(CSE:CWEB) recently posted their Q1 earnings report for 2019. So far Q1 sales grew by 66% to $21.7 million, impressing analysts with steady growth. Ever since Congress passed the Farm bill legalizing hemp production, analysts expect this to be a game changer for the company.

Cannabinoid (CBD) oil is being used in a study with patients suffering from Post-Traumatic Stress Disorder (PTSD). CV Sciences Inc. (OTCQB:CVSI), a manufacturer of hemp base CBD-products, will be using their signature CBD-oil products in this clinical trial published in the Journal of Alternative and Complementary Medicine.

A couple of key points from the article by Danny Brody from Cannabis Investors Magazine

The GRAS Solution

The first of the FDA’s concerns is easily overcome – reputable companies are avoiding specific health claims that might trigger the FDA’s interest and letting the media educate consumers about CBD’s benefits. This method is fueling the massive growth of CBD in tinctures, lotions, and the like, and even CBD for pets.

But putting CBD into food products is a more difficult hurdle to jump.

While the FDA has said they will “advance new steps to better define public health obligations related to CBD,” it has not yet been clarified. Right now, you can legally buy a beverage containing THC in California, but not a beverage containing CBD.

However, there are certain pathways companies can go down and still receive FDA approval. Some foods derived from hemp that may not contain CBD or THC are a prime example. Some foods are classified as “Generally Recognized as Safe” (GRAS). Attaining GRAS status clears the substance to be used in foods and beverages without fear of regulation.

Self-affirmed GRAS is when a company, rather than the FDA, does research on a food product and shares their evidence with the FDA. If the FDA doesn’t question the self-affirmation, the company may assume that the food is GRAS until it is told otherwise.

Some companies have already achieved a self-affirmed GRAS determination regarding the non-CBD containing parts of hemp, like the seeds, oils, and proteins.

CV Sciences (OTC: CVSI) claims that it has achieved self-affirmed GRAS for a CBD product. It is the only CBD company to have done so, though I believe that Charlotte’s Web (CSE: CWEB, OTC: CWBHF) is close and other companies will follow.

Aside from GRAS certification, the FDA has scheduled a public hearing for May 31, 2019 to allow the public to comment, share their feedback, and discuss any foreseeable challenges with CBD-related products.

The main thing they’re after is information and data related to the safety of CBD products. My belief is that with no “intoxicating” effect, and only positive comments from the public about the effects of CBD-infused products, this should be fairly straight forward.

With the FDA’s commitment to protecting consumers, I believe companies will be required to go through the approximately 12-month and nearly $1 million process to achieve GRAS affirmation before they’ll be able to sell any food or beverage products, though the FDA or Congress could speed up matters if either chooses to do so.

With these products soon to be legally marketed in human foods without approval, it’s going to open up an entirely new wave of fully FDA-legal, fully FDA-compliant products in the CBD space, paving the way for significant new opportunities.

In the meantime, as we see with the big retailers getting into CBD, there are plenty of opportunities with the tinctures, creams, lotions, and other non-food CBD products to produce enormous growth for the industry.

You can be sure that Greg and the NICI team will be working tirelessly to deliver you the best opportunities to secure your retirement fortune.





Couple of thoughts about the Friday hearing. The hearing will be very helpful to those companies who do not make health claims about their CBD products, and who can categorically affirm to the safety and consistency of their product. (correct amount of CBD per label description )

So in essence the FDA is basically going to listen to information about the science as perceived by a number of companies (companies attending are getting allotted speaking time, CVSI getting 5 minutes by MacKay).

The FDA certainly knows what CBD is....in view of their ruling on Epiodiolex. So they are not strangers to the compound.

Contrary to a consistent opinion offered here by Mr. V, the Self Affirmed GRAS toxicology report is going to be very vital;. So it is more than a nothing burger.

FDA is all about safety period. You will also see in the article they are also about policing companies who are making false health benefits claims.

I see two very key catalysts on the horizon, one being California giving the okay for CBD edibles / consumables..and as for the hearing what the FDA message may be is "show us your proof of safety of your product". The proof will need to be third party such as with an AIBMR lab company.

AIBMR labs and CVSI did in fact share their toxicology findings with the FDA. They know the science behind our products. As the article says, if the FDA does not challenge it then it stands as self affirmed but not FDA endorsed. The FDA is not in the business of endorsing various products or companies.

In the end, we will see some sort of frame work for regulation and safety. This is where CVSI has the decided edge. Stuart Tomc has been wanting this for a while.

Finally, one other interesting note from the hearing. If you are in the business of retailing CBD and you do not show up at the hearing, you are going to draw negative attention to your company.
The one thing the FDA will definitely get from the hearing is a snap shot of the landscape of CBD companies currently in existence. They will see "who's who" for sure.

But if you're speaking at the FDA panel, you are going to need to know what you are talking about and be able to back it up with factual data.

Bottom line......the CBD retail field will begin to get thinned out post FDA hearing.

You can count on it

This article is very consistent with what I saw on Fox Business this morning. The report I saw on Fox has retailers making shelf room right now for the next phase of CBD retailing which as we all know is the consumables.

These retailers that were named were CVS, Target, Walgreens, Wal Mart to name a few. If you listened very carefully to Dowlings remarks on the call, it is pretty obvious that CVSI is in the conversations with these retailers as we speak.

For those of you who follow the Yahoo board, and in particular captainjonesthe3rd you may have read his commentary about the hammer about to go down on a number of CBD companies who are clearly misrepresenting their product line for composition and amount of CBD in their respective pills or other ingestible items.

This "hammer" will happen after the FDA holds its hearings on May 31. Here is how I think it will go down:

If you are CBD mass distributor, you will need to send some sort of representation to the hearing. Not just corporate reps or VP's or marketing staff, but you are going to need to explain the traceability and the SCIENCE behind why your product is safe for the consumer. So you will need some expert scientific testimony to support your claims. The FDA is very concerned about the type of hemp being used for CBD production and they are concerned about the THC content in CBD from the marijuana plant itself.

For reputable companies such as CVSI, they will be able to explain the very need TO the FDA the reasoning for proof of safety and traceability of other CBD products. I am sure that McKay will explain the painstaking process of GRAS certification and why it needs to be done industry wide.

I believe the FDA at some point will come to the conclusion that an FDA approved testing facility or facilities will be named and your CBD products will need some sort of certification of safety to the public via of some sort of laboratory endorsement.

The basic premise of less than 0.3 THC content would be the constant for all CBD sold for consumption.
As far as other ingredients are concerned, that may not be that important to the FDA. What they are looking at is safety. You are going to have to scientifically prove the safety of your product.

I would also suspect that the FDA will put a number of companies on notice at that hearing. You can be assured that those who are violating FDA guidelines right now will need to be very careful going forward.

Although it is a hearing, don't underestimate the savvy nature of the FDA. The hearing will allow them to find out who the CBD players are and the general landscape of the "who's who" of the whole sale distribution networks.

