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So I've been hearing a lot about this stock lately and one to watch closely in 2012. I found that the company had been given a CRL in 2010 from the FDA for its lead drug APF530 for the prevention of chemotherapy-induced nausea and vomiting (CINV). In March 2011, the company decided not to proceed with a plan to continue in NASDAQ perhaps in an attempt to conserve cash. It voluntarily withdrew its request from NASDAQ to continue its listing. With the CRL response from the FDA and its withdrawal from NASDAQ, the company's stock obviously took a beating in 2011, on top of its financial uncertainty, it brought the stock to the current price levels. Even though the company's stock is currently trading in the OTC markets, the company has been compliant with all its SEC filing obligations.
So back to the point on the chatter I've been hearing that APPA may be a good stock to watch in 2012. As I’ve seen in the past, some stocks almost seemed forgotten to oblivion by the investor community. Watching the stock closely for several weeks now, the stock seems really quiet, but one thing brought my attention, the stock trades around the range of 0.25, but here is the interesting part, it just keep accumulating.
There is something to be said about the company these days. Financially is doing a lot better. One of its biggest investor happens to be Kevin Tang of Tang Capital Management, also a member of the company's Board of Directors. Mr. Tang has an established record of delivering positive returns to its stockholders. Based on its 3rd quarterly report, the company enjoys a cash position of $21M. The company believes it will fund its operations into 2013.
So I dug up a little on APF530, the drug. It is really no joke. APF530 is an antiemetic drug. The company is seeking approval for APF530 to prevent CINV immediately after chemotherapy and, because it has long lasting properties, for long term treatment as it will last for 5 days - All with one single dose. There is only one other approved drugs in the market that can do this, Aloxi. So you ask, what's the difference? APF530 in clinical trials showed better efficacy results than Aloxi.
I found that there is also an unmet medical need from drugs of this type. Many patients that must undergo multiples cycles of chemo don't react well with the first drug choice, and since this market only has one, there are no alternatives for patients. APF530 would be this alternative even if is not chosen as the first drug of choice. The antiemetic market has a market of over 800M per year.
So what's so important about year 2012 for this stock? The company is expected to complete its studies (QT and Metabolism) to support NDA of APF530 in the 1stQ and the company plans to resubmit NDA in the 1st half of 2012. This sets up a scenario for a potential approval in the 2nd half of 2012.
I’m not really a fan of OTC/Pink stocks, but considering there were on NASDAQ when they received the CRL, I will make an exception. I’m convinced; this one is one to watch very closely in 2012. I’ll be watching!
Tags: A.P. Pharma, APF530, APPA, CINV
Permalink Reply by Stocks To Buy on December 10, 2011 at 9:19am AP Pharma Inc. (APPA.PK): I don't know much about APPA but I would say just watch the price. As long as it holds $0.20, it will be ok. If you see a close below $0.20 it could get ugly.
Permalink Reply by Kebatty on December 11, 2011 at 3:57pm Technically speaking, this one is hard to predict, as with many stocks that trade thinly and with low volume. Despite that, it's holding up pretty well. However, as with many Biotech stocks, this one will be driven by catalyst events and news. The premise here is that APPA will be making news in 2012, and it won’t be too long before they start doing so as the 1Q is around the corner. The price is always a concern, if it drops, may be an opportunity for the ones in the know to accumulate. This one is been doing it for the last 6 months.
Permalink Reply by Stocks To Buy on January 26, 2012 at 7:33am Yea it looks like APPA could break out more
Permalink Reply by Mark J on April 2, 2012 at 10:07am Good Call! this one indeed is breaking out more since January. There is a confirmed upward trend. Specially now after the positive news of the QT results. APPA is looking very bullish!!
Permalink Reply by Kebatty on April 3, 2012 at 11:30pm On January the stock had crossed up the 10 EMA and was very close to the 50 EMA. Now in April, The 50 EMA is way over the 200 EMA line signaling a long term uptrend movement. There was a pull back in March after reaching 0.43 which provided a significant support level at 0.35. Now it is on its way up again closing at 0.42 today. In this upswing we are also seeing a lot more accumulation. A key and important event such as the QT study has now been overcome with a positive result and the metabolism study completed. This certainly has brought more confidence and the sentiment on the stock is very positive. With other near term catalyst approaching, there will be significant support at these levels continuing the uptrend movement. The validation study protocol is expected to be completed during the 2nd quarter, and NDA expected to be re-submitted mid-2012.
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