Expert Financial Analysis and Reporting

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 […]

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 […]

Investment Overview I have previously written about Bristol-Myers Squibb (BMY) as having possibly the best pipeline among the major pharmaceutical firms. Despite the new product outlook, I estimate that the loss of sales from products coming off patent will cause overall sales to decrease from $20.4 billion in 2011 to $16.6 billion in 2013. The […]

The PDUFA date for ipilimumab is coming up on March 26th. This is an important component of BMY’s outstanding pipeline. I anticipate approval.   Ipilimumab is Up on the News Front- Will It Be Approved on Its March 26 PDUFA Date? I wrote that I believe that Bristol-Myers Squibb has an outstanding pipeline in my […]

I was expecting approval of ipilimumab for patients who had failed prior therapy. I was surprised that the FDA also approved it for treatment naive patients. The price of $120,000 for a course of therapy exceeded my projection of $50,000 to $60,000.   Key Points The FDA approval of Bristol-Myers Squibb’s new oncology drug Yervoy […]

I think that Bristol-Myers Squibb has one of the most attractive drug pipelines of the big pharma companies. Although it faces a steep patent cliff that by my projections will results in a sales decline until 2014, the stock is attractive because of the highly promising drug pipeline and the dividend yield of 5.2%. I […]