Therapeutic Solutions International Inc (TSOI)

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Phase 1 trial can be skipped. Please do sone DD on trials.
https://camargopharma.com/resources/blog/back-to-basics-505b2-faqs-part-2-clinical-and-nonclinical-studies/#Q1-Can-you-skip-Phase-1-and-Phase-2-studies-for-a-505b2


Q1: Can you skip Phase 1 and Phase 2 [studies] for a 505(b)(2)?

In theory, yes. A 505(b)(2) application may be approved on the basis of any combination of studies or even no studies. However, more typically, a Phase 1 study will be required. This is because a 505(b)(2) application relies on existing information from approved products or products in the literature. This is in contrast to a 505(b)(1) or new chemical entity application in which the sponsor conducts all studies required for approval. To rely on existing information, a sponsor must demonstrate how similar or different their product is from the product used in the existing information. This is known as establishing a scientific or clinical bridge, and is frequently fulfilled through a Phase 1 bridging study.

Having said this, an in-depth knowledge of, and experience with the 505(b)(2) pathway can allow a sponsor to eliminate costly and time-consuming studies, including Phase 1 studies. Camargo has accomplished this is the past via innovative animal or in vitro studies, or for some products by leveraging specific information in the literature. As every 505(b)(2) is different, different strategies can be employed to reduce a sponsor’s clinical (and nonclinical) program.


They released results from their preclinical on the 4Th.

Therapeutic Solutions International Announces Positive Preclinical and Clinical Evaluation of Nutritional Supplement QuadraMune™, Designed to Protect Against COVID-19