Expert Financial Analysis and Reporting

UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program. Earlier this year, Germany granted approval to DCVax-L under its early access program. Early access means that DCVax-L can be prescribed prior to formal approval that might come in 2016. I expect revenues from German sales in […]

DCVax Direct was used in a patient with stage 4 pancreatic cancer whose chemotherapy was stopped. The patient, a Nat Geo employee, is stable at 18 months post diagnosis and gives his very positive view of the efficacy of DCVax Direct. Clinical studies show that 50% of such stage 4 pancreatic patients die within six […]

The FDA does not appear to be concerned about cardiovascular risk with testosterone replacement products so this is a major positive. The FDA is asking the panel to consider if these products are used too much in unapproved indications. The testosterone replacement market has shrunk significantly in 2014 due to the cardiovascular safety issue. There […]

Investment Overview ImmunoCellular and its dendritic cell cancer vaccine ICT-107 were written off as failures in December of 2013 after it was announced that the phase 2 trial in newly diagnosed glioblastoma multiforme (GBM) failed to reach statistical significance on the primary endpoint of median overall survival. However, I believe IMUC is putting forward a […]

Key Points The phase 2 trial of NSI-566 in 15 ALS patients has completed enrollment (surgeries) and final topline data could be available in 1Q, 2015. However, there may be some interim data released at the ANA meeting during October 12 through 14. If the phase 2 data is compelling, it raises the possibility of […]

Investment Thesis Antares (ATRS) common has been hit with a storm of concerns that has caused the stock to decline from about $4.50 in March of this year to a low of $1.94 in August. This note addresses these issues and how they affect my investment thinking. In almost every investment situation I have been […]

Investment Thesis At the time of launch of Surfaxin on November 8, 2013 Discovery Laboratory’s (DSCO) stock was selling at $2.00. By February 2014, it had climbed to $2.65, but has since slid to $1.60. This weakness was due to disappointment with the launch. The ever growing difficulty in gaining quick Pharmacy and Therapeutics (P&T) […]

  The Data Monitoring Committee (DMC) is charged with monitoring the safety and efficacy results of clinical trial. The committee and its chairman are totally independent of NWBO. The Chairman of the DMC says there has been no interim analysis for efficacy of the phase 3 trial. Feuerstein alleged that efficacy results were negative and […]

Investment Thesis In listening carefully to Cytokinetics’ (CYTK) comments over the last three months, I am convinced that the Company will consult with the FDA and EMEA about the design of a new phase 3 trial of tirasemtiv in ALS. They will ask for approval to use the respiratory measure of sustained vital capacity (SVC) […]

Citizens for Responsibility and Ethics in Washington (CREW) have gone after Adam Feuerstein of The Street.com. They have accused him of taking part in a stock manipulation scheme in regard to Northwest Biotherapeutics and other biotechnology companies. I went to their website to get an idea of who they are. They refer to some of […]