OSTEOARTHRITIS PAIN

May 15, 2012

This short interview of Norm Johnson shows his miraculous recovery from extreme knee pain where he found it very difficult just to walk and almost impossible to go up and down stairs.  Norm was in so much pain that he was resigned and ready to schedule knee replacement surgery . . . until he joined a clinical trial and received a single injection of a new wonder drug called “Ampion” into each knee.  Within one hour after receiving the injection, his pain was completely gone and he was able to walk pain free.  Six months later and he remains pain free and you can see him climbing up and down a steep ladder.  Mr. Johnson cancelled his plans for knee replacement surgery.

 

http://www.youtube.com/watch?v=_H7Nbr1CIo4&feature=youtube_gdata_player

 

Share this video with those you know who suffer from knee and joint pain or general pain from arthritis and they will be forever grateful to you.

 

Ampion is an anti-inflammatory that is an amazing treatment for arthritic pain in general and for pain from almost any inflammation.  Because Ampion is a naturally occurring biologic produced by the human body, Ampio Pharmaceuticals expects relatively quick approval by the FDA and regulatory agencies around the world. 


Why Ampio Pharmaceuticals is a Very Strong Buy

May 15, 2012

WHY AMPIO PHARMACEUTICALS IS A VERY STRONG BUY

 

I’ve been following the stock markets since 1969 when I worked as a securities analyst and trader for Charlie Munger and Warren Buffet, and my experience over the past 40 years has given me a pretty good sense of what stocks I should be buying and which ones I should avoid.  It’s taken a long time, but the grey hairs are finally beginning to pay off.

 

When I started my career a few years before I went to work for Mr. Munger, I jumped right into the overcrowded trading floor of the stock exchange that was packed with supercharged and aggressive day traders who were all trying to make a quick killing in just a few minutes.  Instantly I was attracted to the excitement, the fast pace, and the easy money.  I was hypnotized by the streaming ticker tapes and the yelling and screaming to trade stocks that were on the move.  It was really easy to get caught up in day trading, especially if you made money on your first try and as luck would have it, I was unfortunate enough to have been quickly spoiled by easy success.  Let me explain why.

 

One day, my mentor who was watching me closely, took me aside and asked me a question that I will never forget.  With a serious but wise look on his face, he calmly asked, “Richard, do you want action? . . . or do you want profits?”  At first, I was confused by his question but thought for a moment and quickly replied, “What do you mean, or,. . . I want both”.  Smiling, he laughed and said, “you can’t have both.  Day trading has never worked out for sustained periods of time and it never will.  Sooner or later all day traders go broke.  It’s just a matter of time.”

 

Well, at that time I was certain that I knew everything about trading that was necessary, so I continued to pursue my path of fast action and hit and miss profits but decades later I learned from hard, painful experiences that he was right!  Day trading can be fun, but it can also be painful.  Over time, I observed that it was the investors who bought and held for the long term that were the only ones who consistently made the big money . . . and kept it!  The big question now is, “what stocks do I buy to hold”?

 

Over the ensuing decades I developed a screen of variables that I like to filter stock selections through before making decisions to buy.  First, it’s important that the company has something special that the competition lacks.  It can be a patent, a new technology, a better way of doing or making something, a better idea, better management, or impeccable timing.  Second, I like to use technical analysis to help identify price support and resistance levels and also to predict breakouts for better timing.  Third, buying at a low for the year can leverage yields dramatically.  Knowing you will most likely not pick the cheapest price to get in, I have found that averaging down is an excellent way to keep reducing your cost and at the same time, increase your position.  Fourth, fundamentals are extremely important.  Is the company adequately capitalized?  Is management strong?  Is debt reasonable?  Fifth, is the market for their goods or services growing and if so, how quickly?  And finally, what dynamics are influencing the price of the stock? 

 

I have been following Ampio Pharmaceuticals for 2 years now and when I put it through my investment screen, it is clearly a strong buy because it passes every screen with flying colors.