If you listen to Stuart Tomc speak in the past about this issue, he has waited for this moment. No one is better prepared than we are.

Separation from the competition is what this will ultimately bring. If you are mass distributing CBD right now and don't show up at the hearing....you may be a dead distributor walking... and if you do show up you better know what the hell is in your product line and have the science to back it up.

In the end....the mass retailers are going to with safety and high proven quality. With the certifications and the CRN network as lobbying groups you can see we are in the sweet spot for this.

We have full traceability from seed to shelf. I don't know who else can make that claim.

I listened to the Gottlieb interview and basically he has taken the position of being concerned with two major aspects of CBD marketing of which all of us as investors already know.

First and foremost, Gottlieb addresses the false scientific claims of CBD usage (as well he should) from the various fly by night operators in the CBD space.

Secondly he speaks of the dangers of high dosage of CBD and its damage to the body. However, he does not disclose what is "high dosage" and what strain of CBD (marijuana or hemp) in high dosages he is referencing.

The public decides what types of products and consumables it wishes to utilize and purchase.

The FDA is about to get a very good education from a number of expert scientific and highly knowledgeable minds who will bring to the hearing overwhelming evidence of the relationship between cannabinoids and the human brain at levels of less than 0.3 THC.

The market place and the public doesn't agree or subscribe to what Gottlieb is saying. For that matter millions of people have read the science behind CBD and more importantly those of us who use CBD know first hand its effects.

CBD is really a nutrient that offers a number of benefits that the FDA really does not know of or understand.

He speaks of no scientific evidence of CBD and its relationship to curing cancer or tumors.

CVSI does not state that claim or any claim of a cure for a disease or any ailment.

Safety? We have an in depth toxicology analysis and report on our product and its compounds, formulations, as well as the source of each and every bottle and where it came from from "seed to shelf" as well as a QR code on each bottle sold in the state of Indiana and probably soon throughout the US.

This compound (at less than 0.3 THC) and it only becomes a drug in greater concentration levels of THC is now being used by GW Pharma for certain types of epilepsy. We all know that.

The science of the benefits of CBD is overwhelming. The sales numbers and the industry projections are massive.

It's only snake oil if that's how your marketing it. It's value to the consumer comes from education and due diligent research that each and every consumer that takes the product has already done.

There isn't one vitamin out there that if taken in high dosages that won't do damage to you.

FDA is going to get a wake up call on May 31. In the end science and evidence as well as the public demand will prevail.

We have a proven track record of safety and complete transparency with regard to our line of products. No one can touch CVSI.

The CRN is invloved, the National Hemp Association is involved and now Congress is getting ready to put its foot down on getting a clear path to CBD regulation.

Despite his comments, keep in mind he is gone and has zero say in what happens going forward.

There are new sheriffs in town at the FDA.....and they are going to get a lesson in CBD education starting May 31

Yesterdays announcement of CVSI's acceptance into the CRN (Council for Responsible Nutrition) is a huge step for the company.

In order to influence a government agency, Congress, or any one person to act to change a law or regulation, you must have credible advocacy groups, expert witnesses (and in this case the valid factual scientific data) to support your claim or call for action.

While I don't know what exactly will happen at the hearing, I can tell you a few years back, I invested in two weight loss drugs, one from a company called Vivus (VVUS) and from Arena Pharmaceuticals (ARNA)

What I did observe at those hearings was the amount of expert testimony from various independent groups who had studied the drug compounds and the associated potential risks with its use.

Translation:

While the FDA may listen to some of the current companies marketing CBD, they will focus on independent third party information and testimony on what form or strain of CBD they will deem acceptable.

What is critical for CVSI is that the CRN group is advocating for CBD only from hemp and not from marijuana since hemp has been descheduled and not marijuana. It also states that it must contain less than 0.3% THC.

CVSI has been looking forward to this type of regulation. They have been planning for it for years.

The company now has an independent toxicology report for review which gives it a self affirmed GRAS status

The company's product(s) have the support and certification of the National Hemp Association

The company now has membership with only 2 other companies in the CBD space (OLEO and Demetrix) who at this point comply with the CRN standards.


We are locked and loaded for the hearing. The CRN move is a huge one.

Please read the news release on this. Steve Mister is well aware of the legitimacy of these three companies and their CBD products. OLEO infuses drinks with CBD (0 THC) Demetrix is a private bio tech company that produces cannabinoids for beverage mixtures.

The CRN has a very large lobbying base....in addition to Congress wanting approval of some sort of CBD standard, you can see the handwriting on the wall.

Experts will have their voices heard by the FDA. While the CRN is not the government, they are a very powerful advocacy group whose members include AVON, Bayer Health Care, Cargill Health and Nutrition, Clorox,
Natures way brands just to name a few..


As I have said many times, know what you own. Patience is key here, and we need a few final pieces to fall into place.


If you think a few big companies aren't watching this industry and who is emerging as the premier dominant player, then your fooling yourself.

I have read the statement from Gottlieb yesterday....several times..

This statement in the press release is very critical and gives CVSI a significant edge

Ultimately, we remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products. The actions we’re announcing today will allow us to continue to clarify our regulatory authority over these products and seek input from a broad range of stakeholders and examine a variety of approaches and considerations in the marketing and regulation of cannabis or cannabis-derived products, while continuing to protect the public’s health and safety.

It was my understanding that the GRAS study that CVSI had done last summer was in line with FDA protocols.....there would be no point in doing such and paying for a toxicology report that would not meet FDA standards.

The hearing will weed out the "bad actors" in the CBD space. I am sure reputable companies will bring to the hearing their scientists, and credible certifications to provided clarification of what they are selling to the public.

We have GRAS and certification from National Hemp Association, as well as documented evidence and traceability of our product from seed to shelf..


The FDA is going to have to determine what is safe and why they think your product is safe.

We are clearly in the drivers seat on this......way ahead of competitors..

Often times, in these situations, its a company's R and D that is ahead of the curve wins.

Some company is going to be the first to get approval.

I like our chances.....

Thank you sleuth for the link to the Gottlieb remarks made (I think yesterday)..

Those of you who have not seen it, go to the 1:30 or :31 point in the video and you will hear his commentary on CBD and his assessment of where it is.

My take on his remarks is that the FDA is "open" to the pathway for CBD additives to the food supply or beverages, however he admitted that the FDA process could take some time.

What is very encouraging is that the fastest way to get CBD marketed as food additive or beverage additive or dietary supplement is for Congress to get involved and pass legislation that specifically deals with the process of getting it into the market.

Gottlieb did point out and I agree with him on this....that there needs to be a definitive numeric strain of CBD that would be acceptable to the food supply (I would assume that 0.3 is the number).

Because CBD is in the drug Epidiolex, (although I don't know the dosage of CBD in that particular drug) there needs to be separation of the agreed amount of CBD allowed in the food supply versus what is allowed in the drug Epidiolex.


Where I think this is going is that Congress will have to review the commentary and opinions from the various CBD companies out there as to what is in their product.

