Tuesday, January 13, 2009

Obscurity and how to benefit from it

Definition: ob.scu.ri.ty 
Show Spelled Pronunciation [uhb-skyoor-i-tee] Show IPA Pronunciation
–noun, plural -ties.
1. the state or quality of being obscure.
2. the condition of being unknown.
3. uncertainty of meaning or expression; ambiguity.
4. an unknown or unimportant person or thing.
5. darkness; dimness; indistinctness.
6. NEOP (Okay - I added that one)

NEOP lives in obscurity. To be blunt, a lot of people don't know about this company. It's not that they don't know anything about its products... they simply don't know that it even exists... AT ALL...!

Why? For many reasons and, to be honest, many of them were valid at one time.

In the mid-1990's Neoprobe (NEOP) had a market cap of $350 million. The stock hit $22 a share. It was on the verge of financial success and the creation of many millionaires who had invested in it. Neoprobe developed a revolutionary new drug called RIGScan CR (RIGS). This is a new, patented drug and surgical process for patients who have developed colon cancer (remember Tony Snow?).

RIGS allows surgeons to use a radioactive tracer that binds to cancerous tissue, so they can locate and remove all of the cancerous tumor tissue. Right now surgeons still use their eyes and fingers to feel around and locate cancerous tissue (Hopefully!).

Every cancer patient who undergoes surgery to remove a tumor always ask the same question afterward:

"Did you get it all...?"

Why is it important? Because if the surgeon doesn't get it all, then the cancer springs up again and resumes spreading. Getting ALL of the tumor is critically important (if you want to live).

RIGS proved in clinical trials that it is the first diagnostic drug ever that can help the surgeon get it all, rendering the patient tumor free.

However...... the FDA, in all its bureaucratic wisdom, somehow didn't grasp the simple concept that 'no tumor = better outcome'. When all of the clinical trials were finished after years of testing at a cost of $100 million, the FDA asked for more information.

The FDA asked NEOP to go back to the drawing board and give them ANOTHER study documenting how much longer RIGS patients lived. The problem was that the little company was out of money. Like many small drug companies, every dime had been spent reaching that point. There was nothing left. So, the stock crashed and the company almost faded away... with a valid, life-saving drug shelved forever.

Long story made short... over the next eight years NEOP survived by diversifying into a line of new Gamma hardware products and started developing a second drug (Lymphoseek). However, most of the patients from the original RIGS clinical trials had also survived. Researchers were able to track down many of those patients and tally their survival rates. The results were most impressive.

One of the participating primary physicians compiled the data from the patient base, and charted them. Below is that chart.

(Click on image to enlarge)













Top line (blue) - patients who had ALL tumorous tissue removed with RIGS
Middle line (black) - patients who had some cancerous tissue remaining outside the tumor
Bottom line (red) - patients who were treated with the traditional method (surgeon removing the tissue they located using their eyes and fingers)

After four years, about 70% of the RIGS treated patients were alive. Less than 6% of the traditionally treated patients were still alive.

Looks good, right? Common sense says RIGS definitely has a survival benefit, right? Well.... only to people with common sense. The FDA says they still want a formal study. The EMEA (the European version of our FDA) followed suit and asked for the same formal study.

So that's where it is right now. NEOP is gearing up to do that last survival study... RIGS is coming back to life. The EMEA just approved the study design, and NEOP is meeting with the FDA this summer (2009) to harmonize the design of this same trial design.

After the FDA approves the trial design Neoprobe will probably get a development partner who will fund the estimated cost of $25-$30 million. Neoprobe would then "split the pie" with them. But that's okay. Remember, Neoprobe is a tiny company. They could use a deep pocketed partner to finance the final survival study, manage the trial and deal with the EMEA & FDA. Plus, being a tiny company NEOP doesn't need much of the RIGS pie to have a HUGE impact on its bottom line.

But, remember 'OBSCURITY'? NEOP still lives there. Nobody knows that RIGS is coming back to life. Everyone wrote this company off when the FDA delayed the RIGS application.

That's important. 'Why'...? It's simple...

There are a lot of keys to making money. Hard work. Good contacts. Great work habits. Good education. Being smarter than the next guy. Luck. All of those are important...

But I'd trade them all in for one thing: Information!

If you get better information, and you get it sooner than everyone else, then you can make money. Think Gordon Gecko in Wall Street. Well... without the part at the end where Gordon heads off to jail.

Nobody knows that RIGS is coming back to life yet. Neoprobe slipped into obscurity. They aren't on anyone's radar screen. They've made some quiet announcements about RIGS waking up, but nobody is listening. So nobody knows what's happening.

Except me... and now you. Do with it what you will.

DDbuyer