Hey Slider can you tell us what this means? Thanks! On January 15, 2020, Canbiola, Inc. (the “Company”) and H.C. Wainwright & Co., LLC (“Wainwright”) executed a Letter Agreement (the “Agreement”) pursuant to which Wainwright agreed to provide certain exclusive financial advisory services to the Company in connection with a debt financing contemplated by the Company. The Agreement is dated as of December 30, 2019 and has a termination date of March 31, 2020.
As consideration for the services rendered by Wainwright, the Company agreed to, at each closing of each debt financing during the term of the Agreement, issue warrants (the “Wainwright Warrants”) to purchase the number of shares equal to seven percent (7%) of the aggregate gross proceeds committed by an investor divided by the market price of the Company’s common stock (“Common Stock”) on the closing date of such investor’s commitment. The Wainwright Warrants will have a term of five (5) years and an exercise price equal to the market price of Common Stock on the closing date of the applicable debt financing. In addition, the Company has agreed to reimburse Wainwright for its out-of-pocket expenses incurred in connection with its advisory services.
The Company agreed to indemnify Wainwright and its affiliates from and against all losses relating to Wainwright’s engagement with the Company. The Agreement otherwise contains customary terms and representations. The foregoing description of the Agreement is qualified in its entirety by the terms of the full text of the Agreement, attached hereto as an Exhibit.
Thank you for providing an objective and comprehensive analysis of CANB in the context of the CBD sector
Your words of wisdom were sorely missed around here
One fact I will add is that the recent legislation filed by the House does nothing to change the FDA’s viewpoint on the presence of THC in CBD products, which they have classified as a “psychoactive contaminant” in CBD products
In addition, both CBD and THC are each subject to the drug exclusion clause in the FDCA, and the legislation filed in the House only explicitly exempted Hemp-derived CBD from this clause — the current illegal status of Hemp-derived THC in Dietary Supplements (and Food, too) was not changed by this legislation
The FDA explains it right here:
9. Can THC or CBD products be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
There is an exception to section 201(ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.
FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.
When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.
11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.
The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex.
CANB Processing Hemp With Mile High Labs As Partner
Hemp Processing is going to wind up being the hottest growth area in the Hemp/CBD industry in 2020
That’s starting to become a consensus viewpoint in the industry, primarily due to the tremendous dearth of processing capability in America right now
So the demand for hemp processors is sky high right now, and that’s before the FDA green light
So what’s the demand for processing hemp going to look like in 2020 after Congress legalizes Pure CBD as a dietary supplement and food additive and the FDA permits national sales of Pure CBD products through a policy of enforcement discretion?
With interstate sales permitted, the farmers are going to drive a sharply increasing supply of raw hemp, and the CPG industry is going to be driving a sharply increasing demand to turn that raw hemp into CBD Isolate (Pure CBD) for use in the most popular products, including Pure CBD Oil, Pure CBD Beverages, and Pure CBD Food
Turning raw hemp into CBD Isolate is the specific type of processing in which Canbiola and their partner Mile High Labs are engaged
And so to state things even more specifically, the processing of Hemp into CBD Isolate is going to wind up being the hottest growth area in the hemp processing sector in 2020
The Pure CBD formulation continues to look like the one most likely to receive FDA approval for national sales over the other formulations with THC and/or CBG/CBN/CBC in them
Retailing CBD products will undoubtedly heat up again quickly once the FDA gives the greenlight to produce CBD Isolate and sell Pure CBD products under their formal policy of enforcement discretion for Pure CBD Products Only
So CANB is heavily involved in the 2 most probable biggest growth areas of the National Hemp Economy in 2020 — Hemp Processing and Selling Pure CBD Products nationally
CANB is also now a grower as well, in partnership with Shi Farms
When all is said and done, CANB is going to be fully vertically integrated as a grower, processor and retailer of Pure CBD products in 2020
Hemp processing into CBD Isolate looks like it is going to be the hottest area in 2020, and CANB has smartly partnered with the biggest hemp processor in the world, Mile High Labs