 

Here’s why!

 

ü  Ampio Pharmaceuticals is a tiny drug company with a market cap of only 80 million dollars that is trading near its low of about $2.60 per share and has the potential to generate several billions of dollars of revenues annually with their unusually rich pipeline of drugs and breakthrough diagnostic.

 

ü  What Ampio has that is very, very rare is 3 drugs, Ampion, Optina and Zertane, with the potential for each one to be a blockbuster drug generating several billions of dollars each year because they appeal to very large numbers of people who really need them. 

 

ü  Ampion will appeal to millions of arthritis and pain sufferers and because it is so effective and with no visible side effects, it will likely replace the common aspirin, bufferin, Tylenol, Advil and Aleve.  Hard to imagine but it’s true.

 

ü  Optina will appeal to millions of diabetics suffering from macular degeneration and possibly to patients suffering from renal failure.

 

ü  Zertane will appeal to tens of millions of people suffering from Premature Ejaculation.  Ampio Submits Type B Pre IND Meeting Request to the FDA for Zertane™  http://finance.yahoo.com/news/ampio-submits-type-b-pre-110000016.html

 

ü  Ampio has also developed a breakthrough hand-held diagnostic for measuring ORP (Oxygen Reduction Potential) that until now has not been possible with any cost-effective point of care device.  Ampio’s ORP hand held device will serve as a highly valuable tool to quickly assess a patients’ level of health or disease and ability to heal by measuring the ORP in their blood requiring only one drop of blood.  Currently blood pressure, heart rate and rhythm, temperature, respiration rate, reflex reactivity, and pupil reactivity are the only basic indicators used to assess a patients’ vital signs and the ability to measure ORP would be an immense breakthrough.  Ampio’s ORP reader can quickly become a universal piece of equipment worldwide.  Ampio has filed for a quick approval process of a 510K.  Recent press release regarding Ampio’s ORP device.  http://finance.yahoo.com/news/ampio-completes-patient-enrollment-oxidation-110000625.html

ü   

 

ü  Since 2 of Ampio’s drugs, Optina and Zertane, are repurposed drugs, meaning that they were already approved by the FDA for higher doses than what they currently seek approval for, the likelihood for fast approval based on safety issues is high and not nearly as risky as a new drug because their safety has already been proven in prior trials.

 

ü  Ampio’s new wonder drug, Ampion, is naturally produced by the human body and is a proprietary amino acid component of HSA (Human Serum Albumin).  HSA has already been approved by the FDA, therefore Ampion is expected to receive a relatively fast approval.  In fact, the FDA and Ampio management have recently met this month and decided on a plan for Ampio’s path to approval.

 

ü  Efficacy is already proving to be amazingly high for all 3 drugs.  Read the string of past press releases and this short video to see just how amazingly effective Ampion is:  http://www.youtube.com/watch?v=_H7Nbr1CIo4&feature=youtube_gdata_player)  This video, all by itself, is so powerful that it is enough to spark a stampede of millions of patients seeking relief from their pain not to mention large numbers of investors who will see the opportunity of a lifetime to score big.  And then add big pharma’s immense appetite for products like these to and what do you have?

 

ü  A new drug normally requires between 500 million and 2 billion dollars to develop and up to 10 years to gain FDA approval, but this little giant slayer has the ability to gain FDA approval for not only 1, but 3 blockbuster drugs within far less time, far less money and with much less risk.  It is possible to see some of their drugs being sold worldwide in less than 2 years and not 10.

 

ü  Management is strong and has demonstrated the ability to execute the development and approval process for an unprecedented pipeline of drugs and diagnostics in a very short time and for a minimal budget.  It is extremely difficult to imagine a tiny little company like Ampio developing and owning 4 blockbuster products that are on the verge of exploding.

