![](https://investorshub.advfn.com/uicon/714343.png?cb=1637654466)
Thursday, March 28, 2024 10:36:58 AM
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,”
1st Amicus Brief 👇
https://www.sec.gov/Archives/edgar/data/1419051/000149315223045887/ex99.htm
Supplemental Amicus Brief (Ibuprofen v Morphine)👇
https://www.sec.gov/Archives/edgar/data/1419051/000149315223045887/ex99-1.htm
1/11/23 UofM Zoom meeting informing UofM office of Technology Transfer/ Dr. Norma Sue Kenyon 👇
https://www.sec.gov/Archives/edgar/data/1419051/000149315223004263/ex99-1.htm
2/10/23 8K👇
https://www.sec.gov/ix?doc=/Archives/edgar/data/1419051/000149315223004263/form8-k.htm
10/24/22 8k👇
https://www.sec.gov/ix?doc=/Archives/edgar/data/1419051/000149315222029460/form8-k.htm
ReStem’s Demonstratives 👇
https://www.sec.gov/Archives/edgar/data/1419051/000149315223004263/ex99-4.htm
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.
Recent TSOI News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/19/2024 08:44:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 08:44:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/15/2024 06:14:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 07:42:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 07:38:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/09/2024 08:44:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/09/2024 08:39:55 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/31/2024 08:51:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 04:47:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 12:46:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 12:44:01 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/30/2024 06:46:26 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2024 04:01:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 10:03:21 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 07:15:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 07:12:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/21/2024 10:25:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 11:16:15 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/08/2024 05:15:25 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/06/2024 11:34:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 08:42:55 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 01/17/2024 11:15:01 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 01/04/2024 09:03:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 07:44:34 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2023 05:39:49 PM
North Bay Resources Announces Mt. Vernon Gold Mine Bulk Sample, Sierra County, California • NBRI • Sep 11, 2024 9:15 AM
One World Products Issues Shareholder Update Letter • OWPC • Sep 11, 2024 7:27 AM
Kona Gold Beverage Inc. Reports $1.225 Million in Revenue and $133,000 Net Profit for the Quarter • KGKG • Sep 10, 2024 1:30 PM
Element79 Gold Corp Announces 2024 Clover Work Plans & Nevada Portfolio Updates • ELMGF • Sep 10, 2024 11:00 AM
Nightfood Holdings Inc. Completes Major Step on Uplist Journey by Closing Strategic All-Stock Acquisition of CarryoutSupplies.com • NGTF • Sep 10, 2024 8:15 AM
Element79 Gold Corp. Announces Sale of 100% Interest in Elder Creek, North Mill Creek, and Elephant Projects to 1472886 B.C. Ltd. • ELEM • Sep 9, 2024 9:34 AM