We’ve got a new ad today from Stansberry’s Investment Advisory ($49, renews at $199), and it sounds a bit familiar — it’s a pitch for an obesity pill that Dave Lashmet, who now helms that letter, thinks could become the best-selling drug in history.
It’s pretty much a global consensus that obesity and Alzheimer’s Disease are the two biggest “unmet needs” in the pharmaceutical world. We may know what causes obesity, though there isn’t any indication that we know how to stop it from spreading, and we don’t even really know for sure what causes Alzheimer’s, but everyone seems to intuitively know that if someone finds a pill that safely turns either of these epidemics around… well, let’s just say that they’ll be buying sports teams and endowing universities, and probably shopping for monocles and top hats.
But that’s nothing new, of course, we’ve seen pitches for the “cure for obesity (and Alzheimers’) every couple years for decades now — and they always seem to fail, both in practical terms and in terms of making investors filthy rich. Most weight loss drugs that we’ve seen teased over the years either end up with surprise safety concerns, or turn out to not be as effective as hoped. Nobody is going to bend over backwards to pay big bucks for a pill that helps you lose five percent of your body weight in combination with diet and exercise… if we could diet and exercise, we’d probably lose five percent anyway, that’s not dramatic enough.
So the dream is something much bigger — some way to “turn off” that urge to eat a bag of Fritos on the couch at midnight, or to have ice cream every day, or to drink a couple dozen Cokes a week. Pretty much every drug starts out its life in the lab by focusing on some smaller and easier segment where they can show dramatic results without testing it on half a million people, so these anti-obesity hopefuls tend to start out with extreme patients, those who are morbidly obese and probably have specific genetic or inherited tendencies for obesity, and helping those people is important and can be a nice niche business… but the promise, at least for investors, is what if they can also prove that it works on the hundreds of millions of other people who are overweight?
And that’s the pitch from Dave Lashmet, essentially — though it’s not actually Lashmet making the presentation. Here’s a bit of an excerpt from the spiel that’s made by Tom Mustin:
“Today, I’m reporting on what’s likely the biggest story of my career… and what could be the medical discovery of the century.
“It could literally change the world… perhaps save the lives of dozens of your friends and family members… and could hand early investors incredible gains.
“I’ll be revealing critical intel about this situation, BEFORE the rest of the world can capitalize.
“But I want to be totally clear upfront with you…
“I’m not a doctor, medical researcher, or an investment analyst.
“I’m a reporter. And I first heard of this story just a few weeks ago after I was approached by a man named Dave Lashmet.”
So, just to be clear: in this case, no, Tom Mustin is not really acting as a reporter, at least not in the way I think of that role — Tom Mustin is a former TV News Anchor in Denver, but he’s also an actor and a spokesman for hire. I’m quite sure he’s reading the script that Stansberry prepared for him. Many publishers have started doing this for their teaser ad presentations, hiring spokespeople who have that “news anchor” gravitas to give a little weight to their pitches. That’s been the push from advertisers for decades, trying to buy credibility — I’d stop short of calling it evil, whether it’s Walter Cronkite pitching Winston cigarettes or Morley Safer hosting a pharmaceutical company’s infomercial about its latest antidepressant, but it certainly blurs the line to call yourself a reporter when you’re reading an ad.
What else does the ad tell us about this potential “biggest drug in the world?”
“Its chemical compound has the power to save billions of lives… and it’s one of the most guarded, valuable, and unknown secrets in the medical community today.
“Most doctors don’t yet know it exits… let alone the greater public.
“The formula is locked in a vault, outside of the U.S. This groundbreaking chemical compound doesn’t even have a name yet.
“It’s guarded within the borders of one of the safest countries in the world.”
Huh? Ok, if there’s a drug going through the FDA approval process, then the FDA knows exactly what the chemical compound is, and that information is not guarded or secret, it is publicly available. That’s the deal with drug approvals, just like any other kind of patented product — these aren’t trade secrets like the formula for Coca Cola, special recipes that you lock away in a vault and hope to keep secret forever. If you want a patent, you have to reveal exactly what your product is and how it works in exchange for that promise of 20 years of exclusivity, that’s the tradeoff.
Mustin then pours on the drama a bit more…
“It’s the most dangerous disease in the world because it comes back as much as 95% of the time, oftentimes worse than before.
