420 with CNW — FDA Publishes Final Guidance for Cannabis Drug Development

Earlier this week, the FDA published its final guidance on cannabis drug development in the federal register. This comes after it released a draft version in 2020. The guidance outlines the basic clinical study standards, considerations for researchers and the drug development process.

The legalization of hemp in the 2018 Farm Bill is one major reason for the guidance’s release because it made the drug development process for hemp different from marijuana, which is still classified as a Schedule I substance under the Controlled Substances Act. In its statement, the agency said that the guidance outlined its views on topics related with the development of cannabis and cannabis-derived drugs for humans.

The FDA also made a number of nonbinding recommendations for scientists interested in the development of cannabis drugs that could be commercialized. The advice, the agency noted, was centered on addressing the regulatory controls and legal definitions related to cannabis as well as specific questions raised about drugs that contained cannabis.

One section of the guidance centers on how hemp can be distinguished from marijuana by calculating THC content. Legally, hemp is defined as cannabis that contains not more than 0.3% THC by dry weight.

In its final guidance, the FDA advises that researchers determine THC content in their proposed cannabis investigational drug products in the early stages of the development process. The agency notes that this may be useful because any drug products that contain more than 0.3% THC may be considered Schedule I substances.

Meanwhile, legislators and advocates await the FDA’s actions on permitting the marketing of hemp-based products such as CBD oil. Earlier in November, the agency sent warning letters to five companies that sold beverages and food containing CBD. While it did not specify why those particular companies were targeted, the agency did state that the companies sold products that individuals could confuse for traditional beverages or foods, resulting in overconsumption or unintentional consumption of CBD.

CBD (cannabidiol) is an active ingredient derived from the hemp plant. This compound is said to be beneficial for various health issues and, unlike THC, it does not induce any highs when ingested. A continued lack of clear regulations for CBD leaves stakeholders in the grey area and many more frustrated over the FDA’s slow rulemaking process.

In other news, the FDA has been tasked with carrying out a scientific review on marijuana to aid in the evaluation of its federal scheduling, as directed by President Joseph Biden.

For entities that are already conducting cannabis drug development, such as India Globalization Capital Inc. (NYSE American: IGC), the new guidance may simply clarify what they are already doing because any clinical development program can only take place once the needed approvals are granted by regulators, such as the DEA and the FDA.

NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC

About CNW420

CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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420 with CNW — Study Shows Cannabis Boosts Sex Quality for All Genders

In a recent study, participants reported that cannabis increased their desire, intensified their orgasms, and sharpened their sensory perception, providing evidence that cannabis can improve sex. Moser Amanda, a sexologist residing in Denver who has specialized in integrating cannabis and sex, took part as the paper’s lead author.

More than 70% of respondents to Moser’s online questionnaire, which included more than 811 marijuana-using individuals, reported that smoking marijuana before sex enhanced orgasms and boosted desire, regardless of gender or age. The results showed greater sexual satisfaction and functioning. About 62.5% of users claimed that marijuana increased pleasure during masturbation.

According to the authors, the survey’s findings are important for ladies’ satisfaction. Recent research found that women who engage in sex with men are usually less likely to feel sexually satisfied than their partners. The study reports that women are likely to orgasm more frequently when using marijuana prior to sexual activities.

Moser used social media platforms and organizations that advocate for the decriminalization of marijuana and medical cannabis to draw participants. Only adults above the age of consent were eligible to respond.

The authors point out that a number of the results were consistent with earlier studies. For instance, higher desire and orgasmic intensity were reported by both men and women. Women asserted that they might have more orgasms more frequently.

Moser states that when participants used cannabis consciously prior to sex, sexual satisfaction increased by a large margin. Ladies who experience vaginismus and have lowered desire may profit from the ability of cannabis to relax muscles and improve sexual performance.

A 2019 survey with related findings was conducted by a researcher named Becky Lynn, a specialist in women’s reproductive health and university lecturer of gynecology and obstetrics at Maryland’s Saint Louis University. In that survey, women who admitted to using cannabis prior to sex were more likely to say they had more satisfying and intense orgasms.

