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March 14, 2022 - Epoch Times
16:07
Pfizer Quietly Adds Warning That 'Unfavorable Pre-Clinical, Clinical Or Safety Data' May Impact Biz
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This is your daily Facts Matter update, and I'm your host, Roman, from the Epoch Times.
And now let's begin today's discussion by talking about Pfizer.
And to start with, as we've already discussed on a previous episode, the FDA is currently locked in a court battle with a medical transparency group regarding the release of the Pfizer clinical trial data that they have on file.
The Medical Transparency Group, they are suing the agency for this data, arguing that the public has a right to see it, while the FDA on the flip side, they appear to be slow walking the process, and they are making the argument that they'll need about 75 years to release all the documents.
However, as we've already mentioned, the judge in the case, he ruled against the FDA.
And as it currently stands, the judge is forcing the FDA to release 55,000 pages of documents per month starting on March the 1st.
Meaning that we, the American public, should begin to see these documents for ourselves starting in about two weeks.
However, as we mentioned in that previous episode, the FDA is now attempting to delay this release by as much as possible.
And also, two weeks ago, lawyers for Pfizer, they moved in and they attempted to intervene in the case.
Now, ostensibly, the lawyers for Pfizer, they said that they are intervening in this case only to protect Pfizer's trade secrets.
Meaning any trade secrets that might be revealed as a result of these documents becoming public.
However, it looks like there actually might be another reason for why Pfizer is choosing to intervene.
That's because just yesterday, it was revealed that Pfizer made some critical changes to their fourth quarter earnings release.
Specifically, they added some, you can say, peculiar items deep in the section regarding their business risk disclosures.
Let's, in fact, go through some of these changes together.
And before we do, I'd like to give a big shout out to Mr.
Kelly Brown, who is an independent investor, and he's the one who first flagged these changes and then posted his findings over on Twitter.
And by the way, the methodology that he used to flag them is he compared the third quarter earnings reports to the fourth quarter earnings report.
And then when he plays them side by side, he noted all the changes that the company decided to make.
So then, let's move into these documents for ourselves.
The first page, the one that you're looking at up on screen right now, is from page 22 of Pfizer's Q4 earnings release.
And more specifically, what you are looking at falls under the section of possible risks that Pfizer's business, its earnings, as well as its stock price could potentially face in the near future.
And notice what Pfizer added.
It's highlighted there in blue right there on your screen.
One of the new risks that they have identified is, quote, Further information regarding the quality of preclinical, clinical, or safety data, including by audit or inspection.
And just for comparison's sake, take a look at the same section in the report that they put out in the previous quarter over in Q3. And notice that the entire section in blue is missing.
Meaning that during the third quarter of 2021, during the time when the FDA was trying to convince the judge to give them 75 full years to release all the data, well, Pfizer did not think it was an issue.
However, in the fourth quarter, when the judge instead decided to give the FDA only eight months to release all their clinical trial data, well, then suddenly, Pfizer not only had their lawyers attempt to intervene in the case, but also they decided to add a notice to their investors saying that there might be a potential risk in regards to, and I'll quote it again, quote, Clinical or safety data or further information regarding the quality of preclinical, clinical, or safety data, including by audit or inspection.
That is very interesting to say the least.
Then if you go down a little bit further in this same section, there's another part which was added into the Q4 report that's worth mentioning.
I'll put it up on screen for you to see.
And what you're looking at is a red line version of this document.
Meaning that everything in black is the same as it was in Q3, but then the parts in red are new.
They were added in the fourth quarter report.
And so, according to Pfizer, here's one of the new challenges that they are facing.
Quote, challenges related to public confidence or awareness of our COVID-19 vaccine, or Paxlovid, which is their COVID pill, including challenges driven by misinformation, access, concerns about clinical data integrity, and prescriber and pharmacy education, etc.
It's worth noting, at least in my opinion, that they added concerns about clinical data integrity after the federal judge said that the FDA cannot take 75 years to release all of their documents.
Doesn't necessarily mean that there is a connection, but the timing is definitely of interest.
And then lastly, there is one other change that I thought was worth mentioning.
This particular change does not have to do with those FDA documents, but this change does shed a light on how vaccine manufacturers, when they are considering their bottom line, they view COVID in a much different way than you and me, than the rest of the world.
Here's another potential risk that Pfizer added in their earnings release.
