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Wednesday, November 24, 2021 2:07:12 PM
"The extremely promising preclinical data we are generating, as well as the previously published double blind FDA clinical trial and most recently, FDA clearance to enter Phase III, strongly supports the rationale to file for Emergency Use Authorization" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "As a practicing physician, myself and my colleagues are eager to begin using these cells and potentially saving lives
"We are thankful to our Advisory Board, which includes Dr. Francesco Marincola, World Wide Head of Cell Therapy Research for Gilead, and Dr. Santosh Kesari, Principle Investigator on other stem cell trials for COVID-19, for bringing decades of national and international expertise in dealing with regulatory bodies in fast-tracking approval of cellular and gene therapies in helping us to make this monumental decision" said Timothy Dixon, President and CEO of Therapeutic Solutions International. "Given the urgent nature of the ongoing pandemic, and the early suggestions that our cells are effective against the delta variant, we are exploring and pursuing all possible avenues to bring JadiCells to the patients that need them now.
https://www.prnewswire.com/news-releases/therapeutic-solutions-international-prepares-to-apply-for-emergency-use-authorization-eua-for-its-fda-phase-iii-covid-19-stem-cell-therapy-jadicell-301355728.html
https://www.prnewswire.com/news-releases/therapeutic-solutions-international-engages-venvalo-group-to-oversee-jadicell-covid-19-phase-iii-clinical-trial-and-emergency-use-authorization-eua-process-301373258.html
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- Form 8-K - Current report • Edgar (US Regulatory) • 04/24/2025 10:05:30 AM

