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 August 2004 (v04-n08) - Anniversary Issue
See the complete outline below.
 
This is a special issue of our newsletter. We provide detailed updates on all the companies currently in our coverage universe. Weighing in at 150 pages, this is by far the largest issue we have ever done. In this issue we examine all 21 companies in our coverage universe, ranking them from 1st to 21st according to their chances for success over the next 12-18 months. This is easily our most popular issue every year, often becoming a tattered "handbook" in the top desk drawer of professional and independent investors.

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If you are interested in one of the companies listed below you cannot miss this issue.

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In addition to updated milestone tables for all companies, we asked each management team the following four questions:
  1. You are in a room with your peers from the other companies in our Model Portfolio. The audience will invest in only one company. Give me two or three reasons why it should be your company.
  2. What is the most important strategic decision you’ve made in the last year?
  3. What news do you expect to release between August and the end of October?
  4. Does any member of the executive team currently have a hedge, collar, or similar position on your company's stock or stock options?
Introduction
About the format
Definition: Overnight lower risk boundary
Definition: Overnight upper risk boundary
Table: 2004 Anniversary Issue Rankings
Table: 2003 Anniversary Issue Ranking performance

 NOTE: Companies appear on this table of contents in alphabetical order. In the actual report, they are ranked from 1-21 according to their chance for success over the next 12-18 months.

 
Adolor (ADLR) -- 5 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (4 updates since 10/2003)
Disclosure
 
Niches to Riches
POI refresher
Table: Pivotal POI data
Other trials
 
Investment Case
Four Questions
 
Alteon (AMEX:ALT) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (7 updates since 10/2003)
Disclosure
 
What has gone before
Spectra
Table: SAPPHIRE vs. SPECTRA
Cuff versus ambulatory
Dose duration
Dose too high
Other medications
Run-in
Does this ensure success?
Timing
PEDESTAL
Johns Hopkins trial
Partnership
Cash crunch
 
Investment Case
Four Questions
 
Aphton (APHT) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (14 updates since 11/2003)
Disclosures
 
Quickie Insegia science lesson
Gastrin science
Ingenious Insegia
UK Monotherapy trial (PC-6)
PC-4 combo chemo trial
Immunotherapy and chemotherapy
Bottom line on PC-4
Responder analysis revisited
Impact on Insegia
Foreign approvals and marketing
Insegia's other indications
 
Investment Case
Four Questions
 
Cortex (AMEX:COR) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (1 updates since 10/2003)
Disclosures
 
Brief refresher
Neurotransmitters and their receptors
Ahead of the curve
Behind the 8-ball
Financing
Cross-national study of CX516 on MCI
CX717
The orphan path
Future drugs
 
Investment Case
Four Questions
 
Dendreon (DNDN) -- 9 pages
Table: Timelines
Table: Basic Facts
Table: Publication history (32 updates since 10/2003))
Disclosure
 
9902b timelines
Historical enrollment timelines
Historical analysis timelines
9902b enrollment timelines
9902b data timelines
Other Provenge data points
9901 final data report
P-11 data
P-16 data
9902a data
Partnership
Table: Projected Provenge deal value
Who will it be?
Partnership timeline
Provenge market
Gleason ≤ 7 population
Competition
Target Market
APC-8024
Phase II design
Other drugs
trp-p8
Antigen cassette products
Investment case
Four Questions
 
Discovery Labs (DSCO) -- 9 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (22 updates since 10/2003))
Disclosure
 
Strong news flow
The reasons for the low stock price
Investment case
Timelines
Product updates
Setting the stage
Framework for viewing pulmonary research
Nasal CPAP with aerosolized surfactant
Aerosolized surfactant (adult indications)
Table: Comparison of aerosolization vs. lavage/instillation
Aerosolized surfactant to treat acute lung injury
Aerosolized surfactant to treat asthma
New product mixes
ARDS and surfactant lavage
 
Four Questions
Forbes Medi-Tech (FMTI) -- 3 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (7 updates since 2/2004)
Disclosures
 
FM-VP4 next steps
Partnership
Reducol
 
Investment Case
Four Questions
 
Genta (GNTA) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (26 updates since 10/2003)
Disclosures
 
Melanoma
HIPPA dance
Statistical significance reached in survival
Timing for resubmission
CLL
Multiple myeloma
Table: Multiple myeloma treatment schedule
Other Genasense trials
Lung cancer
Acute Myeloid leukemia (AML)
Genta, the FDA, and the industry
Combination trial oddity
Ganite
Cash
 
Investment Case
Four Questions
 
ID Biomedical (IDBE) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (14 updates since 10/2003)
Disclosures
 
FluINsure
FluINsure difference
Development timelines
Second hemisphere, second season
FluINsure market
Partner
FluViral
StreptAvax
Dual-peptide strep/pneumo vaccine
 
Investment Case
Four Questions
 
Indevus (IDEV) -- 8 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (14 updates since 10/2003)
Disclosure
 
Sanctura
Partnership format
Sales strategy
Competitive profile
Sanctura XL
Competition
IP-751
Pagoclone
PRO-2000
Aminocandin
What have you done for me lately?
 