“That’s all about to change, though. Because one company has developed the first-ever secret chemical compound that could save you or someone you love… and the rest of the world.
“Today, you’re going to learn about the first pill in history that studies show 70% of the U.S. population could use a prescription for.
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just click here...“There’s never been a drug in history with such a massive market potential…”
OK, so sure, yes, if there’s a drug that cures obesity most of us either need it or know someone who does. What exactly are they pitching, though? Who is this wonder company?
More about Lashmet:
“… he’s discovered what he believes is the NEXT major player in the incredibly lucrative pharmaceutical industry.
“And when Dave makes predictions like this, people take notice. Roughly one of out every three stock picks Dave made in one of his services in 2020, at least doubled in price.”
A lot of Lashmet’s picks over the years have been biotechs, so that’s not a big surprise — 2020 was a bang-up year for biotech stocks, particularly for those working on vaccines or antivirals that could hook their caboose up to the COVID-19 train, and I’m sure Lashmet pitched several vaccine companies last year that did very well. The biotech indices outpaced the broader market for most of the year, sometimes dramatically — though they’re also very volatile, of course, and biotech stocks in general have had a much tougher time in 2021.
More about this obesity treatment being teased:
“Before today, the only way to beat it permanently was to change your entire lifestyle, like a drug addict or alcoholic.
“Which takes some serious willpower, since studies found high-fat, high-calorie foods like bacon and cheesecake are as addictive as cocaine and heroin.
“Not to mention, fighting this disease is fighting our very genetic programming as humans.
“The New York Times dubbed it ‘the fat trap.’
“For centuries, we have evolved to consume and store energy. Our bodies are programmed to make it extremely hard to lose those fat-fueling energy deposits. Which means your own body sabotages your weight-loss efforts.”
And it will not come as a surprise to any of you that weight loss strategies don’t work for most people, most of the time. More from the ad:
“While companies and products have claimed for years to have the answer to lasting weight loss… none of them do.
“It turns out, we don’t need the powders and supplements and diet plans… the fads, fasting, and cool-sculpting… we don’t need the surgeries and procedures.
“All along, what we did need… was a way to counteract an age-old trigger within our very genes. This trigger within our bodies sabotages weight loss. As much as 95% of the time, it wins. But now we finally have a way to turn that trigger off and win the battle against obesity permanently.”
So what’s the solution? We finally get into a few clues about the specific drug…
“It’s all thanks to the company I’m talking about today. They have the first ever vetted and tested potential cures for the overweight epidemic.
“Can you imagine how much money people will pour into the first weight-loss solution that actually works?
“A solution that doesn’t require revamping your entire lifestyle?
“That doesn’t take years… maybe even decades… to show positive results?
“And that doesn’t end in failure – even years after?
“Just think about how doctors will react to this medication.”
Then we get a few more details about this drug and it’s pathway so far:
“I’m talking about the potential to be among the first ever FDA-approved drug for weight loss that actually works on significant, life-changing levels.
“In the first clinical trials, 2,000 obese patients were tested with this drug’s active ingredient.
“Those who received the drug lost an average of 37 pounds… and more than half lost 15% of their total body weight.
“A third of study participants lost 20% of their body weight.”
That’s pretty good. And better yet, it’s even the simplest of all medicines: A pill. You don’t have to go to the doctor every week, you don’t need to stick a needle in your arm. Mustin (and Lashmet, presumably) say that’s a key to this company’s success, and part of what makes their solution unique:
“So why doesn’t every company create a pill?
“It turns out, protein-based drugs are extremely difficult to get the stomach to absorb. Our stomachs exist to break down proteins like meat and cheese. It’s just our biology.
“And competing companies simply haven’t cracked the code.
“But one tiny biotech company did.
“And instead of leasing the proprietary tech that can turn a protein-based injection into a tablet…
“The creators of the potential first-ever FDA-approved effective weight-loss drug bought the entire company.
“And transformed its FDA-approved weight-loss injection into a pill.”
So not only is it a company that already has an injectable drug for weight loss, but that drug is already approved by the FDA… so that’s a good sign for the pill version, per the ad:
“… for all drugs in clinical trials… there’s always a risk that the drug won’t be approved.
