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

To: nigel bates who wrote (19427)	3/23/2006 9:24:41 AM
From: tom pope	Respond to of 52153

I agree. I used to have a good deal of respect for Ende and now I can't for the life of me figure out why.

To: nigel bates who wrote (19427)	3/23/2006 9:24:59 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Here's JPM on the AC Gemzar decision: "• Comparisons Difficult Between Gem Study and ASSIST-3. There were many issues in the Gemzar ODAC review that, in our view don’t change the regulatory outlook for Telik’s ASSIST-3 trial such as: 1) std of care changed during the Gem/carbo trial and now favors carbo/paclitaxel over carbo alone as a result of ICON4. In contrast, Doxil (ASSIST-3 comparator) remains std of care in 2nd-line OC; 2) overall response rate (ORR) and PFS was not independently reviewed in the Gem trial (and downwardly revised by FDA) whereas clinical data from Telcyta trials is independently reviewed and welldocumented, according to investigators; 3) toxicities with Gem, but not Telcyta, appear additive to carbo; 4) ASSIST-3 is a US-only trial with input from FDA vs. the Gem/carbo trial that was conducted OUS where FDA was not consulted; 5) OC patients in the Gem/carbo study were platinum sensitive where it can be difficult to distinguish clinical benefit vs. ASSIST- 3 where OC patients were documented to be platinum refractory/resistant." "ASSIST-3 Could Form Basis of Approval, In our View. Overall, we believe that statistically significant improvements in ORR and PFS (and a trend in overall survival) in Telik’s ASSIST-3 trial on a stand alone basis could adequately serve as the basis of approval. As a reminder, ASSIST-3 uses 1:1 randomization in 244 2nd-line platinum refractory/resistant OC patients to Telcyta + carboplatin or Doxil where the primary endpoint is ORR with PFS and overall survival as secondary endpoints. Generally speaking, ODAC panels have consistently favored drugs with a compelling risk/benefit profile, well-documented and well-powered studies incorporating current standards of care and favorable safety profiles. From our interpretation of yesterday’s ODAC meeting, none of these issues favored Gemzar/carbo, however, from the ph II Telcyta/carbo study and under the current design of ASSIST-3, all of these issues may eventually favor Telcyta in ASSIST-3."