Meaning that what the entire world is currently praying for, an end to COVID, is explicitly bad for Pfizer's business.
Which, of course, I mean, that's not a new development, but it is interesting that they added into their investor document.
Regardless, in terms of what the FDA's clinical trial documents actually say, well, barring any unforeseen circumstances, we should begin to get those documents into our hands on March 1st.
That's when the first batch of 55,000 pages of documents are set to be released.
And subsequently, the FDA will have to continue releasing 55,000 pages a month until about October, at which point all the documents should be made public, and we will know what the clinical trial data actually was for this Pfizer vaccine.
Until then, if you'd like to check out either the Q3 or Q4 earnings report from Pfizer, I'll throw the links to them into the description box below this video for you to check out, and that way you can actually see the changes that they were making for yourself.
However, in terms of some positive developments for Pfizer's business, well, just about a week ago, They officially submitted their clinical trial data to the FDA in order to get approval to administer the COVID vaccine to babies as young as six months.
And by the way, just for your reference, in case you're not aware, at this moment, the Pfizer vaccine is currently only available to kids over the age of five.
But they are looking to change that.
And the FDA's advisory panel on vaccination, they will actually be having a meeting next week, specifically on Tuesday of next week, in order to decide whether to move forward with Pfizer's request or not.
And actually, there's something rather interesting regarding Pfizer's application that is worth mentioning.
And that is, back in December of 2021, Pfizer announced that their clinical trials in young kids did not really elicit a positive result.
Specifically, back then, they said that the efficacy of the two-dose vaccine series for children between the ages of two and five was disappointing.
However, in a rather unusual move, Pfizer issued a news release at the beginning of this month, February of 2022, in which they announced their decision to pursue applying for this authorization anyway as they continue to study the vaccine because of what they called an urgent public health need.
Here's specifically what Pfizer said in their press release, which was again just issued earlier this month.
Pfizer and Biotech today announced that following a request from the U.S. Food and Drug Administration, the FDA, And so indeed, Pfizer submitted their data in an application to the FDA Pfizer submitted their data in an application to the FDA on February the 1st.
And here's a quote from NPR describing the intent of this particular application.
The companies began to submit data on the safety and efficacy of two doses of the vaccine in this age group, describing them as part of a three-dose primary series in an application for emergency use authorization to the Food and Drug Administration.
Data on the third dose, given at least eight weeks after the second, is still being collected and analyzed.
Now, as of this moment, Pfizer has yet to publicly release any of the detailed safety and efficacy data for children in this particular age group.
Regardless, to give you some context, the entire process of authorizing the vaccine for children between the ages of 5 to 11 took only four weeks.
And so perhaps we will have an answer on these babies within the next month.
And again, the next step in this process will be that on February the 15th, which is next Tuesday, the FDA's advisory panel on vaccinations, they will get together and meet to discuss this data.
However, it's also worth noting that the FDA has recently been following a trend of ignoring their own advisory panel and moving ahead with authorizations anyway, even if the advisory panel doesn't suggest it.
And so we'll just have to wait and see what happens in regards to these kids.
If you'd like to read the primary source documents for yourself, including the news release from Pfizer, I'll throw all that into the description box below this video for you to check out.
And all I ask in return is that you take a super quick moment to smash, smash, smash that like button for the YouTube algorithm.
And now, before we move on over and talk to the CEO of an America First renewable energy company and discuss the way forward for American energy independence, I would like to take a super quick moment and introduce the sponsor of today's episode.
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Now, Roman in the studio, back to you.
And now let's switch gears just a little bit.
While I was down in Texas, I took the opportunity to sit down and speak with Mr.
Jim Lamone, who is the founder of an American-first renewable energy company, and we discussed the way forward for American energy independence.
Take a listen.
As you said, a great CPAC, just great conservatives out here, kind of getting back in that mode that we've got to take our country back.
Same in my company.
We do a lot of great things.
We're a power group, building all across the country, 1,600 on staff.
A great team that I was fortunate to put together that came out of the coal and gas industry.
I'm a veteran, six years Army Airborne Engineer, so we hire veterans first in our company, over 20%.
Strongly pro-American manufacturing.
By the way, that's the cleanest place on the planet to do it, right here, bring it all back to the U.S. And in doing that, we're now over 70% of the goods that we buy in a billion dollars worth of purchases a year right here in good old U.S.A. Wow, that's impressive.
