Wednesday, March 10, 2010 4:08:11 PM
"Lately I have been doing a lot of research about APPA as it relates to potential increased stock prices with its upcoming FDA approval. Below is a summary of all my findings, however as I always tell my colleagues “don’t take my word for it, look it up yourself…due diligence is key”.
Submission of FDA:
In mid 2009 A.P. Pharma (NASDAQ:APPA) announced that it has submitted a New Drug Application (NDA) with the Food and Drug administration (FDA) [1]. This NDA is intended for acceptance of their new drug APF530 [2]. This new drug like some on the market, is designed and tested for one major side effect of chemotherapy “chemotherapy-induced nausea and vomiting” (CINV) [2]. The FDA is expected to approve or decline by March 18, 2010 [1][2][3].
About the Drug and illness
Chemotherapy, the major line of defense against cancer has many side effects one of which is cute induced nausea and vomiting and delayed induced nausea and vomiting. These two side effects amongst many lead to the discomfort of this treatment. APF530 targets both side effects and minimizes them for the struggling patient. Below are a few facts about the treatment:"
-rates for APF530 10 mg dose were generally higher in treatment experienced patients when compared to treatment naïve patients. [4]
- rates for APF530 in treatment experienced patients were numerically higher than those observed for palonosetron. [4]
-new data may suggest potential utility for APF530 in treating patients who have received prior chemotherapy. [4]
- rates for patients receiving cisplatin (highly emetogenic chemotherapy) based regimens were numerically higher for APF530 10 mg when compared to palonosetron in both acute and delayed CINV. Specifically, in acute CINV, APF530 had an 81.1% CR rate versus 75.5% for palonosetron, and 66.0% versus 60.4%, respectively, in delayed CINV. [4]
Future outlook
Chemotherapy is multibillion dollar industry and unfortunately for the patients, it will not disappear any time soon as there is no cure for cancer. Even though there are currently other products on the market for CINV, APF530 has proven to be a good competitor to them. Through my research I believe that this drug will be approved as will take A.P. Pharma to the next level with larger revenues and profits for 2010.
[1]http://seekingalpha.com/instablog/110813...
[2]http://www.streetinsider.com/FDA/FDA+to+...
[3]http://www.rttnews.com/ArticleView.aspx?...
[4]http://www.appharma.com/PDFs/06%2001%200...
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