The video provides a provocative critique of the systemic friction between FDA bureaucracy and medical innovation, though it occasionally prioritizes sensationalist framing over objective regulatory analysis. It serves as a sharp reminder of how the intersection of politics and public health can complicate the path for life-saving breakthroughs.
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$IBRX: Dr. Soon-Shiong and Sean Spicer Expose Biotech War, FDA Warning, and the Two-Faced GovernmentHinzugefügt:
Macro goes here and I am back covering the most exciting stock in the most exciting medical breakthrough on the planet. And I'm going to be covering Dr. Patrick Soon-Shiong and Sean Spicer show today. And you're going to want to stay tuned because the things that Dr. Patrick cannot say and Sean Spicer even cannot say, I will be saying. I am the most opinionated person. I'm a long-term stock holder and I have your interests at heart. Please like, please subscribe, please share and this is not financial advice. Let's get into it.
Let's get right into it. Sean Spicer minute 8 and 1/2 on why he's meeting Dr. Patrick Soon-Shiong again. Record to record, now I'll walk you through this.
We're going to do that right now. No one else has this. No one else. We are the only show that you will see and hear this on, but you need to understand what we're up against because I'll give you my opinion, we're up against some big bad big pharma forces.
That's my opinion.
And I think I'm right. And I'm I would take this very seriously.
The reason is is that Sean Spicer was the press secretary to the president Donald J. Trump in his first term.
He knows the top of the top of federal people. Does he know who's inside the FDA? No, I don't think he does, but I'll get to that a little bit later.
But people come to Sean Spicer and say, "Hey, you know Dr. Patrick, can you help me? My my friend and my husband my wife has this ailment and we need a a solution.
Chemo and radiation isn't doing it." And Sean says, "Well, I'll be glad to help you." So, he's overseeing some of the top people in the United States, but he is not in the FDA. So, he has this top-level view of what's going on, but he can't really understand the FDA.
I'm going to give you some opinions on that in a little bit later.
But first, let's move on.
The next area I wanted to cover is the differentiation between what America is built on, free speech, and what doctors and what CEOs can say to the public. That has to be clear at our level so we can understand what Dr. Patrick can say and what he cannot say. So, I'm going to start that right now. You're you're a world-renowned doctor.
What was your reaction when you got a letter like this? Well, obviously I was surprised, but I think Sean, let me just explain the context maybe of where the FDA came from or coming from. Okay. There's really a tension, a real tension between first amendment of free speech and the FDA's policy of what they call promotion speech. So, this tension has been going on for decades to the sense that This tension of free speech versus what representatives of a company can say about their product has been going on for decades and I think that that is a very very interesting topic because the FDA can exploit that. The big pharma can exploit that and say, "Well, look, they're pumping their their products again. Make them stop."
And the schoolhouse FDA will be the enforcer. I look at the FDA as kind of the junior high and the big government, Make America Healthy Again, Robert F.
Kennedy, Donald Trump, as the high school, the overarching governing body.
Now, the junior high and the high school are different. They're separate. So, what goes on in the junior high is they have their own principals and teachers and whatnot. And what goes on in the high school is somewhat of a higher level, but the high school cannot intervene with the junior high. I view that as the FDA and because I use them as the junior high because they're a little bit more sophomoric. They're a little bit more stubborn and novice in how they deal with things that related to biotech. I think it's very sinister and I think it's very novice.
Let's continue. Actually, there's been legal cases now in the courts between pharma and biotech companies and FDA to try and resolve this issue of what is free speech and what is promotional speech. So, as it relates to our broadcast, the FDA considered a direct-to-consumer discussion because obviously your audience is that. And this as you may know, the administration has now taken on a high priority to crack down on what we call DTC marketing.
And I believe over a hundred letters has now gone out to multiple pharma companies to relate to this issue of So, hundreds of letters. So, I mean, that's that's a large amount when you're talking about small and mid-cap got biotech because a lot of them don't make it. So, a lot of them from go from small to mid-cap and make it and now they're hit with these warning letters of what they cannot say from principal in the FDA. Okay?
