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Expert Financial Analysis and Reporting

Post archive for ‘LinkedIn’

Cryoport: Thoughts About FDA AdCom Meeting on Novartis’s CAR-T Drug Tisagenlecleucel (CYRX, Buy, $4.86)

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 […]

Northwest Biotherapeutics: Why I Believe That the Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Patients Has a Very Good Chance for Success (NWBO, Buy, $0.17)

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 […]

Windtree Therapeutics: Phase 2b Trial Fails Although There Was An Encouraging Signal of Activity (WINT, Take tax loss, $0.34)

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 […]

Portola Pharmaceuticals:  Betrixaban Approval Triggers Big Stock Move-Now What Do We Do? (PTLA, Buy, $55.42)

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 […]

Repligen: Market Likes Spectrum Acquisition and So Do I  (RGEN, Buy, $43.20)

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: Reiterating Buy Prior to June 24th PDUFA Date for Betrixaban (PTLA, Buy, $39.35)

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 […]

Alimera Sciences: Iluvien Sales Seem to Have Caught Traction; It Is Time to Buy! (ALIM, Buy, $1.35)

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 […]

Windtree Therapeutics: Discussion of Licensing Deal with Lee’s Pharmaceutical and Two Imminent Key Clinical Events (WINT, Buy, $0.90)

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 […]

Novartis Releases Three Month Interim Data for JULIET Trial of CTL-019 in r/r DLBCL

Key Points: Comparison of three month data for CTL-019 in the JULIET trial with  Axi-Cel in ZUMA-1 indicates that safety and efficacy are remarkably comparable for the two products. At this point, there seems to be no differentiation between the two. Some analysts are strong propoents of Kite raised the issue that Novartis had manufacturing […]

FDA Announces July 12 AdCom Meeting for CTL-019: Thoughts on How This Might Affect Investor Perceptions of Kite (KITE, Neutral, $80.25) and Cryoport (CYRX, Buy, $3.89)

The FDA has announced that there will be an AdCom meeting for Novartis’ CTL-019 for the treatment of pediatric r/r ALL on July 12. In my June 5th note, I wrote that Novartis was expecting an AdCom meeting for the pediatric r/r ALL indication. The PDUFA date is in late September but I think that […]