Biotech Values

[srsmgja]

Nothing I have recently read changes my personal outlook for a Cladrabine of FTY-720

Cladrabine has no chance for approval without a 2nd trial. An almost 1% cancer rate (in a drug with a known cancer link) compared to 1 ZERO rate in the control group. Take away ALL of the other safety signals, that alone is the basis to request a 2nd trial. If they started today, a second 2 year phase 3 trial would take 1 yr to enroll, 2 years to run, 3/4 yr of data collection and filing, 1 year for FDA review. 5 Years or 2015-16 at the earliest. Say good bye to Cladrabine, IMO.

FTY 720 reported a myiad of side effect in the one phase 3 trial run in the US. By contrast, the FREEDOM 1 trial (run exclussively OUTSIDE the US) demonstrated a much cleaner safety profile. At a minimum, the FDA review of FTY -720 will require upwards of 1 year (despite the priority review). You can be sure of a panel and extensive RISK MAP. That pushes a final decision a few months (march 2011) before release of the second large 2 YEAR phase 3 trial - FREEDOMS 2 trial, with the majority of patients from the US. I can't imagine the FDA approving FTY BEFORE reviewing the results of the 2nd large phase 3 trial. Why should the FDA risk an earlier approval especially with the divergent safety results from the first trials?? Especially after the Tysabri experience.