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Dowling and CVSI are approaching this issue conservatively but rest assured have contingency plans for anything that arises.
CW1a and CW2a are listed in the allowed Kentucky hemp seeds as a Variety of Concern (VOC) which means at least one THC test result above 3000 ppm (0.3000%).
"Current scientific research suggests that phytocannabinoids have
proportional relationships. Therefore, as growers work to increase the hemp plant’s CBD or other
phytocannabinoid production, there is concern about the potential increase of THC levels."
https://www.kyagr.com/marketing/documents/HEMP_LH_Summary_of_Varieties_List_2019.pdf
CEO Joeseph Dowling today.
“To really compete, you have to have a brand that is respected and trusted, and then you have to have scale,” he added. “If you don’t have those two things, you’re not going to be able to compete, and we have both. We are the only company with true fundamentals. We’re profitable. We have cash flow. We’re undervalued compared with some of the THC pot stocks. We’re more profitable than Tilray, and they would say their growth potential is off the charts. We think ours is, too.”
https://www.cbdtoday.com/the-building-blocks-of-cbd-cv-sciences-plans-to-conquer-the-chain-store-market/
BOD Joseph Maroon penned this story last week. He believes his health issues may have been caused by severe stress due to a medical malpractice suit.
(he was found NOT guilty). He had two stents placed. Let it serve as a example, Step away from watching the ticker to save your ticker.
https://opmed.doximity.com/articles/medical-malpractice-stress-syndrome-and-catastrophic-vascular-complications
Joe seemed to tip his hand yesterday showing they are planing for a FDA NDI submission. Only a handful of companies would remain if this is the FDA guidance.
Michael Lavery (Piper)
Thank you. Just following up on that FDA note, Gottlieb obviously not still in charge, but certainly well informed and connected and one of the things he had suggested or sort of seemed to be pushing forward was petitions for new dietary ingredients as a pathway. Is that something you've been preparing for, how do you think you’re position there, is that something you think is likely to be a path you would pursue?
Joseph Dowling
It is a path that we would pursue. I think that Dr. Gottlieb was strongly suggesting that that was a regulatory sort of not requirement, but perhaps and that really aligns well with the existing regulatory framework for our industry. So we've been positioning for this for a while.
As you know a couple of years ago we made the decision to invest in all the toxicology work to achieve. And the only company to achieve self a firm [ph] grasp. Obviously that's one component of being able to get an NDIN process going. There are other steps and we are pursuing all of those steps as well. So yes, we are going down that path Mike, and we think that's a good direction for FDA to go"
Abernathy was referencing the Epidiolex study(very high doses) when she spoke of
possible liver damage. I doubt if she knows anything about the bogus Arkansas study. Everyone relax CVSI will be a winner with FDA regulations.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Just verified in the pluscbd store locator that we did also expand to
the five additional states(Texas,virginia,georgia,montana utah)
Typed in zip codes and Kroger or Smiths are shown.
https://pluscbdoil.com/store-locator/
This may give some indication into the FDA future cbd policy. May be worth watching this morning.
Dr. Amy Abernethy
@DrAbernethyFDA
·
Jul 23
I’ll be testifying Thursday before the Senate Committee on Agriculture, Nutrition & Forestry on the important topic of hemp/CBD and discuss the FDA’s commitment to expediting our work to evaluate the regulatory policies related to hemp & CBD products: (link: https://go.usa.gov/xyV6j) go.usa.gov/xyV6j
More speculation based on pluscbd twitter account. Pluscbd just yesterday added Suja as a company they are following.If it turns out the cbd they may use for their product is from CVSI this would be huge because Coca Cola is a backer of Suja. Suja is also a San Diego company.
"According to a spokesperson for the brand, the product is in an exploratory phase and not currently in production. Samples of Relax shared at Expo West may differ from the potential final release and contracts with suppliers have yet to be finalized, according to the spokesperson.
If authorized, however, the launch would represent the first major U.S. beverage company to enter the CBD-infused drink category."
https://www.bevnet.com/news/2019/expo-west-2019-suja-exploring-launch-of-hemp-extract-shot
This seems to be a continuation of their original patent 9340475.
i see it had a non final rejection in March 2018 then a Final Rejection
in Nov. 2018 so besides me, andrew left of citron missed this one.