In any event, what does seem clear is that if you are interested in getting your CBD product to the mass market, you are going to have to be able to validate the sourcing and toxicology data of your product to someone in some capacity to get approval.

What I would hope to see happen, is that the GRAS study that we have already done, serve as the mainframe for allowing marketing of CBD.


Congress will need to essentially legislate the parameters of the specific strain (or amount of THC) of CBD and then provide for some sort of filing with the FDA that if in fact you can provide an ACCEPTABLE toxicology report on your product (with random testing done to enforce such) that FDA can then grant approval of such.

In any event, we are clearly ahead of the game. I have a feeling that when Stuart Tomc, gets in front of some Congress members, the new director of the FDA and the panel that gave the final recommendation for the approval of Epidiolex, he will shed some serious light on this and get the legislation ball moving.


Congress knows how to move quick, we all know how fast the tax cut happened. It was done in about 60 days....There will need to be some heat put on Congress to move on this....what Gottlieb did say was the FDA route will be long and tedious.....

Just my opinion folks....

Rifleshaft

Bad Karma Kyle...

Thanks for the tip.....I am going to get right on it...

Pyxus International Inc. (PYX)
NYSE - Consumer Non-cyclicals
Investment Recommendation
• We recommend investors sell PYX.
• PYX earns our Unattractive rating. See Investment Rating Details below.
• An Unattractive rating means this stock has more downside risk than upside potential.
• PYX ranks in the 28th percentile of the 2750+ stocks we cover.
• Ranks 107th out of 133 Consumer Non-cyclicals Sector stocks.
Price 01/31/2019:
Economic Book Value per share 52-Week Range
Closing Price as of 01/31/2019: $16.23 Dividend Yield: - Period End Date: 09/30/2018
4 - Unattractive
$16.23 ($75.82) $11.30 - $52.43
Investment Rating Details
Risk/Reward Rating
5 - Very Unattractive 4 - Unattractive
3 - Neutral
2 - Attractive
1 - Very Attractive
Quality of Earnings
Valuation Price-to-EBV Ratio
> 3.5 or -1 < 0 2.4 < 3.5 or < -1 1.6 < 2.4 1.1 < 1.6
0 < 1.1
Accounting vs Economic Earnings
Accounting Adjustments Summary
Stock Price Performance
Last 30 Days Last 60 Days Last 90 Days Last Year
Formulas for Key Metrics
36.8%
13.6% (29.4%) 23.4%
Key Market Statistics
Enterprise Value (MM) EV/EBITDA
P/E (TTM)
$1,756 13.33 5.14
Economic vs Reported EPS
Misleading Trend False Positive Neutral EE Positive EE Rising EE
Return on Invested Capital (ROIC)
Bottom Quintile 4th Quintile 3rd Quintile 2nd Quintile Top Quintile
FCF Yield
<-5% -5%<-1% -1%<3% 3%<10% >10%
Growth Appreciation Period (yrs)
> 50 20 < 50 10 < 20 3 < 10 0 < 3
• Economic Earnings = (ROIC - WACC) * Average Invested Capital • ROIC = NOPAT / Average Invested Capital
• Free Cash Flow = NOPAT - change in Invested Capital
Page 1
www.newconstructs.com
Pyxus International Inc. (PYX)
•
•
•
•
PYX's accounting earnings overstate its economic earnings, which equal (ROIC - WACC) * Average Invested Capital.
For PYX, we made a total of $1,563 million in income statement and balance sheet adjustments to convert accounting earnings to economic earnings in FY18.
We made $1,630 million in adjustments in our DCF valuation of the stock.
Wemake,ingeneral,10typesofincomestatementadjustments to derive NOPAT, 12 types of balance sheet adjustments to derive Average Invested Capital, & 10 types of valuation adjustments in our reverse DCF valuation models.
About New Constructs
• Ourresearchaimstoempowermoreinformed investment decision by providing the most comprehensive and accurate analysis of firms' true profitability and valuation.
• This Ernst & Young white paper demonstrates the superiority of our data and models. The Appendix details exactly how we stack up against traditional firms.
• HarvardBusinessSchool'scasestudy"NewConstructs: Disrupting Fundamental Analysis with Robo-Analysts" features our unique research automation technology.
ROBO-ANALYST RESEARCH

ROBO-ANALYST RESEARCH
02/01/2019
Economic Earnings are 4 - Unattractive
Economic Earnings are almost always meaningfully different than reported earnings. We believe Economic Earnings provide a truer measure of profitability and shareholder value creation than reported earnings because they have been adjusted to remove over twenty accounting distortions.[color=red][/color]
The majority of data required to reverse accounting distortions is available only in the Footnotes and MD&A, which we analyze rigorously. Our core competency is gathering and analyzing all relevant financial data from filings so that we can deliver earnings analysis that best represents the true profitability of businesses.
Economic Earnings per share (EEPS) for PYX for the trailing twelve months earn our Unattractive rating.
Appendix 1 in the report available to members of our website provides a detailed reconciliation between economic and accounting earnings.
Return on Invested Capital (ROIC)
ROIC is 5 - Very Unattractive
ROIC measures a company's return on all cash invested in the business. It is the truest measure of profitability. Stock valuations are more highly correlated to ROIC than any other metric. ROIC is calculated as NOPAT divided by Average Invested Capital.
Weighted-Average Cost of Capital (WACC) is the average of debt and equity capital costs that all publicly traded companies with debt and equity stakeholders incur as a cost of operating.
Companies must earn an ROIC greater than WACC to generate positive economic earnings and create value for shareholders.
PYX's ROIC for the trailing twelve months earns our Very Unattractive rating.
Appendix 1 in the report available to members of our website provides details on all the accounting adjustments we make to provide the best ROIC in the business as demonstrated by Ernst & Young.
Free Cash Flow Yield (FCF Yield)
Free Cash Flow Yield is 4 - Unattractive
Free Cash Flow reflects the amount of cash free for distribution to all stakeholders (including debt & equity). FCF Yield divides free cash flow by enterprise value.
Using Free Cash Flow Yield to pick stocks is not a new strategy. However, our strategy yields superior results because we use a better measure of Free Cash Flow. In the same way our Economic EPS are better measures of profitability than reported EPS, our measure of Free Cash Flow is better than traditional accounting-based Free Cash Flow.
PYX's FCF Yield for the trailing twelve months earns our Unattractive rating.
Appendix 1 in the reports available members of our website provides the income statement and balance sheet adjustments required for an accurate measure of FCF.
Economic vs Reported Earnings
Page 2
www.newconstructs.com Pyxus International Inc. (PYX)

