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The proponents for cbd in food and beverage met with the heavy hitters of the FDA June 15th. Reifer is with SoRSE
I believe we are due a FDA update to congress end of June.
Official Name: Lowell Schiller, Principal Associate Commissioner for Policy
Event Date: 06/15/2020
Location: WEBEX
Subject: Listening Session for FDA Staff: Hemp and Cannabinoid Science Institute
FDA Participant/Group: KAREN MEISTER; PATRICK COURNOYER; STEVEN TAVE; CHARLOTTE CONWAY; AMY ABERNETHY; NAKISSA SADRIEH; DOUGLAS THROCKMORTON; TYNA DAO; SHERENE SEPEHRI; PATRICK CANNON; SHARON MAYL; ERIK METTLER; LINDA KATZ; DOMINIC CHIAPPERINO; PAUL HART; MICHELLE ADAMS; APRIL ALEXANDROW; RANDALL GNATT;
Non FDA Participant/Group: Karil Kochenderfer, Mary Wagner, Scott Riefler (Hemp and Cannabinoid Science Institute);
I posted this back in October but since this cbd study seems to have turned around the patent decision its taken on a higher relevancy. Around the 13 minute mark he talks about the efficiency and how it compares(just as good) to present treatments and then goes on to thank cv sciences who they're working with.
https://vimeo.com/371510595
I start out here.
https://portal.uspto.gov/pair/PublicPair
Check patent number circle.
Enter patent number 10653639 then
Search
Click on Image file wrapper.
Scroll down to November 15
Click on Affidavit.
Hopefully 16 page affidavit from Oliver George with study opens up
This was the study that turned the patent decision around. Its showed that combining cbd and nicotine produced unexpected results making it a novel idea. It was conducted on behalf of CV Sciences. You may have to copy and paste and it may also be locked.
https://portal.uspto.gov/pair/view/BrowsePdfServlet?objectId=K30GDBJ2RXEAPX3&lang=DINO
Now it appears funding has been made available for a follow up study
yesterday. She works with Olivier George who did the initial study.
The more science that backs up the patent makes it much more valuable.
"Congratulations to Dr. Marsida Kallupi, Assistant Professor in the Department of Psychiatry at UC San Diego, for being selected for funding by the Tobacco-Related Disease Research Program (TRDRP). The title of the award is "Effect of CBD on nicotine addiction: evidence from translational models of nicotine intake in rats". The award will further Dr. Kallupi's research where preliminary results showed that CBD completely prevented somatic signs of withdrawal and decreased hyperalgesia in both male and female rats, supporting the hypothesis that CBD may prevent the psychostimulant effects of nicotine and the development of addiction-like behaviors."
https://www.cmcr.ucsd.edu/index.php/news-2/homeblog/266-congratulations-to-dr-marisda-kallupi
Still trying to ascertain if the second round of clinical trials was completed or delayed due to covid. We will probably need results of a study before a pet product is forthcoming.
CBD TRIAL FOR ARTHIRTIC DOGS
Through the Hutson School of Agriculture’s veterinary technology
program, a study is being conducted for use of CBD oil for arthritic
dogs to determine anti-inflammatory properties. This experiment is
using CV Sciences CBD oil, given as directed on the bottle.
Evaluation is performed by a subjective owner survey, bloodwork
and gait analysis with a canine force plate from Tekscan.
The clinical research trials were conducted with 8 privately-owned
dogs for an 8-week duration. For the first 4 weeks of
round one, 4 of the 8 participants took CBD oil and 4
took placebo (Extra Virgin Olive Oil). After midtreatment evaluations, all 8 participants were switched
to CBD Oil. Another round of clinical trials will be
conducted in February 2020 with 12-15 canine
participants.
