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More evidence FDA works for Pfizer as FDA asks Pfizer to send cancer drug for extended approval with zero new trials

More evidence FDA works for Pfizer as FDA asks Pfizer to send cancer drug for extended approval with zero new trials

for Brian Shilhavy
Editor, Health Impact News

As the alternative media is distracted by the baseless claim that Pfizer is using gain-of-function technology to develop new variants of COVID for future vaccines, Pfizer is quietly working with the FDA to build its drug portfolio to compensate the loss of income. due to the decrease in the number of people willing to continue injecting themselves with COVID vaccinations.

The evidence that Pfizer controls the FDA continues to mount.

We previously reported how Pfizer came from virtually nowhere to get the first FDA clearance for experimental COVID injections in 2020, when the two drug companies that had received the most funding and attention became the first to get FDA approval for a new COVID. “vaccine” had been Moderna, with its close ties to Anthony Fauci and the NIH, and Astrazenca with its close ties to Bill Gates.

Pfizer’s contract with Operation Warp Speed ​​to receive funding for the COVID-19 vaccines was different from other drug companies’ because it was conditional on them getting FDA approval and did not include rights to intellectual property for the US government.

This appears to have opened the door for them to grant an exclusive deal with Israel in exchange for data on how the experimental shots affected the people of Israel, effectively turning Israel and its citizens into lab rats. I will see:

Trump Claims He Could ‘Easily’ Be Israeli Prime Minister: Is This Why Pfizer Got First US COVID Vaccine Authorization And Exclusive Rights In Israel?

And a year before Pfizer became a late entrant in the race to get the first FDA clearance for a COVID vaccine, Dr. Scott Gottlieb joined Pfizer’s Board of Directors in June 2019, only two months after ending his term as FDA commissioner under President Trump. A month after joining Pfizer’s board of directors, Operation Warp Speed ​​awarded Pfizer nearly $2 billion to develop the COVID vaccine. I will see:

Former FDA director Gottlieb, now Pfizer board member, pledges $1.95 billion for COVID vaccine

This week, Pfizer reported that they expect sales of its COVID-19 vaccinations and its antiviral Paxlovid to decline dramatically here in 2023:

Despite a plan to raise Comirnaty’s price to between $110 and $130 per dose when the U.S. moves to a commercial model for COVID-19 vaccines this year, Pfizer expects vaccine revenue to drop 64% in 2023.

Pfizer also expects a 58% decline in revenue from the oral COVID-19 antiviral Paxlovid. The company revealed its 2023 guidance on Tuesday in its fourth quarter and 2022 earnings report.

With the declines, Pfizer is targeting a revenue window of $67 billion to $71 billion in 2023.

The projections, which fell short of analysts’ expectations, dampened what could have been a day of celebration, as Pfizer reported revenue of $100.3 billion in 2022, after generating $81.3 billion in sales in 2021. (Source).

But what surprised people in the pharmaceutical industry the most about Pfizer’s forecast for 2023 was that in a “mysterious” FDA approval that was not reported to the media in late 2022, Pfizer received a expanded use approval for its breast cancer drug Ibrance. and reportedly the FDA is the one who approached them to expand the use of this drug!

Angus Liu of Fierce Pharma reported:

It is unusual for the FDA to go after a drug company and ask them to apply for a new drug indication. But Pfizer went through with it and has now quietly unveiled a label expansion for breast cancer with Ibrance.

The FDA has expanded the approval of Ibrance in combination with an aromatase inhibitor to include patients with newly diagnosed HR-positive, HER2-negative metastatic breast cancer, regardless of menopausal status, Pfizer said Tuesday.

Previously, the combination of Ibrance and an aromatase inhibitor was limited to use in postmenopausal women. The FDA granted the new approval in mid-December, according to an approval letter (PDF), but Pfizer tucked the news into its fourth-quarter earnings announcement on Tuesday.

There are other unconventional elements to this approval beyond Pfizer’s late and low-profile disclosure.

For one thing, a review of the updated prescribing information (PDF) for Ibrance shows no new efficacy data in the patient population.

The clinical efficacy section of Ibrance’s label still only includes results from the phase 3 PALOMA-2 trial, which tested a combination of Ibrance and Novartis’ aromatase inhibitor Femara in postmenopausal women recently diagnosed with breast cancer HR+/HER2- and stage 3. PALOMA-3 study. The latter study tested Ibrance with AstraZeneca’s SERD drug Faslodex in previously treated patients, regardless of menopausal status.

It was the FDA that proactively contacted Pfizer in this case. In December 2021, the FDA requested that Pfizer submit an application to include pre/perimenopausal women on the label for Ibrance, according to an FDA approval letter dated December 13, 2022. Pfizer will respond to the FDA’s request and submitted its request on March 11, 2022. , shows the approval letter.

The new approval comes as Ibrance is under increased pressure from Novartis’ Kisqali and Eli Lilly’s Verzenio, particularly after the final overall survival analysis of the PALOMA-2 trial found that Ibrance did not significantly improve the expected of patients’ lives.

The unusual approval raises a question about the basis of the FDA’s decision to request — and then approve — the expansion of Ibrance. (Full article.)

Is there any doubt about who controls the FDA anymore? Pfizer is the largest criminal organization in the world and they could not continue to make huge profits without their control of the FDA.

And how many of you reading this article are co-owners and therefore co-conspirators in the criminal enterprise Pfizer because your retirement fund owns stock in that company? How many members of Congress or state politicians own shares in this criminal organization?

See also:

Understand the times we are currently living in

How to determine if you are a disciple of Jesus Christ or not

Synagogue of Satan: Why It’s Time to Leave the Corporate Christian Church

Has everyone left you because you’re not ashamed to tell the truth? Stay the course!

When the World is Against You: God’s Power to Intervene for Those Who Resist

An idolatrous nation celebrates “freedom” even though they are slaves to the pharmaceutical cult

What happens when a holy and just God gets angry? Lessons from history and the prophet Jeremiah

The most important truth about the arrival of the “new world order” Almost no one disputes it

Insider exposes Freemasonry as the world’s oldest secret religion and Luciferian plans for the new world order

Identifying the Luciferian Globalists Implementing the New World Order: Who Are the “Jews”?

Posted on January 31, 2023

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