However, based on another study, better sex does not necessarily result from consuming more cannabis. A literature review from 2019 found that marijuana affects arousal depending on the dosage, with lower levels of THC associated with more stimulation and pleasure. While most research has shown that cannabis may benefit female sexual function, the study found that too much THC can have a contrary effect.

Additionally, cannabis and sex have been positively linked in various online studies. Also, one survey revealed a possible link between the decriminalization of cannabis and enhanced sexual interactions.

As more enterprises such as REZYFi Inc. step up to provide alternative financing to marijuana industry actors in the absence of access to traditional banks, more innovative products could be introduced on the market so that other benefits of this plant can be brought to the fore.

NOTE TO INVESTORS: The latest news and updates relating to REZYFi, Inc. are available in the company’s newsroom at https://cnw.fm/REZY

About CNW420

CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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420 with CNW — Marijuana Firms Are Boosting Brand Loyalty Through Sale of Cannabis Seeds

With more than 30 U.S. states now allowing some form of cannabis use within their borders, hundreds of businesses have sprung up to supply the almost unending demand for cannabis products. As the market attracts more players and becomes increasingly competitive, companies have adopted unique approaches to stand out from the ever-growing crowd and increase brand loyalty among their customers.

One recent tactic that businesses within the cannabis industry have adopted has been to include marijuana seeds in their product lineups. While this might seem counterintuitive because it could encourage consumers to grow their own cannabis rather than purchase from licensed retailers, cannabis companies don’t see it that way.

Trade Roots cofounder Carl Giannone stated that even though plenty of people who have home gardens grow tomatoes over the summer and spring, a whopping 98% of the tomatoes they consume are bought in grocery stores. Applying this logic to cannabis seeds, Giannone explained that if growing tomatoes encouraged people to buy tomatoes then it would make sense to let your customers grow their own tomatoes.

Now that a federal policy change made it legal for marijuana businesses to sell cannabis seeds, more companies are choosing to offer seeds for purchase to their customers. Some companies are using this new product line to boost their bottom lines while others see it as a way to increase brand loyalty and share their genetics with customers.

Rapper and entrepreneur Berner, who is also the cofounder and CEO of Cookies, a cannabis business based in the San Francisco Bay Area, announced in November that his company would start selling cannabis seeds for home cultivation. The cannabis company launched its marijuana seed bank on Black Friday. According to Berner, the company “broke some internal records” during the launch. He stated that there was definitely demand for marijuana seeds among consumers, adding that the company wanted to empower consumers to explore cannabis and learn about cultivating it from the ground up.

This new market is due for a policy change by the Drug Enforcement Administration, which clarified in 2022 that it was legal for cannabis businesses to distribute and sell cannabis seeds across the country.

According to Ryan Douglas, a cannabis cultivation consultant based in Florida, the move could allow businesses to boost their brand recognition and loyalty through high-quality or rare cannabis varieties. This approach of selling cannabis seeds also has the added benefit of potentially boosting the sales of ancillary enterprises such as Advanced Container Technologies Inc. (OTC: ACTX), which focus on making indoor cultivation equipment.

NOTE TO INVESTORS: The latest news and updates relating to Advanced Container Technologies Inc. (OTC: ACTX) are available in the company’s newsroom at https://cnw.fm/ACTX

About CNW420

CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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420 with CNW — Connecticut Retailers See Brisk Business During First Week of Legal Cannabis Sales

Following the opening of seven adult-use dispensaries on Jan. 10, 2023, the first week of recreational cannabis sales in Connecticut was marked by high customer demand, low stock levels and the introduction of gummies. Businesses increased staff, pushed online transactions, shifted employees from cannabis markets, and fulfilled orders outside for customers waiting in line to keep up with the increased demand.

Despite numerous restrictions on retail cannabis sales, the Department of Consumer Protection (DCP) reported that adult-use sales exceeded $251,000 in the first few hours of operation.