For what ever reason Red Giant has been reinstated as a Florida business name as of June 17 2020. The BOD seems to be the same. http://search.sunbiz.org/Inquiry/CorporationSearch/GetDocument?aggregateId=domp-p12000043266-46798b06-04a0-491f-84b0-af691a9de67a&transactionId=p12000043266-re-d6ce0678-7fac-4603-b43f-02c4777f2751&formatType=PDF
I was hoping Perrigo would partner with cvsi but they seem to put a 250m value on a company that I believe has similar revenues
"In addition to the the supply agreement, Perrigo will acquire an approximate 20% equity stake in Kazmira for $50 million with $15 million paid upon close of the transaction and the balance within 18 months"
www.prnewswire.com/news-releases/perrigo-partners-with-kazmira-llc-to-enter-cbd-market-through-a-two-phased-science-based-approach-301078655.html
Will FDA get serious now that a major brand has a cbd beverage launch?
https://www.foodbusinessnews.net/articles/16209-ocean-spray-launches-new-cbd-sparkling-water-brand
Last I heard the cvsi plants were grown by Dun Agro in the Netherlands.
It's then co2 extracted in Germany and then processed in SD.
It looks like the US growers will be Driftless Extracts in Wisconsin
and Butler Farms in Kentucky.
Not sure but a designation seems to be that they will consider approval. Only two designations have been approved out of 27 designations
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm?StartRow=1&EndRow=25
Joerg filed this May 8th.
https://www.otcmarkets.com/financialReportViewer?symbol=CVSI&id=246061
Also good to see they are up 30% on that news alone.Hopefully cvsi
lawsuit dismissal will follow.Their news came after the bell on Friday
and they gaped up big this morning. Just some food for thought if you're
shorting or trading cvsi
Today's Q1 webcast transcript is here.
https://seekingalpha.com/article/4344875-cv-sciences-inc-cvsi-ceo-joseph-dowling-on-q1-2020-results-earnings-call-transcript?part=single
VS Cronos & Lord Jones We seem undervalued. Cronos paid 300m for Lord Jones cbd that provided them with 2.2m 1st Q. revenues.
"Some $2.2. million of (Cronos) sales this quarter came from the U.S., a segment that includes Lord Jones, a CBD-product maker Cronos bought for $300 million last year".
I emailed the actual study to Dowling and Tomc May 1st.
And suggestd some new products could come out of this.
"he findings may provide practical medical use through forms of mouth wash, gel caps or inhalants"
https://www.preprints.org/manuscript/202004.0315/v1
Yesterdays court documents seem to indicate the cvsi lawyers are setting up to merge all the complaints and then I guess spring the news that the patent has been approved.
A Quote from yesterdays fillings.
"As demonstrated by the above allegations, the related cases all involve the same or similar
parties: CV Sciences and certain of its directors and officers. The related cases all involve the
same or similar events: statements by CV Sciences and/or its officers and directors regarding the
status of the CVSI-007 patent application. The related cases all involve common questions of law
and fact related to whether improper conduct occurred related to statements by CV Sciences
and/or its officers and directors regarding the status of the CVSI-007 patent application.
The related actions all involve the same patent application. For these reasons, notice is hereby
given of the related cases".
CVSI 007 PATENT #10653639 to be issued May 19, 2020.
With the Virtual 2020 Annual Meeting of Stockholders on May 21
we hopefully will receive some guidance (presentation) on the potential of the drug development business.
Australia low dose guidelines reference two of the cvsi studies.#6&7
https://www.tga.gov.au/sites/default/files/review-safety-low-dose-cannabidiol.pdf
Easy come easy go? Does cvsi give back 2.9 million PPP loan?
https://www.cnn.com/2020/04/23/business/treasury-public-companies-ppp-loans-repay/index.html
Dowling's logic to keep the money:
Some of the public companies that received the loans told CNN Business that their situations warrant the federal assistance.
"Even though we're a public company, we're not a big company," said Joseph Dowling, chief executive officer of CV Sciences, a San Diego-based company specializing in hemp-derived, CBD-based pharmaceuticals and consumer products. "We understood the guidelines to be for smaller companies like us."
He added: "Not every public company has the same access to capital."
CV Sciences, following a recent 25-person layoff, is 100 employees in size. Its $2.9 million PPP loan will allow the firm to keep employees and possibly bring back others, he said.
"We're like everybody else, we're affected by this," Dowling said. "We're a little bit dependent upon brick-and-mortar retailers who are dependent upon customers.
Cv Sciences seems to be always in the mix of setting the standards.