ROBO-ANALYST RESEARCH
02/01/2019
Price-to-EBV Ratio is 5 - Very Unattractive
Price-to-Economic Book Value (EBV) measures the difference between the market's expectations for future profits and the no-growth value of the stock.
EBV measures the no-growth value of the company based on the company's current Net Operating Profit After Tax (NOPAT).
When prices are higher than EBV, the market predicts the NOPAT of the company will increase and expectations for profit growth are reflected in the stock. If the stock price equals EBV, the market predicts NOPAT will remain the same and there are no expectations for profit growth reflected in the stock. When
stock prices are lower than EBV, the market predicts NOPAT will decrease and expectations for permanent profit decline are reflected in the stock.
In general, we like to buy stocks with low expectations for profit growth and sell/short stocks with high expectations for profit growth.
PYX's current Price-to-EBV per share earns our Very Unattractive rating.
Appendix 2 in the reports available to member of our website details all the valuation adjustments required for an accurate measure of economiv book value.
Growth Appreciation Period
The Growth Appreciation Period is 2 - Attractive
The market-implied duration of profit growth or GAP measures the number of years the company must maintain an edge over its competitors by earning ROIC greater than the weighted-average cost of capital on new investments.
We believe PYX embeds an Attractive level of market expectations because there is a fairly conservative level of expected financial performance implied by its market price compared to the company's historical performance.
At PYX's current stock price of $16.23, the market is expecting revenue to grow at 5.3% for the next 9 years. Over this period, PYX is also expected to generate an average Economic Earnings Margin of (1.4%).
These results are derived using our dynamic discounted cash flow model.
Learn More
Members of our website get exclusive access to more data and detailed analytics on the 10,000 securities we cover. Stock reports from our website include detailed information on the number and dollar value of every income statement, balance sheet and DCF valuation adjustments we make.
Members also get exclusive access to multiple model portfolios, weekly Long Ideas, and Danger Zone calls, IPO Research, Market Outlooks, Webinars and thought leadership on Machine Learning & AI for Investing and Fiduciary Rule fulfillment.
Members get advanced screening capabilities on our best-in-class metrics like ROIC and Free Cash Flow Yield and alerts whenever there are changes to any of the securities in your custom portfolio.
Performance Hurdles
5 Yr
Historical Performance
3Yr
Last FY
Market Expectations
Default
based on current price
Stock Price
$29.20
$17.56
$26.05
$16.23
Revenue CAGR
(5.9%)
(1.6%)
1.1%
5.3%
ROIC - WACC
(3.7%)
(3.7%)
(4.0%)
(1.4%)
Growth Appreciation Period
-
-
-
9 years
Take a free tour and get a risk-free trial today!
Price-to-EBV Ratio
Page 3
www.newconstructs.com Pyxus International Inc. (PYX)

ROBO-ANALYST RESEARCH
02/01/2019
Appendix: Explanation of New Constructs' Stock Ratings
Ratings
In-depth risk/reward analysis underpins our stock rating. Our stock rating methodology grades every stock according to what we believe are the 5 most important criteria for assessing the quality of a stock. Each grade reflects the balance of potential risk and reward of buying that stock. Our analysis results in the 5 ratings described below. Very Attractive and Attractive correspond to a "Buy" rating, Very Unattractive and Unattractive correspond to a "Sell" rating, while Neutral corresponds to a "Hold" rating.
Risk/Reward Rating
Economic vs Reported EPS
Quality of Earnings
Return on Invested Capital (ROIC)
5 -Very Unattractive
Misleading Trend
Bottom Quintile
False Positive
4th Quintile
3% < 10% > 10%
Ratings
Economic earnings and return on capital metrics are significantly more accurate when as-reported financial statements have been adjusted to reverse accounting distortions and Red Flags. The majority of the data required to reverse accounting distortions is available only in the Notes to the Financial Statements, which we analyze rigorously. Our core competency is gathering and analyzing all relevant financial data (from the Financial Statements and Notes) so that we can deliver earnings analysis that best represents the true profitability of businesses. See the figure below for a list of the Red Flag adjustments we make to a company's reported GAAP profits in order to reverse accounting distortions and arrive at a better measure of a firm's profits.
< -5%
-5% < -1%
Valuation
FCF Yield
Price-to-EBV Ratio
> 3.5 or -1 < 0
Growth Appreciation Period
> 50
4 - Unattractive
2.4 < 3.5 or < -1
20 < 50
3 - Neutral
Neutral EE
3rd Quintile
-1% < 3%
1.6 < 2.4
10 < 20
2 - Attractive
Positive EE
2nd Quintile
1.1 < 1.6
3 < 10
1 - Very Attractive
Rising EE
Top Quintile
0 < 1.1
0<3
Accounting Issues and Red Flags that Distort GAAP
• [color=red]Employee Stock Options
• Pension Over/Under Funding • Excess Cash
• Restructuring Charges
• Pooling Goodwill
• Minority Interests
• Discontinued Operations
• Preferred Stock
• Mid-Year Acquisitions
• Off-Balance-Sheet Financing • LIFO Reserve
• Unrealized Gains/Losses
• Goodwill Amortization
• Unconsolidated Subsidiaries
• Capitalized Expenses
• Deferred Compensation
• Net Deferred tax Assets and Liabilities[color=red][/color][/color]
Page 4
www.newconstructs.com Pyxus International Inc. (PYX)