With three of its four medical marijuana licenses converted into hybrid retail permits to serve recreational users, Fine Fettle Dispensary has seen a fourfold increase in transactions during the past week. The company chose to fulfill orders primarily through online preorders and scheduled pickup times at its various locations, with notification updates sent via text or email.

Similarly, long lines formed outside the Zen Leaf dispensary in Meriden, where customers cheered and were given free donuts and coffee.

To reduce the long checkout line, the Botanist in Montville used a team of staffers outside the store to take customer questions, log orders under tents on mobile tablets and inform customers about available strains.

Connecticut has one of the most restrictive adult-use cannabis markets in the nation. Only 13 businesses of any kind had licenses when it first legalized cannabis, and all 13 businesses paid high premiums to convert their medical cannabis licenses into hybrid retail and production operations.

Producers pay a $3 million fee, while dispensaries pay a $1 million fee. However, if businesses agree to form two separate joint ventures with two social-equity applicants, which includes two additional licenses, the fees could be reduced by half.

The availability and variety of products have also been hampered by potency limits and product bans. THC is limited to 30% for flower and 60% for all other cannabis products under Connecticut’s adult-use program, restrictions that do not apply to the MMJ market.

For recreational users, it is forbidden to use products that are administered like medicine, such as capsules, pills, suppositories, and sublingual products that go under the tongue.

Additionally, Connecticut adopted novel classification systems that prohibit medical and adult-use retailers from using names of conventional cannabis strains, including Gorilla Glue, Gelato or Wedding Cake. Instead, the strains are sold under names with pharmacological connotations, such as Sativarin R T23.12, Indicol VW T28.57 and Hybridol HI T25.13.

Despite the difficulties facing the retail industry, consumer demand is strong, and retailers anticipate business growth in the months to come, especially after the holiday shopping season.

The 2022 MJBizFactbook predicts that recreational sales in Connecticut will reach $300 million to $375 million this year as more growers, manufacturers and sellers come online; projections call for those numbers to reach $650 million to $825 million by 2026.

As these new markets take off, expansion-focused companies such as Flora Growth Corp. (NASDAQ: FLGC) will have more viable options to study as they expand their footprint across the country and internationally.

NOTE TO INVESTORS: The latest news and updates relating to Flora Growth Corp. (NASDAQ: FLGC) are available in the company’s newsroom at https://cnw.fm/FLGC

About CNW420

CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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CannabisNewsBreaks – Flora Growth Corp. (NASDAQ: FLGC) Issues 2023 Forecasted Revenue Anticipating >100% YOY Growth

Flora (NASDAQ: FLGC), a leading all-outdoor cultivator, manufacturer and distributor of global cannabis products and brands, today announced revenue guidance of US$90 million to US$105 million for fiscal year 2023. Flora’s 2023 revenue guidance reflects expected organic growth in its House of Brands division and expansion of its Commercial & Wholesale division capabilities. In addition, the forecasted growth incorporates Flora’s new German-based business as established through the acquisition of Franchise Global Health. “We are pleased to announce that we will meet our guidance for 2022 and are issuing revenue guidance of $90 million – $105 million for the year 2023,” said Luis Merchan, chairman and CEO of Flora. “Our 2023 forecasted revenue range represents anticipated growth in excess of 100% over last year and highlights our continued momentum, despite a challenging macroeconomic backdrop that has disproportionately impacted the cannabis industry.”

To view the full press release, visit https://cnw.fm/5oe5H

About Flora Growth Corp.

Flora is building a connected, design-led collective of plant-based wellness and lifestyle brands, designed to deliver the most compelling customer experiences in the world, one community at a time. As the operator of one of the largest outdoor cannabis cultivation facilities, Flora leverages natural, cost-effective cultivation practices to supply cannabis derivatives to its commercial, house of brands and life sciences divisions. Visit www.FloraGrowth.com or follow @floragrowthcorp on social media for more information.

