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I'm retired and make a living investing and trading stocks. Careful research has paid off with big dividends and I will always continue to learn as much as possible about any company I ever invest in. There is always risk associated with any investment and I have found that thorough research... More
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  • Is Ampio About To Melt Up?

    In last weeks press release from Ampio Pharmaceuticals (AMPE) Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the FDA letter summarizing the FDA's conclusions of the Ampion Phase III Trial stated, "The strength of the evidence is robust." "Upon review of the dataset received on November 5, 2013, FDA concludes that study AP-003-A can be considered as one of two "pivotal trials" required in support of a BLA." "This recommendation is based on the fact that study AP-003-A was adequate (n=329) and well controlled (normal saline), the trial conduct was acceptable and the study met its primary endpoint (change in WOMAC score at 12 weeks)." The final trial for the potential blockbuster Ampion looks very promising and is scheduled to begin next month with results known by May.

    Ampion is a novel anti-inflammatory that has shown remarkable results for both efficacy and safety in its last two trials. To repeat, the FDA even called Ampion results "robust." Ampion is expected to be used for a larger number of indications with the first undergoing final pivotal trials for osteoarthritis of the knee and thereafter for the 27 million osteoarthritis sufferers of remaining joint illnesses. The company also announced plans for upcoming Ampion trials to treat Chronic Obstructive Pulmonary Disorder, COPD, and Crohn's Disease. If Ampion is approved, and it is looking brighter every day, Ampion could easily become a new blockbuster drug for Osteoarthritis and several other maladies. Ampion is a far more attractive option to knee and joint replacements.

    All by itself, the drug Ampion would be more than enough to create very excited and happy investors, but this company has a pipeline beyond Ampion that would make any Fortune 500 company envious. Ampio Pharma is also developing 2 other blockbuster drugs that are equally likely to succeed with an FDA approval and equally close in time for approvals. Optina used to treat Diabetic Macular Edema, "DME", is in a Pivotal Phase 505 B 2 Trial with completion expected in Q1 2014 and Top Line results soon after. October 7th, an Independent Data Review Committee announced positive interim results and recommended continuation of the trial.

    Optina may have a large advantage over the competition because it is a pill and not an injection. If approved, Optina will probably gain the support of insurance companies and government because it will be far less expensive than competing drugs like Lucentis and Eylea. An article that appeared in the scientific journal, Retina Today featured a cover story on Optina last year called, Oral Danazol For DME. The article explains how Optina works to actually repair the leaking blood vessels in the eye and not just mask symptoms. The progress of Optina is being watched very closely by Regeneron (REGN) shareholders because an approval of Optina could be devastating to the injection Eylea and results from the prior trail were so successful, the trial was concluded ahead of schedule.

    Zertane is used to treat the male sexual dysfunction of Premature Ejaculation and while the company has been very quiet about Zertane, it is about to receive approvals in 19 countries and management is in discussions with several large pharma companies about a possible licensing deal or partnership. It is estimated that close to 25% of the male population suffers from PE. The company is also developing Zertane ED that is used to treat both PE and ED simultaneously in one pill. The biggest challenge developing Zertane was creating a Patient Outcome PE Questionnaire that was acceptable to the FDA for the Phase III trial. Early this year, the FDA approved Ampio's POPE and cleared the way for the final trial that is estimated to be around 12 weeks in duration. At this month's Piper presentation, Mike Macaluso, Ampio CEO, said to expect an announcement by the company by the end of this year about Zertane.

    Oxidation Reduction Potential, "ORP" is a revolutionary diagnostic that has the potential to save millions of lives and billions of dollars. A patient's ORP is measured using the company's proprietary RedoxSYS™ diagnostic system, a point-of-care diagnostic system enabling rapid analysis of multiple markers of oxidative stress. Recent studies produced positive results for hip fractures and traumatic brain injury Ampio owns worldwide patents and is pursuing worldwide commercialization with approvals expected in 2014.

    Like all emerging pharma stocks, Ampio Pharmaceuticals has been controversial and volatile, offering traders the short-term price swings they require for profit opportunity and investors the long-term uptrend that is solidly in place. Ampio has been the object of healthy skepticism in several articles for the last two years, but now appears poised to begin delivering successful pivotal trials, licensing deals and FDA approvals by early 2015.

    Young and fast-rising companies like Ampio are typically technology rich and cash poor but Ampio finds itself with plenty of cash and even recently raised an additional $25 million to insure adequate financing for its active clinical trial activity.

