Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-46

For anyone who might be interested
....here is an extremely interesting article with links that show how the FDA is involved in making money for the medical system.......https://www.thedesertreview.com/opinion/columnists/the-great-ivermectin-deworming-hoax/article_19b8f2a6-0f29-11ec-94c1-4725bf4978c6.html?utm_medium=social&utm_source=email&utm_campaign=user-share
I point you to this portion of the article about half way through.
"""So you want to ALSO review clinical studies in people. For example, Remdesivir, a favorite of Big Pharma, a failure against Hepatitis and the Respiratory Syncytial Virus, worked in a test tube against Ebola. Still, when they tested it in people, it was a dud – just as many died in the placebo group as the Remdesivir group – about 53%.So they tested it against COVID-19. A small study with 541 patients getting Remdesivir versus 521 on placebo showed no statistical difference in death and a 24% rate of serious adverse events in Remdesivir; however, against all odds, the FDA approved the drug for emergency use against COVID-19.https://www.nejm.org/doi/full/10.1056/nejmoa2007764To add insult to injury, the WHO later completed another study in which Remdesivir failed miserably and failed to reduce death in COVID. Dr. Ilan Schwartz made it clear, “This puts the issue to rest — there is certainly no mortality benefit (from Remdesivir).”https://www.nytimes.com/2020/10/15/health/coronavirus-remdesivir-who.htmlYet, the FDA did not revoke their Emergency Use Authorization for some strange reason, and they have maintained Remdesivir as their “go-to” drug. You can bet the majority of our 648,000 Americans who died from COVID-19 first received a dose of Remdesivir – at an average of $3,100 a pop – because it was on the protocol. We cannot expect a small thing, like the drug doesn’t work, to subtract from our FDA’s absolute prerogative to decide what is best for us – and what drugs we should purchase with our hard-earned health care dollars."""

My point is..... PAR is up against powerful people and companies. We really need good people to work wonders to get PAR approved in the USA (my opinion) Whether those people are successful....time will tell.