jonathan acshoff on sppi
Healthcare/Biotech
SPPI – Downgrading to Sell from Buy, pt lowered to $4 from $11…ODAC briefing documents decidedly negative, in Jonathan’s view. Friday, the FDA made public the briefing document reviewing satraplatin’s data submitted in its NDA application, and although these documents tend to be negative, we believe that this document is particularly so. The documents tend to be negative, we believe that this document is particularly so. The documents highlights five points of issue: 1) progression-free survival (PFS) as defined for satraplatin has never been used by the FDA; 2) PFS reliability as measured in the trial is questionable; 3) pain progression as measured in the trial is highly questionable; 4) 51% prior docetaxel use by patients may be too low, and 5) positive overall survival (OS) data may be required for approval.