ROBO-ANALYST RESEARCH
02/01/2019
New Constructs® - Research to Fulfill the Fiduciary Duty of Care
Ratings & screeners on 3000 stocks, 650 ETFs and 7000 mutual funds help you make prudent investment decisions.
New Constructs leverages the latest in machine learning to analyze structured and unstructured financial data with unrivaled speed and accuracy. The firm's forensic accounting experts work alongside engineers to develop proprietary NLP libraries and financial models. Our investment ratings are based on the best fundamental data in the business for stocks, ETFs and mutual funds. Clients include many of the top hedge funds, mutual funds and wealth management firms. David Trainer, the firm's CEO, is regularly featured in the media as a thought leader on the fiduciary duty of care, earnings quality, valuation and investment strategy.
To fulfill the Duty of Care, research should be:
1. Comprehensive - All relevant publicly-available (e.g. 10-Ks and 10-Qs) information has been diligently reviewed, including footnotes and the management discussion & analysis (MD&A).
2. Un-conflicted - Clients deserve unbiased research.
3. Transparent - Advisors should be able to show how the analysis was performed and the data behind it.
4. Relevant - Empirical evidence must provide tangible, quantifiable correlation to stock, ETF or mutual fund performance.
Value Investing 2.0: Diligence Matters: Technology is Key to Value Investing with Scale
Accounting data is only the beginning of fundamental research. It must be translated into economic earnings to truly understand profitability and valuation. This translation requires deep analysis of footnotes and the MD&A, a process that our robo-analyst technology empowers us to perform for thousands of stocks, ETFs and mutual funds.
DISCLOSURES
New Constructs®, LLC (together with any subsidiaries and/or affiliates, 'New Constructs') is an independent organization with no management ties to the companies it covers. None of the members of New Constructs' management team or the management team of any New Constructs' affiliate holds a seat on the Board of Directors of any of the companies New Constructs covers. New Constructs does not perform any investment or merchant banking functions and does not operate a trading desk.
New Constructs' Stock Ownership Policy prevents any of its employees or managers from engaging in Insider Trading and restricts any trading whereby an employee may exploit inside information regarding our stock research. In addition, employees and managers of the company are bound by a code of ethics that restricts them from purchasing or selling a security that they know or should have known was under consideration for inclusion in a New Constructs report nor may they purchase or sell a security for the first 15 days after New Constructs issues a report on that security.
DISCLAIMERS
The information and opinions presented in this report are provided to you for information purposes only and are not to be used or considered as an offer or solicitation of an offer to buy or sell securities or other financial instruments. New Constructs has not taken any steps to ensure that the securities referred to in this report are suitable for any particular investor and nothing in this report constitutes investment, legal, accounting or tax advice. This report includes general information that does not take into account your individual circumstance, financial situation or needs, nor does it represent a personal recommendation to you. The investments or services contained or referred to in this report may not be suitable for you and it is recommended that you consult an independent investment advisor if you are in doubt about any such investments or investment services.
Information and opinions presented in this report have been obtained or derived from sources believed by New Constructs to be reliable, but New Constructs makes no representation as to their accuracy, authority, usefulness, reliability, timeliness or completeness. New Constructs accepts no liability for loss arising from the use of the information presented in this report, and New Constructs makes no warranty as to results that may be obtained from the information presented in this report. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. Information and opinions contained in this report reflect a judgment at its original date of publication by New Constructs and are subject to change without notice. New Constructs may have issued, and may in the future issue, other reports that are inconsistent with, and reach different conclusions from, the information presented in this report. Those reports reflect the different assumptions, views and analytical methods of the analysts who prepared them and New Constructs is under no obligation to insure that such other reports are brought to the attention of any recipient of this report.
New Constructs' reports are intended for distribution to its professional and institutional investor customers. Recipients who are not professionals or institutional investor customers of New Constructs should seek the advice of their independent financial advisor prior to making any investment decision or for any necessary explanation of its contents.
This report is not directed to, or intended for distribution to or use by, any person or entity who is a citizen or resident of or located in any locality, state, country or jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would be subject New Constructs to any registration or licensing requirement within such jurisdiction.
This report may provide the addresses of websites. Except to the extent to which the report refers to New Constructs own website material, New Constructs has not reviewed the linked site and takes no responsibility for the content therein. Such address or hyperlink (including addresses or hyperlinks to New Constructs own website material) is provided solely for your convenience and the information and content of the linked site do not in any way form part of this report. Accessing such websites or following such hyperlink through this report shall be at your own risk.
All material in this report is the property of, and under copyright, of New Constructs. None of the contents, nor any copy of it, may be altered in any way, copied, or distributed or transmitted to any other party without the prior express written consent of New Constructs. All trademarks, service marks and logos used in this report are trademarks or service marks or registered trademarks or service marks of New Constructs.
Copyright New Constructs, LLC 2003 through the present date. All rights reserved.
Page 5
www.newconstructs.com Pyxus International Inc. (PYX)

In response to Bad Karma Kyle and Interwest Transfer Agent not being part of the Verified Shares Program please be advised:

Direct Transfer LLC acquired Interwest Transfer in December of 2017...

So Interwest IS IN FACT part of the Transfer Agent Verified Shares Program. I spoke with Interwest about this. I was informed that they are now operating under the Direct Transfer LLC operations umbrella and are indeed a part of the Transfer Agent Verified Shares Program. They have been operating under Direct Transfer LLC and its policies since the acquisition..


You can look them up Direct Transfer LLC..

www.otcmarkets.com

Under Transfer Agents

Space Lady...

I watched the video as well. When I spoke with Keely Moxley at NASDAQ she mentioned to me that very rarely does a company get uplisted in 4-6 weeks.....

She mentioned that it is not uncommon for the process to take close to a year.....

I too came to the same conclusion, about Mona and Mona III. If you look at the moves they have made here, it is obvious what is happening.

It's rather apparent that NASDAQ needed Mona out, and not only him, but more importantly, his son was removed from any kind of corporate governing power. That coupled with the new Chief Accounting Officer will give NASDAQ the assurances of integrity with regard to the fiduciary responsibility within the company.

Every thing else is in place as far as I can see

We could be looking at any day now on this.....

I listened to Stuart Tomc's interview on the radio show last week. He is a brilliant speaker and simply knows the science of our products inside and out.

When the farm bill was signed, I don't think anyone expected an immediate statement from the FDA in essence proclaiming "Not so fast" on the retailing and marketing of CBD.

I can see why a lot of investors became frustrated with that statement and such began the sprouting of seeds of doubt about CVSI. I always have maintained to focus on the fundamentals of a company. Sophisticated investors do that. Wall street looks at the top line and the bottom line on each quarter. Throw in the company debt picture and the sentiment of the market/and or the company relative to the sector, and then the stock price behaves accordingly.

I've noticed commentary about the IR company, and its lack of PR messages about CVSI. As an investor, I want to hear news that will directly impact the stock price. (Being good or bad). I'm not interested in "good will" news. Knowing where they are speaking and conducting seminars is important to know. It tells us what type of marketing of the company they are involved in. Stocks do move on news....that is either positive or negative. Especially earnings reports or major finance deals.

I was pleasantly surprised by the letters to Scott Gottlieb from Senators Ron Wyden and Jeff Merkley regarding the clarification on CBD for interstate commerce. See article below:

HTTPS://WWW.NUTRAINGREDIENTS-USA.COM/ARTICLE/2019/01/21/SENATORS-SEEK-CLARITY-FROM-FDA-ON-CBD-QUESTION
(Article is dated today)

It appears what the FDA wants to do is get a handle on what exactly is permissible to market and sell. So when Stuart remarked in his interview that this was the moment they were preparing for since 2014, it all made sense to me.

When you read the article, and the request for clarification from Wyden and Merkley, they..... as well as prospective hemp farmers want to know about CBD. In particular how it can get into the mainstream economy. Hemp in its other forms will be important...but CBD is where the focus is.

He (Tomc) says very clearly in his interview that they have met all the requirements to receive approval. The seed to shelf process has more than enough transparency to warrant immediate approval.

It's clear that the FDA cannot just sit on this. They are getting pressure right out of the gate with this from these two Senators. They are going to have to provide some clarification or pathway sooner rather than later.

We are on the cusp of a major catalyst here folks. It would seem to me that the FDA would deal FIRST with those companies who are immediately compliant with product safety and then get to those who are producing CBD without any scientific proof of whats in or not in their product(s) The FDA is going to have to show "good faith" in their pathway statement and willingness to help companies become compliant. But....they have to start with some company....they have to present a model or example of what they are referring to as "compliant"

I believe this step is a critical one. I am not so sure we can get a major retail distribution deal without some form of FDA approval. However my belief is, they will get this done...when that does happen, I can see a major buy out offer for the company. I can see a beverage company or a major institutional food company getting its 2400 plus stores, and all the other retailers who are ready right now to start selling our CBD products.

I like our position, both from a financial/earnings stand point and from a regulatory stand point.

We are in the eye of the perfect storm.

