GlobeStar Therapeutics Corp (GSTC)

[beer$$money]

$GSTC Agreed The Big Dogs are on it!! But moving at Lawyer speed (a very slow walk(:

Company has retained new legal counsel:
Edward T. Swanson, Esq.
GlobeStar Therapeutics (GSTC) is teaming up with Advanced Innovative Partners (AIP) to design and implement clinical trials of Project Amethyst, an investigational therapy for multiple sclerosis (MS) that aims to reduce neurodegeneration. “We were impressed with the clinical results obtained in Italy for treatment of multiple sclerosis patients using Project Amethyst,” said Stanley Satz, PhD, AIP’s chairman and chief science officer.
“These results provide a good foundation for establishing more comprehensive clinical trials with AIP’s partners,” Satz said, adding, “We are thrilled to advance the opportunities for Project Amethyst.”

The full online news article can be found at https://multiplesclerosisnewstoday.com/news-posts/2023/06/21/globestar-aip-partner-design-ms-trials-project-amethyst-therapy/.

JK also mentioned long time Associate "Spivak" will be added as an Advisor.

Kenin M. Spivak, a highly regarded executive, entrepreneur, financier, author and attorney, is the founder, chairman and CEO of SMI Group, a Los Angeles-based company that forms and grows businesses worldwide, and owns a fully licensed SEC-registered investment bank.
https://www.imdb.com/name/nm1221859/bio/

$GSTC those who made it to the very end of JK's Emerging Growth Conference 60 presentation heard him say GSTC is going to apply for Orphan Drug Status. That opens the door to some significant beneficial opportunities for the Clinical Trial in India with AIP!

The Orphan Drug Act (ODA) first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. In 1984 the ODA was amended, redefining rare diseases as those affecting “less than 200,000 persons in the United States” (the prevalence-based definition) or more than 200,000 persons, but for whom “there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from the sale in the United States” (a commercial viability definition)

The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including:

Tax credits for qualified clinical trials
Exemption from user fees
Potential seven years of market exclusivity after approval: JK mentioned this.

JK also mentioned Grant Money as someone asked how you going to pay for this Clinical Trial?

OOPD Clinical Trials Grants:
The FDA Office of Orphan Products Development (OOPD) was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition.
Orphan products clinical trials grants are a proven method of successfully fostering and encouraging the development of new safe and effective medical products for rare diseases/conditions. The Orphan Products Grants Program has been supporting clinical trial research since 1983 and has facilitated the marketing approval of more than 60 products. OOPD funded grants ensure that product development occurs in a timely manner with a very modest investment.
At any one time, there are typically 60 to 85 ongoing grant-funded projects.

Now who are the Experts in Orphan Drug Development?
https://www.advancedinnovativepartners.com/news.html#header9-3i

India's Rising Role in Global Clinical Trials: Embracing Opportunities in 2023 Overview of the Clinical Trials Industry in India July 28,2023

In 2019, the New Drugs and Clinical Trial Rules (CT Rules) went into
effect, ushering in a significant shift in India's clinical trial landscape.

These regulations aimed to improve regulatory transparency, streamline the approval process, and prioritize patient safety. As a result of the reforms, trials and drug approvals have been accelerated, regulatory compliance has been improved, and intellectual property and data integrity have been strengthened. By partnering with international CROs with a strong base in India, pharmaceutical and biotech companies can tap into their extensive resources, knowledge, and global experience. This collaboration empowers companies to navigate the intricacies of clinical development, regulatory compliance, and post-approval activities with greater efficiency and effectiveness.

Read more at:
https://health.economictimes.indiatimes.com/news/industry/indias-rising-role-in-global-clinical-trials-embracing-opportunities-in-2023-and-beyond/102177590