Dowling and Mackay met with FDA Jan. 16th.
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);

SpaceLady, A past 8k from the Alkaline water co.
"A88 Infused is also developing and preparing for the initial launch of its planned hemp extract product, which will be marketed under the trademark Soothe™.....

We may also decide to market Soothe™ if a supplier meets and complies with FDA’s GRAS regulations with respect to a self-certification regarding the safety and GRAS status of the use of hemp extract.

We expect to produce Soothe™ as a low calorie or no calorie, hemp extract-infused water in five flavors. We may change the composition of our planned hemp-extract-infused product as necessary to comply with federal, state or local laws, regulations or guidance".
https://www.sec.gov/Archives/edgar/data/1532390/000106299319001122/form8k.htm

The pluscbd website has been changed around.
https://www.pluscbdoil.com/

Odd. Maybe something brewing for the Farmers Golf tournament.
Wondering why Hendrix Hemp after years of mostly following
hemp related sites suddenly overnight add close to 50 golf related sites
he is following?
https://twitter.com/HendrixHemp/following

possible mega for cvsi. In past post I've mentioned in May of last year
Multi billion dollar company Perrigo has been in talks with a cbd company.
In todays presentation at the ICR Perrigo ceo talks about future "BIG"
ideas of cbd and nicotine. the slide 11 also shows the pluscbd gummies.
Listen about the 17 minute mark about how Perrigo dominates the otc nicotine cessation category and then about minute 19 mentions cbd and
nicotine. Tomorrow he presents at the big JP Morgan Healthcare

http://wsw.com/webcast/icr6/prgo/

The pet products idea arose out of the theory that since cvsi is doing a study on arthritic dogs and pluscbd that this would lead to pet products.
Dr tony Bannon of Murray State mentions to Josh that they are
doing the study about minute 51. Its assumed that cvsi wants to have some
science backed study before releasing a pet product. Thats their style.
Study began in October I believe.

https://soundcloud.com/hemphappyhour/episode-62-southern-hemp-expo-part-1

Also from a student from Murray State
"Cristen Blake Shaw currently studies Pre-Veterinary Medicine at Murray State University. Cristen is heading an undergraduate research study. Currently, she is researching the effects of hemp-derived CBD Oil on arthritic dogs as an anti-inflammatory, pain-reliever, etc. alongside her research mentor, Dr. William DeWees, DVM."

Hiring for drug development project.
Urgently hiring
Project Manager
CV Sciences, Inc. operates two distinct business segments: a drug development division focused on developing and commercializing novel therapeutics utilizing synthetic CBD; and a consumer product division in manufacturing, marketing and selling plant-based CBD products to a range of market sectors. The Company has its offices and facilities in San Diego, California.

CV Sciences is seeking an experienced Project Manager to provide support to the Chief Executive Officer in drug development activities. This individual will be joining a company with one of the fastest growing consumer product categories in the U.S and will be entrusted with information specific to CV Sciences, its employees, and investors that are highly confidential and critical in nature.

Some of the duties Project Manager will assume include:

Partner with team leaders to manage the development and execution of project team strategy.
Establish and maintain functionally integrated project schedules in accordance with established structures to enable accurate project analyses, identification of critical path activities and areas of resource constraint.
Independently identify and manage project objectives, work plans, timelines, budgets, providing formal and informal status updates as needed.
Facilitate and document project team meetings, cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership.
Develop relationships with key functional stakeholder groups and their leadership across the organization.
Manage key external vendor activities and associated budget when directed.
Contribute to successful execution of Project Management department goals and activities.
JOB REQUIREMENTS

Bachelor’s Degree in a life science field.
3+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry and basic knowledge of project management practices, tools and methodology.
Knowledge of drug development process and interdependencies of key functions to include research, pharmaceutical development, non-clinical, clinical PK, metabolism, clinical research and manufacturing.
Excellent team member with a strong willingness and ability to work across projects at different stages of development in a fast-paced, entrepreneurial environment.
Ability to drive consensus and decision-making.
Outstanding written, verbal and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across the organization.
CV Sciences Inc is an Equal Opportunity Employer