    Risk is always present will all companies, especially publicly traded companies where the markets are susceptible to elements beyond a company's control and Ampio is no exception, but with all the overwhelming news to come, Ampio appears more likely than not to be headed for a Melt-Up that could surprise big.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    Tags: REGN, AMPE, long-ideas
    Dec 10 8:27 AM | Link | Comment!
  • Jacobus Attack On Catalyst Backfires; Gives Investors Second Chance To Buy Cheap

    On October 18th an article titled "Catalyst Pharma: Orphan Drug Poseur, Profiteer" attacked Catalyst Pharmaceutical Partners (CPRX) and sent shares plummeting from $3.60 to $1.50. The article cleverly, but misleadingly portrayed Jacobus Pharmaceuticals as the savior and Catalyst Pharmaceutical Partners as the anti-christ. But yesterday something went very wrong for Jacobus when it was discovered that they have been hiding the fact that they manufacture their drugs in an abandoned Nuclear Reactor Test Site and that for over 16 years they have repeatedly been cited for serious violations by the FDA for unsafe manufacturing and have been issued a "Warning Letter" from the FDA. Some of their infractions include, unsanitary conditions, foliage and plants growing through the walls and floors, powdery substances covering half of the floor space, open holes in doors, and unsafe manufacturing practices.

    Now that the word is getting out, it won't take long for LEMS patients and their families and physicians to discover the potential dangers of Jacobus' 3, 4 Dap. The recent Meningitis outbreak caused by improper manufacturing practices is still fresh in consumer's minds. Jacobus' 3, 4 Dap may have treatment benefits, but the price may be too high when the exposure to unsafe manufacturing practices is factored in.

    Firdapse Phosphate Salt and 3, 4 Dap Free Base are both given for free in clinical trials, but LEMS patients will likely take advantage of the current safer and professionally run Firdapse trial while it is still available.

    The violations Jacobus has been cited for are so serious and numerous that they beg the question, "How long did Jacobus think they could get away without being caught for intentionally omitting to disclose flagrant safety violations for so many years?" A recent BOMBSHELL BLOG shedding new light on Jacobus reveals actual government documents citing their violations. "Are You Sure You Would Take this Drug Even If It Was Free?" blows the lid off Jacobus with this major story about how a drug company secretly hid important safety information and kept it from the public.

    Catalyst shareholders should be expected to be upset by the misleading article, but in reality, it did them a favor because the story backfired on Jacobus and at the same time showed the strength and professionalism of Catalyst and created a second chance to buy shares cheap for those who missed the move earlier.

    On October 8th I wrote an article about how undervalued Catalyst shares were compared to really good comps of Aegerion Pharmaceuticals (AEGR) and Acadia Pharmaceuticals (ACAD). They were selling at $3.30 then. Today they are $1.53. Since nothing has changed in the company and their progress with Firdapse and CPP115 is still solidly on track, Catalyst shares are an even better and outstanding buying opportunity now. All of the analysts covering Catalyst are projecting target prices of between $4 to $5. And that is only for the next year because as Firdapse gets closer to approval, the price will most likely be in the teens. And the projected approval date for Firdapse is 2015.

    As for Jacobus, one has to ask, "Just how serious could Jacobus be since they had orphan drug designation since 1990, and 23 years later they still have no approval."

    As soon as shares tumbled to $1.50 about a half dozen vulture-like law firms announced they were available to unhappy shareholders who felt they were damaged by Catalyst and that they were all looking for a lead plaintiff. Anything can happen in a court of law but these lawsuits all appear frivolous because the company did state on their web site that there was competition for Firdapse. Now we can also see that after 23 years, the competition was not very serious.

    Jacobus is conducting a clinical trial for their 3, 4 Dap Free Base, but consider their poor manufacturing practices, the instability of their version 3, 4 Dap and the fact that dosage is still unknown and will take considerable time and additional studies to determine. In the meanwhile Catalyst already has "Breakthrough Therapy" designation from the FDA that can shorten the time to approval even further. Also consider that once LEMS patients learn about the potential dangers of 3, 4 Dap, they may likely pass on its trial and switch over to Firdapse that is safe.

    The pharmaceutical business is a risky one and has risk of failure of drug trials, risk of inadequate capital to continue as an ongoing concern, and of course an investment in any publicly traded company always includes risk of unexpected market conditions.

