The good folks over at the Money Map Press are selling memberships in their “Passport Club” this week, and your impetus for signing up is that they will reveal their top-secret obesity drug that they think will be approved in about a week.
The Passport Club, by the way, is one of those “lifetime” offers that most of the big publishing houses (or at least, most of the ones that are affiliated with Agora) promote every now and then — you pay a big up-front fee ($4,750 in this case) and then get all (or almost all) of their newsletters for life, with no further charge except maybe $100 or so per year for “maintenance” and, for those who still mail, mailing costs.
(Here at Stock Gumshoe we also offer up a lifetime subscription option — we call it the “platinum” Irregulars membership because the credit card companies we use get antsy when we use words like “lifetime,” which, in our case, means you get to be a paid member for as long as Stock Gumshoe exists. And who could imagine a world where Stock Gumshoe doesn’t exist? Of course, our option is only $200, and we don’t charge you any kind of “maintenance fee” — after all, this being the internet age, the 100th member doesn’t really cost us any more than the 99th.)
But I digress…. we were about to make you filthy rich, right? Or at least, find out which stock it is that the Money Map folks think will gild your lily. Here’s how they get our attention:
“For 15 Years Doctors Have Been Pleading, Unsuccessfully, With the FDA to Approve a Drug to Fight a Disease That, According to the World Health Organization, Affects as Many as 100 million Americans… and One Billion People Worldwide.
“On June 27th, They Could Finally Get It…
Paving the Way For What Some Experts Say Could Be The ‘Best Selling Drug in Prescription Medicine History'”
So yes, that “best selling drug in prescription medicine history” bit is not from me … and perhaps it’s not even from Money Map’s own lips, it’s from “some experts.”
But still, they say the decision is expected from the FDA on June 27 and it could be a massively popular drug, so that’s a near-term catalyst and just the kind of thing that can cause abrupt spurts in a stock, which means it’s just the kind of action that causes Scrooge McDuck dreams among investors and, therefore, makes for ad copy that undoubtedly sells newsletters very well.
What is this all about?
Well, they do reveal after a few pages of blather that it is an obesity drug — and you don’t need me (or five pages of charts and graphs) to tell you that obesity is probably the largest and most expensive health problem facing the United States, or that much of the world is likely following in our increasingly deep footprints on that path.
The teased upshot from the Money Mappers is that a third of Americans are potential customers for this drug, and perhaps as many as a billion people globally, numbers which would make Lipitor blush (Lipitor is in decline now thanks to the loss of its patent, but had about 15 years of sales that peaked at over $6 billion a year in just the U.S., the kind of numbers that every pharmaceutical executive mumbles about in his dreams).
Here are a few of the details from the teaser:
“Based on what we’ve found, we believe one drug in particular will break a long string of FDA denials and be approved on June 27th of this year – just a few days from now.
“When it happens, we expect the stock price of the tiny pharmaceutical company that developed this drug to jump substantially, handing you a very real opportunity to double or triple your investment in a matter of hours or days.
“There’s also significant long-term potential here, too.
“Right now, this company boasts a market cap of barely $1.5 billion – about 150th the size of drug giants Johnson & Johnson and Pfizer.
“Now, imagine you’ve just created a drug that 100 million people not only need… but have been waiting almost a decade to get their hands on…
“A drug doctors can’t wait to be able to prescribe to needy patients…
“This is why a number of experts believe it has all the makings of the next “super drug.”
“Even if the annual dosage price for this drug is just $1,250 per year (Lipitor cost north of $2,000 per year when Pfizer held an exclusive patent)… and if only one-tenth of the potential market uses the drug…
“That’s the potential for more than $12 billion in sales for just a single year – nearly $4 billion more than Lipitor’s average annual sales the past three years.”Are you getting our free Daily Update
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And, as it’s the FDA and the Money Map folks undoubtedly have some lawyers on speed dial, they do include this disclaimer:
“… can we tell you for certain this will all unfold as we’re predicting, and on the date we’re anticipating?
“No, we can’t.
“As anyone in the drug development business will tell you, the FDA is notoriously unpredictable when it comes to drug approval.
“And even though we have very good reason to believe approval for at least one drug that treats this disease is a ‘slam dunk’ – the FDA has been particularly tough on similar drugs in the past.”
So … they “believe” it’s a slam dunk, but every once in a while the ball catches the rim and comes bouncing right out if you try to slam it too hard. Now that I would know, being not particularly gifted in the jumping department.
Why do they think that the FDA will approve the drug this time around? Well, it seems to be an argument of both efficacy and physician pressure … here’s how they describe it in the ad:
“For the better part of two decades now, they’ve been pressuring the Food and Drug Administration (FDA) – the group that vets the safety and effectiveness of newly developed drugs and grants marketing approval and conditions – to please, please approve any drug that can help curb it.
“And they’re frustrated that every drug that’s come before it that shows promise in dealing with disease has been denied.
“In fact, last year the American Society of Bariatric Physicians took the unprecedented step of publicly questioning the FDA for its refusal to approve what looked to be a series of promising drugs – saying the non-approval ‘handcuffs physicians’ who treat the disease.
“‘I was definitely disappointed,’ said ASBP president Dr. Larry Richardson. ‘This was the third drug the FDA has turned down in the last year or so, for one reason or another.’
“One doctor even called the FDA’s consideration of these drugs “unbalanced” compared to other drugs in terms of weighing the risk/reward factors.
“But today, doctors have good reason to believe their long wait will be over. Millions of Americans sick with the ailment are hopeful, too.
“Right now, there are two drugs up for approval in the coming weeks. And after examining the data from all Phase 3 studies, both received sought after “recommendations for approval” from the FDA’s highly influential Endocrinologic and Metabolic Drugs Advisory Committee.
“While the FDA is not bound to follow the Advisory Committee’s recommendations, they typically do. And the “yes” votes were overwhelming: 18 to 4 (and one abstention) for one drug… while the other drug being considered earned a 20-2 approval.
“Experts assume the panel recommended FDA approval of the drug based on two things:
- the favorable safety findings; and
- the fact that the drugs seemed to work.
“In one double-blind test involving 3,100 people with the disease, over half of them showed significant improvement – while those taking the placebo only fared half as well.”
So that’s the basic premise — which makes sense given the risk-averse nature of the FDA these days. The FDA can easily feel pressured to approve a drug that might save the lives of folks with late-stage lung cancer, for example, since side effects won’t matter much and the drug won’t reach hundreds of millions of people with unforeseen consequences. But for a non-acute “disease” like obesity, which won’t kill anyone overnight, you can easily see the qualms. It could easily be prescribed to millions of people in the first mon