Job Type: Full-time

Salary: $80,000.00 to $120,000.00 /hour

Experience:

Pharmaceutical/Biotechnology: 3 years (Preferred)
Education:

Bachelor's (Preferred)
License:

Project Management Professional (PMP) (Preferred)

Saved 30% on leaflymarket with free shipping. Only nine sku's though. https://www.leaflymarket.com/products/catalog?brand=PlusCBD%20Oil

Dec. 9th also registered the domains potentiacbd.com potentiahemp.com.
So now we have domains newharvest, potentia, and happylane.
Hopefully they fill in the blanks soon.

Happylanecbd.com was also registered Dec. 9th.
My guess is a pet product?

A new trademark request.
Mark Image
Word Mark HAPPY LANE

Goods and Services IC 003. US 001 004 006 050 051 052. G & S: Body care and toiletry products, namely, skin moisturizers, balms, lotions, creams, and serums containing CBD
IC 005. US 006 018 044 046 051 052. G & S: Dietary and nutritional supplements; topical balms, moisturizers, lotions, creams, and serums for analgesic purposes; supplements in the form of gummies, capsules, drops, and sprays; all of the foregoing containing CBD

Standard Characters Claimed
Mark Drawing Code (4) STANDARD CHARACTER MARK
Serial Number 88717203
Filing Date December 5, 2019
Current Basis 1B
Original Filing Basis 1B
Owner (APPLICANT) CV Sciences, Inc. CORPORATION DELAWARE 10070 Barnes Canyon Road, Suite 100 San Diego CALIFORNIA 92121
Attorney of Record Rosie H. Kim
Type of Mark TRADEMARK
Register PRINCIPAL
Live/Dead Indicator LIVE

Mitch keeps pushing for his Kentucky hemp.
https://www.mcconnell.senate.gov/public/index.cfm/pressreleases?ID=384B7108-33BC-4427-A8F4-7A209E4C6644

Watching giant Perrigo who back in May announced "that it is in active discussions with several leading CBD companies to identify the best partner to create high-quality reliable CBD products"
A otc cbd nrt product would fit perfectly into their portfolio of self care products.

https://www.perrigo.com/press-release/perrigo-unveils-self-care-transformation-plan-2019-guidance-and-long-term-growth

"It won't be long....Paperwork already filed for more large retailers to carry ingestibles. Pages 72-76
https://mjbizmagazine.com/digital-issues/2019-10-NovDec/72/#zoom=z

CVSI has probably already tried to summit a NDI.

http://www.nutritionaloutlook.com/regulatory/crn-rebukes-fda-agencys-alarmist-consumer-update-cbd

" Mister said that FDA continues to call on the CBD industry to produce research to validate the safety of CBD; however, while the agency has received “meaningful safety data” in the form of new dietary ingredient (NDI) notifications and GRAS submissions from "responsible companies,” the agency has so far “dismissed” these. Mister said FDA has not established an appropriate framework to encourage more of the research it claims to seek: “[T]he agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded.”

In the CV Sciences letter, Tomc offered CV Sciences’ own research: “The FDA stated that it cannot conclude that CBD is generally recognized as safe (GRAS) and this is because a GRAS affirmation is directly linked to a specific ingredient and conditions of use (serving size, age restrictions, etc.). To this point, we can share our research that supports the safety of our specific ingredients for our intended consumer. We believe that the FDA’s statements that CBD is not GRAS are directed toward companies that have piggybacked on our research, without addressing the significant differences in ingredients, products, levels of CBD, and serving size recommendations.”