Investment Case
Four Questions
Introgen (INGN) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (12 updates since 10/2003)
Disclosure
 
Advexin regulatory strategy
Phase II strategy
Phase III strategy
Likelihood of success
Other Advexin programs
Surgical adjuvant
Mouthwash
INGN-241
 
Investment Case
Four Questions
 
Medarex (MEDX) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (10 updates since 10/2003)
Disclosures
 
Pivotal MDX-010 trial
Trial basics
Table: Pivotal trial arms
Chances for success
MDX-010 plus chemo
Other programs
MDX-060
MDX-070
MDX-1100
MDX-1185/1103
IPO Benefits
 
Investment Case
Four Questions
 
Nabi  (NABI) -- 5 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (7 updates since 10/2003)
Disclosures
Understanding Nabi
Table: Nabi products on the market
StaphVax
WinRho SDF
PhosLo
Keeping your eyes open
 
Four Questions
 
Onyx (ONXX) -- 7 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (11 updates since 10/2003)
Disclosures
 
Clinical pathway
RCC Phase II
Pivotal Phase III RCC
Other indications
Melanoma
CDK-4
Hypertension
Systolic hypertension
Adverse event grading criteria
FDA focus
RCC oral presentation
9006 in melanoma - The Royal Mardsen experience
9006 in melanoma Phase I/II
9006 hypertension abstract
 
Investment Case
Four Questions
 
Pharmos (PARS) -- 5 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (5 updates since 10/2003)
Disclosures
 
News flow at the ready
The recent financing
Update on the pivotal trial
Opportunity to buy
If TBI trial is successful
Other issues
 
Four Questions
 
SciClone (SCLN) -- 12 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (7 updates since 10/2003
 
Disclosures
The year in review
The new crew
What is the new SciClone?
Schering & Zadaxin
Product Updates
It's about inflammation again
Hepatitis C
Table: Key Zadaxin trials for Hepatitis C
Facts about HCV treatment
Table: Typical sustained viral response rates
What efficacy is needed in the pivotal trials?
Competitive landscape
Table: HCV drugs in American clinical development
IL-21 lurking as a competitor
Table: Zadaxin vs. IL-12
Cancer
Cancer immune deficiency
Treatment-related immunosuppression
How Zadaxin helps
Prior clinical research
Hepatocellular cancer trials
Melanoma cancer trial
Final items for the future
 
Investment Case
Four Questions
Seattle Genetics (SGEN) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (13 updates since 10/2003)
Disclosures
 
SGN-15
Next steps
Competitive marketplace
Partnership
SGN-30
Patent issues
SGN-40
Multiple myeloma
SGN-35
SGN-75
 
Investment Case
Four Questions
Sonus (SNUS) -- 7 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (13 updates since 10/2003)
Disclosures
 
Competition
Table: TOCp, Xyotax, Abraxane comparison chart
Development stage
Infusion time
Preparation time
Patient time in office
Volume
Manufacturing & cost
Comparative efficacy
Partnership
 
Investment Case
Four Questions
Targeted Genetics (TGEN) -- 4 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (8 updates since 10/2003)
Disclosures
 
Rheumatoid arthritis
Clinical trial timelines
Patent "dialogue"
Cystic fibrosis
Clinical trials
HIV/AIDS
 
Investment Case
Four Questions
 
Valentis (VLTS) -- 4 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (debuted July 2004)
Disclosure
 
Deltavasc basics
Initial disease target
Current therapies
Deltavasc science
Anticipation
Managing expectations
 
Investment Case
Four Questions
 
ZymoGenetics (ZGEN) -- 6 pages
 
Table: Timelines
Table: Basic Facts
Table: Publication history (6 updates since 10/2003)
rhThrombin (recombinant human thrombin)
rhF13 (recombinant human Factor XIII)
TACI-ig
IL-21
Strategic positioning
Current status
What others say
The future
 
Investment Case
Four Questions
 
Macro Market Commentary
Shifting sands don't obscure short-term risks
 
NIBM Model Portfolio Performance
 
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