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May 2004
(v04-n05) |
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- Main Story
- pgs. 15 Genta (GNTA)
- Macro Market Commentary
- pgs. 16-20
- Biotech Monthly Coverage Update
- pg. 21-29
- NIBM Model Portfolio
- pg. 30
- (Full outline below...)
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When we debuted the
NIBM Model Portfolio in August of 2001, Genta (GNTA) was one of the
original five members. Its debut amounted to a few paragraphs. Genta
received expanded treatment as the Main Story of the March 2002 NIBM
Newsletter. In the nearly three years of covering Genta, we have
published 42 NIBM Alerts on the company. We have written something about
Genta in almost every single one of the 32 NIBM Newsletters. |
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| Despite what is already
heavy coverage of Genta, we decided to add to it by focusing this Main
Story on the company. |
Subscriber direct access |
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| We wanted the
chance to revisit our coverage in light of the negative ODAC meeting
earlier this month. We also wanted to take an appropriate amount of
space to understand what Genta’s first experience in front of the FDA
with Genasense means for its presumed future experiences with the FDA. |
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| The following is an outline of this issue of
the NIBM Newsletter. |
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- Main Story - Genta (GNTA)
- Introduction
- Disclosures
- Investment Case
- Lawsuits
- Melanoma
coverage history
- Enrollment
size and pattern
- Table: Selected NIBM
commentary on melanoma enrollment
- Table: Genasense melanoma
trial enrollment estimate
- Table: Genasense melanoma
trial enrollment estimate update
- Accelerated versus Full
approval
- Updated survival information
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- Technical difficulties, please
stand by...
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Determination of response
- RECIST criteria
- Actions have consequences
- Table: Example of ORR protocol
error
- Disease scanning and
progression
- Sand in the Vaseline
- Bottom line?
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- Why
bother
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Rehabilitation of the melanoma NDA
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- The CLL
trial
- Enrollment
size and pattern
- Table: Genasense trial
enrollment estimates
- Accelerated approval
- Determination of response
- Disease scanning and
progression
- Bottom line
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- The
myeloma trial
Genta and Sanofi
- Bankruptcy
- Table: Genta cash burn comparison
- Macro Market Commentary - "Macro
market worsens"
Biotech Monthly Coverage Updates
- Indevus
- Table: Comparison of urge
incontinence drugs
- Label claims
- Checklist: Label claims
- Nabi
- Dendreon
- ID Biomedical
- Next-gen FluMist trials
- FluMist pricing
- Injected vaccine strain mis-match
- StreptAvax
- Seattle Genetics
- Discovery Labs
- SciClone
- Sonus
- Alteon
- ZymoGenetics
- Pharmos
- Table: Pharmos update
- Table: Upcoming milestones
- Introgen
- Aphton
- Medarex
- Forbes Medi-Tech
- Onyx Pharmaceuticals
NIBM Model Portfolio Performance |
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