m$teamworkotc
4 days ago
GlobeStar is focused on efforts to obtain regulatory approvals for, and then commercialize, Project Amethyst™. Project Amethyst™ is a compound intended to treat neurodegeneration from MS, consisting of a patented custom drug cocktail of Minocycline, Fluconazole, and Atorvastatin. Each of these drugs has been approved by the FDA for separate applications. GSTC is the exclusive worldwide licensee for the all patents and patent applications relating to this compound.
GlobeStar is endeavoring to arrange financing to commence a study of the pharmacokinetic action of the three drugs, and then to initiate a clinical trial. Pharmacokinetics looks at changes in a drug after administration. A pharmacokinetic study generally requires from two weeks to eight weeks.
GlobeStar is discussing the parameters for a pharmacokinetic study with several Clinical Research Organizations (CRO's) in Europe and India. The CRO selected by GlobeStar would assist the company, SMI HealthCare LLC (SMIHC) and Advanced Innovative Partners (AIP) to develop a clinical trial plan. GlobeStar intends to seek FDA guidance in the development of that plan.
Following completion of the pharmacokinetic study, GlobeStar intends to arrange financing for SMIHC to manage an initial clinical trial in India, as well as regulatory filings, intellectual property rights filings, manufacturing, sales and distribution in India, Southeast Asia, Africa, and the Middle East. The clinical trial likely would require approximately three to six months. If results are positive, the trial would support regulatory clearance in India and potentially other countries, facilitating the Company's transition to revenues. Results also could be used to accelerate progress toward regulatory approval in the United States, though an additional trial likely would be required to obtain FDA approval.
It is anticipated that AIP will provide advice to GlobeStar and SMIHC on the global design, strategy and execution of clinical trials, regulatory filings, intellectual property rights filings, and manufacturing for Project Amethyst™.
m$teamworkotc
4 days ago
GlobeStar is focused on efforts to obtain regulatory approvals for, and then commercialize, Project Amethyst™. Project Amethyst™ is a compound intended to treat neurodegeneration from MS, consisting of a patented custom drug cocktail of Minocycline, Fluconazole, and Atorvastatin. Each of these drugs has been approved by the FDA for separate applications. GSTC is the exclusive worldwide licensee for the all patents and patent applications relating to this compound.
GlobeStar is endeavoring to arrange financing to commence a study of the pharmacokinetic action of the three drugs, and then to initiate a clinical trial. Pharmacokinetics looks at changes in a drug after administration. A pharmacokinetic study generally requires from two weeks to eight weeks.
GlobeStar is discussing the parameters for a pharmacokinetic study with several Clinical Research Organizations (CRO's) in Europe and India. The CRO selected by GlobeStar would assist the company, SMI HealthCare LLC (SMIHC) and Advanced Innovative Partners (AIP) to develop a clinical trial plan. GlobeStar intends to seek FDA guidance in the development of that plan.
Following completion of the pharmacokinetic study, GlobeStar intends to arrange financing for SMIHC to manage an initial clinical trial in India, as well as regulatory filings, intellectual property rights filings, manufacturing, sales and distribution in India, Southeast Asia, Africa, and the Middle East. The clinical trial likely would require approximately three to six months. If results are positive, the trial would support regulatory clearance in India and potentially other countries, facilitating the Company's transition to revenues. Results also could be used to accelerate progress toward regulatory approval in the United States, though an additional trial likely would be required to obtain FDA approval.
It is anticipated that AIP will provide advice to GlobeStar and SMIHC on the global design, strategy and execution of clinical trials, regulatory filings, intellectual property rights filings, and manufacturing for Project Amethyst™.
Augster
2 weeks ago
Aqua, you probably know this business and process as well as, or more than anyone on the board. Is it as simple that Jim was handed a layup and just isn't able to get it done? I wouldn't consider it a scam, as the Italy trials show otherwise. Time to bring in a CEO who understands the process and can get this to the finish line. It appeared that Jim surrounded himself with knowledgeable people, but for whatever reason it's not progressing. Like you said, why can't Spivak's company, or someone else write a check to get the toxicology study completed. What about the wealthy people at that Florida conference Jim went to a couple years back when he said several people wanted to support the company's efforts. I don't know, maybe Jim spending too much time on VXIT. I would have thought GSTC was his golden goose, hugely disappointing to this point.
Aquahoya
2 weeks ago
I stopped calling him a long time ago. The only information that I received that told me he was actually working on this was contacting Tim Coetzee for MS Society and contacting Mass General when Jim and group had a sit down with them. Which I got confirmations from. Those people are trust. Jim, clearly, lost a lot of peoples and shareholders trust a while ago. They updated the patent. I spoke to the Patent owner, Fabrizio, who says Jim just talks a lot. Clearly, Jim needs to be replaced. He doesn't care.