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The FDA issued draft guidance for clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. The FDA is taking comments and suggestions for the next 60 days. The guidance does not address the development of fully synthetic versions of substances that occur in cannabis.
As part of drug development, sponsors may conduct clinical trials under an investigational new drug (IND) application to determine if a drug is safe and effective for a particular intended use. The IND application provides a mechanism for those developing a new drug to conduct studies and ship their proposed drug to clinical trial sites. The data obtained from these studies may later become part of a new drug application (NDA), which is then used to formally propose that FDA approve a new drug for sale in The United States.
Organigram Holdings Inc. (NASDAQ: OGI) (TSX: OGI) reported its third-quarter net revenue fell to $18.0 million from last year’s $24.8 million for the same time period ending in May. The net loss increased 783% to $89.8 million from last year’s net loss of $10 million. The company noted that several things went wrong which led to the drop in revenue. Organigram said in its statement, “Lower flower sales volumes and a lower average net selling price driven by increased competition and as the large format dried flower value segment of the recreational market grew in Q3 2020 while there was a delay launching Organigram’s large-format value product due in part to a reduced workforce from COVID-19 and earlier delays in packaging material and equipment.
Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF)closed on a C$34 million offering that was announced on July 2, 2020. The company said proceeds of the offering will be used to fund Grassroots’ high-return expansion projects, replenish its working capital as well as for general corporate purposes.
Joseph Lusardi, CEO of Curaleaf, said, “Our successful completion of this private placement further strengthens Curaleaf’s balance sheet and provides additional flexibility to support our future expansion initiatives as we look to extend our leadership position in the fast-growing U.S. cannabis market.”
The psychedelic industry is seeing a boom in the creation and expansion of ketamine clinics. The growth is in this industry has come about as the acceptance of the medical marijuana industry spread across North America. A group of medical professionals believes that this stigmatized substance may offer effective treatment for those suffering from mental health crises.
Known colloquially as special K, super acid, and cat valium, ketamine was added to the U.S. schedule of controlled substances in 1999. A “dissociative anesthetic,” ketamine has a street reputation for its dream-like high.
In Other News
Papa & Barkley, the leading cannabis wellness company in California, best known for its award-winning topicals and tinctures, today announced the launch of its Releaf Gummies, a line of sugar-free, gluten-free, keto-friendly, zero-calorie, full spectrum, and solventless edibles. They come in four fruity flavors: Tart Apple and Berry Burst, which are vegan, and Juicy Orange and Wild Strawberry.
Designed for health-conscious consumers, Releaf Gummies are Papa & Barkley’s first line of edible wellness products. Great for stress, anxiety, relaxation, sleep, and acute pain, each gummy contains 5mg of THC, making it easy for consumers to control and increase their dose as needed.