Biotech Values

[spartex]

Dew, any thoughts on what DNDN is doing as a strategy with their P-11 trial as it relates to FDA BLA filing and review for approval?

See this post by eagleeye (yahoo dndn MB); some interesting thoughts on what could possibly play out.

Thanks, Spartex


<<They're not submitting p-11 efficacy data unless the BLA is still in process while that data happens to mature.>>

It was curious to listen to yesterday's call. Gold said he expected a panel in early 2007 and approval in mid 2007. Why? DNDN knew its trial results in August 2005 or earlier. August 2005 until June/July 2007 makes no sense. DNDN is not taking 2 years from the date it has data to get Provenge approved. IMO, DNDN is purposefully waiting so that it can go for the whole enchilada early next year. And, DNDN will wait on p-11 efficacy before it goes to a panel -- guaranteed. Yesterday proved it. I never thought that until yesterday, but now I fully believe that. That is also why DNDN will not have any partner until after approval.

I think many wonder why PFE (or whoever) would wait to partner. They say why not do it now. Well yesterday gave us all the answer. The partner delay is not because of the partner, it is because of DNDN and the time value of money. If Provenge gets approved with a larger label (p-11), any partnership is instantly worth multiples more than on 9901 alone.

Another thought is that if DNDN includes p-11 efficacy data and that data is good, then IMPACT becomes utterly meaningless. I think the FDA could tell DNDN to scrap IMPACT if p-11 is good. That could be another reason why DNDN is submitting p-11 efficacy. Scrapping IMPACT would save DNDN a lot of money for sure.

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