Cv sciences has a partner membership in CASP.
https://www.aoac.org/news/aoac-scientists-approve-official-method-of-analysis-for-cannabinoids-in-hemp/
A new patent application is listed but not yet published. Found this in the continuity tab of the recently allowed patent. Filed the day after the allowance. They have this planned out. Will keep a eye out.
16/841,834 filed on 04-07-2020 which is Pending claims the benefit of 15/426,617
THE LOAN AMOUNTS will be FORGIVEN.(Free money)
PAYCHECK PROTECTION PROGRAM (PPP) INFORMATION SHEET:
BORROWERS
The Paycheck Protection Program (“PPP”) authorizes up to $349 billion in forgivable loans to
small businesses to pay their employees during the COVID-19 crisis. All loan terms will be the
same for everyone.
THE LOAN AMOUNTS will be FORGIVEN. as long as:
The loan proceeds are used to cover payroll costs, and most mortgage interest, rent, and
utility costs over the 8 week period after the loan is made; and
Employee and compensation levels are maintained.
Payroll costs are capped at $100,000 on an annualized basis for each employee. Due to likely
high subscription, it is anticipated that not more than 25% of the forgiven amount may be for
non-payroll costs.
Loan payments will be deferred for 6 months.
Is it possible that this patent will also lead to over the counter smoking cessation products. Patent seems to include smoking cessation along with
smokeless tobacco
"Various modifications may be made without departing from the spirit or scope of the present invention. For example, although the pharmaceutical compositions disclosed herein are formulated for use in treating smokeless tobacco addiction, it should be recognized that the compositions also may be effective for use in smoking cessation."
In light of the new patent allowance the meeting with the FDA back in January takes on a new meaning. At the time I thought CVSI seemed the odd man out of this coalition. All the other companies are providers of Pharmaceutical grade cannabinoids. CVSI used the cbd from Noramco in the
recent study and affidavit submitted to the patent office that helped turn the patent approval around. Noramco is part of Purisys. Two of the other companies are making cannabinoids thru cellular agriculture. Just trying to figure out if there is a common denominator why cvsi is in this coalition.
Event Date: 01/16/2020
Location: Silver Spring, MD
Subject: Listening Session with the Cannabidiol (CBD) Coalition
FDA Participant/Group: ALISON THOMPSON; JOSEPH FRANKLIN; RACHEL OSTERMAN; CARA WELCH; LOWELL SCHILLER; SHARON MAYL; MICHAEL LEVY; MELISSA ROBB; CASSANDRA TAYLOR; DENNIS KEEFE; APRIL ALEXANDROW; STEVEN TAVE; REBECCA GOLDBERG; SHERENE SEPEHRI;
Non FDA Participant/Group: Brendan Carroll, Marc Scheineson (Alston & Bird LLP); Cynthia Bryant (Demetrix, Inc.); Bill Grubb (Noramco); Angelo Fefekos, Etan Bendheim, Jeremy Friedberg (LAVVAN, Inc.); Wendi Young (Mile High Labs); Josh Hoerner, Scott Warner (Purisys); Douglas “Duffy” McKay, Joseph Dowling (CV Sciences, Inc.); Trevor Peters (Willow Biosciences)
Maybe no PR for awhile?
From thefly.com "CV Sciences allowed patent for addiction to smokeless tobacco, Bloomberg says CV Sciences CEO told Bloomberg in a phone interview that the patent news is a "very big deal" for the company, though he expects the patent process to take another six to eight weeks."
Read more at:
https://thefly.com/landingPageNews.php?id=3066902
Updated Patent status ALLOWED -- Notice of Allowance Not Yet Mailed.
Excellent news for lawsuits and future business model
Patent to be issued soon? Patent office just posted "Notice of Allowance Data Verification Completed" This designation is usually followed by issue of patent within six weeks from the information I've looked into.
