klimanjaro
6年前
Expecting Green light from health Canada this week with FDA submission. NSP will rock on those news. Company is getting ready for clinical trial 2. It shows confidence to get Health Canada approval.
due to circumstances created by the COVID-19 pandemic measures, the Company will be delaying the filing of its annual financial statements and related management discussion and analysis for the year ended December 31, 2019 until a date that is on or before June 15, 2020.
> Pretty common for a lot of companies to delay under the COVID-19 situation as I stated on May 7th IMO the delay of the financials is only due to circumstances created by the COVID-19 pandemic; if you happen to follow the Stockwatch daily news feed you will have seen tons of companies notifying the delay of their financial statements.
- Not immediatly filling a PP at half the price of the current stock price which held for over a week. (Is the PP still open?)
> I doubt the PP will be open much longer, probably close soon! I’m not waiting I'm in :<)
- Is there a reason why investors are not wanting to hold this half-priced deal with amazing warrants for 4 months from pp closing?
> Given the times we are living in a lot of people want flexibility and the 4 month hold is likely a deterrent for some.
- Feel free to add why a investor should buy before seeing 2019 year end
> You can wait until they are released (before June 15th) but you are waiting 5 ½ months putting a lot of emphasis on waiting for past history when NSP is moving forward. I made my 2019 prediction on January 4th proving links to charts, etc. supporting my guess. Even if my $3.1 million guess turns out to only be $2.9 million – it’s a good year over year improvement.
> Based on the news releases etc. during the quarter, Q1Y20 was heading to be an exceptional quarter and the results may still be great. Q2Y20 will likely be tempered due to the COVID-19 situation but as I stated on May 7th - lots going on that we just haven’t been told about yet ;<)
klimanjaro
6年前
Health Canada reviews the CTA and notifies the sponsor within 30 calendar days from the date that the application is considered complete. Questions may be issued during the review, and the sponsor will have 2 calendar days to provide the response (exceptions can apply). Note that CTAs are required for phases I to III clinical trials. The authorization (No Objection Letter) is mandatory prior to initiating the trial and importing the investigational product(s) in Canada.
If the HPFB provides authorization, the study can be underway with human subjects that are informed and have given their consent to be administered the drug for their participation. Note that a Canadian Ethic Committee must also approve the study material (protocol, Investigator’s Brochure and Informed Consent Form). Tests are conducted in a controlled environment where drug administration procedures and results are closely tracked, monitored and analyzed.
Priority Review (PR) applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases, that is, once the clinical development is completed. The total review timeline is reduced from 355 days to 215 days.
On the other hand, the Notice of Compliance with condition (NOC/c) applies to drugs with promising evidence of clinical effectiveness throughout the clinical trial phases. In summary, the NOC/c can be granted with less clinical data than usually expected, that is with Phase II study results or interim reports of Phase III studies. Approval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s benefit and safety. The total review timeline is reduced from 355 days to 235 days.
The condition needs to be agreed to with Health Canada. Some of the conditions of the NOC/c may include a requirement to closely monitor the drug for safety and adverse reactions and to provide HPFB with regular updates. Once the conditions are met, the designation of “with condition” is removed from the NOC.
klimanjaro
6年前
Naturally Splendid Announces
Clinical Trial Application Submitted to Health Canada for
Phase 2 COVID-19 Clinical Trial
Dear Naturally Splendid subscribers,
Vancouver, British Columbia, May 26, 2020 - Naturally Splendid Enterprises Ltd. ("Naturally Splendid" or “NSE” or “the Company”) (FRANKFURT:50N) (TSX-V:NSP) (OTC:NSPDF) is pleased to announce the following update regarding progress for a Phase 2 clinical trial treatment for COVID-19.
The Company is pleased to announce that Clinical Trial Application (CTA) has been submitted to Health Canada for a COVID-19 Phase 2 clinical trial, using Cavaltinib™ as the subject test drug. The same study protocol is being prepared for submission to the U.S. FDA regulatory authorities.
After initial review of data for a Clinical Trial Application (CTA), Health Canada has advised that the Bioligic Division within the Health Canada Office of Regulatory Affairs Biologic and Radiopharmaceutical Drugs is the appropriate channel to submit the completed CTA.
The study will be an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization (WHO) to determine if Cavaltinib™ is viable treatment that can improve clinical symptoms and reduce the number of COVID-19 infected patients from progressing to mechanical ventilation with intubation and death.
The trial will begin as a Phase 2 study and after an interim analysis is performed on the first 40 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial. The Phase 2 portion of the study is expected to last 4 weeks, which will include monitoring of patients and correlating of the data.
With positive preliminary data, the clinical trial would move directly from a Phase 2 into a Phase 3 as guided by Health Canada.
As set out in Naturally Splendid’s news release dated May 19, 2020, Naturally Splendid entered into a letter of intent with Biologic Pharmamedical (Biologic) to form of a joint venture for the purpose of developing and pursuing Phase 2 clinical studies, utilizing one of Biologic's patented technologies as a candidate for a potential COVID-19 treatment. The proposed joint venture entity will be granted certain rights from Biologic’s patents as it relates to applications for treating COVID-19 infections. The categories to be licensed will include, but are not limited to COVID-19 applications, as well as additional respiratory indications that may arise out of the Phase 2 clinical trial
About Cavaltinib™
CavaltinibTM displays novel pharmacology discovered by Biologic and shown today to be a potential fit as a drug candidate for COVID-19 patient treatment. This candidate drug has been run through Biologic’s research program that was designed to study key drug targets involved in the regulation of immune system and inflammatory activity. The research has already shown Cavaltinib™ irrefutably inhibits IL-6 and several other cytokines central to the ‘cytokine storm’ phenomenon. The Company believes CavaltinibTM will show the same positive results in mitigating the ‘cytokine storm’ with COVID-19 patients.
Biologic Pharmamedical’s research methodology for probing key drug targets with this novel drug is based on rigorous clinical study that utilizes accepted allopathic research protocols, thus affirming for medical practitioners the efficacy of Biologic’s subject drugs – both nutraceutical or pharmaceutical - with methods and results that are familiar to mainstream medical practitioners.
We caution that this news release is not making any express or implied claims that we have the ability to eliminate the SARS-CoV-2 virus at this time.
The scientific content of this news release has been reviewed and approved by Biologic.
About Naturally Splendid Enterprises Ltd.
~ Blue ~
6年前
NSPDF clients USA, Canada, Europe and Australia
The Company remains very much focused on hemp…but has now expanded our expertise and reach to include not only the nutrient packed hemp staples of; hemp seed hearts; proteins and oils, which was re-branded “NATERA®” in 2014…but now our proud to offer a much wider range of hemp formulated Company Branded Consumer Products that includes sports and practitioner formulated lines as well as Bio-technology Advanced Products that are proprietary to Naturally Splendid such as HempOmega™.
Additionally, Naturally Splendid has grown to over 25,000 square feet of Processing and Manufacturing based upon an comprehensive Vertical Integration Strategy, focused on two distinctively separate yet complimentary Revenue Streams.
The Vertical Integration Strategy feeds a Distribution Network that leverages the strength of combining the Distribution Network of Company Branded Products as well the distribution reach that our Contract Manufacturing Clients have established. The combination of these two Distribution Channels creates a distribution network that includes virtually every major retailer in Canada, as well as reach into the USA and over 300 retail outlets in Australia as well as an on-line presence in Germany. Naturally Splendid has exported to multiple countries in Asia and is proactive in developing distribution there as well as in Europe.
https://www.naturallysplendid.com/about/OUR%20COMPANY
klimanjaro
6年前
Naturally Splendid’s (NSP.T) proposed joint venture with Biologic Pharmamedical takes aim at COVID-19
Joseph MortonBYJOSEPH MORTON
May 19, 2020
IN HEALTH-MEDICINE, PHARMACEUTICALS
joint venture
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Naturally Splendid (NSP.T) signed an LOI with Vancouver-based Biological Pharmamedical Research to form a joint venture to continue developing and pursuing phase two clinical studies, using one of Biologic’s patented technologies as a candidate for a potential treatment for COVID-19.
The company has been working to support Biologic with its plan to conduct COVID-19 phase two clinical studies in Canada, United States and abroad with its patented pharmacological tech. The company can’t express a guarantee that they’re going to be accepted, but Biologic has been given the nod to fast track a clinical trial application (CTA) to Health Canada following a preliminary review of the data.
Here’s what Biologic’s all about from their website:
Biologic pharmamedical is involved in the research and development of nutrient- and nutraceutical- based technologies or analogues of these natural compounds using pharmaceutical or medical research models to help define how they interact and modulate cell signalling and behaviour.
The pandemic has overloaded hospitals and generally put a substantial strain on the health care system. It’s caused shortages of respirators and other essential equipment, and other assorted intensive care unit bottlenecks.
The treatment offered by Naturally Splendid is an amplified variant of one of Biologic’s existing technology. This patented tech when taken in capsule form could reduce or eliminate the need for infected patents to congregate in hospitals or clinics for infusions or other treatments. The capsule delivery system, if it works, would increase the effectiveness of treatment at a fraction of the cost, up to and including eliminating the need for hospitalization, and provide more safety for our at-risk front line medical staff.
Joint venture terms
When the transaction’s completed, Naturally Splendid will own 16% of the joint revenue and be granted a 10% royalty on gross sales of all the products from the study. Biologic will own 82% of the JV with 2% devoted to key personnel within Biologic.
The JV will be granted certain rights from Biologic’s patents as they relate to treating COVID-19 infections. The licensed categories will extend past COVID-19 to include additional respiratory indications that may come out of a fast-tracked phase two clinical trial. Biologic will continue their in vitro program on tissue and cell models to find further pharmacological mechanisms associated with treatment of other diseases and problems like rheumatoid arthritis, ulcerative colitis, Crohn’s disease and other autoimmune or autoinflammatory diseases.
Under the proposed joint venture, NSP will invest $500,000 CDN cash into the joint venture for the purpose of.:
(a) preparing documentation for submission of the CTA to Health Canada.
(b) preparation of formal phase 2 clinical trials
(c) $100,000 CDN for inventory of the Covid- 19 treatment product for phase 2 clinical trials ;
(d) ongoing clinical trials and further research and development for a period of twelve (12) months overseen by Biologic; and
(e) preparing documentation for pre-IND application for a phase 2 COVID-19 clinical trial with the U.S. FDA.
(f) preparing and executing our own internal pilot trial
The company estimates the clinical trial phase for COVID-19 related issues will take anywhere from a month to three months with an extra twelve month period intended to further expand the pharmacology.
Naturally Splendid teams with Biologic Pharmamedical for a Phase 2 clinical study
—Joseph Morton
lookylookie
7年前
The Canadian #hemp stocks we’ve dug up could see significant upside following the passage of the Hemp #FarmBill in the U.S. Congress
SmallCapPower | December 17, 2018: The Hemp Farming Act of 2018 was a proposal to amend the status of hemp (less than 0.3% THC) under federal law, by removing its status as a Schedule I controlled substance, and instead classifying it as an agricultural commodity. The bill has passed the U.S. Senate, as well as the House, and is now awaiting a signature from the President before it becomes law. Following the passage of the bill into law, according to Brightfield Group, the industry could grow from its current size of US$800 million to over US$20 billion by 2022. Not surprisingly, hemp stocks have reacted exceptionally well to this news. Today we have identified four Canadian hemp stocks that could continue to see further upside as they begin to tap into an emerging industry.
Naturally Splendid Enterprises Ltd. (TSXV:NSP)
Hemp ????$NSP ????$NSPDF ????$50N
#NaturallySplendid Enterprises is a vertically-integrated biotechnology and consumer product company specializing in industrial hemp products. The Company’s line of products target a range of markets with various uses, including hemp protein isolate, hemp-based performance products for athletes, superfoods, meal replacements, energy bars, and pet food. Naturally Splendid distributes products to the U.S., Canada, Australia, Germany, and South Korea. The Company’s production capacity currently exceeds 22,500 sq. ft. and operates the only organic-specific hemp processing facility in North America. The Company reported $499,538 in revenue for the three months ended September 30, 2018.
Market Cap: $16.3 Million
1-Month Returns: -5.9%
YTD Returns: -59.0%
Source: https://smallcappower.com/top-stories/canadian-hemp-stocks-upside/
Oceandavid
8年前
Big part of Naturally Splendid’s future.
For large beverage companies, the push into pot is all about the fear of missing out. After getting beat on trends including craft beer, coconut water, and flavored seltzer, the drink giants don’t want to miss the next trendy ingredient: cannabis. Whether it’s the THC that gets you high or the nonpsychoactive CBD, weed components are being infused into drinks with an eye toward the mass market.
PepsiCo Inc. faces a struggle for growth as consumers turn away from sugary soda. Its shares took a hit recently after its chief financial officer told analysts the company had no plans for cannabis. Coca-Cola Co. recently acknowledged it was looking at the possibility of infusing CBD into “functional, wellness beverages around the world.” The interest of Coke was more validation for the burgeoning cannabis industry, which has moved from the black market to the stock market and now appears to be on its way to the supermarket.
Beverages are forecast to make up 20 percent of the market for marijuana edibles by 2022, according to Canaccord Genuity
Legal marijuana sales are expected to rise to $11 billion in the U.S. this year, from $9 billion in 2017, and cannabis-infused beverages account for less than 1 percent of that. But a recent report from the bank Canaccord Genuity Group Inc. estimated that sales of drinks infused with THC or CBD, forecast to make up 20 percent of the edibles market, will reach $600 million in sales in the U.S. by 2022. In Colorado, which became the first state to legalize recreational marijuana in 2014, sales of cannabis drinks almost doubled in 2017 and are up an additional 18 percent in the first half of this year, according to Flowhub LLC, which tracks marijuana sales data.
The current pot investment boom got started in August when Constellation Brands Inc., best known as the maker of Modelo Especial beer and Robert Mondavi wine, plowed $3.8 billion into Canopy Growth Corp., an Ontario-based cannabis company. Molson Coors Brewing Co. has invested in the industry, and the liquor giant Diageo Plc is rumored to be interested, which has helped drive the value of at least 10 Canadian companies above $1 billion. Alcohol companies are concerned that young professionals might swap out their usual wine or cocktail for a weed beer or some THC-infused water, an idea known as the “substitution effect.”
Canopy has been secretly working on cannabis drinks for the past couple of years in an area of its Ontario campus known as the Section 56 Exemption lab. It’s trying to sort out how much of it to put into beverages, how long it will take for effects to be felt, and how long they take to wear off. When Canopy was talking to Constellation about a partnership last year, it didn’t mention the project for fear that the big guys would steal the idea. Now, Canopy Chief Executive Officer Bruce Linton argues there’s a massive market for weed drinks. “I think I would quit if I was the CEO of a beer or spirits company and I was not allowed to move on this,” he says. “I would quit because you know you’re going to get fired in the future because you didn’t catch it.” —With Kristine Owram
mikHigh
8年前
HUGE, US BEER PARTNERSHIP! Naturally Splendid Announces Proprietary HempOmega™ Approved for Hemp Fortified Beer Formulations and Commences Production
VANCOUVER, British Columbia, Oct. 24, 2018 (GLOBE NEWSWIRE) -- Naturally Splendid Enterprises Ltd. (“Naturally Splendid” or “NSE” or “The Company”) (TSX-V:NSP) (OTCQB:NSPDF) (Frankfurt:50N) is pleased to announce an Exclusive Sales Agreement with Sipp Industries Inc. (OTC: SIPC), which has received approval in the states of Colorado and Illinois to include HempOmega™ as an ingredient in their custom formulated hemp beer and has produced their “Major Hemp Brown Ale” and newly developed “Major Hemp H-IPA brands to multiple locations throughout Colorado and Illinois.
Under the terms of the Agreement, Naturally Splendid grants Sipp limited exclusive rights to purchase HempOmega™ for use as a beer beverage additive in its Alcohol Tobacco Tax Trade Bureau (“TTB”) approved hemp beer recipe, and to sell its TTB approved hemp beer recipe to third party beverage companies, in Colorado and Illinois on an exclusive basis pending meeting certain volume and activity levels. Additionally, Sipp is in the process of applying to TTB for regulatory approvals to include HempOmega™ in beer formulations in California and Texas and will be granted limited exclusive rights for those states upon final approval from TTB for inclusion of HempOmega™ into beer formulations.
