Despite questionable statistical data, the decision remains highly political and given the safety profile, CBER appears motivated to approve additional products to stimulate R&D activities in cancer immunotherapy. BAC notes that Jesse Goodman, Director of CBER, appears to have influenced Celia Witten to 'lower the bar' by changing the efficacy question during the initial advisory panel voting and believe it is a good indicator of CBER's intentions.
Firm understands that DNDN is well prepared for a potential launch and believe Provenge can be out on the market by late 2007. If approved, they see potential upside to their TP to $29 and if an approvable letter is received potential downside to $6. Maintains Neutral as they remain cautious about the outcome of the IMPACT trial.
Notablecalls: DNDN was in play yesterday and I suspect this note by BAC's William Ho will create some additional buy interest in the name. Mr. Ho assigns a 2:1 (66%) probability to the approval. I suspect DNDN can move past the $18 level today.
DNDN 1-yr chart: