Archive for August, 2014
Neuralstem: Previewing Upcoming Important Events and Some Thoughts on the StemCell Patent Infringement Lawsuit (CUR, $3.62 Buy, August 26, 2014)
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 […]
Antares Pharmaceuticals: An Update on Key Issues (ATRS, Buy, $2.14)
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 […]
Discovery Laboratories: My Current Thinking on the Surfaxin Launch and Aerosurf Phase 2 Trials (DSCO, Buy/Hold, $1.62)
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) […]
Northwest Biotherapeutics: Independent Chairman of the DMC Committee for DCVax-L Phase 3 Trial Chastises Adam Feuerstein for Inaccurate Articles (NWBO, Buy, $6.43)
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 […]
Derma Sciences: Second Quarter Results Were Disappointing; Going From a Buy to a Hold (DSCI, $9.72)
Derma Sciences released second quarter results this morning and this is my quick take. I will have a more detailed update later after the conference call. The results were disappointing relative to my expectations. Advanced wound care products were up only 11% versus my expectations of 30%. Traditional wound care products were up 18%, which […]
Cytokinetics: More Thoughts on the Potential for a Phase 3 Trial of Tirasemtiv in ALS (CYTK, Buy, $4.20)
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) […]