We are just days away from the Ampion clinical data and if the data matches the successful previous clinical trial results that were observed in Australia, what would stop Ampion for being a $1B+ drug? So assuming that the data from the clinical trials are positive, then I can't find a single reason why the market for Ampion wouldn't be at least $1B or more.
It is well known that current OA treatments cost around $1000 per injection and the effectiveness of these treatments is marginal at best. Should't that be a reason for orthopaedic surgeons to switch their recommendation and prescribe Ampion if again its proven to be superior? And why wouldn't the results be as good than the ones observed in previous trials? The fact that the effectiveness of Ampion was proven to be very successful in treating OA in previous trials (it even made the national Australian TV news) and superior to the current alternate treatments, shouldn't that tell us that chances are that the results would be at least as positive as they have been in the past?
So, lets do some math here. If this is a $1B market that this drug deserves and it's after, what would the stock price be? Currently, at approximately $5.50 a share with a $220 million market cap, wouldn't it be reasonable to assume that this stock would soon be valued at $20, just for the Ampion market alone? And if Ampion is successful, wouldn't that inspire confidence in Optina, Zertane, ORP, and NCE001? I think so. This is the reason why I am so heavily invested in this stock. Shouldn't you?
You do now that AMPE did not report much meaningful data from its phase 2 study? For example, it didn;t report what baseline pain scores were, how many patients were enrolled (data was reported on n = 30, but don't know if that was ITT or PP), what AEs were.
AMPE did not disclose enough information to think this is a meaningful drug.
I'm sure that Zertane partnership is right around the corner.....
The data was more than adequate to prove Ampion's potential. In addition, one has to pay attention to public announcements and get some more clues. Why would FDA suggest a trial design if there was not enough convincing data? Do you think they would have wasted their time? Think again but hey, you are a short and you would much rather be sweeping these clues under the rug. At the end of the date, what matters is what is about to come out.
From the April 3 news release:
"Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) today announced FDA acceptance of its IND and the treatment of the first fifteen (15) patients in its clinical trial using Ampion™ to treat osteoarthritis (OA) of the knee.
Dr. Vaughan Clift , Ampio's Chief Regulatory Officer noted, "We are grateful to the FDA for suggesting our trial design include a run-in portion to assure an optimized dose. This randomized, placebo-controlled, double-blind trial proceeds in two parts. This study design will allow us to present two well-conducted clinical trials for a biologic license application (BLA). The first run-in portion of the trial, designated as the "Spring Study" will evaluate two doses of Ampion™ in 320 adult patients suffering from moderate to severe OA of the knee. This run-in portion will determine the optimal dosage of Ampion™ that will be used in the second portion of the pivotal trial. The number of patients required in the second part of the study will be determined based on an analysis of the first part."
When you run the numbers for Ampion, the price per share becomes extremely large. $20 is just a tiny fraction f what shares will sell for. Then when you add Optina, Vasaloc, Zertane, Zertane ED, NCE001, ORP and the 150 compounds that Ampio owns . . . well you get the idea. Even to most optimistic forecasts will very likely be shattered.
In only one year AMPE will be very well known and very expensive.
Once the Ampion study is complete a few things will happen. All the naysayers will realize they got approval from FDA for expanded studies, they achieved a major milestone, the treatment works, and those with other drugs are in major trouble. this is a major find and once evidence is out this will hit the newswire like a fire storm. the day to day action on the stock is not of my concern. Ampion and Optima results are all i am looking at. IMO this is a great investment. Look at what happened srpt, pcyc and others -they popped big on data. the beauty of this and everyone knows it, is the the safety data.