“According to Dave Lashmet, the weight-loss pill we’re talking about today is an extremely rare case. He believes the risk is downgraded almost to zero. In fact, he thinks this drug has a 98% chance of being approved by the FDA. Changes like these are unheard of in the medical world.
“… why does Dave think this company is highly likely to get an approval? Because the active ingredient in the drug has already been approved in injection form.
“And, if that wasn’t enough, a drug with the same active ingredient has been approved in a pill form to treat another disease.
“That means the active ingredient and chemistry has already been studied, reviewed, tested by the FDA, and is proven to work.”
We are also told that there haven’t been major side effects for this drug, and it has gotten lots of endorsements from doctors:
“One weight-loss gastroenterologist called the active ingredient a ‘breakthrough’ and said it was ‘highly effective for the management of weight.’
“A doctor at Northwestern University remarked this active ingredient was ‘the start of a new era’ in the fight against obesity.”
So the story is that this company already has an FDA-approved obesity drug that works, it’s making a pill version that they’re sure will get FDA approval, and it’s going to ramp up and become the best-selling drug in history. A couple more tidbits from the pitch:
“This company is already building factories in the United States and Europe to prepare for the surging demand that has already led to shortages of its incredible, world-changing drug.”
And, importantly, it’s a drug that required maintenance dosing… not a one-shot cure:
“you need to keep taking this drug to maintain the effects, just like cholesterol or blood pressure.”
That always sends dollar signs blinking across the eyeballs of biotech investors, because the best customers are repeat customers.
So what’s the story? Thinkolator sez that Dave Lashmet here is recommending pharmaceutical giant Novo Nordisk (NVO), which dominates the global diabetes market with its insulin and other drugs… but also has a higher dose version of a diabetes drug, semaglutide, that was approved back in June for weight loss for adults with “general obesity.” That drug is called Wegovy, though it’s the same active ingredient as the diabetes drug Ozempic, just in a higher dosage, and it is approved as a subcutaneous injection.
And, yes, as teased, Novo Nordisk did buy a company last year, Emisphere Technologies, in order to get access to their technology for oral drug delivery — they were already using Emisphere’s formulation for their oral version of semaglutide for diabetics, under the name Rybelsus, and the oral treatment for obesity, which I don’t think has a name yet (so that part of the tease is true, drugs often don’t get a brand name until they are approved), is reportedly beginning Phase IIIa clinical trials this year as they try to expand their obesity business (that was announced earlier in the year, though I haven’t seen any updates more recently). That will take a while, that’s a 68-week trial, the same as they had for injectable Wegovy, so we probably won’t see a potential approval for the pill until 2023 sometime, at the earliest.
Novo Nordisk has been active in obesity for a long time, but this is their most promising product — and it sounds like it is much more effective than anything else that has been approved for “mass market” obesity indications. There are other obesity drugs, including setmelanotide (Imcivree) from Rhythm Pharmaceuticals (RYTM), which Lashmet teased a couple years ago as a game changer in ads for for his more expensive newsletter, but that one, while it had good results in its target audience, is still very much aimed at specific genetic disorders of obesity — so they’re going after a few thousand patients at a time, not millions like Novo hopes will be the case with Wegovy (and like Wegovy, it’s also an injectable, though they are testing an extended release injection as well).
Sometimes it’s better to go with the big and established company — pundits often get pushback when they tease a mega-cap company, especially in their higher cost newsletters, but its certainly a safer path. Just one of many reasons why investors are often happier, in the end, with entry-level newsletters at $49 or $99 that give sensible suggestions, than they are with the fancy $4,000 “upgrade” letters that shoot for the stars and often miss, as Lashmet has so far missed with RYTM (I don’t know whether or not he still recommends that one, to be clear).
So yes, if anyone can launch a mass market drug for hundreds of millions of people and build a market for that drug by changing the way doctors treat obesity, it’s probably Novo Nordisk. Obesity and diabetes go hand in hand, and every doctor who treats diabetics already has a Novo Nordisk salesperson popping by the office every week. And, to be fair, Lashmet has touted the potential of this Novo Nordisk drug before, too, back in June after it was first approved — and some optimism about that, and reassurance about the political pushback on drug prices probably not being as bad as had been feared earlier in the year, helped to bump NVO from around $80 when that Wegovy approval was announced, to almost $120 at its peak a few weeks ago (it’s back down to about $104 today).