So speaking of renewable energy, and you run part of your company's solar energy aspect of it, what do you make of the Biden administration's push for renewable energy?
We prefer to leave it to the market.
What we've done in the solar, the large-scale utility solar, is we've driven it down now to about half the cost of gas.
But even at the best of what we'll be able to do is about 30% of the grid.
We've got another 20% as we bring storage on.
The balance is going to be good, clean American natural gas.
So our point is we're blessed with this great natural gas.
We should be drilling it, including public lands.
We can do it responsibly.
We do that in solar every day.
We can certainly do it in natural gas.
When we do, huge creation of great American jobs.
We can export that fuel as well.
Make countries, we call it freedom fuel.
Make them less dependent upon other types of fuel.
Help balance the trade deficit.
Use this great American economy to really get back to strong job growth.
That's a big part of what I'm doing out there.
Bringing back American manufacturing, the cleanest place on the planet, and also use all our available resources.
Don't be restricted as politicians that are selling out our country to buy Russian gas.
Let's use our own.
This isn't a great American economy that easily, easily could see another 20 million jobs if we brought manufacturing back and unleashed America's energy potential.
Yeah, it's funny because there seems like even before this interview, you said that you're almost like a unicorn, right?
A conservative that's running a renewable energy company.
But it seems almost like that's a false dilemma because, for instance, I read a report that said that after Joe Biden pushed to have more wind energy, that's going to be a boon, at least in the short term, for European wind turbine manufacturers because we just don't have the technology, apparently, to generate wind turbines and it's going to send billions of dollars to Europe.
But it seems like the way you're doing it within the private sector seems to be the more intelligent way.
It is.
And what we do is solar panels, we buy as much American supply as we can, and then we go to Europe.
Turkey provides a fair amount.
Although we have recently invested in a facility in California that we're looking to move to Arizona because we want to achieve 100% American manufacturing.
It's very interesting.
Our customers, once we start helping them understand what we call our patriotism score index, where we look at what percent, in our case 10% of our net income goes around the country, the most needy where we build, including Arizona, about $4 million a year.
Hiring veterans out of our 1,600, over 20% veterans.
The general population is only about 4%.
Then you look at it from a manufacturing standpoint, as I said, 70%.
When our customers start hearing that, we're no more expensive.
We're just that much better at being really true good Americans and providing great customer service.
Today, we probably negotiate 60% of our work because there are patriots out there that once you explain to them that we're stepping up and doing a little bit more, they come in fantastic numbers for us.
Wow.
So this Patriot Score Index, it's almost like an alternative to the EGS score, right?
It is.
It's something my team came up with, hugely proud of them.
The great thing that it's kind of moved us into is the vendors know that's part of our scoring system.
Sure, they've got to be competitive, price, and schedule.
Top two or three?
Then we'll look over to the score and see who gets the work.
Now they understand that.
They're starting themselves to do the same thing.
And we see these factories that were down to maybe 50 workers in Pennsylvania or Arizona, other places.
And now you go back and they're 200 in just a few years.
We're continuing to grow 100 million a year, one of the fastest-growing private energy companies in the country, but we're doing it the right way and bringing these jobs back.
And not only that, but a lot of great Americans, as they should be, are concerned about the environment.
What better place to do it in good old clean USA versus China or India, who are 2, 3x more emissions than we do here in America?
Now, it is worth noting that that was not the full interview.
Because, among other things, Mr.
Jim Limone was an alternate elector during the 2020 presidential election, and then furthermore, he spent about $300,000 of his own money to fund the security during the Arizona election audit.
Jim is also, by the way, in the process of running for the Arizona Senate on an American-first platform.
However, almost as unbelievable as it is to say, given the fact that I'm an American citizen in America, well, with things as they are here on YouTube, I don't feel comfortable showing that part of the interview on this platform.
And so, if you'd like to check out the interview in its entirety, you can do so over on Epic TV, which is our no-censorship video platform.
The link to it will be right there in the description box below this video for you to check out.
I hope you click on it.
I hope you check it out.
I hope you subscribe to Epic TV and join us on this journey of exploring this beautiful, beautiful world of...
Honest journalism based in truth and tradition.
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And then, until next time, I'm your host, Roman from the Epoch Times.
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