New logo's and branding coming?
https://www.trademarkia.com/company-cv-sciences-inc-4443057-page-1-2

You're right chilling. Sorry to lead you astray. I have poor hearing.
This is kind of a synopsis of what transpired at the fda hearing.
https://www.marijuanamoment.net/gop-senator-says-he-tried-cbd-and-jokes-about-its-hair-regrowth-potential/

The patent application is alive. A request for continued examination has been filed.
The study from Scripps Research and a affidavit from Dr George Oliver
has also been submitted. The claims seem to be modified so that lower concentrations of cbd are used. Maybe Space lady can paste and copy some of the
study and claims here?

todays senate fda nominee hearing had some intesting exchanges on cbd. Listen at the 1hour 53 minutes as Senator Rogers tells the fda nominee how
cbd works for him and the fda nominee's comment. https://www.help.senate.gov/hearings/nomination-of-stephen-m-hahn-md-to-serve-as-commissioner-of-food-and-drugs

The name Cantine will be waiting for a product approval
NOTICE OF ALLOWANCE (NOA)

ISSUE DATE: Nov 12, 2019

U.S. Serial Number: 87241834
Mark: CANTINE
Docket/Reference Number: 008342.00021

New video from cvsi and Murray State.

Good insight.A new complete cbd line to empower women. Potentia

New trademark perhaps for international marketing?
Word Mark POTENTIA
Goods and Services IC 003. US 001 004 006 050 051 052. G & S: Body care and toiletry products, namely, skin moisturizers, balms, ointments, lotions, skin cleansers, creams, body oils, massage oils, roll-on oils, baby lotion, baby oil, lip balms, and serums; shampoos and conditioners; cosmetics; anti-aging creams; mineral make-up; eye creams; foundation; all of the foregoing containing CBD derived from industrial hemp
IC 005. US 006 018 044 046 051 052. G & S: Dietary and nutritional supplements; supplements in the form of gummies, capsules, drops, soft-gels, and sprays; topical balms, skin cleansers, moisturizers, lotions, creams, body oils, massage oils, roll-on oils, baby oil, baby lotion, and serums for analgesic purposes; medicated cosmetics; ointments; all of the foregoing containing CBD derived from industrial hemp

Here is the video of the presentation Joe referenced in the earning call."I'm very pleased to announce the publication of a scientific poster on a study that CV Sciences sponsored with the Scripps Research Institute, and the University of California at San Diego"
They do acknowledge CVSI at the end of presentation.

https://vimeo.com/371510595

CVSI will not have to worry about this,(using agricultural hemp) but a lot
of the competition will.

USDA rules will eliminate a lot of the cbd companies hemp sources.

"According to Oregon CBD, one of the world’s leading producers of high-CBD hemp seeds, “No high cannabinoid content, type III (CBD) plant variety in existence can meet this strict test unless harvested early or is genetically modified. This rule eviscerated the trimmed CBD flower market for 2020. Gone. No one, including us at Oregon CBD, has CBD seed varieties that can be trimmed and sold under these new rules.”
http://www.roguevalleymessenger.com/dont-smoke-the-messenger-new-fda-rules-bust-hemp-boom/

New full page ad in Lucky's November magazine highlights the direction of marketing.
What WE DO MAKES A DIFFERENCE.
CREATING CHANGE AROUND HEMP IN THE MINDS OF MILLIONS
WASN’T AN EASY TASK BUT, COLLECTIVELY, WE DID IT.
In the new and emerging hemp CBD market, many
companies claim to be the best or most trusted,
and it can be hard to know who to believe or what
brand to choose. Being industry experts, we know
it’s more than just the products that matter. That’s
why, at PlusCBD™ Oil, what we do is truly different.
+ US Hemp Authority Certified
+ Products Studied in Randomized
Controlled Trials
+ Generally Recognized as Safe (GRAS)
Self-Determination
+ Full Traceability – From Seed to Shelf™
+ Independent Third-Party and DNA Testing
+ Unparalleled Quality Control
+ QR Codes on Every Label for Increased
Transparency
+ Widest Product Selection Available

https://2erape3gkyv5ojcr3ljlepou-wpengine.netdna-ssl.com/wp-content/uploads/2019/10/LM_1119_352_01-Final.pdf

