Expert Financial Analysis and Reporting

Investment Position My position on BMY is that patient investors can buy the stock for the dividend yield and wait for the projected resurgence in growth in 2013. I don’t own the stock yet, but I might be a buyer at some point. A potential catalyst for my decision is the anticipated release of full […]

Introduction and Purpose of this Report I believe that the anti-coagulant drug market is poised to become the next blockbuster category in cardiovascular disease following the path of the hypertension and cholesterol drugs. This could mean that sales would reach several billions of dollars arising from several individual blockbuster products. If I am correct, there […]

Introduction and Purpose of this Report I believe that the anti-coagulant drug market is poised to become the next blockbuster category in cardiovascular disease following the path of the hypertension and cholesterol drugs. This could mean that sales would reach several billions of dollars arising from several individual blockbuster products. If I am correct, there […]

Overview of Advisory Committee Meeting The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 6-9 against approval of dapagliflozin for the treatment of type II diabetes. This will almost certainly result in a Complete Response Letter from the FDA on the PDUFA date of October 28. As I pointed out in a recent report on […]

Investment Thesis There was modest investor disappointment with Johnson & Johnson’s second quarter results reported on July 19, 2011. The stock closed down $0.37 to $66.72 while the market increased sharply. This was due to disenchantment of some investors with the modest operational sales and earnings growth. With foreign currency effects and a lower tax […]

Overview of Advisory Committee Meeting   The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 6-9 against approval of dapagliflozin for the treatment of type II diabetes. This will almost certainly result in a Complete Response Letter from the FDA on the PDUFA date of October 28. As I pointed out in a recent report […]

Overview of Five Briefing Questions Posed by FDA on Dapagliflozin On Friday, July 15, 2011 the FDA published on its website the questions that it has asked the Endocrinologic and Metabolics Drug Advisory Committee to address in its July 19, 2011 meeting on dapagliflozin. My impression on the initial reading of the questions is that […]

Overview and Investment Thesis The strong Bristol-Myers pipeline story is key to the investment thesis and is driven by three potential blockbusters: Yervoy, which was just approved; apixiban which has reported very encouraging phase III data and is likely to be approved in 2012; and dapagliflozin. Of the three, the outlook for dapagliflozin is the […]

Transcept just released a press release on July 12, 2011 with disappointing news on Intermezzo. The release reads as follows: “Transcept Pharmaceuticals(TSPT) announced today that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) on […]

Investment Thesis Transcept’s new drug for insomnia, Intermezzo, received a Complete Response Letter on October 26, 2009 in which the FDA acknowledged that it was effective. However, the agency failed to approve the drug because of concerns about dosing and potential next day residual effects. Transcept addressed and in my opinion has successfully answered these […]