The problem, if you’re caught up in the idea of getting a “life changing” investment result, is that Novo Nordisk is a $250 billion company, one of the biggest pharmaceutical firms in the world. Yes, they are aiming to double the size of their obesity business, hoping to get it up to a couple billion dollars in sales over the next few years, and maybe it will surprise them and grow much faster than that (it’s an expensive drug, a couple thousand dollars a month, and may have to be taken in perpetuity to remain effective, so there will be pushback from insurers), but even a couple billion dollars doesn’t make a huge dent for Novo Nordisk… this is a company that is just a hair short of $50 billion in annual revenue already. And they do face some pushback globally when it comes to insulin pricing, so it’s possible that some of their foundational products could see softer revenue in the future.
And they just announced last week that they are actually facing some challenges with Wegovy on the manufacturing side — this is from their press release on Friday:
“Novo Nordisk today announced that a contract manufacturer filling syringes for Wegovy® pens for the US market has temporarily stopped deliveries and manufacturing following issues with Good Manufacturing Practices.
“As a consequence, Novo Nordisk does not expect to be able to meet demand in the US in the first half of 2022 and few new patients are expected to be able to initiate treatment. The priority for Novo Nordisk is patients who have already initiated treatment with Wegovy®. Novo Nordisk currently expects to be able to meet demand in the US in the second half of 2022.”
So that might slow the buildup of Wegovy sales, and take a little wind out of the sails of investors if they downgrade their forecasts when they announce their results in February… though they’re really just a few months in on building that market, so it shouldn’t have a dramatic impact on Novo’s actual earnings over the next six months.
On the plus side, they’re super profitable, they pay a little dividend (1.6% right now), Wegovy seems to be very safe and effective so far, and if they can build the dominant obesity franchise to accompany their diabetes franchise and their other drug programs there’s still plenty of room to grow. The stock is expensive relative to its own history (it trades at about 32X earnings, and has averaged about 25X over the past decade or so), but arguably deserves that premium valuation if the obesity business and their oral diabetes drugs can really grow from here.
So buying Novo Nordisk here is probably a little bit of a stretch, that means you’re buying a stock with a PE of over 30 that is only growing its earnings by about 10% a year right now (this gives us a PEG ratio of 3, and when I’m cautious I prefer to buy with a PEG below 2), but if Lashmet is right about the rapid growth that Wegovy should have, and after that the oral formulation of semaglutide if it’s approved, then it could certainly work out well. It’s not a terrible idea, it’s just that the dividend is below average for a megacap pharma company, the growth is not currently stupendous, and you’ll probably have to be patient as NVO tries to build a market for semaglutide.
Sound like your kind of stock? Want to watch to see if some of the bloom comes off the rose, or are you willing to bet on Wegovy being a barn burner in a few years? Have other favorites in the anti-obesity space?
Let us know with a comment below.
Yes you are correct. I am a subscriber
Dave is “The Man”.
NVO has been a good investment over the years. Collect the dividends, albeit small, in the mean time until FDA approval….
I’ve thought that the fundamental reason weight loss medicines fail in practice is that the control of weight gain involves multiple genes perhaps hundreds in which any one gene makes a small but independent contribution re: glucose, fat metabolism, endocrine negative feedback mechanisms to increase satiety and decrease hunger after eating, mitochondrial genes that regulate exothermic vs endothermic heat production,, etc, etc. But adding to the complexity of weight control are the genetic factors related to one’s endowment of will power and delayed gratification and perhaps vanity, ambition, and good judgement. It would be interesting to review the differences in the incidence of adulthood obesity in groups of children who scored high vs low on table top tests of delayed gratification, you know, the ones where children are asked not to eat the mm’s placed in front of them as the experimental monitor leaves the room for a few minutes. Children who score high on tests of delayed gratification do well as adults in many aspects of life related to personal achievement. I think in many people the genetic contributors of these psychological traits to weight gain/loss are more important or weightier than the basic science of glucose and fat metabolism.
I think that may be the most cogent response to the complex issues surrounding weight loss and pharmacology I’ve ever read! Well done and thank you.
Interesting response with respect to the genetic components responsible for obesity. As mentioned, I agree there is a host of physiological parameters that must also be considered as cofactors.
