Expert Financial Analysis and Reporting

Introduction I have started to write a newsletter on a weekly or bi-weekly basis to supplement my reports and blogs. In this week’s edition, I start with some thoughts on financing strategies for biotechnology companies. This can have an impact on stock prices second only to product development news. I follow this with some brief […]

One Approach for Investing in Emerging Biotechnology Stocks I write on biotechnology and pharmaceutical companies of all sizes, but I have spent much of the last year focusing on small biotechnology companies ranging in size from as low as $50 million in market capialization.to about $400 million. There is much less analyst and investor attention […]

Introduction This report deals with the just announced management change at A.P. Pharma (APPA.OB) and the positive impact that I believe it will have on the stock. It does not get into an in-depth discussion of the fundamentals and financial projections for the Company. For those wanting more background, I would refer you to past […]

Overview A.P. Pharma has just released the disappointing news that it has received a Complete Response Letter for APF530. The press release described three issues that led to the CRL. · With respect to chemistry, manufacturing and controls (CMC), the FDA has requested the refinement of one product quality analytical test method, and that certain […]

Investment Opinion and Background I initiated coverage of A.P. Pharma (APPA.OB) in April of 2012 with a Buy. I am anticipating approval of its lead drug, APF530 at the March 27, 2013 PDUFA date. I believe that the company has successfully answered the CMC issues that resulted in a Complete Response Letter to its earlier […]

Catalyst AP Pharma (APPA.OB) announced that it has resubmitted its New Drug Application (NDA) to the FDA for its lead product candidate, APF530, for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). A.P. Pharma expects to be notified that the FDA has accepted the refiling and has established a Prescription Drug […]

Investment Thesis and Price Target I initiated coverage of A.P. Pharma (APPA.OB) with a buy at $0.42 per share on April 25, 2012. I am reiterating a buy at the current level of $0.64 per share. For more details on the fundamental outlook for A.P. Pharma please refer to my initiation report called Unusual Potential […]

Investment Thesis The equity offering by A.P. Pharma of 102 million shares at $0.52 per share has put pressure on the stock, but it is gradually recovering and the current price of $0.58 presents a buying opportunity in my opinion. I initiated coverage with a buy at $0.42 per share on April 25, 2012. I […]

The FDA issued a safety communication on June 29, 2012 further advising physicians on the link of ondansetron (Zofran) to QT interval prolongation; this condition can cause abnormal heart rhythms that  in some cases may be life threatening. This follows a previous communication on the same concern on September 11, 2011. Because AP Pharma’s competitive […]

Investment Thesis The FDA issued a safety communication on June 29, 2012 further advising physicians on the link of ondansetron (Zofran) to QT interval prolongation; this condition can cause abnormal heart rhythms that  in some cases may be life threatening. This follows a previous communication on the same concern on September 11, 2011. Because AP […]