Carl;

The NASDAQ is not a government agency. The paperwork and listing process rests within the NASDAQ listing folks who are evaluating the application.

I don't believe the SEC has any involvement with NASDAQ's approval or disapproval.

What ever information the NASDAQ people needed from the SEC they have already received. (Although you never know)

Kyle, Space Lady and Myself have spoken directly with Keeley Moxley of the NASDAQ and she did not tell me that there was any delay because of a government shut down...

I don't recall her telling Space Lady or Kyle anything along those lines either..

I could be wrong, but I do know NASDAQ is not government anything.

Kyle...

I spoke with her as well.. the past history of the company has been cleared up...

If the history of Mona et,al would have been an issue NASDAQ would have said something and the uplist would have been immediately denied.


They have paid their fines...and have settled the one accounting issue with the SEC. File is closed....

They have a new CFO and now a new CAO....new players on the board and a host of other things they have done correctly...All of the suspicious characters of past years are gone and out of the picture..

CVSI would not have filed their application had they not thought this out way in advance....

What NASDAQ wants to see is the state of affairs of the company NOW....


“is it possible after almost 6 months might NASDAQ still consider approving this hypothetical uplist?”

She was quiet for a few moments and I could almost hear the wheels in her head turning before she stated “well, based upon what you’ve told me we would look very hard at such an application likely asking the company numerous questions and for numerous documents as well as asking what their plans to avoid similar behavior in the future would be”.

You can be assured the company will provide whatever NASDAQ is looking for and as far as other documents, the SEC has everything NASDAQ would need to confirm other details..

I don't think the credibility of CVSI is now in question....although you continue to espouse that it is

Space Lady...

Interestingly, I spoke with her as well this morning. I didn't mention the name of the company I was referring to, but Ms. Moxley was very professional and did mention to me a couple of things;

One being the 4-6 week uplist time frame that many people got caught up on is extremely quick and happens very rarely...

She has seen uplist applications take up to a year or slightly longer...and that is not uncommon....

As you stated and as she told me....NASDAQ would not be responsible to publicly inform the shareholders of a denial. That remains the responsibility of CVSI and by law they would have to disclose such information of a rejection to the shareholders. CVSI would have 72 hours to inform us.

She was not specific with me as well, but when I asked her about OTC CBD companies in general seeking uplisting with NASDAQ she did remark that these were being looked at on a case by case basis, but could not confirm any other details..

With all due respect to BKK and Vandy.....the past financial dealings of Mona and the accounting issues and other information that both of these guys feel is grounds for rejection are not in play here. If in fact that would have been an issue we would have gotten a rejection notification a long time ago...

I believe we are in the process as Joe Dowling stated....Ms. Moxley said the process can take a while.....and that it is not uncommon for that to be the case....

On another note.....for CVSI to be attending this ICR conference in SF in front of big investor groups, hedge funds, and other CFA's and CFP's tells me that if they thought they weren't going to be getting this approval, they wouldn't be attending....

It's pretty clear if there is one company out there that is diligently working with maintaining high standards, quality controls and other certifiable business operating protocols it would certainly be CVSI....

Thanks for the update Bad Karma Kyle on instadose.....here is some really good information on them..

Folks....this is exactly what I spoke about yesterday in my post...read this article.....and you will see what I mean..

As I have said...know what you own

Instadose: When the scam is so brazen that it becomes unintentional ...
https://equity.guru/2018/12/.../instadose-scam-brazen-becomes-unintentional-comedy/

Great Info ANIA77...

One thing I always have told my friends who have invested in CVSI and other Cannabis stocks, and to my Investor Hub friends is to be ready for a wild ride.

The CBD market is going to become a battleground with different never heard from before players. This company is no different. Suddenly they appear with a ridiculous price point for CBD..

Interesting that they would attempt to even try to penetrate the US Market based on the position the FDA has already taken regarding regulating CBD.

I agree with ANIA77, their CBD product appears to be from the marijuana plant and not hemp...

All of us have to understand that with the signing of this new law, CBD and hemp derivatives are going to be flooding the market. The battle for market share and courting the big players (GNC, Vitamin Shoppe, Walgreens, CVS Wal Mart etc) is going to heat up..

If you look at the articles that are written about this sector, you see general articles about the growth of the industry, and then you see this type of article whose express purpose is to get the attention of both the investment community, and the CEO's of a Charlottes Web and CVSI...this is very typical of companies trying to get some sort of leverage or create a perception of fear or uncertainty.


I urge all of you to be aware of these things.....since the bill was signed a little more than a week ago, you are seeing a lot of articles written about the sector and about various companies...some positive and some negative.

The FDA statement if you stop and think about is really a positive thing. CVSI is the only company that has invested any money in the science and toxicology of their product line. One of the claims the FDA has investigated and has commented on is what is actually "IN" their product lines...(I call your attention to the warning letters that were sent by the FDA in 2017 to three or four companies. These letters cited false health and scientific claims as well as the labeled mg of CBD did not match up to testing done by the FDA)


CVSI never received any such letters, and if you read the press release dated Sept 10 on the self affirmed GRAS you will see the comment in their report that testing was conducted with respect to "stringent FDA standards". Furthermore, the traceability of each batch from seed to shelf is worth a fortune. Who else can make that claim?

I love our position. Stuart Tomc is highly respected and known in the industry. This big companies looking at national roll out deals with CBD already know what they are looking for. These companies are going to be very selective to WHO is going to be their partner.

If I am the CEO of one of these companies, I am buying from a respected wholesaler of this product. There is no one that I know of who has taken the quality control steps that we have taken. We have no FDA violations...in fact we are in the pole position from the regulatory standpoint...we have far more scientific evidence about our product and a great panel of people (Josh Hendrix) who will be able to influence and explain the science of our product to the FDA..

Know what you own here.....this is the time where patience is critical and if you have short term trader money in CVSI....you may not enjoy the ride.....

Finally, we need to desperately get off the OTC....read the difference between the NASDAQ exchange and the OTC exchange and you will understand and see the manipulation that has gone on..there are as many as 300 market makers on the NASDAQ...the large spreads between the bid and asks show you manipulation that happens on the OTC ....in addition to the fact that there are far fewer OTC market makers than NASDAQ market makers..

I am hopeful we are going to get some quick answers to the CBD question and FDA statement from CVSI..

I would like to think that when they independently tested their product, that the protocols for testing were in line with the FDA's.

With the passing of the farm bill Thursday, I am hopeful that a copy of our toxicology report for our GRAS certification was FED Ex'd to the FDA's desk Friday morning.

I am also hopeful that there will be swift movement on this by the FDA.....

We are in need of an uplist for NASDAQ, and Dowling is headed to a huge Institutional Investors expo in a few weeks...These big boy investors will need to have the CBD question answered prior to any investment...(based on a NASDAQ listing).

The FDA statement appears friendly in context....It appears that they want to create a pathway to get this product out there (in so far as food and drink infusions)....and we need big retailers to know that we are and have been in clear on the selling and marketing of CBD for years now...

