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Re: nodummy post# 20310

Monday, 06/15/2020 7:14:18 PM

Monday, June 15, 2020 7:14:18 PM

Post# of 64653
WOW!!! GREAT QUESTIONS!!! That totally slipped past the Goalie!!!!

THANKS FOR YOUR POST!

I honestly forgot that “Supplements”
don’t need FDA Approval.

Maybe Phase 2? Then Phase 1?

Hmmmmmm.....

Seems odd to me as well~

“.... I have a couple of fair questions

#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...”





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