“Profit from a Unique $3.35 Billion FDA Backdoor Opportunity”

What's Bret Jensen's "company in the fast lane for 2,715.13% growth?"

By Travis Johnson, Stock Gumshoe, April 28, 2015

Bret Jensen last regaled us with the stock we “wouldn’t admit to knowing” about six months ago, but he’s got something very different to pitch today in his latest teaser ads for Small Cap Gems.

Back in September, the stock he teased was RCI Hospitality Holdings (RICK), the operator of strip clubs and “breastaurants” around the country… and it has been, well, flat over those last six months or so (no pun intended. OK, maybe slightly intended).

Today, in a sure sign of having achieved Renaissance Man status, he moves on from strip clubs to biotech… and he’s teasing another small cap stock that he says has already turned $10,000 into $41,626, and that might have another 1,000%+ gain coming on the back of their FDA “backdoor” approvals.

So let’s find out what the stock is, shall we? I think you probably know me well enough by now to know I’m not going to be able to tell you whether the drugs they’re trying to get approved are any good, or even what a reasonable valuation for a biotech stock is these days… but I can at least tell you the name and get you started, and I know that a great many Gumshoe readers are avid biotech investors who can probably opine much more wisely than I on the stock.

The intro is plenty exciting:

“The FDA has just opened a backdoor for a fast growing company to bypass the standard drug approval process… putting this company in the fast lane for 2,715.13% growth!

“URGENT: This story is developing faster than expected and the stock has already taken off over 316%… only underscoring my belief that even bigger gains are coming.”

There are all kinds of “backdoor” approvals that get touted when it comes to the FDA — the FDA approval process is so mysterious to most investors, and we all have such a general idea of “it’s really expensive and takes a decade or more to approve a drug” that the backdoor notion has almost immediate appeal… there’s a sneaky way to get approved more quickly, and make money faster! Hurray!

This time, it’s apparently a backdoor that has to do with a reformulation of an existing drug…

“I want to tell you about a tiny pharmaceutical company the FDA has recently given the green light to skip the standard drug approval process.

“The result? Backdoor access to a $3.35 billion market opportunity.

“And because of this unique FDA backdoor approval process we’re looking at one of those rare times when you’re able to say that 500% or 1,000% revenue increases are conservative targets.

“In fact, my own math suggests growth of as much as 2,715.13% based on just the drugs on their way to the market right now….

“It permits the company to take highly-profitable drugs to market in less than half the standard time — AND at a fraction of the usual cost….

“The company I’m going to tell you about today has discovered an FDA backdoor to legally skip this pathway and cut costs by 99.4%.”

OK, so cutting costs by 99% sounds pretty good. How about some more clues so we can ID the company?

“… the backdoor they’ve been granted typically only requires one confirmation study for a drug to be approved.

“We’re talking a cost of just $3-7 million, compared to the $1.3 billion usually required to develop a drug….

“The FDA has already given them the green light into one relatively tiny $99 million market — which means the stock is still cheap, even with the recent price surge.”

And then some more specifics about that FDA loophole:

“…. a second pathway — the 505(b)(2).

“This legal ‘backdoor’ pathway allows drugs to skip years of testing, as long as the active ingredient has already been approved.

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“And our specific company already has 5 drugs in the ‘public’ pipeline — 4 with an approved active ingredient.

“We can expect to see all the drugs in the market by 2017.

“But I’m expecting one of their most promising drugs to go live anytime between now and early 2016….”

OK…. so that gets us close enough to an answer that I can guess. But a few more tidbits and we can be 100% certain… this is a company that focuses on drug reformulations, improving on the solubility or the usability of existing approved drugs (ie, making them easier for hospital staff to administer, or giving them a longer shelf life, or making them work faster or slower, etc.). Here’s a wee bit more for the “clues” pile…

“The FDA-approved backdoor already lets this company take highly profitable drugs to market much faster and for pennies on the dollar…

“Yet this company also has one more advantage up its sleeve.

“You see in January 1983 Congress passed a law called the ‘Orphan Drug Act’ …

“… an extra 7 years’ worth of market exclusivity — and that, on top of any patents a company already holds….

“… our company has three Orphan drugs either in, or coming, to market, they also produce regular drugs.”

And then we get the core of the argument — that they have a big, large-market drug that is going to turn them into a huge winner over the next two years:

“This is the game changer drug.

“It’s the number one reason why I believe this stock will take off imminently… and turn our play into a $1 Billion+ company.

“We’ll call it ‘Drug C’.

“It treats Chronic Lymphocytic Leukemia and Non-Hodgkin’s Lymphoma.

“Every year there are around 86,520 combined new cases of the diseases in America alone