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January 2004
(v04-n01) |
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- Main Story
- pgs. 1-18 ODAC panel sends strong signal to biotech investors
- Macro Market Commentary
- pgs. 19-21
- Biotech Monthly Coverage Update
- pg. 22-28
- NIBM Model Portfolio
- pg. 29
- (Full outline below...)
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On December 16, 2003,
the FDA conducted a meeting with the Oncologic Drugs Advisory Committee
(ODAC). The FDA requested ODAC address the idea of endpoints in cancer
clinical trials, including specifically endpoints in lung cancer trials.
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| About 100 pages into the
368-page transcript, it became apparent this meeting deserved serious
attention as the discussion not only affected several of the companies
in our coverage universe, but suggested some fairly dramatic changes are
in store for the way clinical trials are conducted and reviewed at the
FDA. |
Subscriber direct access |
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| The following is an outline of this issue of
the NIBM Newsletter. |
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- Main Story - ODAC panel sends strong
signal to biotech investors
- Introduction
- Disclosures
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Background
- Accelerated
versus regular approval
- Flood of new
treatment modalities
- Competitive approvals
- Why
surrogates matter
- Consistency, please
- Time to disease progression (TTP)
- Positive aspects
- Negative aspects
- Other TTP issues
- TTP conclusion
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- Progression-free survival (PFS)
- Survival
- Lung cancer discussion
- Sleuthing efficacy
- Objective responses
- Lung cancer and PFS
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- Company-specific implications
- Genta
- Full approval
- Accelerated approval
- Other issues
- Investment implications
- Dendreon
- Investment implications
- Medarex
- Investment implications
- Onyx
- Sonus
- Investment implications
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- Conclusions
- Macro Market Commentary - "Fed edit
shocks stock prices"
Biotech Monthly Coverage Updates
- Genta
- Dendreon
- Partnership
- Allos Therapeutics (ALTH)
- RSR-13
- Phase III trial
- The surprise filing
- Filing analysis
- Meaning for Dendreon
- Our handicap of the Allos
situation
- Targeted Genetics
- PAREXEL
- Seattle Genetics
- Discovery Labs
- Adolor
- Sonus
- Alteon
- Aphton
- Onyx
NIBM Model Portfolio Performance |
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