What would be required to get Trump's new favorite COVID antibody treatment on the market?

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The drug President Trump believes 'cured' his COVID-19 isn't approved for use for ordinary Americans and still must clear many regulatory hurdles before it is.

Fact check: Trump's antibody therapy not made from fetal stem cells but fetal-derived cells used during testing

That's different from the regular approval process, which requires that"the drug is determined to provide benefits that outweigh its known and potential risks," according to FDA. Regular drug approval requires FDA to review applications within 10 months. A priority review designation for drugs that offer"major advances in treatment or provide treatment where none existed" takes six months,An EUA is even faster than a priority review but has no set timetable, said FDA spokesperson Chanapa Tantibanchachai.

An EUA could come very quickly if the FDA feels Regeneron's data is solid or, some fear, due to influence from the White House., such as hydroxychloroquine. That drug was pushed strongly by Trump and was initially approved for emergency use, which was later revoked.called upon FDA to base any approvals on established scientific standards.

If Regeneron were to receive an EUA for its monoclonal antibody treatment, it would not mean the company could market it long-term.

 

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Again he's delusional, he's not cured and should stay isolated.

Does he or his family have any financial interest in that corporation?

As usual...one rule for the rich, another for the poor. Funny that

Well thanks for taking one the team! Lol

If Trump can give millions of Americans free Covid medicine costing millions of dollars per treatment... Why do people freak out for if Biden/Harris wants to let people keep their ACA insurance covering cancer, diabetes, heart disease, maternity?

President said he wants everybody in need can use it, for free. Right?

Lets say the nearest Chemist gives a 10% discount after a lot of arguments, pleadings on Regeneron. It still is unaffordable thanks to Obama's Affordable Care mess.

This mandate is for your children; The Americans... the World has changed, you need a powerful president realDonaldTrump to do the work to save your homeland. PLEASE, follow this 👇 and VOTE.

The coronavirus is Mongolian biological weapon! If don't believe it, they may slowly end killing humanity!

What and ASS the USA Today is - instead of being grateful of a cure you mock Trump for getting better. Democrats hate America

He’s not cured. There is no cure.

Every drug that was recalled by the FDA was once cleared for use by the FDA

Yeah everyone knows that, Trump himself has said that, what’s your point?

Yeah he sounds really cured here. 😂

How rich will Kamala get from the manufacture and sale of the drug? Kamala Harris' husband is Douglas Emhoff - a big Pharma lawyer for Merck (the vaccine manufacturer)

Thank you to all the folks volunteering to test drugs and vaccines.

Seemed to get through all those 'regulatory hurdles' in less than 24 hours for Donnie. Why not for the average American?

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