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Tuesday, April 02, 2024 1:30:21 PM
Then kindly explain how you and your cohorts ignore completely the contextual value of this statement made by $TSOI on SEC.gov under penalty of perjury:
22. Beginning in late August 2021, TSOI began requesting associated description of the cell numbers and characterization documentation as well as temperature logs, and chain of custody and regulatory paperwork to clinical trial doses held by UM that came from the original transfer in 2018 from both UM and Jadi Cell. TSOI’s requests were ignored, delayed, and evaded from for close to 18 months. Once the transcripts from Patel and Ricordi became public TSOI, and this Amici, grew very concerned that the cells could not be validated by virtue of their own testimony under oath and that should we continue on with the Phase 3 clinical trial we likely would never get a Biological License Agreement (BLA) with the US FDA. Ricordi, and by extension Patel, filed an Investigational New Drug application to conduct the phase 1/2b. They told FDA they were using the biologic drug referenced in Drug Master File (DMF) 18138. The same DMF we licensed exclusively from Jadi Cell. The drug referenced in DMF 13138
describes the drug from the ‘176 patent as “expresses at least three cell markers selected from CD29, CD73, CD90, CD166, SSEA4, CD9, CD44, CD146, or CD105, and does not express at least three cell
markers selected from CD45, CD34, CD14, CD79, CD106, CD86, CD80, CD19, CD117, Stro-1, or
HLA-DR.”
23. Everything this Amici has described to this court came directly from the COA’s and other
documentation from Jadi Cell, UM, and University of Utah and directly contradicts any validation that
they were using JadiCells, which, as described above, express Nanog or the 3 biomarkers described in the “176 patent. It seems to me that there has been a concerted effort here to not document actual cells as claimed in ‘176.”
https://www.sec.gov/Archives/edgar/data/1419051/000149315223045887/ex99-1.htm
![Bullish](/static/images/ih2-bull.png)
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