What re branding would have looked like at the cancelled March expo. https://www.seanpedeflous.com/portfolio/30x30-tradeshow-rendering/
Ad campaign.Vote on favorite. Not a fan-let them know.
https://surveyhero.com/c/a70b2391
Their new labeling and ad campaign are depicted in the April issue of wholefoods magazine. I imagine they need to roll out this week the new labels so as not to confuse. Page 23
https://xdigital.spiweb.com/publication/?m=34523&i=654708&p=24
New packaging design revealed. Coming spring 2020. Scroll down to see.
Note warning on bottom-nice touch
http://www.robertscottbell.com/natural-remedies/remembering-toni-bark-secret-coronavirus-carriers-nationwide-virus-tests-real-death-rate-mask-mania-iis-immunization-information-dairy-fat-is-ok-stuart-tomc-cv-sciences-plus-cbd-oil-endocann/
Curious to see what cvsi has in store for their rebranding of
their flagship product which is supposed to occur in conjunction with expo west beginning tomorrow. Joe brought this up during his ICR presentation
in January. At first he said rebranding and thats what the slide presentation said but then he hedged a bit and I believe said restructure?
Anyway you would think there would be some hoopla involved.
FDA signals a change
Also this week, Dr. Stephen Hahn, the newly appointed commissioner of the U.S. Food and Drug Administration (FDA), acknowledged that American consumers want CBD.
He said Wednesday that the agency is working to move forward with regulations.
“We’re not going to be able to say you can’t use these products. It’s a fool’s errand to even approach that,” Hahn said at the NASDA meeting.
https://hempindustrydaily.com/usda-drops-dea-testing-requirement-while-fda-acknowledges-demand-for-cbd/
Management is not mia. Here is Joe just 5 days ago out promoting.
New Frontier Data Chief Knowledge Officer, John Kagia, joined an esteemed group of panelists today at @NCIAorg's #NECannaBizCon to discuss Investment Opportunities in Hemp & CBD!
— New Frontier Data (@NewFrontierData) February 20, 2020
Thank you, fellow panelists (thread): pic.twitter.com/QUlf4HXbU3
Duffy Mackay highlights the long term strategy vs short term profits.
https://www.naturalproductsinsider.com/business-operations/natural-catalysts-duffy-mackays-move-supplement-trade-org-hemp-specific-advocacy
"given as directed on the bottle" seems to imply the pet product
has been manufactured already and just possibly waiting for the study
to finish up
CBD TRIAL FOR ARTHIRTIC DOGS
Through the Hutson School of Agriculture’s veterinary technology
program, a study is being conducted for use of CBD oil for arthritic
dogs to determine anti-inflammatory properties. This experiment is
using CV Sciences CBD oil, given as directed on the bottle.
Evaluation is performed by a subjective owner survey, bloodwork
and gait analysis with a canine force plate from Tekscan.
The clinical research trials were conducted with 8 privately-owned
dogs for an 8-week duration. For the first 4 weeks of
round one, 4 of the 8 participants took CBD oil and 4
took placebo (Extra Virgin Olive Oil). After midtreatment evaluations, all 8 participants were switched
to CBD Oil. Another round of clinical trials will be
conducted in February 2020 with 12-15 canine
participants.
page 11
https://www.murraystate.edu/academics/CollegesDepartments/HutsonSchoolOfAgriculture/CenterForAgriculturalHemp/CAH%20Annual%20Report%202019.pdf
A conservative Stuart Tomc talks cbd safety yesterday. https://www.naturalproductsinsider.com/regulatory/lets-talk-hemp-cbd-safety
Possible indication of direction that cvsi is heading.
Driftless and cvsi have been shown to be partners thru videos and talks.
Driftless has issued a newletter:
following updates are potential contracts and partnerships for Driftless:
• Distribution Discussions
o Engaged potential partner about CBG production and distribution for
2020
• Visited headquarters of purchasing partner
o Delivered final proposal for 2020 acreage contracting
o Discussed partnership on 2019 production
? Pellet samples have been set to lab for extraction
o Driftless is attempting to sign a multi-year multi-phase contract
• Discussions with organic purchaser progressing for USDA Certified Organic extract
o Discussed partnership on 2019 production
o Discussed a multi-year agreement starting in 2020
? Lab samples will be required prior to signing
• On-track to become one of the first seed to bottle traceable processor with USDA
certified organic stamp on each stage of production