Yeah there has to be a trial with statistically significant results. Not significant results by taking some patients and not others to prop up a study, not using anecdotal evidence like EINDs versus objective results from a clinical study. The letter from the FDA pretty much put CYDY in a corner, no more screwing around it has to show results that withstand scrutiny.
It is important to remember what exactly triggered the FDA's response in the first place. You can trot right on over to R/CYDY and see some of the worst ideas ever hatched to get this drug approved. The harassment campaigns born out of that group got to a point where the FDA had enough and issued a rebuke. That rebuke included the conspiracy theorists and pseudo-scientists and directly addressed the insanity they were pumping.
What is really sickening is that the R/CYDY group isn't made up of humanitarians, it's a bunch of shareholders who directly benefit from the approval the drug. They make money if it gets approved. All the concern for humanity is window dressing. That's why the glom onto the datamining and data manipulation. It drives the result they want, not the result that should happen.
Now that group is pushing ahead to dump letters, tweets and phone calls on Congress. Thinking that Congress can force the FDA to go against it's mission parameters and approve a drug that has not yielded the solid results needed in a clinical trial. It here is what will happen from that, the FDA is going to get pissed again and pummel CYDY. Nader hasn't had the courage to settle down the worst of his investors and set the record straight, everyone including the FDA can see that. So yeah they can blame Nader since he is running the show, and they should.
It's not like the FDA doesn't have justification to put CYDY under heavy scrutiny. The levels of shadiness behind Nader, his PRs, attempted end runs around regulatory procedures, misstatements and outright lies, demands the FDA not take anything from CYDY at face value. It's the credibility loss many of us have been talking about for months. It's now taking center stage at the worst time possible.
The lawsuits against CYDY are joining together to form a major class action. You don't lump your cases together unless you have a leg to stand on, otherwise one motion wipes out the whole thing. So this will go to trial. It means Nader and Scott Kelly will be deposed by lawyers who make their money exposing frauds and catching people in lies. It means testifying in open court where snafus and misstatements get crushed.
So if you want to focus your efforts some where, go after Nader and Kelly. It's time to clean house and get new management.
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