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Tue Mar 24, 2020, 08:18 PM

FDA Grants Experimental Coronavirus Drug Benefits For Rare Disease Treatments

Source: NPR

March 24, 2020 7:26 PM ET
SYDNEY LUPKIN

The Food and Drug Administration gave an experimental medicine called remdesivir to treat COVID-19 what's called orphan drug status on Monday.

To qualify for an orphan designation, drug companies must show that their product will treat a population of fewer than 200,000 patients or that it would be unprofitable.

With more than 52,000 confirmed U.S. cases of COVID-19 reported as of Tuesday afternoon, the illness is under the technical threshold for a rare disease. But cases are rising quickly and it seems inevitable that they will surpass 200,000.

The agency's decision would provide lucrative incentives to the drug's maker, Gilead Sciences, and could keep lower-priced generic versions of the medicine off the market for several years if remdesivir is approved for use, public health advocates say.

Read more: https://www.npr.org/sections/health-shots/2020/03/24/821035311/fda-grants-experimental-coronavirus-drug-benefits-for-rare-disease-treatments



-snip-

Think Gilead Science the FDA and then

Joe Grogan......................

https://www.linkedin.com/in/joe-grogan-81b7845

7 replies, 3056 views

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Reply FDA Grants Experimental Coronavirus Drug Benefits For Rare Disease Treatments (Original post)
turbinetree Mar 24 OP
Turbineguy Mar 24 #1
turbinetree Mar 24 #2
Turbineguy Mar 24 #3
triron Mar 24 #4
catsudon Mar 24 #6
TheRickles Mar 24 #5
CountAllVotes Mar 24 #7

Response to turbinetree (Original post)

Tue Mar 24, 2020, 08:22 PM

1. Would that exemption

go away at 200,000 patients?

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Response to Turbineguy (Reply #1)

Tue Mar 24, 2020, 08:26 PM

2. That is very good question................I would think so................but not sure...........

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Response to turbinetree (Reply #2)

Tue Mar 24, 2020, 08:27 PM

3. If we get lucky,

they are protected. I don't have a problem with that.

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Response to turbinetree (Original post)

Tue Mar 24, 2020, 08:27 PM

4. 200,000 Worldwide? How would the recipients be chosen?

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Response to triron (Reply #4)

Tue Mar 24, 2020, 08:53 PM

6. a few countries can already synthesize this

Gilead had offered the formula to many countries for free,

i can only cite Taiwan's progress as im more familiar with it, they were able to produce milligrams at first, and then grams, but you need lbs of this stuff.

the source materials are only available from China, USA, and India in large quantities.

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Response to turbinetree (Original post)

Tue Mar 24, 2020, 08:43 PM

5. Not the first time for Gilead

Back during the bird flu scare, Gilead Pharmaceuticals was given similar government backing and protection for its drug Tamiflu, despite the existence of an equally effective generic medication. At that time, about 15 years ago, the Chairman of their Board of Directors was none other than Donald Rumsfeld. So it was about as blatant an example of corruption as could be found.

I wonder what familiar names are on their Board of Directors now....

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Response to turbinetree (Original post)

Tue Mar 24, 2020, 09:04 PM

7. Coronavirus Patients in Limbo as Gilead Suspends Emergency Drug Access

https://www.nytimes.com/2020/03/23/health/coronavirus-drugs-remdesivir.html

>>Overwhelmed by demand for an experimental treatment for coronavirus, the drug maker Gilead abruptly shut down its emergency access program, leaving doctors and families scrambling for answers.

The company said it was setting up a broader access program that could try to help more people, but some said the transition is delaying remedies for very ill patients who have few options.

“We have heard zero. We know nothing,” said Genny Allard, the mother of Jack Allard, a 25-year-old New Jersey resident who is in a medically induced coma and on a ventilator at Hackensack Meridian Health JFK Medical Center in Edison, N.J. “I’m just, like, apoplectic at this point. I have a kid who is sick and the doctor wants to give him the next medicine that is supposed to help.”

The drug, remdesivir, is being studied in several large-scale clinical trials around the world, including a huge trial announced last week by the World Health Organization. But the results have not been reported yet, and it is still unclear whether the drug works against the coronavirus. It was studied to treat Ebola, but did not work well enough against that virus.

*******

Pushed it though with no credibility whatsoever!

Truth of the matter = who the hell knows!


Way to go big boy pharmaceutical pigs!





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