    One month ago, Catalyst shares were a good value at $3.60 per share and today at under $2.00, they are an outstanding value for large percentage returns in the next year as Firdapse moves closer to final FDA approval. I strongly believe this recent selloff offers a second chance to buy Catalyst shares cheap before they trade at much higher prices.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    Nov 04 4:06 PM | Link | 2 Comments
  • Lucrative Investment Opportunities In Next Generation Natural Food Companies

    A major shift in eating habits is occurring across the globe. It's long-term in nature and is creating exceptional investment opportunities for those who recognize the trend and act. The food in our Standard American Diet is the primary cause of today's health crisis: pandemic levels of heart disease, cancer, diabetes and obesity. Widely followed health experts like Dr. Oz, Dr. Joel Fuhrman, Dr. Caldwell Esselstyn, and others are telling their patients and followers which foods to avoid and which to consume. The NIH, the FDA, and physicians across the country are warning of the dangers of excessive amounts of salt, sugar, animal based foods, processed foods, chemicals, and GMO's. They are educating us about the need for all natural nutrient dense foods from greens, vegetables, fruits, nuts, and seeds.

    Reflecting this trend, shares of health food companies have been heating up. Sprouts Farmers Market (SFM) climbed a whopping 123% in its first day as a public company. Investors paid only $18.00 in Sprouts' IPO last August and now shares are trading at $48.68, a gain of 166%. Whole Foods Markets (WFM) gained 50% in the last 12 months and has been on a steady uptrend for the past 5 years rising from $4.00 to $60.00.

    This trend towards eating for health is expected to last for generations because modern medicine is not able to solve the crisis that threatens every person on our planet. Pills for high blood pressure, high cholesterol, diabetes and weight loss, and chemo for cancer are not working. Hippocrates was right over 2,000 years ago when he said, "Let food be thy medicine and medicine be thy food." Food is the only answer.

    Science is making new discoveries about the nutrients we require for a healthy body and is telling us about the harmful ingredients in many of the foods we eat. Dr. Joel Fuhrman developed the most advanced scientific method for measuring the nutrients in food . . . the Aggregate Nutrition Density Index (ANDI Scale) used by Whole Foods Markets and leading nutritionists.

    The ANDI Scale measures the total nutrient density of food including vitamins, minerals, antioxidant capacity, phytonutrients and micronutrients and ranks each food with a score from zero to 1,000 points. To put the nutrition of our foods into perspective, milk, meat, chicken, fish, cheese, eggs, butter or any dairy product rank under 50 points while kale, watercress, collards and several other dark leafy greens rank a perfect 1,000 points because they are loaded with super nutrients missing in most foods. In his lifetime achievement book, "The China Study", Dr. T. Colin Campbell recommends keeping our animal food intake below 8% of our total diet.

    The desire for healthy foods is so strong that even giants like 7 Eleven and McDonalds are seizing this opportunity to generate more sales by offering their customers healthier choices. 7-Eleven says they want to be our healthy-snack store. Rebecca Frechette, a vice president of merchandising at 7-Eleven says, "Better-for-you is one of the fastest-growing segments of the snacking category." McDonald's says it will offer value-menu customers a side order of salad, fruit, or vegetables as an alternative to French fries. These healthy alternatives will be set in motion in the fast food giant's 20 top markets, including China.

    Popular films like "Forks Over Knives", "Food Inc.", "Super Size Me" and dozens of others are changing the eating habits of millions of viewers. Books like "Eat Right America", "Super Immunity", "Eat To Live", "The China Study" and many others are influencing millions more to eat healthy, all natural, nutrient dense foods and to avoid many harmful foods in the Standard American Diet. This trend toward healthier eating continues to gain strength because it is clear that those who adopt the new vegan, nutrient dense diets are living far healthier lives and enjoying a better quality of life.

    All natural nutrient dense foods are clearly the new generation of foods for better living and there are three ways to participate in this exciting new investment opportunity. The national supermarket chains offering healthier foods are enjoying faster growth and faster rising share prices than their traditional food counterparts and still offer more investment opportunity in the future. Most of them are publicly traded and provide the advantage of liquidity for easy purchase and sale, but they are not completely focused on nutrient dense foods and therefore cannot offer a maximum play on this new breed of foods. Nonetheless, Whole Foods Markets, Sprouts Farmers Market, The Fresh Market (TFM), Natural Grocers (NGVC) and others are still good investments because they are positioned over their competitors to take advantage of this new trend.

    Then there are the publicly traded healthy food companies such as Annie's (BNNY) that has been a pioneer of healthy foods for decades. Annie's claims to sell natural and organic foods, but close examination of the ingredients of their products shows they are frequently using heavy salt, sugar, and chemicals and do not qualify as all natural nutrient dense foods. What used to be considered healthy foods is changing fast. Beware of the majority of large established food companies that incorrectly and misleadingly boast healthy foods. The ingredients in tiny print will tell the ultimate truth; so put on your glasses and read the labels before you buy or invest.