 

ü  Management’s plan to license their drugs to different companies in different countries is smart and out of the box thinking because these foreign companies will best understand how to gain the quickest regulatory approvals in their respective countries and generate larger revenues and earlier.

 

ü  The price of Ampio Pharmaceuticals shares have been depressed by short seller pools of money that take advantage of stocks like Ampio that have little following on Wall Street because they have not been vetted by mainstream underwriters.  The reason AMPE has not been vetted by mainstream Wall Street underwriters is simply that Ampio made a decision to access the public markets through the acquisition of an existing publicly traded company that was virtually an empty shell with no operations and no liabilities.  That saved AMPE a lot of time and money and it seemed like a smart move at the time but the downside was that the mainstream underwriters were not part of the vetting process and consequently will not acknowledge Ampio until they see something happen like a meteoric rise in the share price or a major deal, both of which are on the verge of happening.

 

ü  Ampio is positioned for a steady stream of positive news releases relating to how well their drugs work, FDA and other government approvals, licensing deals and to profitable revenues, all of which will not go unnoticed by Wall Street as it is today.

 

ü  As soon as positive news begins to unfold, buyers will emerge from cyberspace sending share prices higher and the short sellers will be forced to cover their short position sending shares even higher yet and then move on to easier pickings.

 

ü  Technical chart patterns for the past 6 months reveal that AMPE is completing a quadruple bottom in the $2 to $3 range.  As the stock approaches $2.50, selling dries up and the price firms followed buy short lived buying sprees.  This next bounce off $2.50 – $2.60 appears to be one that could be far more powerful than recent bounces because the shorts are dangerously close to losing enough liquidity to cover their positions and there is very little stock offered for sale until the $6 to $8 level.  The big driver will be an unexpected breakthrough news release.

 

ü  The biggest overnight surprise could easily come from a major institutional investor discovering this outstanding opportunity or from a major pharma company with a big appetite and an even bigger checkbook seeing an amazing opportunity to control a huge pipeline of drugs for a small amount of money.  A big pharma player could easily offer $10 or $20 a share in cash and a large number in their shares sending AMPE to well over $50 in the not too distant future.

 

ü  Think about these numbers:  For the past 6 months AMPE has traded an average of around 100,000 shares per day that translates to a rough total of about 13,000,000 shares.  The short positions for that period were under 5 million shares.  That means that if the shorts already covered their positions, (and I do not believe they have.  I think they are still short) there were about 8 million shares that were purchased and held.  Remember, for every share trading, there is a buyer and a seller.  This means that some buyer or buyers are quietly buying AMPE and socking it away.  A lot of it too because AMPE only has about 30 million shares outstanding.  It could even be a large pharmaceutical company quietly trying to build an ownership position.  At these prices, it won’t take much money to send this stock flying.

 

I believe now is the perfect time to begin acquiring shares of Ampio Pharmaceuticals while they are cheap.

 

I have no position in Ampio Pharmaceuticals, neither long or short.

 

Richard Cavalli



Share this Amazing Cure For Knee Pain With Joint Pain Sufferrerss

May 15, 2012

Share this Amazing Cure For Knee Pain With Joint Pain Sufferrerss

SHARE THIS AMAZING VIDEO WITH JOINT PAIN SUFFERERS

 

This short interview of Norm Johnson shows his miraculous recovery from extreme knee pain where he found it very difficult just to walk and almost impossible to go up and down stairs.  Norm was in so much pain that he was resigned and ready to schedule knee replacement surgery . . . until he joined a clinical trial and received a single injection of a new wonder drug called “Ampion” into each knee.  Within one hour after receiving the injection, his pain was completely gone and he was able to walk pain free.  Six months later and he remains pain free and you can see him climbing up and down a steep ladder.  Mr. Johnson cancelled his plans for knee replacement surgery.

 

http://www.youtube.com/watch?v=_H7Nbr1CIo4&feature=youtube_gdata_player

 

Share this video with those you know who suffer from knee and joint pain or general pain from arthritis and they will be forever grateful to you.

