Based upon TSOI SEC filings, the P2 IND/Trial led by Giancomo Lanzoni, Camillo Ricordi, Norma Sue Kenyon et al used as basis for the aforementioned FDA cleared Phase III IND - it appears the Phase III CV19/ARDS trial was cleared by FDA (honor system) but Tim Dixon/TSOI after several yrs fighting obfuscation discovered (UofM/Miller School’s P2b IND) disturbing flaws/inconsistencies.
And I quote:
“ 25. In regard to the phase 2b that was allegedly conducted using the claimed JadiCells, it’s as if they applied to FDA to conduct clinical trial in pain using 600mg ibuprofen and referenced the drug master file for ibuprofen, but in reality, gave the patients 10mg morphine, and disclosed in the scientific report the benefits were because of ibuprofen. 26. While Amici acknowledges suggesting Appellant and Appellee likely have unclean hands, this Amici supports the ruling by the PTAB for the reasons they clearly enunciated, and respectfully ask this Court to see Appellants and their motives for what they likely are – fraudulent attempts to pass off less potent stem cells that merely meet the ISCT standards for biomarkers using the JadiCell and its superior potency, but not testing to be sure it is a JadiCell that would distinguish it from these other companies like Restem and Arugula’s attempts at producing MSCs that will clear an FDA Phase 3 trial and qualify for a BLA, as TSOI set out to do when it entered into two (2) ELPAs with Appellee. Based on the foregoing, this Amici respectfully requests that the Court affirm the Board’s finding that Restem failed to carry its burden of proving that claims 1-15 of the ’176 Patent are unpatentable. Respectfully Submitted,”
What will the FDA/DOJ/FBI/SEC/FINRA do with this information? Time will tell. Guaranteed: J33, MHG, ANP CR GL NSK JP NR KM RG et al will continue to ignore. Rock - hard place.
Whilst the law sorts that mess out, TSOI filed a new ALL ARDS CAUSATION P3 IND 👍 Which would be the natural progression egardless of UofM et al’s circumstances.
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