I am hopeful we will get a message from CVSI on this....and better yet a "no comment" position from the FDA on our GRAS certification....meaning that they are not endorsing our product, but have no reason to deem it unsafe....

Deetew..

Always liked your posts and highly respect your opinion...both here and on the Yahoo board...

I read the statement from the FDA yesterday, and from what I read, CVSI is not in any violation of any Food and Drug Cosmetic Act or any FDA violation regarding its selling and marketing of its CBD products.

When the FDA sent out warning letters a few years back....CVSI did not get a warning letter from them as they were NOT involved in the selling of their CBD products as a "dietary supplement" or claiming medical benefits that are not medically proven.

The sector today was down as a whole....which I believe is directly related to the overall performance of the market. I don't think that this statement has caused the drop in the sector...

What I do know, is that there are three ways to be GRAS certified...two of which are directly from the FDA in one of two scenarios

1.) Being part of an IND drug cocktail that is being studied in a clinical environment. Epidiolex recieved FDA GRAS certification thus recieved the approval in June....stock is in the tank by the way.

2.) Formal filing for such through the FDA which just like the drug approval process would take probably 2-3 years or more to get their blessing.

3.) Self affirmed GRAS (which is the case with CVSI) in which you submit your findings to the FDA for "comment".
I don't know for a fact but I am hoping that the self affirmed GRAS toxicology report that CVSI paid for has been filed or submitted to the FDA for review. I do know and have read that if the FDA does not challenge the findings then it is presumed that your are considered "safe for consumption," but with the same disclaimers that you read on vitamin labels

In any event....I think that CVSI is way ahead of the curve here because of the study from an independent lab that hopefully has submitted studies to the FDA in the past and is recognized as a credible laboratory science organization.

What we don't know about the FDA statement is what is involved or length of time required for the process of "pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make pathways for the lawful marketing of these products more efficient"

This is quite confusing, and may be the reason also why the sector was down as well.

In any event, the FDA is going to have to move fast with this....because the section of farm bill that legalized hemp and all its derivatives is legal and removed from the CSA...but now is in the control of the FDA and the FDA doesn't really have a clear definition of who can sell CBD from Hemp.

Any thoughts on this?

I am just hoping that the self affirmed GRAS study was not in vain or has no value to the FDA.

I am also hoping that the FDA didn't muddy the water for big retailers who are or were ready to put in in huge orders..

Kyle forgot to add this part of the article.....which does not affect CVSI and their selling and marketing of CBD as they are NOT in any violation of any misrepresentation or claims outlined in the article...


Editor's note: Looking for an in-depth look at the current landscape of CBD and strategies to mature it as an industry? Join us for the CBD and Hemp Extracts: How Do We Move Forward? workshop on Wednesday, Nov. 7, at SupplySide West 2018. This workshop is underwritten by CFH, CV Sciences, Elixinol, KGK Science, Neptune Wellness Solutions and RAD Extraction & Processing.[color=red][/color]

Carl...

You are spot on with this....

The farm bill I feel was baked in... But the NASDAQ up list does several things for us....first and foremost it gets us off the OTC where the stock is manipulated and unless we have a cataclysmic event the MM's manipulate the price...

I think 25% increase is realistic...I see the stock trading at $6.00 to $6.50 range with NASDAQ listing....but we will see institutionalization investing at the point.

My point is this.....I am in this for the big retail box stores becoming retail customers. We all know money follows money.

Once a major retailer falls and signs on with CVSI....and with Stuart Tomc as the front man with these major Vitamin retailers (they all know him from Nordic Naturals) this will certainly happen....CBD can be added to a lot of things, and we have the toxicology data (GRAS) to attract these players...

If you do the math on all of these big retailers....(Vitamin Shoppe, GNC, Walgreens, Wal Mart, Target, Costco, you name it) The number of stores they have in the USA and the sales that will result from these relationships is unreal......

And as you said...it all boils down to earnings....just that simple my friend.....we got to get off the OTC...to me....that is huge for us.....

Keep in mind...the bill is not law yet.....once it becomes law, you are going to see serious deals being made with respect to CBD........these big retailers are ready....I would bet that there are purchase orders ready to go just waiting for the shipment date...

Back to basics...remember the savvy investor moves in when a stock is on sale....this is where we get paid to wait.,.....

Space Lady..


You should report them to the FDA based on this statement to you:

Yes, all terpene and flavor ingredients we use are consider GRAS by the FDA.

Total misrepresentation about GRAS


This the stuff that the FDA is looking for.....

Vandy...

If you read the CVSI report (10Q or 10K)...you will read the information about the funding of the CVSI 007 drug...they make it clear that the funding will come from sources within the company, and they do say very clearly that in the event that they run out of money, or can no longer get money for the ongoing research or development, they in fact will have to terminate the development of the drug.

With regard to your questions regarding stores they are trying to get into:

First, any negotiations with any major big box retailer would always be confidential and private. That is proprietary information and without question who ever they may be talking to would require confidential discussions. There is no way a corporation would discuss any such sensitive information in any press release or news item.

At this point NASDAQ is the next key move.....OTC stocks do not trade like NYSE or NASDAQ stocks....more importantly, institutional investors, do not go near OTC stocks for many reasons, one of which is the lack of transparency with the way shares are often priced and traded....I have followed this stock extensively on Level II and have seen manipulation occur a number of times.

You do not have intimate knowledge of their infrastructure, nor do I, so those questions will be answered in the very near term as their sales grow and from what market areas the new sales will come from.

The other questions you are asking with regard to "meeting demand, production capacity, etc." are questions that as a shareholder they have already given forethought to.

The sector is down today all around. CW, KSHB, Canopy, Aphria, Cron, all are down today.

My personal opinion is that until there is a major distribution deal announced with a big box retailer, or the NASDAQ listing is announced, this is where the stock is going to trade...somewhere in the $4.75 to $5.50 range.

The FB was indeed built into the price with not only, CVSI but other related companies as well.

Once we see the big players get in the game....and there is enough commentary on the part of many big box retailers that they are poised to take action...then you will see a huge spike in the price..

Just Google the number of locations Vitamin Shoppe has, GNC has, Wal Mart has, Walgreens etc.....and you will see...

As many analysts have stated...they expect very quick movement from these companies coming into the retail space once we have the law in place....


Company is situated perfectly......the Farm Bill has now created a brand new market.....

Check the news feeds....Senate is voting today at 3:45

House will get it tomorrow

@amyklobuchar

Senate to vote on Farm Bill today at 3:45

They don't write the content of these articles you are speaking of.

If you read the bottom portion of most every article written about them they clearly define who they are and the business they are in.

They are not touting their developmental smokeless tobacco gum. It doesn't exist right now. Still in development.....

Post some of the articles you are speaking about.......I am curious to see


To do that would definitely get themselves in legal trouble.....

Agree...

The actual science is what I am not an expert on....and as I had stated in my past posts....not a fan of the gum project......way too much hassle with FDA and the clinical trials.....

