Expert Financial Analysis and Reporting

Overview Before reading this report, I would suggest reviewing my initriation report on Cryoport of April 12, 2017   and my update report of July 19, 2017. Without information contained in these reports, it might be difficult to put my comments in this note in perspective. Based on new guidance from CEO Jerry Shelton, it appears that […]

Report Highlights The pending approval of Novartis’ Car-T drug tisagenlecleucel is the beginning of a new era of drugs based on manipulation of genes, most commonly referred to as gene therapy. This promises to be a new dynamic to biopharma drug development that will be a strong (the major?) driver of industry revenues for the […]

An FDA advisory committee will consider the BLA for Novartis’s CAR-T product tisagenlecleucel tomorrow, July 12th for the treatment of relapsed/ refractory acute lymphocytic leukemia. This will be the first FDA review of the new CAR-T products. I have spent some of today reading the FDA briefing documents for the members of the committee. There […]

Overview This report is an extensive update on almost everything I know about the DCVax-L phase 3 trial and is over 20 pages long. The catalyst for this report was the recent information on the still blinded phase 3 trial presented in June at ASCO. It will take dedicated investors a great deal of time […]

Key Points: The phase 2b trial failed, but there was an encouraging signal of activity. The failure was related to clogging of a cartridge used in the medical device used to deliver Aerosurf which affected some patients in the 50 minute dose cohort. In patients unaffected by this problem, results were positive and if they […]

Investment Thesis There was considerable uncertainty as to whether the FDA would approve betrixaban so that the approval caused a sharp jump in the stock price. The question I am asked is whether the stock will back off from current levels allowing investors to acquire the stock at a better price or even if existing […]

Investment Thesis I view the acquisition of Spectrum, Inc. as a significant positive for Repligen as I will discuss shortly. I have recommended Repligen consistently since my initiation report of December 4, 2012 at a price of $6.13. My belief at the time and continues to be that this is one of the best healthcare […]

Portola has two drugs in late stage development that I believe are likely to be approved in 2017 or early 2018 in both the US and Europe. Betrixaban is an anticoagulant drug that is an oral factor Xa inhibitor. It has the same mechanism of action as two blockbuster drugs: Bristol-Myers Squibb/ Pfizer’s Eliquis ($3.3 […]

Key Points In 1Q, 2017 unit sales of Iluvien increased 34% in the US and foreign unit sales increased 32%.Management believes that these rates of growth could continue for the balance of 2017. Management also believes that it can reach breakeven or turn cash flow positive later in 2017. My model shows the Company achieving […]

Introduction This report discusses a new licensing deal with Lee’s Pharmaceutical and alerts investors to two upcoming catalysts for the stock. In July, the critical results from the phase 2b trial of Aerosurf will be published. Before then in June, results from the phase 2a trial in babies of the 26 to 28 weeks will […]