Replies to post #23661 on $heff's $tation of $tocks & $olid DD

[Investor100]

Additional "DD" @ APPA

Sheff, adding to what you posted- I found this info on another board which I think compliments what you have highlighted.

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I deceived to update my previous summary thread with some additional information. Would like to thank some of our fellow users here; who's very informative threads and replies I have incorporated into this to make it a more comprehensive summary. I encourage everybody to do their own due diligence and make their own decisions about their investments and finances, but I think this is a good place to start. Please comment and add any additional information that I may have missed. And if you like the summary, please help keep it bumped and near the top of the board. Without any further introduction, let's get to the summary:

APPA's drug, APF530, is up for FDA approval. APF530 targets the 1 billion dollar CINV market (chemotherapy-induced nausea and vomiting market). The PDUFA date, scheduled by the FDA, is set for March 18, 2010. If approved, APF530 is scheduled to launch later this year.

A similar version APPA's drug (Aloxi) has already approved by the FDA. Aloxi contains the 5-HT3 antagonist palonosetron. APF530 contains the 5-HT3 antagonist granisetron. (These 5-HT3 antagonists are what are used to treat and prevent nausea and vomiting.) What APPA is trying to do it to create a new version of a similar approved FDA drug. APPA's NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. A 505(b)(2) NDA is much easier to get approved than a normal NDA filing for a new chemical entity. APPA will rely on previous FDA safety and efficacy findings for main ingredient granisetron, which has already been found by the FDA to be safe and effective.

APPA is attempting to get approval from FDA for APF530 by showing non-inferiority to Aloxi. APPA's double-blind Phase 3 trial results appear to indicate that they have accomplished that goal. APPA has also shown that there is no significance difference to Aloxi in regards to adverse effects. APF530 was even found to be statistically (not significantly, but still statistically) better than Aloxi in the averse effects areas of moderate and severe headaches. If the FDA agrees with APPA's findings, APF530 should be approved. And if approved, APF530 will be only one of two FDA approved drugs for the treatment of both acute onset CINV and delayed onset CINV.

APPA's APF530 has a few advantages over Aloxi in the way it is administered to the patient. One of these advantages APF530 has is that it addresses the issue of Aloxi requiring an intravenous (IV) line to deliver the drug into the patient's bloodstream. Not all chemotherapy treatments are administered intravenously, so having Aloxi, that can only be delivered through an IV line, can be an issue. APPA's APF530 is administered via a simple single subcutaneous injection (a shot) and is designed to treat and prevent CINV for at least 5-days with that single injection (maintaining therapeutic levels for those 5-days). Also, APF530 has shown in their Phase 3 trial results to have a tendency to be even more effective over multiple treatment cycle.

APPA has a fairly low share float and has a good amount of insider ownership. APPA put into place a new management team in late 2008. That new management team has done an amazing job with the company. Last October, one of APPA's directors, Kevin C. Tang, purchased 2,443,181 shares of his company (which put the total amount of shares he personally owns at 10,436,506). Other company insiders have also acquired additional shares of the company throughout last year. APPA also has a nice amount of institutional ownership. The top two institutional owners both have a low turnover rating.

APPA has saved up a fair amount of cash. According to their own estimates, they should have enough cash to fund their operation through 2010. They pocketed 8.1 million dollars though a private placement deal last October. And on January 11th of this year, they received a payment of 2.5 million dollars from one of their affiliates.

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