Good point..

That may be what they are doing. You are correct on that part..

They patented their product in 1885 as a French wine Coca nerve tonic, In 1886 when Atlanta Fulton County passed prohibition legislation, Pemberton (developer and founder) developed a nonalcoholic versos of French Wine Coca now known as Coca Cola...

Formulas can be algorithms which are in fact are definitely patentable... The coke formula is such...

They are proprietary and intellectual property....belonging to the companies...

So to be clear....the name Coca Cola is trademarked.....the formulas and recipes fall under the patent as they are considered algorithms

Mr. Vandy...

You are getting the CVSI 007 smokeless tobacco gum development confused with Nicorette and "smoking cessation" gum.

They are submitting the fast track to the FDA upon the IND filing under "unmet need" which is one of several options that would qualify for the HB 505 fast track process.

Formulas can be and are patented....Ask Coca Cola.....ask Pepsi. ask Miller Lite......these are proprietary formulas. Specific ingredients for their products...


Space Lady has it right.....those of us who understand the patent process understand the road that CVSI is traveling. Patent rejections are ongoing and frequent in the process of obtaining one....

The company never represented to the shareholders any evidence of a drug that was in play financially or was any form of revenue. The words "candidate" and "pre clinical" were used often. Any shareholder who would invest in any company based on a patent process in the developmental stages needs to take a look at their investing strategy and rethink it.

The company is not guilty of anything relating to information surrounding CVSI 007....

As I mentioned.....this is part of the gamesmanship associated with certain OTC stocks and the various short plays that have been going on recently with many stocks in this sector...(APHA....CRON, XXII, to name a few).....


Dowling explained the science of CVSI 007 a while back at one of the conference calls.....this science deals with effects of smokeless tobacco and the what the gums efficacy (based on their science) will have on those that chew tobacco.

Major League Baseball is real big on this right now, as they know they have a number of players who chew tobacco regularly and have a hard time kicking the habit...

You are implying and comparing through your recent posts that the gum they are developing is smoke cessation oriented.

While I recognize you are entitled to your opinion, your argument on CVSI 007 and its properties does not deal with factual data..

ANIA77...

Is all “naked” short selling abusive or illegal?

When considering “naked” short selling, it is important to know which activity is the focus of discussion.

Selling stock short without having located stock for delivery at settlement. This activity would violate Regulation SHO, except for short sales by market makers engaged in bona fide market making. Market makers engaged in bona fide market making do not have to locate stock before selling short, because they need to be able to provide liquidity. However, market makers are not excepted from Regulation SHO’s close-out and pre-borrow requirements.

Selling stock short and failing to deliver shares at the time of settlement. Rule 204 requires firms that clear and settle trades to deliver securities to a registered clearing agency for clearance and settlement on a long or short sale in any equity security by the settlement date or to take action to close out failures to deliver by borrowing or purchasing securities of like kind and quantity by no later than the beginning of regular trading hours on T+4 for short sale fails or T+6 for long sale fails and fails attributable to bona fide market making. If a firm that clears and settles trades has a failure to deliver that is not closed out by the beginning of regular trading hours on T+4 or T+6, as applicable, the firm has violated Rule 204 and the firm, and any broker-dealer from which it receives trades for clearance and settlement, is subject to the pre-borrow requirement for that security.

Selling stock short without having located stock for delivery at settlement and failing to deliver shares at the time of settlement. This activity may violate Regulation SHO’s locate and close-out requirements, as explained above. In addition, in fall 2008 the Commission adopted Rule 10b-21, referred to as the “naked” short selling antifraud rule. Those who deceive about their intention or ability to deliver securities in time for settlement are committing fraud, in violation of Rule 10b-21, when they fail to deliver securities by the settlement date.

Selling stock short and failing to deliver shares at the time of settlement with the purpose of driving down the security’s price. This manipulative activity, in general, would violate various securities laws, including Rule 10b-5 under the Exchange Act.

Vandalayind

Your observation about Market Makers is exactly correct. While I don't agree with much of your other opinions you are spot on with this.

What makes OTC investing extremely risky, is this very subject you have mentioned. Market Makers.

The reason OTC companies( that have any kind of future ) need to uplist to major exchanges like Nasdaq and Nyse is the manipulation and games that they play.

Until a company gets on one of these exchanges, their stock does not trade in the "true" sense of a Nasdaq or NYSE stock.

If you are buying a large block of stock on the OTC you are a victim of what the market maker has on inventory to sell you. The same goes with selling. Even with a market order for buying stock, you are at the mercy of them and when they are going to fill you. In a fast moving volume scenario, there is not so much manipulation. Assuming there is comparable selling and buying going on. They love that scenario.

They may be holding thousands of shares at a certain price, but will often wait for the price to drop and pick up inventory at let's say $4.00 to sell you the buyer at $4.50.

This is why OTC is risky and has such an unpredictable pattern to it.

On the Nasdaq, or Nyse, if you are buying 1000 shares at a limit of $5.00 per share, there has to be a seller going through a clearing house that is registered to the exchange that is selling for that price.

There is inventory on these exchanges...but not to the degree or with the dominance or control of OTC stocks.

With exception of news events, or financial reporting either negative or positive, they control the price of the stock to a certain degree.

There are on average 14 market makers on the Nasdaq. These are typically investment companies that buy and sell the securities through the electronic network which is how Nasdaq operates.


So, on the Nasdaq you are buying from these houses. They buy and sell based on the price of the stock as it trades relative to the stock and its performance in the true trading sense. On the OTC you are dealing with a different element. The price in which they decide is right for them. As you mentioned they are in to Naked Shorting.

Nasdaq market makers are openly competitive and facilitate competitive prices. That is not what happens on the OTC... In general, OTC Markets are typically less transparent than exchanges and are also subject to fewer regulations. OTC market makers decide what the price is going to be.


My point to all.....uplisting to a major exchange is critical to any OTC stock. Many don't make it for a number of reasons....primarily because their companies don't meet the criteria.

Big investment firms do not invest in OTC for this reason and the risks associated with the games they play.

This is another reason for the upgrade being essential....to use a baseball analogy if your are an OTC stock your are "A" ball in the minor leagues, where as the NYSE or NASDAQ is the major leagues.

Naked Shorting is illegal, but it goes on especially in the OTC Markets because of the lack of regulations and transparency.

The biggest catalyst in addition to the Farm Bill by far is the NASDAQ listing.....that will take us away from the OTC Market maker grips and give CVSI the investor credibility that it will need to achieve a very attractive stock price.

If OTC market makers want to drive down the price of a stock...they employ this technique ...it still happens today despite the fact that it is illegal.

If I had to guess...today the stock dropped .20 cents or so in the last hour of trading....my guess is Naked Shorting on the part of them

Despite all the good news that we have on the horizon, we will need the NASDAQ listing and the capital markets associated with it to really hit it big..

While the Farm Bill is big.....the uplist to NASDAQ is even bigger.....

If that happens.......it will be a whole new ball game for CVSI....