Monday, June 15, 2020 6:38:51 PM
#1 QuadraMune(TM) is a labeled as a "dietary supplement"
https://clinicaltrials.gov/ct2/show/NCT04421391?term=quadramune&cond=COVID&draw=2&rank=1
The FDA states that:
https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements
"The U.S. Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed"
The disclaimer on the site that tracks these studies says:
https://clinicaltrials.gov/ct2/about-site/disclaimer
"Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators."
So is it correct that the TSOI clinical trial is only a privately backed, non government funded, not FDA approved clinical study?
#2 The study is listed as a Phase II study which fits the 500 person narrative.
But where is the data on the Phase I study? Was there a Phase I study?
thanks!
TSOI has yet to mention this QuadraMune(TM) dietary supplement in any SEC filings to date. It has only been mentioned in recent press releases. Why is that?
It seems awfully convenient and a bit fishy that TSOI just magically decided that this dietary supplement somehow could be effective against Covid-19, especially considering the history of some of its insiders allegedly being involved in medical related scams in the past.
Recent TSOI News
- 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
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/16/2023 11:17:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/16/2023 11:13:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/13/2023 06:50:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/13/2023 05:44:55 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/21/2023 09:24:52 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/15/2023 11:10:01 AM
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