Posted on 04/20/2020 7:12:49 AM PDT by SeekAndFind
The U.S. Food and Drug Administration (FDA) and Novartis have reached an agreement to allow the Swiss pharmaceutical company to proceed with a clinical trial of hydroxychloroquine for patients with COVID-19, the disease caused by the novel coronavirus.
Novartis announced on Monday that it will begin enrollment for phase III of the clinical trial within the next few weeks and that the study will be conducted in more than a dozen U.S. labs. The trial is set to evaluate the anti-malaria drug, which President Trump has repeatedly touted as a potential "game changer" in the fight against COVID-19. Health officials have insisted, however, that not enough is known about the drug to determine its efficacy.
The FDA last month issued an emergency-use authorization for hydroxychloroquine to be distributed and prescribed by doctors to COVID-19 patients when a clinical trial is not available.
The Novartis clinical trial will study the anti-malaria drug's effects on approximately 440 patients, the company said, adding that the drug supply would be provided by Sandoz, its generics and biosimilars division.
"We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease," John Tsai, head of global drug development and chief medical officer at Novartis, said. "We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study."
Trump has repeatedly promoted hydroxychloroquine's in recent weeks, even as health officials on the White House coronavirus task force stress that there is no scientific evidence the drug is effective in treating COVID-19.
(Excerpt) Read more at msn.com ...
Ecstatic over your nephew’s recovery. That is great news.
costa rica has an extremely high success rate with hydroxy without zithromax i don’t know if they used zinc. someone needs to ask them. key is they started it early before person went to icu. They have been using it since march 18, 2020
660 cases 5 deaths of which 2 I believe before they started using it..(both mid 80’s)
Perhaps these people can tell us why India - pop. 1.4 Billion - has a covid death toll of 500 vs USA’s 40,000?
is the test purposely designed to discredit Hydroxychloroquine’?
Shh.
Ye gads is right ... unless the FDA is funding the Novartis study, why does any business need the Fed’s approval to do a study? If this study is initiated by Novartis all they have to do is follow a reasonable scientific protocol, check all the correct boxes, and publish their study parameters and the findings.
Tell the FDA to F.O.
RE: Perhaps these people can tell us why India - pop. 1.4 Billion - has a covid death toll of 500 vs USAs 40,000?
I wouldn’t point to India as a paragon of reliable reporting.
They haven’t done enough tests to begin with. With that limitation, how will we know how many have died from CoVid-19?
Thank you for sharing your nephew’s expserience. That’s another great story to tell the skeptics.
Please give my best wishes to him for his total healing!
The ‘Fuhgeddaboudit’ Agency ramps up like never before.. Uh huh.. Speedy Gonzalez , the new Director, says Speed Kills!
This is so cool.
Novartis has no stake in this. It’s a public domain generic.
Except I can see why they want to.
Show a public domain generic dime a dose drug is as good or better as the highly touted new drug of their competitor.
It’s also a public service.
It’s the sort of thing Fauci should have had set up and ready to go (sometimes called clinical trial in a box) if he had truly done his job over the last 36 years.
Possible, since Trump did not specify the full regimen, plus a pharmaceutical company would likely not want such a inexpensive drug to be what shows success.
RE: Novartis has no stake in this. Its a public domain
Actually, Novartis is a major producer of Hydroxychloroquine.
It says in the article:
The announcement from Novartis follows the company’s move to pledge 130 million tablets of hydroxychloroquine to supply global clinical research efforts focused on the drug.
We're being poorly served by the government/big pharma/industrial complex.
My wifes friend works at an Amazon warehouse locally. She was just diagnosed with the Wuhan flu. She has been prescribed the drug and sent home. At least in Northern Kentucky you can now get it as an outpatient.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.