NOTE TO INVESTORS: The latest news and updates relating to FLGC are available in the company’s newsroom at https://cnw.fm/FLGC

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

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420 with CNW — US Air Force Grants Cannabis Waivers to More Recruits Than Anticipated

As cannabis reform has swept across the country, there have been questions about how institutions that still abide by prohibitionist cannabis policies would deal with an influx of cannabis users among their ranks. Last September, the U.S. Air Force and Space Force launched a pilot program that would allow recruits who had tested positive for marijuana during the enlistment process to enlist.

The two military branches announced last year that while active members were still banned from using cannabis regardless of state laws, new recruits who had high enough scores on their qualification tests, did not have convictions on their records, and met enlistment standards would be eligible for a waiver.

This waiver would allow prospective space cadets and pilots to retake the cannabis test 90 days after they failed their initial test rather than receive a permanent ban. The waiver was the military’s attempt at offering leniency to prospective recruits coming from states with legal medical or recreational markets.

Just a few months later, the Air Force revealed that it had granted recruits way more waivers than expected when it launched the program. The Air Force stated that that while it estimated that around 50 recruits would qualify for the waiver annually based on prior individual data on drug screening, the military branch had already granted the second chance waivers to more than 40 applicants from September through the end of December 2022.

According to Chrissy Cuttita, Air Force recruiting service spokeswoman, the Air Force expects an increase in waiver requests as more states adopt a more permissive stance toward marijuana and derivatives of THC.

At the time of the program’s launch, the Air Force and Space Force said that they would review the results of the program after two years to see if they would make the waiver a permanent feature of the recruitment process. If the pilot program is integrated into the Air and Space Forces’ recruitment process, the two military branches will be in line with the Marine Corps, Navy and Army.

The pilot program will run until late 2024, after which the Air Force will make a decision on whether to make it permanent or scrap it.

This would be a major step for the Air Force as the military branch made an announcement two years ago reiterating that active members weren’t allowed to bring products infused with hemp such as lotions, lip balms and shampoos to the base.

Furthermore, the Air Force warned members to be careful with miracle sticky buns as marijuana was still illegal under federal law and a positive THC metabolite test could result in a “separation from service.”

Members of the armed services may freely enjoy the medicinal benefits of cannabis compounds once companies such as India Globalization Capital Inc. (NYSE American: IGC) commercialize the formulations they are developing from THC and other cannabinoids.

NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC

About CNW420

CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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420 with CNW — Texas Authorities Start Process to Issue Additional Medical Marijuana Dispensary Licenses

According to a press release issued by the Texas DPS, the department is now accepting applications for the possibility of adding more medical marijuana dispensaries. The application window, which opened on Monday, is expected to close on April 28, 2023.

The release stated that the number of licenses that would be approved would be decided in the future. However, it’s doubtful that the agency will set a limit before the summer since the legislature might pass legislation that could allow for more permitted dispensaries.

Texas legalized medical cannabis in 2015. The diseases and conditions it covered as well as the amount of THC that was permitted, however, were very limited by the law. A few years later, the legislature expanded the list of ailments that could be treated through the Compassionate Use system. Even so, some activists think the program allows few conditions, and they’re optimistic the legislature will allow for expansion this year.

Texas currently has only three licensed dispensaries, all of which are in Central Texas. With so few dispensaries offering cannabidiol with low THC levels, some activists believe the supply is insufficient to meet demand.

Nico Richardson, the interim CEO of one of the licensed dispensaries, Compassionate Cultivation, thinks the DPS’s action is unwarranted. According to him, New York and Florida have more patients in a comparable program than Texas. Additionally, he claims that issuing more licenses would be counterproductive because licensed producers are only allowed to keep the product in the manufacturing facility.

The patients’ base for cannabis’ medical use has increased since legal use debuted in 2015. At first, only patients with uncontrollable epileptic seizures were eligible for prescriptions. However, a law passed by the legislature in 2019 allowed more people to gain access to the program, making it possible for people with multiple sclerosis, autism and terminal cancer to obtain prescriptions.