What they consider direct-to-consumer promotional speech.
So, my reaction is we received this letter in that context as a high priority.
And then it it elevated to a warning letter relating to two things. One, a TV ad and two, the Sean Spicer podcast.
>> This is really interesting because when he talks about a warning letter, so it elevated to a warning letter from two things.
From the TV ad and from the Sean Spicer podcast. Now, the first thing I said when this warning letter came out was, "Well, nobody in the FDA is watching Sean Spicer." I mean, come on. These guys are bookworms. They're nerds.
Right? They're they're they're not going to go out on YouTube and seek out Dr. Patrick Soon-Shiong.
Somebody's going to tell them about this. Somebody's going to submit this to the right here, the FDA bad ad program also received complaints regarding the promotional communications Frank Tiva.
So, who's submitting these complaints?
Is it Adam Feuerstein? I don't think so.
He's just a he's a nobody, right? He's just a cheerleader for big tech.
So, who is it? I think it's people that have something to lose. Everything in this world is built on is predicated on incentives. What incentives do you have What incentives do we have as investors?
We want stock to go up. Why? Because we view this as a cure, as a future significant breakthrough much like Jonas Salk to polio.
He cured it, a vaccine.
This is the new polio vaccine in my opinion. I could say that because I'm not Patrick Soon-Shiong. I'm a guy that is trying to get to as many people as we can. So, please share this with people that you think are going to like this programming. Let's continue. Yes.
The TV ad as it turned out, we never aired the TV ad. And they never aired the TV ad. So, that more evidence is mounting on somebody inside some three-letter agency saying, "We got to get these guys." Or Merck or or Johnson & Johnson's given us a bunch of money, $50,000 in our back pocket and we're not doing enough and they're unhappy.
Seriously, America is like a kangaroo court and this is a war. My father, who's a physician, I said to him on the last show, I said I maybe I was a little bit harsh on some people. He goes, "This is a war." And it really opened my eyes.
Yeah, this is a this is a war.
And this is a war you don't see in other mature markets. You don't see this in the China biotech. You don't see this in Hong Kong. You don't see this in Singapore, in Taiwan. You don't see this political jockeying between people that need cure and people that want to continue to make money.
And it's just a shame, but they are doing the right thing. They are going to Saudi Arabia. They are going to Macau.
Macau is an entry way to China and they're making waves that way. Super smart and we are going to win. Let's go.
And here I am now with you. Wait I just Doc, can I be clear on something?
So, they cited a TV ad as problematic. Because in in their opinion, I I don't want to put words in your mouth, but I I want to make sure I'm understanding this.
Because in their opinion, a this supposed TV ad would have been a direct-to-consumer effort. Is that is that kind of what they would they would claim?
>> They they would claim exactly what I'm going to clarify today with you that >> Okay, but but I I'm sorry. So, I So, I just want to be clear. Was there ever an ad though?
No.
There was never an ad. So, you see the kind of that we're dealing with, the kind of war that we're fighting. There was never an ad. Yet, the FDA is threatening lawsuits on things that don't even freaking exist.
I'm going to try and keep the swears to a minimum. I am passionate. I'm sorry about that. Let's move on. Let's move on to the next section which ironically deals with free speech. When you're doing an interview and I'm asking the questions, you're I think you've always been open and honest and transparent cuz I ask, "Okay, well, where can I get this? Or how can I do it?" Like I don't know. I I I get it, but I'm also kind of like that it sounds like you've got to be a human lawyer walking around all the time.
>> It's basically that. I think, you know, so I I live personally in a very strange world now, right? I am the owner of the LA Times. So, our free speech and first amendment is really what I live for in the LA Times. I'm a scientist and clinician. I look after patients. I am a inventor. I develop drugs that I think will make an impact, but I'm also the owner and founder of ImmunityBio with a approved product. So, now I fall under first amendment, but I also fall under the FDA policy that has real policy under what speech I can do under what I consider promotional. So, you're right.
