Therapeutic Solutions International Inc (TSOI)

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In the context of the situation with TSOI and JadiCell Stem Cell Treatment, there are some significant financial and regulatory considerations. TSOI has identified a novel cellular marker associated with the therapeutic response to JadiCell Stem Cell Treatment. However, there have been some puzzling developments:

Exclusive Patent Rights and IND Purchase: Therapeutic Solutions spent $3.1 million on obtaining exclusive patent rights for JadiCell's use in the lung. Additionally, they agreed to purchase the University of Miami's IND (Investigational New Drug) for $4 million. These investments signal their commitment to advancing the treatment.

Phase 3 Trial Delay: Despite the preparations and investments, it appears that Therapeutic Solutions has not moved forward with an FDA-cleared Phase 3 trial, even though such a trial could have substantial financial implications.

Potential Revenues: A successful Phase 3 trial for a biologic treatment in a major organ that addresses an incurable disease can result in substantial revenues. In the case of ARDS (Acute Respiratory Distress Syndrome), the potential financial impact is significant, with a rough estimate indicating possible revenues in the billions.

For example, a calculation based on treating 190,000 ARDS cases at $200,000 per treatment suggests potential revenues of $38 billion annually.

The financial opportunity is substantial, and it's natural to wonder why the project isn't moving forward.

Questions Regarding Proof: There are concerns about the lack of proof or evidence for the "claimed cells" and their therapeutic effectiveness. TSOI has raised questions about this issue, as indicated in their 8K filing.

University of Miami's Involvement: The University of Miami, its employees, including Dr. Ricordi and Dr. Kenyon, and University of Miami Council Javier Peral II, seem to be involved in the situation. However, it is stated that they have not provided answers regarding the proof of the claimed cells.

In summary, the situation raises questions about why a Phase 3 trial, with the potential for substantial revenue, has not moved forward, and there is concern regarding the evidence and proof of the claimed cells.