New BOD seems like a great asset for future Nadaq uplisting.
https://ir.cvsciences.com/press-releases/detail/139/cv-sciences-inc-appoints-beth-altman-to-its-board-of

White house signs off on usda interim rules last Friday. Expect release anytime soon.
https://www.marijuanamoment.net/white-house-signs-off-on-proposed-hemp-rules-from-usda/

More Coca Cola analogies yesterday at Supply side west.
Karagianes continued, “That way, it allows us to work with other individuals. It’s almost like this: With Coca Cola, the magic of Coca Cola isn’t really a Coca Cola plant. It’s really the syrup. That’s their special thing that they do. And they have different manufacturers who can run Coke syrup all over the place. So that’s the real thing. Our [company’s] PlusCBD Oil Gold formula is the holy grail, and we can do that as long as we have Futura and Fedora. It just has to have the same qualitative and chemical matrix as our GRAS oil, so we can pretty much grow it anywhere. We’re pretty nimble in that regard.” From a good article with other CV S quotes.

http://www.nutritionaloutlook.com/regulatory/hemp-landscape-theres-more-hemp-supply-cbd-demand-companies-say-supplyside-west-2019

For all you Stuart Tomc fans. A new hour and half video that begins at 1 hour 5 min.Again lots of great info on what distinguishes CV S from the competition. He gives a impromptu tour of CV Sciences at 2 hours 30 min that highlights how their ready for the fda. " come on FDA"

news.
https://www.globenewswire.com/news-release/2019/10/22/1933231/0/en/CV-Sciences-Inc-Appoints-Dr-Paul-Blake-to-its-Board-of-Directors.html

Did you know our BOD Dr. Maroon, is also Chairman of the GNC Medical Advisory Board? The seven new products to be released in November would
fit perfectly into the cbd cosmetics line that GNC now offers.

Pluscbd for arthritic dogs study at Murray State underway.

"Cristen Blake Shaw currently studies Pre-Veterinary Medicine at Murray State University. Cristen is heading an undergraduate research study. Currently, she is researching the effects of hemp-derived CBD Oil on arthritic dogs as an anti-inflammatory, pain-reliever, etc. alongside her research mentor, Dr. William DeWees, DVM."

From yesterdays senate agricultural hearings.
Hemp rules coming ‘within next couple of weeks,’ USDA Deputy Secretary says.
Hopefully have a "perfect storm" effect with earnings, USDA and FDA regulations

News.
http://www.globenewswire.com/news-release/2019/10/17/1931262/0/en/CV-Sciences-Inc-Announces-Expanded-Distribution-Partnership-With-The-Vitamin-Shoppe.html

New from FDA. May be the warnings before the guidance?

https://www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding

The USDA submitted its interim final rule, titled “Establishment of a Domestic Hemp Production Program,” to the White House Office of Management and Budget on June 27. We should hear from OMB any day now.(they promised early fall) What will be interesting to see is how strict the guidelines will be especially in regards if hemp seeds need to be certified.
On September 9th Canopy Growth was able to secure a meeting with the OMB to present their recommendations. There are very few companies that use certified seeds and it will be a great advantage to cvsi if certified seeds are required. USDA interim rules will probably come before FDA.
CG presentation to OMB
https://www.documentcloud.org/documents/6414846-2019-09-03-OIRA-Testimony-Hemp-Testing-and-Seed.html

Stuart Tomc new lecture series video. The one he did about 18 months ago has 34k views. Lots of new information.

Murry State University is doing a study on arthritic dogs and pluscbd. Looks like pet products will be coming someday. Minute 51
https://soundcloud.com/hemphappyhour/episode-62-southern-hemp-expo-part-1