 

Ampion is an anti-inflammatory that is an amazing treatment for arthritic pain in general and for pain from almost any inflammation.  Because Ampion is a naturally occurring biologic produced by the human body and has no known side effects, FDA approval is expected to be relatively quick


Share This Video Proving Miracle Cure For Knee Pain

May 15, 2012

SHARE THIS AMAZING VIDEO WITH JOINT PAIN SUFFERERS

 

This short interview of Norm Johnson shows his miraculous recovery from extreme knee pain where he found it very difficult just to walk and almost impossible to go up and down stairs.  Norm was in so much pain that he was resigned and ready to schedule knee replacement surgery . . . until he joined a clinical trial and received a single injection of a new wonder drug called “Ampion” into each knee.  Within one hour after receiving the injection, his pain was completely gone and he was able to walk pain free.  Six months later and he remains pain free and you can see him climbing up and down a steep ladder.  Mr. Johnson cancelled his plans for knee replacement surgery.

 

http://www.youtube.com/watch?v=_H7Nbr1CIo4&feature=youtube_gdata_player

 

Share this video with those you know who suffer from knee and joint pain or general pain from arthritis and they will be forever grateful to you.

 

Ampion is an anti-inflammatory that is an amazing treatment for arthritic pain in general and for pain from almost any inflammation.  Because Ampion is a naturally occurring biologic produced by the human body and has no known side effects, FDA approval is expected to be relatively quick


Ampio Pharmaceuticals is Ripe For Takeover by Big Pharma

May 4, 2012

Pharmaceutical drugs are big business and Big Pharma is always on the hunt for new drugs to fill their pipeline of inventory expiring from patent protection.  Developing new drugs is a huge gamble costing anywhere from 500 million to 2 billion dollars just for one drug, the time is lengthy and the risk of failure is high.  A much-preferred solution for big pharma is to either license new drugs from the developers/owners, or even better, simply buy out the companies when they gain FDA and/or other government approvals.

Ampio Pharmaceutical (AMPE) owns 3 drug candidates in their portfolio that big pharmaceutical companies would kill to own because their foundational drugs are losing patent protection and heading to generics, and the time and cost to develop new drugs is almost prohibitive. With their high potential to become blockbusters and low risk of failure, Ampio’s three stars will be highly coveted. It is not a question of “if”, it is a matter of “when”.  The big pharmaceutical players are there right now, quietly watching for that first signal that they need to pounce and beat out their competition to buy out Ampio Pharmaceutical lock, stock and barrel.  That signal comes in the form of regulatory approval and should happen very, very soon. How quickly? Read on and judge for yourself.

Throughout the world, government agencies tasked with drug regulation focus primarily on safety. If all drugs were safe, governments would let the marketplace determine how well they worked — if they weren’t picking up the tab. But since governments are the largest purchasers of drugs, they also want to understand the clinical and economic efficacy of a given drug. The perfect storm for regulatory approval would therefore be: (1) safety and lack of side effects is commandingly demonstrated; 2) clinical trials prove a drug is highly effective; (3) the disease significantly impacts a large percentage of the population; and 4) the drug saves the government a great deal of money by reducing treatment costs and improves the productivity and quality of life of its citizens.

Remarkably, Ampio’s three top drug candidates meet all the above criteria.  It is difficult for the marketplace to believe any company, especially a small one, could have even one drug that accomplishes all these criteria, let alone all three drugs.  It is like a racehorse owner winning the Triple Crown  – with three different horses.

Since the above is a mighty strong statement, let’s explore the facts  concerning Ampio’s pipeline on a drug by drug basis that lead to that conclusion.

