- Banc of America has some positive comments on Dendreon (NASDAQ:DNDN) saying they anticipate an approval decision on Provenge by May 15th, under the condition of completing the Ph III IMPACT trial, and expect potential stock price appreciation in the near term. This view is based on firm's recent interviews with an ex-FDA general counsel, a regulatory executive in a major pharmaceutical company and CBER panel members.
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.
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.
2 comments:
"lowered the bar"...Are you kidding?? Anyone even remotely familiar with the DNDN story knows that the FDA changed the question to MATCH EXACTLY what's in the FDA guidelines.
Are you short? LOL
Either way buy the stock and sell both the 15 calls and puts with 50% return if it ends over $15 or breakeven if it ends at $12 by May 15. or just pockt most of the premium as it errodes by May 11th
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