One of the causes for fewer patients in Texas is the cap on the ailments that qualify for the Compassionate Use Program. The legislature can enact laws to broaden the range of physical conditions that the program can treat.

Medical cannabis use has grown in popularity in recent years, with 37 states legalizing its use in the United States.

Sid Miller, the Texas agriculture commissioner, also declared his support for the legalization of medical cannabis last summer. Miller is one of the top Republican leaders in Texas to advocate for the full legalization of medical cannabis.

As the state loosens its strict controls and more players enter the medical cannabis industry, there is a likelihood that the demand for alternative funders such as REZYFi Inc. will grow, given the lack of action in passing federal marijuana banking laws.

NOTE TO INVESTORS: The latest news and updates relating to REZYFi, Inc. are available in the company’s newsroom at https://cnw.fm/REZY

About CNW420

CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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CannabisNewsBreaks – IBN to Shine the Spotlight on 2023 Marquee Events for Cannabis Drinks Expo

IBN (“InvestorBrandNetwork”), a multifaceted communications organization with 50+ brands, today announced its re-engagement with Cannabis Drinks Expo to serve as an official media sponsor for its marquee exhibits in San Francisco and Chicago. The events, to be held later this year, will be organized by Beverage Trade Network and draw industry stalwarts, public policy experts and renowned innovators. As part of a larger multi-year series, they have grown to become the largest gathering of the cannabis drinks industry around the globe. In its capacity as the media sponsor, IBN will leverage its array of extensive corporate communications solutions to heighten the visibility of both events while elevating the recognition of participating companies via an array of digital channels and full-scale media distribution. In addition, IBN will deploy articles via CannabisNewsWire’s key syndication outlets and extend reach via multiple highly trusted brands that have accumulated a collective audience of more than 2 million through social media and newsletter distribution. “Cannabis Drinks Expo has become a key part of driving ongoing development within this unique sector of the cannabis market. We are pleased to be collaborating again with their team of organizers,” said Jonathan Keim, IBN’s communications director. “We will be leveraging the latest tools in digital outreach and social media management for both events this year.”

To view the full press release, visit https://cnw.fm/r2yG2

About IBN

IBN consists of financial brands introduced to the investment public over the course of 17+ years. With IBN, we have amassed a collective audience of millions of social media followers. These distinctive investor brands aim to fulfill the unique needs of a growing base of client-partners. IBN will continue to expand our branded network of highly influential properties, leveraging the knowledge and energy of specialized teams of experts to serve our increasingly diversified list of clients.

Through NetworkNewsWire (“NNW”) and its affiliate brands, IBN provides: (1) access to a network of wire solutions via InvestorWire (“IW”) to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) full-scale distribution to a growing social media audience; (5) a full array of corporate communications solutions; and (6) a total news coverage solution.

For more information on IBN, visit https://www.InvestorBrandNetwork.com

Please see full terms of use and disclaimers on the InvestorBrandNetwork website, applicable to all content provided by IBN wherever published or re-published: https://IBN.fm/Disclaimer

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

To receive SMS text alerts from CannabisNewsWire, text “Cannabis” to 844-397-5787 (U.S. Mobile Phones Only)

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Lexaria Bioscience Corp. (NASDAQ: LEXX) CEO Anticipating ‘Best Year Ever’ in 2023

  • Lexaria Bioscience recently released its 2023 annual letter from CEO Chris Bunka, providing a strategic update to all stakeholders
  • The letter highlights the key milestones achieved in calendar 2022, outlines expectations for calendar 2023, and indicates why Chris Bunka expects 2023 to be the company’s best year so far
  • 1In calendar 2023, Lexaria expects to attain FDA registration for an investigational new drug (“IND”) program and commence Phase 1(b) clinical study evaluating the safety and tolerability of DehydraTECH(TM)-processed CBD as a treatment for hypertension
  • The company will also be pursuing commercial relationships in 2023 even as its R&D continues to progress by engaging in discussions with potential collaborators who may license the patented DehydraTECH technology

Lexaria Bioscience (NASDAQ: LEXX) started calendar 2022 with optimism, which according to CEO Chris Bunka’s recently published annual letter to shareholders (https://cnw.fm/doJop), turned out to well founded. Now, as the company begins calendar 2023, “that optimism is, if anything, even stronger today.” Lexaria has reason to be optimistic about the current year, coming off a year that saw it successfully fulfill its primary objectives and tick most, if not all, of the boxes on its priority list.

At the start of calendar 2022, the company intended to introduce its patented DehydraTECH(TM) drug delivery technology to world-leading collaborators and to avoid raising additional funds through the capital markets. It also planned to develop its DehydraTECH-CBD hypertension program, explore whether DehydraTECH-nicotine pouches could replace nicotine administration via inhalation (smoking), and evaluate DehydraTECH-CBD as a therapeutic against other conditions such as epilepsy, dementia, and diabetes. Lexaria, through Chris Bunka’s letter, is pleased to report that these objectives were wholly completed in 2022 or are nearing completion in early 2023.

The completed objectives include the introduction of DehydraTECH to potential licensees via ongoing discussions as well as the completion of EPIL-A21-1 animal study evaluating DehydraTECH-CBD as an anti-seizure therapeutic and the HYPER-H21-4 human clinical study evaluating DehydraTECH-CBD as a potential treatment for hypertension.

The results affiliated with the primary objectives of the HYPER-H21-4 study, namely the blood pressure and pharmacokinetic performance, were positive, with no serious adverse events observed. It is, therefore, accurate to say that the study was a success, Bunka writes. Moreover, in the EPIL-A21-1 study, DehydraTECH-CBD demonstrated certain performance enhancements, namely more efficacy at lower doses and more rapid action, than Epidiolex, a leading CBD-based anti-seizure medication. Of note, and following the success of the EPIL-A21-1 seizure study, Bunka writes, Lexaria is rating its DehydraTECH-CBD for seizure investigation as one of its highest priorities along with the DehydraTECH-CBD for hypertension and DehydraTECH-nicotine.

In the Q1 of calendar 2023, the company expects to complete dosing in the human nicotine study NIC-H21-1, the animal diabetes study, and the animal dementia study, having initiated them in late 2022. The company is also evaluating a series of secondary objectives of HYPER-H21 4 study, with some of the findings and additional results expected within this period.

Remarkably, the company achieved these milestones and managed the growth while exercising excellent fiscal controls. In fact, and despite the inflationary pressures, Lexaria hit its annual 2022 budget, +/- about 2%, building on an accomplishment that began in 2021. This helped the company preserve its existing capital and stay true to its earlier commitment not to raise additional funds by issuing equity or taking on any debt. As a result, its cash in hand is enough to support operations through nearly all of 2023 without needing to raise additional capital if the company chooses to reduce its R&D spending.

“However, as we prefer to keep advancing our applied R&D at as rapid a pace as we can, we are also continuing to pursue capital-strengthening possibilities that do not involve the issuance of any equity,” Bunka writes.

According to the letter, the R&D programs and the capital-strengthening opportunities are interlinked. If successful, the DehydraTECH-CBD hypertension program, for example, is expected to help increase not only Lexaria’s corporate value but also the probability of reaching one or more commercial out-licensing agreements within the pharmaceutical industry. In addition, the success could also pave the way for more commercial pursuits of its DehydraTECH-CBD for therapeutic use. Similarly, if the nicotine study is successful, the company feels it will have inched closer to completing its scientific investigations, positioning it to market the technology to the global nicotine industry in pursuit of growing revenue streams.

“Each of these three areas of investigation [DehydraTECH-CBD as a hypertension therapeutics, DehydraTECH-CBD as an anti-seizure medication, and DehydraTECH-nicotine] has the potential to support important industry relationships that prove meaningful or even transformative for Lexaria. Because of the obvious medical and market needs in each of these three sectors, we will be pursuing commercial relationships in 2023 even as our R&D continues to progress,” the letter reads.

