The Phase II results as you stated were excellent. As we all know these do not necessarily carry over to Phase III. But 2400 pts enrolled and the time length to the trigger point would be favorable indicators of positive results in CHF. Not a bad market. So I'm betting on a favorable outcome as your looking for a 4-5 bagger versus maybe a drop to 1.5-2 on failure.
I'll be interested in your review of their literature, including the VP025 kicker.
PAD is dead for the moment IMHO. But it's built into the current price unless you can't read what's been released { Guys on the Motley Fool board think any end point subjectively measuring walking is doomed anyway.} Re press release
Vasogen Announces the Early Close Out of the SIMPADICO Peripheral Arterial Disease Trial
Toronto, Ontario - August 30, 2005
Vasogen Inc. (NASDAQ:VSGN; TSX:VAS), focused on the development of immune modulation therapies for the treatment of cardiovascular disease, today announced the early close out of the 550-patient, double-blind, placebo-controlled phase III SIMPADICO trial of its Celacade™ technology for the treatment of symptomatic peripheral arterial disease (PAD). The decision to close out the trial at this time is based on a recommendation received from the SIMPADICO Steering Committee.
The Steering Committee’s recommendation was based on a recommendation by the trial’s External Safety and Efficacy Monitoring Committee (ESEMC). The ESEMC recommended the early close out of the study based on the absence of a sufficiently strong efficacy signal and their observation of a modest imbalance in the distribution of a small number of malignancy cases. Based on the Steering Committee’s own review, and the findings of an independent expert in medical oncology, the Steering Committee concluded that no safety concern existed. However, given that the ESEMC’s analysis also incorporated efficacy information and all patients have completed the assessments necessary for the analysis of the primary endpoint, the Steering Committee recommended the early close out of the trial.
“While the Steering Committee does not agree that a safety concern existed, our knowledge that the ESEMC’s analysis also considered efficacy led to our decision to recommend stopping the study at this time,” stated Dr. Jeffrey Olin, Professor of Medicine at the Mount Sinai School of Medicine, Director of Vascular Medicine at The Zena and Michael A. Wiener Cardiovascular Institute in New York, Principal Investigator and Chairman of the Steering Committee for the SIMPADICO trial. “We are now proceeding to lock the data base, fully analyze the data, and report the final results of the trial.”