Our conversation in my mind during that time was me under the context of speaking about Alpha 15, speaking about the patients that I have what I call single patient INDs which I get authorization from the FDA because it's unapproved to give them treatment for whether her lung cancer, brain cancer, etc. But, I think the concern was this confusing to your audience. Was I in a friendly way presenting or promoting anti-voids proved useful bladder cancer?
So, if you don't mind, Sean, I would like this purpose and thank you for giving me the audience and opportunity.
I laugh because this is really childish what he has to go through. He's a 70-year-old MD, founder and chairman, basically a breakthrough artist of our time terms of how he has created something. Creative people create and he has to go back to junior high and apologize. To clarify so that there's no question that I explicitly and the purpose of this podcast with me at least from you is to really clarify and if you don't mind, I'd like to read directly from the label and the safety so that this So, yeah, he's covering his ass and he doesn't have free speech.
Sean Spicer doesn't have free speech.
You know who has free speech? We do. I do. My name is Macro Ghost. Good luck finding that name in the the yellow pages, right? I'm anonymous for a reason. I always want to protect people that know me or protect my name. I don't want the FDA knocking down my door. I don't want any trouble. I just want to call it as I see it and I want people to have that inside knowledge track on how opinionated I am on some topics that deal with macroeconomics including but not limited to biotechnology. Oh, and one last thing I wanted to cover before we do move on is he reads through this checklist of things he has to say and it just reminded me of junior high like, you know, apologizing to, you know, music going to detention center or you know, writing a a note to somebody and then having to apologize for it.
It's just really weird behavior that it doesn't exist in in markets that I've operated in. I lived in China a long time, Taiwan, Hong Kong, Macau, Singapore, Thailand. There's nothing like this. So, when I see something like this, when I see a 70-year-old master of his craft having to basically basically apologize on air for his faults that he did up in the last podcast which were not faults at all, I start scratching my head and I'm thinking like, well, you know, there's a big problem here.
There's a big junior high principal problem and they don't have to answer to the high school. That's why I made that analogy. Let's move on. The next part I want to get to is kind of like a blink and you'll miss it, but it's really important and it it should be out there.
Should have had more screen time, but here it is. safety information that I should make >> Call it an FDA. That's Call it an F Look at this.
FDA hostage video. Physician tells Senate something has gone seriously wrong in the FDA.
A panel of physicians, patient advocates, and biotech executives testified Thursday during a Senate Special Committee hearing that the F the Food and Drug Administration's process for approving rare disease therapies has become increasingly unpredictable, erratic, and may be stalling life-saving therapies. We all know this as biotech investors, but the fact that this is now being brought in front of the federal, the top level government, the junior high has now has has to answer to the school board in the high school. I think that's what we're getting at and hopefully this problem can get resolved as time goes by because the FDA is like the SEC and many of the these other three-letter organizations, they don't have a boss and if you have people that don't really have responsibility with a 2.0 GPA running these things because they're not doing things are not being productive. They're not producing iPhones. They're not producing Amazon or Androids. They're ruling over a class of potential drugs and potential life-saving investments that and they're they're playing God.
They're playing PC principal and there's no room for that. There's no room for politics when you're talking about saving people's lives, especially saving people's lives. And so, it's finally I wanted to include this because if you blink And I I appreciate, but but what was the remedy that they proposed?
It's gone. They don't even spend enough time on it. So, wanted to give that the respect that it deserves and let's go to this portion this is very interesting portion of of the show about a minute later. EHS writ large watch the show cuz they can learn a little something about what's going on out there. The Secretary Kennedy and others are pushing. Do you think that somebody was out to to like somebody clearly watched the show and said, "This is something that I can bring to the FDA to rat on him." That's what he's saying. Ratted on you. Is is that a question? Sure. Patrick responds in a jokingly manner and I picked up on that. I pick up on that stuff. He thinks in my opinion, he thinks there is somebody ratting on him. And of course, I mean, who else would again, high school junior high antics. We're now in junior high and we have to do this all over again where we have life-saving therapies, potential vaccines, and we have to play kindergarten. We have to play PC principal like in South Park.