1) Ampion:

Ampion has been shown to be a powerful anti inflammatory (see Ampio’s press releases on Ampion’s clinical trials and the video below which just appeared on local news in Adelaide, Australia where the clinical trial was performed

http://www.youtube.com/watch?v=_H7Nbr1CIo4&feature=youtube_gdata_player)

This video that shows the miraculous power of Ampion is in the early stages of going viral to the mainstream public.  Soon, it will be seen by millions who will for the first time have a glimpse at the potential of Ampio’s pipeline.  With today’s high speed social media, millions of people will soon discover Ampion – including the Big Pharma companies that may have been snoozing — and it is sure to light a fire under those who have been watching and playing coy.

Ampion’s discovery story is fascinating and speaks to the genius of Dr. David Bar-Or, Ampio’s chief scientist.  Recognizing that the body shuts down the inflammatory response in the brain with patients suffering from head trauma (good thing since continued brain swelling within a rigid skull would be very bad), Dr. Bar-Or worked for years to isolate Ampion, the molecule responsible.

Ampion is a biologic, meaning it is found naturally in the body – a fact that suggests inherent safety.  Ampion is simply two amino acids present in human serum albumin (HSA), and HSA has been given to people for decades.  When heated for commercial preparation, a number of these amino acids break off of the HSA molecule and form the Ampion molecule.

Virtually every 600 mL preparation of HSA given to patients over the years contains a quantity of Ampion similar to the quantity given to the patients in the clinical trials, but in these trials, the Ampion is concentrated into a single injection into the site of knee pain, rather than diluted throughout the entire body as it is with the intravenous use of HSA. The literature is replete with references to the anti inflammatory properties of HSA, which is surely due to the sole action of Ampion (as HSA is an extremely large molecule, it can be used therapeutically for only a very small number of applications).

Ampio has announced that it will be meeting shortly with the FDA on guidance for market approval for this drug. The FDA has come under great criticism over the years, but they have a heavy burden. They take their responsibility to protect very seriously. Though often bureaucratic, the FDA people are fully human and have no desire to block products that are clearly safe and effective in addressing major disease states.

With all this in mind, it is reasonable to assume that the pathway to approval will be relatively fast and uncomplicated, with a favorable outcome highly likely.  It is hard to imagine a market larger than the anti inflammation market (think arthritis, rhinitis, Crohn’s disease, Lupis, routine analgesics, etc.  Think aspirin, bufferin, Tylenol, ibuprofen).  Furthermore, with the recognition of the full safety of Ampion and its efficacy as the body’s natural anti inflammatory, it follows that we should see Ampion available not just as an injectable, but in over the counter formulations such as eye drops and nasal sprays for allergies and oral tablets for pain without the significant side effects of all current anti-inflammatories, pain relievers and steroids.

2) Optina:

Optina is a reformulation of a drug called danazol, which has been used world wide for the treatment of endometriosis in women for nearly forty years.  As such, the safety/side effects profile of the drug is well known and documented at typical dosages of 400 to 800 milligrams.

Dr. Bar-Or made another remarkable discovery recognizing that danazol inhibited fluid leakage from the vessels into the tissues, but only at very low dosages of approximately 20 milligrams, or 1/20th to 1/40th of the dosages typically prescribed for danazol. This highly counterintuitive finding (increased effectiveness at decreased dose) served to give Ampio a very strong patent position just confirmed in their April 27th press release to remain in force until the year 2030.

In diabetes, the vessels become hyper permeable, and any tissues susceptible to fluid buildup (like eyes and kidneys) are likely to incur damage. In the eyes of diabetics, the fluid that builds up behind the retina can cause detachment leading to blindness – a malady that affects countless people annually.

Ampio announced in a March 19th press release that it was terminating its clinical trial in Toronto, Canada, at St. Michael’s Hospital, due to favorable results in order to present the data (soon to be released by the independent Clinical Research Organization) to the FDA. It appears then that the FDA will soon see favorable data on a drug that is ultra safe, likely to be inexpensive, and effective for a disease that is responsible for millions of cases of blindness each year – a disease that currently has no real recognized and cost effective treatment.

