Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him

[brooklynite]

Source: New York Times

The drugmaker Regeneron said on Wednesday evening that it had submitted an application to the Food and Drug Administration for emergency approval of the experimental antibody cocktail that President Trump had praised just hours earlier without evidence as a “cure” for the coronavirus.

The company said that at first, access to the treatment would be extremely limited, with only enough doses for 50,000 patients, a far cry from the “hundreds of thousands” of doses that Mr. Trump said in a video released Wednesday he would soon be making available to Americans free of charge.

In the five-minute video, Mr. Trump said that it was a “blessing from God” that he had been infected with the coronavirus and that the Regeneron cocktail had suddenly made him feel better. “I felt unbelievable,” he said. “I felt good immediately.”

There is no evidence that the treatment is the reason he was feeling better, and his doctors have said he has taken other drugs as well.


Read more: https://www.nytimes.com/2020/10/07/health/trump-covid-regeneron.html

[Walleye]

1. Doesn't trump have money in that company.?

[apnu]

11. Or does that company hold debt on Trump?

[Walleye]

16. Good point. We need to track that down if we can. It really stinks the way he's pushing these drugs.

[hlthe2b]

2. How willing will these a'hole anti-choicers be when they realize the origin of the

manufacture of this monoclonal antibody (fetal cell lines)

[Botany]

13. The anti-choicers didn't say shit when they were sterilizing women that ICE was holding

BTW I doubt that they know or want to know that fetal cell lines come from abortions.

[Boogiemack]

3. Except it hasn't "cured him." He is still a raving maniac who is sick and dying.

The drug plus the steroids are masking his symptoms big time.

[PubliusEnigma]

4. What, no hydrochloroquine?!?

[C_U_L8R]

5. This is so wrong.

Go back and do the real work to keep Americans safe.

[iluvtennis]

22. ++++++ agree. nt

[yaesu]

6. how many millions, billions did tRump make pumping their stock? nt

[ananda]

7. Bam! Now follow the money.

... who has stock in the company...

and who makes money off the distribution....

[soothsayer]

8. Better hurry before he takes a turn for the worse

[ashredux]

9. Trump owns stock. Follow the $

[llmart]

10. I'm with Kamala on this one...

when she said she would only take a vaccine if the scientists approved it. She would not take a vaccine just because Trump was pushing it.

Most Americans agree with that.

[Hoyt]

12. If Regeneron's antibody cocktail has proven effective and relatively safe - compared to dying - it

should get emergency approval as an option with all the disclaimers that go with something like this.

An "effective" treatment would be big news.

[louzke9]

21. EXCELLENT LINK....

Re the treatments Trump is receiving. They are all experimental with and the circumstances surrounding when and why they are used, is included in this article. Regeneron's antibody treatment is currently FDA rated as "compassionate" use, a designation with limitations as opposed to emergency approval. But these treatments should not be viewed yet as CURES. Neither are they a vaccine. Not everyone who receives these drugs survives COVID19 either. Trump exaggerates his own experiences with the drugs he is receiving. Trump is not FREE of COVID19 nor out of the woods as he announces and pretends to be. Dr. Conley touted the antibodies in Trump's blood as proof he is recovering, HOWEVER, Regeneron is REFUTING this claim stating Dr. Conley is picking up the antibodies provided from the REGENERON treatment.

https://www.cnn.com/2020/10/04/health/covid-trump-drugs-remdesivir-dexamethasone-explainer/index.html

[douglas9]

14. Trump's antibody treatment was tested using cells originally derived from an abortion

This week, President Donald Trump extolled the cutting-edge coronavirus treatments he received as “miracles coming down from God.” If that’s true, then God employs cell lines derived from human fetal tissue.

The emergency antibody that Trump received last week was developed with the use of a cell line originally derived from abortion tissue, according to Regeneron Pharmaceuticals, the company that developed the experimental drug.

The Trump administration has taken an increasingly firm line against medical research using fetal tissue from abortions. For example, when it moved in 2019 to curtail the ability of the National Institutes of Health to fund such research, supporters hailed a “major pro-life victory” and thanked Trump personally for taking decisive action against what they called the “outrageous and disgusting” practice of “experimentation using baby body parts.”

https://www.technologyreview.com/2020/10/07/1009664/trumps-antibody-treatment-was-tested-using-cells-from-an-abortion/

[Lonestarblue]

15. This is why the we need full disclosure of Trump's infection and treatment.

Trump may have had an extremely mild form of the virus but demanded extensive treatments. He has recovered far too quickly, if indeed he has recovered, or perhaps he is just pumped full of steroids. If we are to believe Dr. Conley, Trump was given at least three forms of treatment simultaneously. How are doctors now treating Covid patients to know what worked and just how bad Trump’s condition was?

Regeneron needs to do a controlled study first because their product is promising, but having Trump push it should make anyone suspicious.

[louis-t]

17. Wait, I thought hydroxychloroquine was the game changer!

[NCjack]

25. Chlorox. UV light on a broom stick shoved up your ass. So many cures --

how are we to know what to choose? Maybe the FDA can sort it out using science.

[llashram]

18. yeah we paid for trumps care

so he basically got another freebie from us...now if the company gets approval for this mix, who is going to pay the 500(arbitrary sarcasm) dollars a shot for as many days it takes to bring down the virus load(allegedly)...certainly not this clown in office now.

[Ilsa]

19. "Quick! Let's get approval before 45-750 crashes!" nt

[halfulglas]

20. Watch out for the terms, too.

We have to remember Compassionate Use I believe indemnifies the company from being sued for bad results, after all patient knows it's practically his best or even last chance for survival, but may not work. But giving emergency approval for more widespread use - does this also indemnify the company, or are they liable for ill effects or not the best choice even? We have to be careful because now that Trump is pushing this theme that he is cured from this drug, people are going to be reluctant to participate in the trials because the trials mean you may get the placebo instead of the real thing. Heck, if this is a real cure, if you have the virus you want the cure (even if it's wishful thinking that it's the cure). You want what the president got. Drug company reaps bigger riches. If a considerable amount of people have really bad effects weeks or months or years later and want to sue, company says but the FDA approved it!!

[Harker]

23. There's a scam in it somewhere.

Dammit, I feel like a four-year-old... are we there yet?

[Bayard]

24. Can't imagine it would be much better than these

https://www.fool.com/investing/2020/10/05/report-moderna-and-pfizer-vaccine-trial-participan/