So, FDA, if you're listening to the show, grow up. There's people out there that have cancer that need something else. Let's get through this process of not only IBRX approval, but Innovance, Iova, let's get these approvals going if the evidence is there which a lot of the times it is and you're dragging your feet meanwhile Saudi Arabia has NSCLC non-squamous cell lung cancer being able to be treated by Entiva and IBRX. We did is this this doesn't sound like there's a bunch of dudes at the FDA or dude ads. They're sitting around watching the Sean Spicer show every night. I wish they do. I hope more people do. But I guess my question is like this seems a little weird. Like somebody somebody wanted to This is coming from the highest level of government. He was the press secretary.
For him to say this, this is extraordinarily significant in its language and nomenclature. Come after you. Well, in the warning letter, the FDA referred to what they call the bad the bad ad program and that they received some of this issue information from through the bad ad program. Who that may be or what what what was received from him, obviously I have a comment on this. Why this show? Why the Spicer show? The bad ad programs, someone that has something to lose with power or influence over the junior high FDA used that power, used that influence to hit the stock. Could this be a hedge fund? It could be. Go back to Roaring Kitty and GameStop. The hedge funds just kept shorting on their shorts until they were liquidated. They didn't have an FDA to lean on back, you know, with with GameStop. There's no FDA there.
It's just a meme. But here there is. So, somebody is doing something, exercising some sort of influence and there's big money behind it. Not just with biotech, not just with big pharma, with the hedge funds as well. And I wanted to bring that point up. No idea, but they did acknowledge they have this program and and somebody sent them with this show. Well, I have a couple ideas. "I have a couple ideas," he said. Interesting, isn't it? The devil is in the details, isn't it? And the last thing I wanted to cover is this right here because I know how significant Sean Spicer is, who he is, and just the significance of these two guys sitting down together. So, let's listen to that.
And this is fascinating to me. I By the way, it's funny you're you're a doctor or scientist. I think to the extent that I have any authority and I'm government will come after me for saying this. I think the the government >> will come after him. The government will come after him.
A guy that was Trump's right-hand man.
It's crazy. It's crazy.
>> [laughter] >> I only have a minute left, but like is our government reaching out and saying, "Hey, we see the potential here." Is somebody in our government you don't have to name names, but like I I'm fascinated by the fact that everyone else wants to talk to you about this, but is our government doing this? Well, I can't name names, but these very senior government officials are sending me patients to ask me to go to the FDA to receive what they call single patient INDs to treat these patients as part of the the program.
So, it's it's so I mean, again, my words, if you're listening FDA, my words, not the doctor's. It's fascinating to me. It's sad to see that people who could help move this along to make it available to everyone aren't maybe doing as much as they could, but they're willing to call to get help for a loved one or a co-worker or whatever. I I just I think this is what's wrong with with everything right now.
>> Yes. And I know you you've been a champ going out there helping so many people to the extent you can. I I mean we're going to add philanthropist to your title, too, because you've you've done so much good for people. So, doctor, thank you for coming High level government officials are going through the back door to get to back Patrick Soon-Shiong and are probably getting treatment, right? I mean, this is probably the most important to me part of the video and it came at the very end.
That's why you always stay to the end of videos, right, people? Even to mine, right?
You're getting information here. These people are selfish.
They're only out for themselves. These high level whoever it may be, I don't know. I don't want to name names. I don't get involved there.
But people are going to Patrick through a back door because of their rank and file in the government and they don't want to fight for him in the FDA. The only person fighting for Patrick is us and Patrick. Nobody else.
That's where I'm going to leave it. If you like this video, please share it.
Please retweet it. Please comment.
Everything helps. And next year this time, 2 years from now this time, I'm going to make a significant influence on the global population in terms of knowledge about biotech, in terms of getting the government to work for them because the government doesn't work for you guys right now. It works for itself and that must change. Thank you very much and I will see you in the next video.
>> [music] [music] [music] [music] [music] >> I'm blowing >> [music] >> soda maxim, two atmospheres, bad winds.
I'm blowing soda maxim.
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