Pharmacyte Biotech Inc (NASDAQ: PMCB) Gets Ready to Resubmit Investigational New Drug (IND) to the FDA
Pharmacyte Biotech Inc (NASDAQ: PMCB) gave an update on its actions to remove the hold on treatment for inoperable, locally advanced pancreatic cancer from the U.S Food and Drug Administration (FDA).
The FDA asked for more information before it could give approval
After Pharmacyte an Investigational New Drug (IND), the FDA asked it to hand in more information and studies before getting approval. Pharmacyte has now finished other assays and studies on its treatment. The company is completing its findings before presenting them to the FDA.
According to Kenneth L. Waggoner, the CEO of Pharmacyte, the company understands why the FDA needs more information as it uses live encapsulation which is a relatively new treatment. He adds that the company believes the FDA will approve their IND from the assays and additional studies.
Waggoner reminded people that the company had updated them on the clinical hold given by the FDA while they sought additional data in June. Fortunately, the company is ready to show the regulator its new IND package.
Because the company hopes that this submission will be fruitful, it has partnered with Austrianova and Contract Research Organizations (CRO). Moreover, it has added more scientists and regulatory experts.
Pharmacyte experienced delays while conducting its studies
Waggoner states that Pharmacyte faces supply chain disruptions and delayed material deliveries due to COVID like all other companies worldwide. As a result, there have been days in completing its assays and studies.
The delays have also caused disruptions as the company manufactures encapsulated live cells and empty capsules needed for the assays and studies. Furthermore, the labs carrying out the assays and studies have had to wait a long time to receive the products they need for the assays and studies.
Fortunately, Pharmacyte managed to conduct several tests. One test evaluated the product stability of CypCaps, the drug they were testing. The researchers tested its stability after storing it at -80° for 3,6,9,13 and 18 months.
Pharmacyte also set out to carry out biocompatibility studies. They managed to complete six after designing eight studies. The company is still doing the remaining two. Another study Pharmacyte is conducting is the pig study, which addresses the biocompatibility and long-term effects of implanting CypCaps.
American Battery Metals Corp (OTCMKTS: ABML) Clinches A 13.8 Acre Property Situated At Storey County, NV
American Battery Metals Corp (OTCMKTS: ABML) bought a 13.8-acre property in the most significant industrial park worldwide – Tahoe Reno Industrial Center, situated at Storey County, NV.
Utilizes advanced extraction technologies
It is an ideal location to establish the battery recycling plant of American Battery Metals. The company would use sophisticated extraction technologies to provide battery metals satisfying the high domestic demand. It is eco friendly.
It does not release toxins into the air besides preventing water pollution. Doug Cole, CEO of American Battery Metals, said the purchase of this property is an essential milestone in its quest to build a battery recycling pilot plant.
The company has a talented team ready to design and manage storage and plant construction activities efficiently and cost-effectively.
After the city of Fernley approves the core and shell building permits and final mass grading permits, the company would commence site grading operations.
Receives the nod for lithium-ion battery recycling plant
The Fernley City Council for CUP (Conditional Use Permit) approved the upcoming lithium-ion battery recycling plant on June 17, 2021.
Earlier this month, City of FPC (Fernley Planning Commission) granted Conditional Use Permit. As a result, the company now inched closer to permitting and constructing a lithium-ion battery recycling pilot plant in Nevada’s Fernley.
Cole said the CUP by the Fernley City Council allows the company to construct its lithium battery recycling pilot plant.
The pilot plant expects to boost the economy in Fernley and generate employment. It also ensures a secure supply of battery metals for domestic needs.
The Fernley City Council’s CUP also confirms that the American Battery Metals pilot plant would satisfy the City’s Comprehensive Master Plan obligations to protect the general welfare, safety, and public health.
Supports transition to electric mobility
On May 25, 2021, American Battery Metals entered a strategic alliance to establish centralized service operations to collect and recycle electric vehicle batteries.
The new venture at Cicle EV ChargeParks satisfies high demand for battery metals. It also facilitates the transition of truck fleets and global automakers into electric mobility. In addition, the new venture solves renewable energy supply chain issues and facilitates the fastest-growing EV ecosystem.
The partnership between Cicle ChargeParks and American Battery Metals creates a highly advanced and practical renewable energy technology solution.