Accordingly, Lexaria’s CEO expects calendar 2023 will be the company’s “best year ever.” Among the key milestones the company intends to achieve is a Food and Drug Administration (“FDA”) registration for an Investigational New Drug (“IND”) program that will sanction the commencement of a Phase 1(b) FDA-registered clinical trial evaluating the safety and tolerability of DehydraTECH-CBD as a treatment for hypertension. The company expects this research program will dominate the second half of calendar 2023 and beyond.

In all, the registered clinical trials for DehydraTECH-CBD are expected to culminate in the filing of a new drug application (“NDA”) via the abbreviated 505(b)(2) pathway. To support this shortened route to commercial approval, Bunka says, Lexaria will leverage precedent safety data generated from the clinical study of FDA-approved Epidiolex. In its trials, for example, Epidiolex demonstrated the pharmaceutical’s safety and tolerability when administered chronically but at much higher doses than Lexaria’s intended dosing of DehydraTECH-CBD.

Still, the company maintains that DehydraTECH-CBD is not its only long-term plan for FDA registration. “Stakeholders can follow our progress in other areas of therapeutic interest through the results we receive in our applied R&D programs,” emphasizes Bunka.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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420 with CNW — NJ Senate Committee OKs Bills Allowing Cannabis Companies to Deduct Expenses on Tax Returns

Cannabis businesses in New Jersey may soon be able to enjoy tax benefits that have been available to companies in other industries for decades. Thanks to cannabis’ federal status as a controlled drug, licensed marijuana businesses cannot access tax benefits, including deductions, despite paying billions of dollars in taxes.

The New Jersey Senate Budget Appropriations Committee recently approved two bills that would finally make it possible for cannabis businesses to deduct some expenses on their state tax returns. The companion measures came from the Assembly and the Committee’s chamber before the committee made them identical and advanced them. The pair of bills, which are merely a stopgap measure as IRS Tax code 280E still blocks cannabis businesses across the country from making federal deductions, were passed in a unanimous vote.

Licensed marijuana businesses in New Jersey will at least be able to deduct some expenses from their tax returns under the two companion bills. The version of the bill introduced by Assemblymember Annette Quijano was amended in committee before advancing past the full chamber in October. During the amendments, committee members agreed to eliminate a provision that would have locked out cannabis businesses with gross receipts of more than $15 million of the state tax deductions. On the other hand, the Senate version of the state tax deduction bill was amended to include these Assembly provisions.

Even if the companion bills are enacted, however, cannabis businesses still won’t be able to file for tax deductions in their federal tax filings due to federal law.

According to a 2022 fiscal analysis, the economic impact of these legislations will likely be mixed. For starters, states may end up losing an “indeterminate annual loss of revenue” as cannabis businesses would have relief from some of the tax they currently pay to the state. On the other hand, this is good news for businesses that will have the opportunity to reduce their annual tax obligations and increase their revenue.

According to the Office of Legislative Services (OLS), gaining access to these tax deductions and credits may allow cannabis businesses to “generate more economic activity.” This could indirectly result in an “indeterminate amount of additional annual revenue” for local and state governments, the OLS noted.

Aside from New Jersey, several other states are working to alleviate the unique financial pressures that challenge the cannabis industry due to federal prohibition. Cannabis regulators in Iowa have revealed that they will ask the legislature to take up reform on the matter while a House committee in Pennsylvania advanced legislation to allow cannabis businesses to make certain tax deductions for expenses last year.

As states lose patience over federal inaction on matters of enacting cannabis regulatory reforms, sector actors such as Flora Growth Corp. (NASDAQ: FLGC) could increasingly see state-level reforms aimed at supporting the industry overcome some of the hurdles they face.

NOTE TO INVESTORS: The latest news and updates relating to Flora Growth Corp. (NASDAQ: FLGC) are available in the company’s newsroom at https://cnw.fm/FLGC

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