Good job Brevin on Y for the dd.
Been watching the "followings" on the PlusCBD twitter account for a couple
of months. It seems to give hints in advance of where cvsi is going.
They just added Target to companies their following. We'll see
https://twitter.com/YouPlusCBD/following
There are now over 1200 stores in California alone with our products. Just wait till next month when it is actually legal in other forms other than lotions.
https://pluscbdoil.com/store-locator/
Its a good sign that the FDA is putting this out there https://www.fda.gov/media/128479/download
Wolfman the reason and remedy for trademarks.
On December 20, 2018, the CSA was amended to remove hemp from the definition of marijuana and specifically exclude “tetrahydrocannabinols in hemp (as defined under section 297A of the Agricultural Marketing Act of 1946)” from Schedule I, 21 U.S.C. §812(c )(17). The goods identified did not potentially comply with applicable federal laws until that date. Because the identified goods consist of or include items or activities that are or were prohibited under the Controlled Substances Act, the applicant did not have a valid basis for filing the application. Nevertheless, to the extent the applicant’s goods are derived from cannabis plants that meet the current statutory definition of hemp, the goods may presently be lawful.
Due to the changed circumstances and the potential lawfulness of certain products and activities that meet the definition of the Agricultural Marketing Act of 1946, as amended (AMA), applicant may request to amend the filing date of the current application to be December 20, 2018. See Examination Guide 1-19 Examination of Marks for Cannabis and Cannabis-Related Goods and Services after Enactment of the 2018 Farm Bill https://www.uspto.gov/sites/default/files/documents/Exam%20Guide%201-19.pdf. Applicant must specifically state for the record that such a change to the filing date is being authorized and must establish a valid filing basis under 37 C.F.R. §2.34 by satisfying the relevant requirements. See 37 C.F.R. §§2.34 et seq., TMEP §§806 et seq. In the event of such an amendment, the undersigned examining attorney will conduct a new search of the USPTO records for conflicting marks based on the later application filing date. TMEP §§206.01, 1102.03 For instructions on how to satisfy basis requirements online using the Trademark Electronic Application System (TEAS) form, please go to the Basis webpage.
In lieu of amending the filing date, may elect to abandon the current application and file a new application with a new fee that will have an application filing date that is later than the enactment of the December 20, 2018 amendments to the AMA. Alternatively, applicant may respond to the stated refusal by submitting evidence and arguments against the refusal.
Please note the following advisory.
Prior-Filed Application
The filing date of pending U.S. Application Serial No. 87559569 precedes applicant’s filing date. See attached referenced application. If the mark in the referenced application registers, applicant’s mark may be refused registration under Trademark Act Section 2(d) because of a likelihood of confusion between the two marks. See 15 U.S.C. §1052(d); 37 C.F.R. §2.83; TMEP §§1208 et seq. Therefore, upon receipt of applicant’s response to this Office action, action on this application may be suspended pending final disposition of the earlier-filed referenced application.
In response to this Office action, applicant may present arguments in support of registration by addressing the issue of the potential conflict between applicant’s mark and the mark in the referenced application. Applicant’s election not to submit arguments at this time in no way limits applicant’s right to address this issue later if a refusal under Section 2(d) issues.
Although applicant’s mark has been refused registration, applicant may respond to the refusals by submitting evidence and arguments in support of registration. However, if applicant responds to the refusals, applicant must also respond to the requirements set forth below.
Request for Information
To permit proper examination of the application, applicant must submit additional information about the goods. See 37 C.F.R. §§2.61(b), 2.69; In re Stellar Int’l, Inc., 159 USPQ 48, 50-52 (TTAB 1968); TMEP §§814, 907. The requested information should include fact sheets, brochures, advertisements, and/or similar materials relating to the goods. If such materials are not available, applicant must provide a detailed factual description of the goods. Any information submitted in response to this requirement must clearly and accurately indicate the nature of the goods identified in the application.
A recent change to federal law in the Agricultural Improvement Act of 2018 (2018 Farm Bill) has changed the definition of marijuana under the CSA to exclude industrial hemp which has a delta-9 tetrahydrocannabinol content of no more than 0.3 percent on a dry weight basis. If the “hemp” has more than 0.3 percent on a dry weight basis, then it is still marijuana under the CSA and goods comprised of ingredients from any part of the plant other than the mature stalks and sterilized seeds of the Cannabis sativa L plant would also be prohibited marijuana.
