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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: A.J. Mullen who wrote (15221)	1/12/2005 12:04:30 AM
From: fred hayes	Read Replies (1) \| Respond to of 52153

>she was asking the most straight-forward questions and refusing to be fobbed off< Yup, that's the one...(:>) fred hayes

To: A.J. Mullen who wrote (15221)	1/12/2005 3:01:36 AM
From: zeta1961	Read Replies (1) \| Respond to of 52153

refusing to be fobbed off. Must be a British expression<g>..so wonderful to meet up with one of 'us'.. DNDN...oh God, what to say..several different Provenge trials that unless one has been following this company closely, can be hard to keep it all straight..I'll try.. Today's PR was about study 9902A, n=98, last patient enrolled mid2002(all gleason scores), 'trending' to fail stat. significance in overall ITT population for time to disease progression(TTP)across entire gleason scale, the primary endpoint, co-primary: time to pain onset(no data or trend available) ...secondary endpoint is overall survival(OS)...which is 'trending' similarly to 9901 study.. No Numbers were given to us today...Apparently, 9902A was designed to be a pooled study for the 9901 study that had failed stat. significance for TTP, but they found clear differences in the gleason less than 7(which did reach stat significance for TTP but gleason greater than 8 failing in TTP)..January '04, right before H$Q, they made an announcement that there was stat significance not only in TTP, but also time to pain(over 80 weeks and still counting)and overall survival in the gleason less than 7..Made it in the Wall Street Journal, lots of fanfare and financing done..Partner is a comin'... In the meantime, they'd begun 9902B, with an SPA for patients gleason less than 7 which is still enrolling..this is supposed to be the pivotal trial..enrollment to be completed by 2H'05..primary endpoints: TTP, time to pain onset. Secondary, Overall survival.. In October '04 we heard again about 9901 from DNDN stating that the pre-specified 3 year since last patient enrolled survival data 'look' was 'statistically significant for survival across all gleason scores and better survival than any other heretofore published P3 ..(last reference is Taxotere providing a 2.5 month survival advantage in hormone refractory, asymptomatic prostate cancer at ASCO '04(the subject of study in all above studies).."we can't reveal #'s, but will be presenting at 'a scientific conference in '05. At this time, partnering came up again..they wanted the US and share exUS and with much confidence stated:"we'll decide who deserves to partner with us, who brings the most to DNDN for this paradigm shifting treatment." There is also a P11(eleven) Provenge study..a Phase 3, placebo controlled for post-prostectomy patients with increasing PSA's..primary endpoint PSA doubling time.. P16 study: Provenge+Avastin...primary endpoint: PSA doubling time...Data to be released ASCO-Prostate cancer conference in Feb '05 where the 9901 final survival data will be discussed(new news from today) So, big concern..why are the less than 7 gleason patients not showing good TTP as they did in the 9901 trial because the pivotal 9902B is hinged on success in this population..The hope has been that they could use TTP as surrogate for survival, get Provenge to market sooner than having to wait for survival data.. Can one make generalized opinion based on these 98 patients re: how the pivotal will do re:TTP?...the final TTP data for 9902A will not be available 'til summer '05...brings up possibility that 9901B will have to wait for survival data, ability to enroll patients is also in question given today's release(per management today when asked about enrollment)... This basically is the synopsis of what was discussed today during the presentation and the Q&A except for brief overview of their pipeline.. I personally took them to task..I've owned this company in the past, been following them for almost 3 years now..since the October survival data release without #'s..and "we'll partner with who deserves to partner with us."..hearing that manufacturing is not completely taken care of..I've been angry with their imo, overly confident attitude and use of PR's for attention without hard #'s for the investor to make an informed judgement..and we got more of the same today..and I told them this in these blunt terms..I took advantage of the fact that: I am not an analyst that they wine and dine, not a VC, nor have a boss to be afraid of!...a scientist also asked for more #'s and expressed frustration...They were polite, honest about not knowing yet what to make of this data since they'd just received it and spent last night writing up the PR...Analysts did not ask about partnering.. They did remain optimistic about Provenge's ultimate success.. It was standing room only, people sitting on the floor at both the presentation and Q&A..disappointment was palpable not only with mgt but analysts in the room.. I imagine it will take a few days to find out if they'll get downgrades for potential 1-1.5 year delay to filing if pivotal fails TTP and they have to wait for survival data and how much the 9902A results mean to Provenge... I hope this helps!..Personally, I'm not even going to trade this one on the downdraft..if mgt was not so busy being unrealistically confident on their road shows, less glitzy and chummy with the analyst world..I'd think differently.... But who knows..next month the final 9901 survival data may change sentiments.. Headed to sleep!..If this is not coherent..please forgive me and I'll try to answer Q's tomorrow..but i wanted to get this out tonight.!..Ashley, Marc please add or modify as you see fit! Elisabeth