Expert Financial Analysis and Reporting

Resubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are: Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep […]

The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]

  Investment Opinion The FDA problems encountered with rivaroxaban are a significant, but not crushing negative for the investment thesis of Johnson & Johnson (JNJ). I would still be buyer of the stock. This is a very large company not overly dependent on any one current or future product and still has an excellent new […]

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 […]

Management was quite optimistic about prospects for 2009 as both Zegerid and Glumetza are doing well. The company is looking for a 24% gain in product revenues. Summary of Key Points 1. The Santarus analyst meeting was very encouraging in regards to the new product outlook. 2. The company could end the year with $65 […]