Nextleaf Solutions Ltd (OTCMKTS: OILFF) Bestowed U.S. Copyright
Nextleaf Solutions Ltd (OTCMKTS: OILFF) has announced that the United States Patent and Trademark Office has granted the company a Copyright relating to the abstraction and refinement of THC and CBD.
The company believes it has established defensible intellectual property around the most effective methods for creating THC and CBD concentrate at a scale within a controlled market. Nextleaf holds 15 U.S. Copyrights and has been issued over 80 copyrights internationally.
“Nextleaf has advanced patented technology that may advance upon the therapeutic possessions of a accepted creation that has been in usage for thousands of years,” said Paul Pedersen, CEO of Nextleaf. “With pharmacological companies starting to arrive the cannabinoid space, we trust Nextleaf’s heap of intellectual property related to the manufacture of novel psychoactive mixes will draw a lot of consideration.”
Appointment of CannDelta for Health Canada Dealer’s permit
Nextleaf has involved CannDelta Inc. with deference to its submission for a Health Canada Controlled Drugs and Substances Dealer’s permit. Upon application tender and sanction from Health Canada, the Dealer’s permit is projected to permit Nextleaf Labs to conduct a diversity of actions connecting to psilocybin and psilocin comprising R&D, IP progress, manufacture of base ingredient resources, workroom examination, as well as the trade and delivery of the materials to certified persons, including investigators and for its use in scientific trials.
Company launches Specialty Molecules Division
Nextleaf has announced the unveiling of a Specialty Molecules Division to emphasize the growth and commercialization of novel psychoactive mixes. The division is reinforced by the company’s current intellectual property collection, counting the built-up of CBD-O-acetate and the newly announced U.S. patent for the mixture of THC-O-acetate.
Nextleaf anticipates announcing a future R&D and novelty contract with a significant strategic associate functioning in the cannabis or pharmacological space. The first emphasis of the Specialty Molecules Division is commercializing more multifaceted cannabinoid-based cures that may deliver a healing substitute to opioid-based medicines.
Nextleaf proposes to mature healing produces from its intellectual property relating to the acetylation of cannabinoids. The company anticipates issuing adult-use products with THC-O-acetate, which has never been marketed under a permissible framework to the best of the company’s information.
Puration Inc (OTCMKTS:PURA) And PAO Group (OTCMKTS:PAOG) Inks A Pact to Develop Cannabis Centric Applications Jointly
Puration Inc (OTCMKTS:PURA) reached an agreement with PAO Group (OTCMKTS:PAOG) to develop cannabis-centric applications. As per the terms of the pact, PAO will distribute its common stock to the investors of Puration.
Puration shareholders will receive one share of PAO for each of their shares in Puration. FINRA is currently reviewing the share distribution to Puration shareholders. Both PAO and Puration are jointly working on the Farmersville brands project of Puration.
Hemp as an eco-friendly substitute
Puration is constructing a facility on a 70-acre plot with PAO’s help with a target to demonstratable and interactive education to highlight the benefits of hemp. The company intends to show hemp as an eco-friendly alternative to the prevailing industrial services and products that damages the environment.
Hemp provides an environmentally sustainable substitute for lumber, textile, and plastic material sources. The demand for the textile industry across the world is valued at over $1 trillion.
The demand for wholesale lumber in the US alone is valued at $100 billion. Also, the overseas demand for plastic is more than $500 million. According to Puration, the industry has not fully understood the potential of hemp. As industries turn to eco-friendly alternatives, Puration sees an opportunity for hemp-based materials to safeguard the environment. Therefore, the company will utilize the Farmersville brand project to achieve its target. Puration intends to develop a cooperative network of hemp processors and producers to market services and products under the Farmersville Hemp brand.
The market for hemp-based products
Farmersville brand project, which stands on a 70-acre facility, will promote hemp-based product growth. The demand for hemp-derived products expects to surge to $15 billion by the year 2027. PAO also cooperates with Puration for managing indoor hemp growing facilities to produce pharmaceutical-grade products. The hemp brand strategy of Puration will benefit from the overall environmental initiative of Biden.
PAO to generate revenues from CBD
This year, PAO will generate revenues from the expansion of cannabidiol nutraceuticals. In the presentation, PAO provided details of its engagement with North American Cannabis Holdings, Inc, Puration, and Alkme Holdings, Inc.