In addition, applicant must submit a written statement indicating whether the goods identified in the application comply with the Controlled Substances Act (CSA), 21 U.S.C. §§801-971. See 37 C.F.R. §2.69; TMEP §907. The CSA prohibits, among other things, manufacturing, distributing, dispensing, or possessing certain controlled substances, including marijuana and marijuana-based preparations. 21 U.S.C. §§812, 841(a)(1), 844(a); see also 21 U.S.C. §802(16) (defining “[marijuana]”).
Finally, applicant must provide written responses to the following questions:
Do or will applicant’s identified goods include any oils, extracts, ingredients or derivatives from the plant Cannabis sativa L (also known as cannabis, marijuana or hemp)?
If the answer to Question 1 is “yes,” does the hemp used or to be used in applicant’s goods contain more than 0.3 percent delta-9 tetrahydrocannabinol (THC) on a dry weight basis?
If applicant has any documentation relative to the THC content of the oils, extracts or derivatives used or to be used in the goods, please submit them with the response.
If applicant’s goods do or will contain oils, extracts, ingredients or derivatives from the plant Cannabis sativa L which has more than 0.3 percent delta-9 tetrahydrocannabinol on a dry weight basis, identify the part or parts of the plant used in obtaining the oils, extracts, ingredients or derivatives.
Do or will the goods include cannabidiol (CBD)?
If so, will there be more than a trace amount of CBD in the goods, e.g., more than 50 parts per million (PPM)?
Do or will applicant’s identified goods include CBD which is derived from, oils, extracts or ingredients from plants other than Cannabis sativa L?
Please provide a listing of the ingredients used in each of the items shown as specimens in the application. If such a listing appears on the rear portion of the labeling for each product, applicant may satisfy this request by submitting photographs of the labeling.
Whats interesting in regards to the snack bar industry connections and CV Sciences is that the Nellson manufacturer of snack bars brought in two of CV Sciences advisory board members Dr. Ziegenfuss and DR. Lopez.These are the same doctors who just completed the first clinical cbd trial that CVSI just announced last week.
https://www.nellsonllc.com/news/nellson-llc-affiliates-with-industry-leading-scientific-experts
Read this new interview with Duffy Mackay to get a sense of the future direction of the cbd market. Excellent Begins on page 16.
https://beyondthc.com/wp-content/uploads/2019/05/Beyond-CBD-bulldog-edition.pdf
The annual shareholders meeting video presentation has been posted.
Excellent presentation by Duffy Mackay https://ir.cvsciences.com/presentations/detail/2697/cv-sciences-inc-2019-shareholders-meeting---june-11-2019
CEO Dowling during his annual meeting presentation mentioned we would be hearing more about influencers in regard to marketing. Noticed this simple instagram photo was shot by Spring Studios. Seems odd to have them do such a simple shot so I suspect we will be seeing more from this influencer.
https://www.instagram.com/p/ByqOv3Nhlso/
Also the midday keynote speaker will be Stuart Tomc.
This could be a important event with Walmart and Whole Foods in attendance.
https://www.foundermade.com/east-2019-schedule
Appeal hearing on the patent scheduled for August 28th 1 PM
Just for the record as it stands now CANTINE
is their trademark for smokeless tobacco cessation preparations.
and NEW HARVEST is there trademark for cosmetics containing CBD.
I spoke to Joe yesterday specifically about the Lazy Acres CBD on label policy. He said California AB 228 will change all that.
My biggest take away is that CV-007 is going to happen and
it received a big boost with the hiring last week of the project manager for drug development. I believe Joe said that she was from Scripps Research
which would mean another top quality hire.(Joe mentioned her name if anyone remembers please post)
When asked if this new hire meant that cv-007 would proceed with or without
a patent Joe quickly asserted that they will have the patent.This was a powerful statement in light of whats happened.
Is that you Benjo? I'll be there questions in hand.
With 1200 retail stores in California already carrying our products
its easy to see how important the AB228 legislation will be. California
is presently about 35% of the national total. I suspect this percent
will rise considerably with the passage of AB228 hopefully next month.