    The third and most exciting investment opportunity in this next generation of healthy foods is small private companies. New companies providing all natural, nutrient dense foods with the highest nutrient to calorie ratio are the wave of the future and those that can provide the best tasting foods and that have large production have the potential to grow exceptionally fast.

    The typical profile of these new healthy food companies is that they are small, private, and not publicly traded yet. Some will entertain investments; some will not. It takes a little more work than just putting in an order with your broker to buy shares of stock, but it's very easy to send an email to a contact on their web site and inquire if investment opportunities are available. If an investment opportunity is available, the growth potential can be immense because of the long term rapidly growing demand for their products and the shortage of real all-natural nutrient dense foods. Evidence of how investment in private natural food companies is heating up is expressed in theForbes article, "How NatureBox Raised $10.5 M In 7 Months To Disrupt The Healthy Snack Industry".

    DrFuhrman.com offers a growing line of all natural nutrient dense soups, salad dressings, vinegars, snacks and other items such as chia seeds, flax seeds and nutrition bars. The downside is that sales are limited because Dr. Fuhrman foods are sold only on his web site and not to the large retail stores. The market for Dr. Fuhrman foods is also somewhat limited by the fact that his foods have zero added salt and sugar making them exceptionally healthy, but also very bland in taste. Dr. Fuhrman is one of the world's leading nutrition and health experts and has a large following of loyal patients and customers. He has helped thousands of patients recover from life threatening illnesses using only all-natural nutrient dense foods. It is likely that Dr. Fuhrman intends to launch his food products into large retail stores at some time in the future.

    The most exciting new player in this space is Holly's Natural Foods. It has spent five years researching and developing its broad line of all natural nutrient dense foods. Holly's has a large manufacturing facility capable of extremely rapid expansion to meet any size orders from the largest national retailers. Holly's Natural Foods focuses on taste, nutrition, and convenience and is now offering the best tasting, all natural, nutrient dense snacks to large retail chains under the Holly's label and under Private Label. Holly's line of products is growing fast and includes chia kale chips, chia apple crisps, pumpkin seeds, chia peanut butters, dried cranberries and fruits, nutritional yeast, nuts, chia seeds, sacha inchi, kale, & veggie instant soups, ancient grains such as quinoa and more new products every month.

    NutriPops™ and SuperPops™ are Holly's breakthrough snacks where one delicious 2-ounce popsicle delivers more nutrition than an entire meal and has less than 80 calories. Because NutriPops™ are the easiest and best tasting way for kids and adults to get their daily greens, fruits and veggies, Holly's believes they will become a blockbuster seller and are the perfect solution for the National School Lunch Program. Holly's is also offering their products to schools, hospitals, assisted living facilities, vending companies, and foreign importers that all have a big appetite for healthy snacks. Holly's is focused on product development, marketing, and sales. Holly's runs a lean company with small headcount.

    NatureBox.com recently raised over $10 million and is offering an attractive line of healthy snacks that are popularly priced and delivered directly to the customer's home. NatureBox has an interesting model that should do very well but may have limited sales because they are not marketing to the big retailers yet. Some NatureBox snacks are granola, fig bars, apple chips, nuts, cheddar stix, and more. For the most part, the salt and sugar levels are lower than traditional snacks; but they still are not nutrient dense and do not fit the profile of all natural nutrient dense foods. The level of nutrients is very low compared to the foods of Dr. Fuhrman and Holly's Natural Foods but NatureBox products are still better than most foods on the market and should do quite well.

    In conclusion:

    There is an exciting new investment opportunity to enjoy lucrative returns from large retailers that are positioned to attract health conscious customers and from small private companies offering all natural nutrient dense snacks. Look into Whole Foods Markets, Sprouts Farmers Market, The Fresh Market, Natural Grocers and other private healthy snack companies on their web site and simply send them your request for information about any potential investment opportunities.

    There is risk associated with every investment and the companies mentioned in this article are no exception. It is preferable to find an investment that mitigates as much risk as possible by assuring that products are already developed and that manufacturing is already in place to meet the growing demand. In the case of the more mature publicly traded companies, they provide less risk but also far less reward. The biggest opportunities are in the new private all natural nutrient dense snack food companies like Holly's Natural Foods and other similarly structured companies.

    Oct 15 12:18 PM | Link | Comment!
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