Misiu143- beautiful explanation of what happen and how the FDA has purposely tried to hold back CyDy and Leronlimab. Yet there are people who still try to gloss over what they did despite all the lives lost to this pandemic. Why would the FDA deny such protocol and the bigger question is why would people support that action . Other big pharma companies have been allowed a very wide range of changes at different intervals of there trials to look for any positive data to justify the approval of drugs like Remdeathisnear who showed no benefit at all against Covid 19 , not to mention the many side effects accompanied by this very dangerous molecule. One only needs to look at the 1 million deaths under its approval , if that’s not evidence enough I don’t know what is. It goes to show what has become important in this country and it is an absolute crime that needs to be investigated
We do not know what CYDY presented to FDA as justification for 4-doses. Why? Because the company did not and still does not have a competent CMO to interface with the FDA. If as you say CYDY provided the FDA with the dose escalation safety and efficacy......either you don't know or the FDA officially lied when they said in the letter that they did not get the safety data aggregated for HIV - and hence halted HIV trials.
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