CVS and Sprouts represent a large percentage of CA. retail and hopefully
next month will offer more than topicals. Going to get interesting.
Possibly as soon as July.
"California-based hemp companies would be able to move forward in huge strides with this regulation,”
https://hempindustrydaily.com/california-may-soon-join-other-states-in-legalizing-cbd-foods-bypassing-fda/
It would seem the Vibrant Health partnership would be newsworthy?
https://shop.vibranthealth.com/collections/green-superfoods/products/green-vibrance-cbd?variant=27959650287639
Manitoba Harvest Broad Spectrum Hemp Extract Self-Affirmed GRAS Status was co-sponsored by Klersun and Robertet which makes me think this has been in the works for a long time.
So now the French company is claiming the same GRAS status.
https://www.happi.com/contents/view_breaking-news/2019-05-31/robertet-builds-cbd-portfolio/
In a new video Stuart seems to imply that our main competitor is using a isolate. This is the second video this week with the theme of "whats going on" About the 20 minute mark he begins his show and tell.
FDA May 31 agenda.
2-5 minute comment-presentations only allowed.
https://www.fda.gov/media/126123/download
CV Sciences 2019 National Sales Meeting was held May 13-14 with
80 attendees.This is usually when they introduce plans for new products
Looks like this is part of new property expansion in San Diego.
Just received my products and noticed a new return address.
CV Sciences
6370 Nancy Ridge DR. Ste. 111
San Diego, Ca.
Here is a commercial listing with info
http://listingsprod.blob.core.windows.net/ourlistings-usa/71721fe7-e6eb-4f47-aaf9-d6c1c5f0abd0/6d3444a1-8df7-4d4f-9857-e2fad6209553
New corporate presentation from this weeks seminars,
https://d1io3yog0oux5.cloudfront.net/_bae9b7dd407beaeb518b5711f100177e/cvsciences/db/354/2645/pdf/CV+Sciences+May+2019+Presentation.pdf
Part 2 with CVSI Duffy Mackay. Another informative quick read.
https://hempindustrydaily.com/distinct-products-distinct-plants-thats-the-only-way-part-2-of-a-qa-with-cv-sciences-exec-doug-mackay/
Todays audio presentation is still available.informative. Just push the play button.
http://wsw.com/webcast/canaccord34/cvsi/
CEO live audio presentation this morning in 10 minutes. Live 10 AM Eastern.
http://wsw.com/webcast/canaccord34/cvsi/
Proof of exploitation?
Fidelity 13f states their 186,484 share's have been loaned out.
LSV Asset management also has 186,484 shares of CVSI.
LSV Investment Philosophy:
"The fundamental premise on which our investment philosophy is based is that superior long-term results can be achieved by systematically exploiting the judgmental biases and behavioral weaknesses that influence the decisions of many investors. These include: the tendency to extrapolate the past too far into the future, to wrongly equate a good company with a good investment irrespective of price, to ignore statistical evidence and to develop a “mindset” about a company.
LSV uses a quantitative investment model to choose out-of-favor (undervalued) stocks in the marketplace at the time of purchase that have potential for near-term appreciation. LSV believes that these out-of-favor securities will produce superior future returns if their future growth exceeds the market’s low expectations".
BOD DR. Maroon and DR.Amy talk PlusCBD in this excellent article Looks like Pittsburg Steelers are getting PlusCBD.
https://www.outdoorjournal.com/gear/how-to/benefits-cbd-oil-athletes-outdoors/
14.51 M in revenues will keep our Northland Securities analyst happy.
The larger leaps begin Q2. This sounds more reasonable.
Q1 2019 (Mar 2019) 14.51M
Q2 2019 (Jun 2019) 18.52M
Q3 2019 (Sep 2019) 21.59M
There was some news this morning
https://ir.cvsciences.com/press-releases/detail/110/cv-sciences-inc-to-present-at-upcoming-investor
This presentation was from April. Maybe they'll post a new one for May?
https://d1io3yog0oux5.cloudfront.net/_6b727abef481c9eb11ac530143e59948/cvsciences/db/354/2645/pdf/Corporate+Overview+March+2019.pdf