Although I believe delayed gratification may play a role in controlling obesity, the work on delayed gratification completed by Mischel at the Bing Nursery school has more or less been discounted recently in a study (including Mischel) reported in the Journal of Economic Behavior and Organization. See https://anderson-review.ucla.edu/new-study-disavows-marshmallow-tests-predictive-powers for a summary of the publication. The current view is that BMI is not correlated as earlier predicted.
I’m a retired biochemist/molecular biologist and together with my wife who has worked in pharma we are astonished by the host of new pharmaceuticals (and supplements)that are marketed for questionable benefits. A good example is Prevagen. There is a great summary article on the Center for Science in the Public Interest website about the misleading claims.
Reducing obesity is, however, somewhat easier to quantify than cognitive improvement so the placebo effect is more relevant with many supplements. With Wegovy time will tell. Will it prove to be like the drugs for restless leg syndrome that may questionably outweigh the benefit?
The Swiss dividend withholding-tax rate is 35%, so when the investor is paid $1,000 in dividends, $350 is withheld. However, Switzerland separately has a tax treaty with the U.S. that lowers the dividend tax withholding to 15%. Yet it will withhold the treaty rate only if the investor’s wealth managers or accountants have applied for it in advance of receiving their dividends.
Good point, though technically it’s Denmark in this case, not Switzerland, and I think their rate is 27%.
Another great one from the Thinkolator, thank you Travis! Not ready to bet on Novo Nordisk/ Wegovy at this point, I will keep it on the watchlist for now. Wouldn’t Eli Lilly also have a shot (pun intended) with its tirzepatide drug (http://bit.ly/Tirzepatide1)?
Totally in agreement that this is an incredibly well thought out comment on the complexity of the ‘weight loss issue’ we face today.
I too would love to see the results of the long term developmental studies for delayed gratification with regard to weight gain/loss and put them to the test against these types of results, so that one might get a better idea of whether they were going to fall into a percentage of individuals that a drug like this is never going to help with any probability in the first place.
Another major concern is the effects of things like environment and availability of healthy lifestyle modelling in the individuals home and neighbourhood.
This again makes weight loss an issue which involves so many more issues, from economic, to social all resulting in deeply ingrained and comfortable psychological habits. Habits which will improve at differening success rates with a weight loss drug, depending largely on an individual’s ability to learn to delay gratification in the face of these obstacles.
This to me seems to require yet another layer of psychological drugs( which ironically can cause more weight gain), or counseling… none of which may be in the average North Americans Health budget long-term.
Finally this comment is just a personal pet peeve about the way scientific’findings’ are generally reported to the lay person, especially whenever something is trying to be sold. All we are told here is that the company has previous FDA approval for an injectable version of this drug (which I have never ever heard of, or it’s supposed stellar results).
Most importantly though is that we are supposed to base all this and be caught up enough to buy in to shares of this drug simply because, we don’t know any better and they have told us on the :
“In the first clinical trials, 2,000 obese patients were tested with this drug’s active ingredient.
“Those who received the drug lost an average of 37 pounds… and more than half lost 15% of their total body weight.
“A third of study participants lost 20% of their body weight.”
This tells us very little, when it doesn’t list the weight loss average in lbs of those who received a placebo, did they lose 47 lbs on average or 2lbs? Or for that matter did they even test against a placebo ( likely yes in a FDA approval trial,). What is the overall statistical significance of these findings and how was the experiment designed to account for all the other variables we just discussed? Conveniently none of this I brought up in the sales pitch copy, and I understand why, it is because it is effective. Still in this age that is no longer of information but more about how to be misled by a partial reveal of the data available to the general public it really bothers me to see his practice invading the world of the stock market where people making misinformed errors in judgment can lose entire lively hoods not just a few extra lbs of fat.
Thank goodness we have Travis and Doc Gumshoe to sleuth out these investment advertisements so we can choose without paying ridiculous subscription fees for sme of these sales pitches
Pa
So sorry. Pardon all the typos. I was getting quite heated and running out of time on lunch lol
I know someone using Wegovy, it is being approved by most healthcare plans. For her, it is working incredibly well after years of failed dieting, metformin, and other behavioral counseling. I think this is a game changer drug for weight loss — it’s not like the amohtimine like drugs of the past. No negative side effects for my friend either.
This class of drug , if indeed a semiglutide version,, stimulates incretin receptors with the side effect of delayed gastric emptying, sometimes nausea. Not real promising for obesity as target rather than controlling blood sugar, where people have at least that additional motivation to lower food intake and have glucose test feedback.
I observe the likely cost: ‘it’s an expensive drug, a couple thousand dollars a month, and may have to be taken in perpetuity to remain effective’. I live in Australia, where medical care is essentially free, and necessary medication is subsidised. For weight control, this medication will not be subsidised in Australia. There is less than 10% of the Australian obese adult population who could afford it, and most of them would want to use that cost for other purposes. For ‘private use’, one syringe (4 doses – 4 weeks – for diabetes will cost $(Australian) 1700.00. This would be the cost per week for weight control in Australia. Other diabetes medication (oral or injection) is much, much less expensive, and semaglutide is only available for diabetes when all other medications have failed.
How this will pan out in the USA, Canada and Europe I cannot predict, except that it is likely to be limited by its cost to persons for whom that cost is essentially a whim, who want to continue their lifestyle, nevertheless slim down to look very trim on the internet.
Anecdote: My dad of 83 years has probably had the most undiversified portfolio you can imagine during several decades.
Basically 80% Novo.
Contrary to all sound stock investment advice this strategy has worked out really well for him so I guess keeping it simple can work out…
Obviously due to the sentimental factor I myself obviously had to buy NOVO march this year when i stared my personal stock investment journey. It has made consistant profit with a current status of 61+ %.
So for what it’s worth personally and historically I can vouch for NOVO as a sound investment both short and long term.
Best
Growing up in the 1950s, there were over 400 students in our primary school. ZERO were obese. Two brothers were what we might call “sturdy”. Their parents were also “sturdy.” In the early 1960s, Japanese scientists “invented” high fructose corn syrup (HFCS). FDA asked a few scientists to investigate. Their response: “Ban it” (HFCS)from entering the US. The FDA scientists were fired. Our stomachs produce a hormone (messenger) called “leptin”. Leptin senses when our stomachs are FULL. This hormone “message” travels to the brain. In response, the brain produces a hormone called “ghrelin”. Ghrelin travels to the stomach with its reply, “OK, brain, I got your message. NOW STOP EATING!” HFCS breaks this chain, such that we don’t realize that we have eaten enough, and we KEEP EATING!
Years ago, at the Agriculture Department office in Congress, I asked about banning HFCS. Response = “We can’t do that. The corn lobby is too strong.” NOTE: Laws in Scandinavia (Finland, Sweden, Denmark, Norway) BAN LOBBYISTS! THEIR BALLOTS LIST, BY CATEGORY AND SUBCATEGORY, what people pay for with their tax money. Three (3) ballot choices, one per category: pay the same, pay more, or less. Tick one box for each category and subcategory. Broad categories include emergency response. healthcare, transportation/infrastructure (roads, bridges, local, long distance, rapid transit, rail, maintenance, bicycle lanes, etc.), education, sports, culture, parks and recreation, environment, etc. As one Swedish voter said, “Well, we may pay high taxes, but WE KNOW WHAT WE PAY FOR!”
Politicians either do what the people instruct, or the next election, they may resign, or are voted out of office. If the voters’ wishes are followed,then they may be reelected, or elected to higher office.
PS Typically, phone calls to each Congressperson’s office are grouped into categories and tallied every day. A report on “How is the mail/are the phone calls running?”was/ is? still given to the Congressperson. Each email letter to members of Congress used to be “worth” ten (10) votes However, a mailed, WRITTEN letter (showing that the author is a voter in the Congressional district who took the time to send same) was worth TWENTY-FIVE THOUSAND VOTES!. Signed, FAXed letters arrive the fastest. Pre 9/11, the halls of of Congress were crowded with people. Anyone could walk right into the gallery, sit down, and watch proceedings, including debates. A reporter holding a microphone while interviewing a Congressman, asked him why he changed his vote. “Because that’s the way the mail was running.” Reporter, “What mail?” Holding up the fingers on one hand + the other hand’s thumb, the Congressman replied, “Six letters.” 6 X 25,000 = 150.000 votes. In his mind, the member of Congress KNEW that he WOULD LOSE the next election if 150,000 votes went to his opponent. THIS is democracy. POWER TO THE PEOPLE! PS I happily witnessed, sitting in the Senate gallery, when the Civil Rights Act was passed.