A “Historic” FDA Decision Could Mean Historic Gains… if You Move Now

Keith Fitz-Gerald Sep 07, 2017

Last week’s headlines were hectic, depressing and downright scary…

…which is why I’m thrilled to have something great to share with you today.

And that is?

An almost completely overlooked development in the fight against cancer.

It’s so important that it could mean a new lease on life for children and adults fighting blood cancers – more specifically, acute lymphoblastic leukemia (ALL).

Lost in last week’s chaos was the fact that pharmaceutical giant Novartis AG (NYSE:NVS) was granted FDA approval (following an incredible 10-0 unanimous vote from the agency’s advisory committee to recommend approval) for their leukemia drug, Kymriah.

What makes this so critical is that it’s the first treatment of its kind to receive such an approval to be used outside of clinical trials.

According to my good friend and colleague, and Money Morning’s Biotech Investing Specialist, Ernie Tremblay, “In early clinical trials at Children’s Hospital of Philadelphia (CHOP), 27 kids out of 30 treated with [Kymriah] went into complete remission from their disease. Twenty-four months later, the majority of them were still leukemia free.”

The FDA itself called the decision a “historic action,” but I think it’s got the potential to be nothing short of a revolution in cancer immunotherapy.

Your Immune System is the Strongest Medicine We Know

If you’ve never heard the term before, immunotherapy is a highly specific area of biotechnology that involves using the body’s own immune system to fight cancer.

We’ve talked about this in the past but this is so important that it bears repeating.

Immunotherapy has been around since 1908 when Russian biologist Ilya Ilyich Mechnikov received the Nobel Prize for his work on phagocytosis – which is a $5 word meaning the body’s active response to a foreign body like bacteria or… you guessed it… cancer.

Classic cancer treatments have involved identifying tumors by the specific organs they attack, like your spleen, kidneys, lymph nodes, and so on. But that could only go so far because what you’re really talking about are changes in cell structure that take place at the molecular level.

Thanks to new discoveries, ongoing research, and significantly more computing power, doctors now understand that the human immune system may be our most powerful weapon in eradicating cells that have undergone those tiny but deadly changes.

That’s set the stage for a transformational investment opportunity.

Treatments based on bodily systems, such as chemotherapy and the like, were often as toxic as the cancers that they were targeting. But immunotherapy harnesses the body’s own immune system by teaching it to identify, fight, and ultimately eradicate cancer at the molecular level.

Immunotherapy is not quite Star Trek technology but not entirely far off either. There are already approved immunotherapy treatments for various types of cancer, including prostate, kidney, lung, and melanoma to name a few. And there are additional treatments in the pipeline for leukemia and non-Hodgkin’s lymphoma, for example.

According to a June 2016 report from QuintilesIMS, more than 70 new cancer treatments launched in just the past five years. I see that doubling this year based on how fast the science is advancing.

Amazingly, I don’t see the stock market catching on… yet.

You’ve got to move quickly if you want to get ahead of the pack, though.

Not only is cancer a leading cause of death worldwide, but the latest studies suggest that half of all adults will get a cancer diagnosis during their lifetime. As in one of every two people.

Until I began my research, I would never have thought that something so sinister could have such investment potential. But the data quickly convinced me otherwise.

Cancer takes a $300 billion bite out of the world’s economy annually right now. By 2030 that figure will hit at least $458 billion, according to the World Economic Forum. I think we’re talking perhaps double that, though, because I’ve never seen an NGO forecast conservatively.

Here’s where it gets interesting and potentially very profitable.

The World Health Organization suggests less than 1% of all disease funding goes to treating cancer and other diseases causing the most death. That’s $200 billion, according to the Institute for Health Metrics and Evaluation. Meanwhile, the QuintilesIMS Institute forecasts global medicine spending to rise to $1.5 trillion by 2021.

Ergo, the field faces staggering growth of at least $1.3 trillion.

And Novartis’ FDA approval has just kicked off a fierce competition in that $1.3 trillion space.

The Landscape is Changing

When Ernie and I sat to talk about this incredible development, he told me, “Every year, 14 million people will hear from their doctors that they have cancer. Tens of millions more already battle it heroically every day. And until now, a cure has been out of reach.

That’s one reason I’ve always recommended that my readers avoid putting money into cancer treatments – especially those in the early stages of development, with the lowest odds for making it through clinical trials.”

…until now.

Now that the FDA has given the greenlight on Novartis’ last resort leukemia treatment and cancer immunotherapy, Ernie sees the floodgates opening… and the development of promising new treatments for prostate cancer, breast cancer, lung cancer, leukemia, lymphoma… all cancers… at all stages… will go into hyper-drive.

Every major pharmaceutical firm developing its own T-Cell immunotherapy treatment could become involved.

But, according to Ernie, there’s only one you need to think about.

And, I agree.

It’s a tiny lab based in Texas, with the essential “missing piece” that every major firm will need to perfect their cancer treatments.

To me, that means a bidding war that could send this $10 stock through the roof overnight.

From a medical perspective, this could lead to millions of lives being saved.

From an investment standpoint, this could also be one of the greatest opportunities in modern history.

Here’s Ernie to tell you more

Best regards for great investing,


One Response to A “Historic” FDA Decision Could Mean Historic Gains… if You Move Now

  1. Mukesh Parikh says:

    Hi Keith ,
    Can you please give us an update on EKSO. It went down after reverse split from $ 7 to $ 1.15 as of today .
    Thanks, Mukesh Parikh

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