Naturally Splendid CEO, Mr. Doug Mason states, “We are more than pleased to see the success Sipp has attained with our proprietary HempOmega™ ingredient in their beer formulations after significant testing. After a year of testing, Sipp has developed a hemp beer with broad consumer appeal. Additionally, Naturally Splendid is pleased to have formed a strategic relationship with Sipp that will begin to aggressively market HempOmega™ as an ingredient to both craft and national beer companies in the United States.”
To continue catering to the growing Colorado market, Sipp Industries initiated production of Major Hemp Brown Ale with Denver based brewing partner Sleeping Giant Brewing Company. Based on forecasted demand, the companies have made contingency plans to more than triple production to fulfill expected demand. Over the course of 2017 and 2018, Major Hemp Brown Ale quickly gained in popularity throughout the state of Colorado expanding to over 50 new restaurants, bars and establishments. MHBA has been featured in Denver’s Westword, hosted two consecutive 4/20 events and continues to receive reorders from existing customers.
Sipp Industries will continue working with partners to distribute MHBA throughout the state of Colorado. The companies believe they will continue to satisfy current orders and significantly grow its list of recurring customers over the course of the year.
President of wholly-owned subsidiary Major Hemp, Ted Jorgensen, commented, “As we approach our third year in the hemp beer business we couldn’t be more excited about 2018 and beyond. We have a loyal and growing customer base that is opening up opportunities for our Major Hemp branded beers nationally. The company is currently speaking with additional multi-state beer distributors to expand the market for Major Hemp Brown Ale outside of the state of Colorado. Jorgensen continued, “We are finalizing logistics and regulatory matters with several opportunities for mass distribution. Additionally, we have a pending purchase order with a third-party in the Midwest we are finalizing terms with. There is no shortage of demand for Major Hemp Brown Ale and we look forward to executing further sales and partnerships over the coming weeks.”
The company is excited to report it is making plans for production and distribution of Major Hemp branded beers in the state of California which is the largest craft beer state in the country as well as Texas.
Sipp Industries, Inc. a multifaceted corporation specializing in technology, manufacturing and distribution of commercial and consumer products, announces that it has completed new label designs for flagship hemp beer “Major Hemp Brown Ale” and newly developed “Major Hemp H-IPA.” The Company reports that it is in the process of submitting both labels for Certificate of Label Approval (COLA) to the Alcohol and Tobacco Tax and Trade Bureau (TTB).
The Brewers Assocaiton, conducted a study and found that overall U.S. beer volume sales were down 1% in 2017, whereas craft brewer sales continued to grow at a rate of 5% by volume, reaching 12.7% of the U.S. beer market by volume. Craft production grew the most for microbreweries.
Retail dollar sales of craft increased 8%, up to $26.0 billion, and now account for more than 23% of the $111.4 billion U.S. beer market.
About Naturally Splendid Enterprises Ltd.
Naturally Splendid is a biotechnology and consumer products company that is developing, producing, commercializing, and licensing an entirely new generation of plant-derived, bioactive ingredients, nutrient dense foods, and related products. Naturally Splendid is building an expanding portfolio of patents (issued and pending) and proprietary intellectual property focused on the commercial uses of industrial hemp and cannabinoid compounds in a broad spectrum of applications.
For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-673-9573
On Behalf of the Board of Directors
Mr. Douglas Mason
CEO, Director
Contact Information
Naturally Splendid Enterprises Ltd.
(NSP – TSX Venture; NSPDF – OTCQB; 50N Frankfurt)
#108-19100 Airport Way
Pitt Meadows, BC, V3Y 0E2
Office: (604) 465-0548
Fax: (604) 465-1128
E-mail: info@naturallysplendid.com
Website: www.naturallysplendid.com
https://globenewswire.com/news-release/2018/10/24/1626122/0/en/Naturally-Splendid-Announces-Proprietary-HempOmega-Approved-for-Hemp-Fortified-Beer-Formulations-and-Commences-Production.html
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