Expert Financial Analysis and Reporting

Investment Thesis Finally, the FDA comes through with the approval for Makena SC. My Buy recommendation on Antares is based on an extensive and promising pipeline which I wrote about in my August 17, 2017 report This Small, Emerging Biotechnology Company Is Poised for Explosive Growth Based on Five Major New Product Introductions by 2020. […]

Introduction This report deals with comments made by President Trump in the State of the Union address in which he indicated that he wants to give terminally ill patients the right to receive experimental drugs, even though they might only be in phase 1 development. This could have positive implications for DCVax-L and DCVax Direct […]

Investment Opinion Conceptual Reason for Recommendation My recommendation of Bristol-Myers Squibb is in contrast to the small, not well-researched biotechnology companies on which I usually focus. BMY is a large, complex and well analyzed multinational company with a broad product portfolio and burgeoning pipeline. It requires as much time to analyze as several small biotechnology […]

Regulatory Update Antares announced that it has scheduled a Type A meeting with FDA for Xyosted which is intended to resolve issues that have stalled the FDA regulatory review. Antares requested the meeting on December 21, 2017 in response to a Complete Response Letter on Xyosted. The meeting will take place on February 21, 2018. […]

Reason for this Note I was prompted to write this note after listening to a July 2017, You Tube segment in which Dr. Keyoumers Ashkan spoke about his belief that DCVax-L could be a major advance in the treatment of brain tumors. Here is the link to this approximately 13 minute video. His comments on DCVax-L […]

Purpose and Summary of This Report My key takeaway points are summarized at the end of this report. I urge you to first go through the full text, but if for whatever reason you are impatient, you can start from the back of the report. The primary purpose of this report is to provide data […]

Portola announced after the close on December 22, 2017 that the FDA will extend its review of AndexXa (andexanet alfa) by 90 days. According to the Company, it just submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process.  This constitutes an amendment to the submission […]

Antares Pharma announced on December 21st that it had submitted a request to the FDA for a type A meeting in response to the CRL that it received in October on Xyosted. This action and timing is in line with what I have been expecting. See my note of November 9, 2017:  My Hypothesis on […]

Portola Pharmaceuticals announced today that the FDA has given the go-ahead for the commercial launch of Bevyxxa (betrixaban). This drug was approved in the US on June 23, 2017 and at the time Portola said that it expected to launch Bevyexxa in the US in the September to November time frame. However, in early September […]

CYTK announced today that the VITALITY-ALS trial in ALS failed which is obviously a significant disappointment. The stock is trading down to $8.00 in pre-market trading. I had thought that there was a good chance for success in the trial, but recognized that ALS is a tough disease in which there have been innumerable drug […]