Here Is How Nader Earned The Ire Of The FDA.
1. He sees the FDA as a crutch and hand holder. That is not what the FDA does.
You will hear him frequently talk about meetings and communications with the FDA. It's always about getting guidance on how to run the business. The meetings have become time wasters for the FDA because rather than deal with finished work product and steps forward, they are dealing with a CEO who doesn't come prepared. Nader has used these meetings and communications to ask the FDA to do things they would never do. "Conditional EUA" anyone?
2. Nader Cuts Corners Against The FDA's Warnings.
So when Nader has these studies set up the FDA has in the past stated things like "The bare minimum for this sort of study is X, typically these studies have between Y and Z number of patients." Nader will dully nod his empty head and go for the bare minimum. The latest COVID study is another great example. Lump everyone into the study, get a general P value. When that blew apart in the results, Nader tried back tracking. Had he done more than the bare minimum we wouldn't pay the price for all this attempted corner cutting.
3. He Is Being Held Responsible For The Harassments Of The FDA.
Turns out the FDA hates outside influence attempting to influence regulator decisions. Remember when Nader did all those EINDs and the FDA took it away because it seemed like he was trying to circumvent the regulatory process? They had to tell him to actually enroll people in the studies. Now jump forward to more recent times where "investors" have undertaken email and Twitter campaigns to try and force the FDA's hand.
The fact it was organized, traceable back to Reddit and you could see people sharing copy paste letters and contact information reminded them of Nader's EIND scheme. In fact you would be hard pressed to not suggest that another publicity campaign was not the doings of Nader. In fact how slow was Nader to tell people not to bother the FDA? Yeah not a good look.
4. Nader Is Synonymous With Misinformation.
Nader is at best the most incompetent CEO to ever shame the biotech sector. At worst he is a long running con man who has narrowly avoided long term legal repercussions for years. Either way he creates a black hole of doubt that sucks in everything he touches. So when he submits studies to the FDA, they are absolutely going to question what ends up on their desk. Look at the much touted 84% number. Nader took a study that underperformed and manipulated the data to the point such an outrageous number was possible.
5. Circumventing The FDA.
His running around to other countries is also not a great look. It would be one thing if he was submitting multiple applications at once and everyone was seeing it for the first time. But what Nader has done is get turned around by the FDA, and then seek out other countries hoping to get around the FDA and sell the drug elsewhere. Again not a big deal if he submitted all at once and the EU, UK, and other countries said sure and the FDA said try again or no way. It happens, but Nader has a history of making stupid end run attempts around the FDA.
6. Partial Submissions and Delays.
In a pandemic it is a really bad idea to screw around with getting all your data in on time. Holding up the FDA, issuing over confident PRs, and delaying a possible life saving drug for months on end. Yet that is exactly what Nader did.
So yes the FDA probably hates Nader and with good cause.
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