Lastly, Ampio has stated that it’s selection criteria for patients in the Optina trial favored patients that had protein in their urine – an indication that the patient has some degree of diabetic nephropathy, a severe kidney complication resulting in millions of diabetics requiring costly and drastic dialysis. It will be interesting to see if Optina also reduces the passage of protein into the urine of patients presenting with that complication.

3) Zertane:

Speculation has it that the market for premature ejaculation (PE) is four times bigger than the market for erectile dysfunction (ED). Ampio’s Zertane demonstrated in their Phase III clinical trial results studying over 600 patients an average increase in male staying power of four times (two times longer than placebo) with no significant adverse events. This remarkable outcome was published in the peer reviewed prestigious European Journal of Urology.

Ampio has stated that they will be presenting Zertane to the FDA in the very near future.
Again, with a plethora of data supporting the safety and efficacy of the drug, it is reasonable to conclude that the path to approval by the FDA for Zertane will be relatively straightforward.

Ampio will also be seeking guidance from the FDA on the suggested path for approval for their patented compound of Zertane plus the compounds for ED (vaso dilating compounds called PDE-5 inhibitors like Viagra – which reportedly goes off patent in 2014). This combination compound would in essence be a “super Zertane” offering the benefits of ED and PE enhancement. As both Zertane and the PDE-5 inhibitors have significant proof of safety and efficacy separately, it stands to reason that regulatory approval will be contingent on demonstrating that the composite drug is safe in combination. Again, a task that is considerably less arduous than the approval process of a new drug.

The company has announced that it has already secured license agreements with two major pharmaceutical companies for the distribution of Zertane, and is in negotiations with several others. It is reasonable to assume that upon approval of Zertane by the FDA that the value of and demand for those license agreements will appreciate dramatically.

In summary, Ampio has arguably achieved the unparalleled task of developing three highly significant and uber safe drugs to address major disease states that have few, if any, effective remedies (and certainly no remedies without significant side effects).  Due to the inherent safety of these drugs and the existing proof of clinical and economic efficacy, validation of these claims by the FDA as well the regulatory agencies of other countries is expected to be relatively swift and, by the above analysis, nearly certain.

The conclusion is that AMPE is a very attractive, ripe, cheap and easy takeover target for giant pharmaceutical companies with bottomless checkbooks and strong motivation that could grab them in an unannounced instant, causing the price of their shares to soar in the feeding frenzy.

Hang on for a wild ride and be especially careful if you are short because Big Pharma has a bottomless checkbook that will not even notice the short sales.  So far, the short players have been enjoying an easy ride keeping the lid on the price of this stock, but as soon as a big pharma player makes an announcement, or as soon as a major favorable announcement is made by the company, the price will soar because the influx of buyers will overwhelm the short players sending them running for cover and adding even more to the upside explosion of the shares of Ampio Pharmaceutical.  There are fewer than 30 million shares outstanding and the naked short sellers will be forced to buy at the market to cover their short positions and deliver the shares they sold.

There used to be an old saying that was frequently heard back in the 70’s . . . “He who sells what isn’t his’n, usually winds up going to prison”.

I have no position in AMPE and have had no compensation from any source and therefore I am not biased by financial self interests. I have been following the company for two years and do have a personal interest in seeing Ampion products reach the market as quickly as possible for those friends and family of mine who need them.  I must also profess a personal desire to see short sellers brought to justice for ruthlessly and unethically attacking this company and destroying other promising companies less formidable than Ampio.  They are destructive forces in Wall Street and cause harm to shareholders, companies and the general public.  Their actions harm the abilities of perfectly good companies to raise the lifeblood capital of all business.  I refer you to the riveting description of the insidious tactics of these players reported in the link below:

http://www.deepcapture.com/wp-content/uploads/story-of-dendreon.pdf