Research Links 9.26.09

This post on IV will lead off my research blog from now on. Thank you OnegoalX10:

http://tinyurl.com/c9hzon

DNDN website
http://www.dendreon.com

DNDN webcasts
http://investor.dendreon.com/events.com

Slideshow from Analyst Day presention 9/24/09

http://tinyurl.com/y9mvlko

Steveporsche adds color to the cancer drug ramp up slide

http://tinyurl.com/y9dtj3m

Merriman post Analyst note: $49-50 target

http://tinyurl.com/yd9wpa6

Herper/Forbes on the Analyst Day

http://tinyurl.com/ybgw42u

Ocyan on Rest of World (ROW) partnering

http://tinyurl.com/ybog4zm

Yanquitrader looks at valuation

http://tinyurl.com/ychocyt

Pre-Analyst Day analysis of company situation by Fordwill:

http://tinyurl.com/ydblfnc

New Guidance from FDA on immunotherapy

http://tinyurl.com/nc8ntg

The Street and Deutsche Bank’s take on the new FDA guidance and DNDN

http://tinyurl.com/l794f7

Ocyan’s take on the Morgan Stanley presentation on 9/14, especially on timelines

http://tinyurl.com/mfyw9g

Rufus’s post for those who want further links and reading to see why Provenge isn’t just a blockbuster drug, it’s proof that the way DNDN engineers it’s drug works, and late stage PC is just the beginning:

http://tinyurl.com/md6t8h

Canaccord Adams 29th Annual Global Growth conference notes

http://tinyurl.com/qs34as

2009 Q2 Earning call notes including manufacturing capacity expansion:

http://tinyurl.com/p424jd

2009 Q2 Earnings Call Notes:

Casey’s takeaways:

http://tinyurl.com/qbhyby

Merriman’s notes:

http://tinyurl.com/o5kg5t

Duetsch Bank’s notes:

http://tinyurl.com/p4xadf

Ocyan’s notes

http://tinyurl.com/qpk27j

Research notes from Citi:

http://tinyurl.com/op6yte

Xconomy’s Timmerman’s interview with founder Henney:

Pt 1: http://tinyurl.com/lzxtfz

Pt 2: http://tinyurl.com/ktok5j

Casey’s 7-14 conversation with DNDN CFO Greg Schiffman

Pt 1: http://tinyurl.com/mhzxoo

Pt.2: http://tinyurl.com/lfugwn

Mark Mitchell’s 15 part expose’ on the Provenge delay and Wall Street Corruption:

http://tinyurl.com/kwq7en

7-14 Rodman Renshaw brief

http://tinyurl.com/n8un5g

Annual Shareholder Pre-Meeting Reception Notes, courtesy Swells:

http://tinyurl.com/nq5f8d

Response from Dr. Gold to the “there is no pipeline” comments from the above post…courtesy Saul K.

http://tinyurl.com/m8wjre

ASM Meeting Notes:

From Xconomy/Luke Timmerman:

http://tinyurl.com/l7ne8p

Ocyan summarizes the milestone events for DNDN over the past 5 years
http://tinyurl.com/mr97dc

Widely distributed AP article about the breakout of immunotherapy

http://tinyurl.com/kqjlac

Nature April 09 on Provenge, courtesy Rufus:

http://tinyurl.com/ncc3dd

Rufus’s Provenge Owner’s Manual

http://tinyurl.com/m4dqya

Provenge Video

http://tinyurl.com/l7jxsy

Article on Dr. Gold from 2004 by Timmerman

http://tinyurl.com/ovfz62

Rufus on why Provenge works when others have failed

http://tinyurl.com/qcel5z

Elizabeth Stanton at Bloomberg digs into “the plunge” (the drop from $24 to $7 in 70 seconds before the halt on 4/28)

http://tinyurl.com/dxllnp

David Miller with a great article about the IMPACT data and a stunning side effect chart, Taxotere vs. Provenge

http://tinyurl.com/cukbr3

Michael Murphy’s take on 4/28

http://tinyurl.com/czehxa

Xconomy (Timmerman)…no devil in the details on IMPACT results

http://tinyurl.com/dgn7rh

David Miller on the AUA/IMPACT results

http://tinyurl.com/d6of4t

A view from a urologist on the AUA results:

http://tinyurl.com/dhp9yq

Ocyan take on the IMPACT results on 4/28 PR

http://tinyurl.com/dzqufl

And then summarized the AUA slides

http://tinyurl.com/che5fs

Please visit CareToLive, a website dedicated to getting late stage PCa patients the options they deserve, to see their latest on the announced successful Phase III FINAL study known as IMPACT:

http://caretolive.com/

Rufustoe’s interview with top immunologist Dr. Hy Levinsky, a member of the 2007

Pt. 1

http://tinyurl.com/dclbkm

Pt. 2

http://tinyurl.com/cpe8y7

Pt. 3

http://tinyurl.com/cdt3dt

Pt. 4

http://tinyurl.com/cue9ao

Rufus’s takeaways:

http://tinyurl.com/c7qvmy

PR release on P-11 trial for earlier stage PC:

http://tinyurl.com/c8lzw8

PR release on Trp-p8, it’s first small molecule drug candidate targeted for multiple cancer indications:

http://tinyurl.com/dyyp6l

Dew, Clark, and David Miller on IHub discussing off-label use of Provenge:

http://tinyurl.com/d55kk4

Ocyan breaks down p values correlated to survival ratios:

http://tinyurl.com/dbyco6

Walldiver rips the “Provenge is a cumbersome treatment” argument a new one on Seeking Alpha:

http://tinyurl.com/cql837

David Miller, Revenge of Provenge, Minyanville: “I've spent a great deal of time talking to urologists, urological oncologists and patients about this drug. Urologists and patients will readily adopt this drug.”
http://tinyurl.com/c3eted

Very solid article on the Provenge story by Andrew Pollack, NY Times
http://tinyurl.com/c6chw6

Provenge trial data: pre-IMPACT
http://tinyurl.com/3kuve3

The Basic Data (pull down for chart of 9901, 9902a, and pooled data)
http://tinyurl.com/bf4r6...

BIO CEO IMPACT transcript

http://tinyurl.com/d7v4un

David Miller on IHub on potential post-approval adoption

http://tinyurl.com/chjspj

Luke Timmerman on Trp-p8 (D-3263)
http://tinyurl.com/5ta2u7

Neuvenge PR Nov 08
http://tinyurl.com/5pepjb

Oct 6 Interim CC Transcript

http://www.biotechspeculators.com/archives/235

May 2008 Washington CEO article on Dendreon
http://tinyurl.com/5mufhv

Rufus with Schlom’s vaccine + docetaxel study review:
http://tinyurl.com/4c3k6s

CD54/Provenge and survival (ASCO)
http://tinyurl.com/6nz5e8

Preliminary P-11 (earlier stage PC) results:
http://www.medicalnewstoday.com/articles/56248.php

Tooskookum's famous "Provenge will be to prostate cancer what aspirin is to cardiology" post
http://tinyurl.com/6er6yk

Post CR Letter CC transcript, 5 10 07
http://tinyurl.com/6syqea

Briefing docs for March 29 Advisory panel:
http://tinyurl.com/29t5xn
For KM survival curves, go to Clinical Briefing Document and pull down to p. 25 and 35

Dendreon FDA Advisory Committee Transcript
http://www.fda.gov/ohrms/dockets/ac/cber07.htm#CellularTissueGeneTherapies

Dr. Scher’s letter that was posted in The Cancer Letter before the FDA delayed Provenge approval, mixed in with rebuttals from Walldiver (w/help from IV board members):

http://tinyurl.com/d2xmmy

And from BSR’s David Miller:

http://tinyurl.com/arvro5

Politics and the Provenge: A Disheartening, Infuriating, Sickening Summary

The fight to bring the following events to light have been led by many heroes. Three that stand out are Ted (Investor Village nicknamed Warlord2010), Kerry, who has dedicated countless hours to litigating the issue (IV nickname KDDublin) and Greg (IV deep_daddyo).

On May 9, 2007 the FDA sent Dendreon a Complete Response Letter (aka denied approval) indicating that despite a 17-0 vote on safety and 13-4 vote in favor of drug efficacy, Dendreon needed to submit additional data to be granted drug approval. The FDA had never before overruled an advisory committee for a life saving drug.

The official reason given by the FDA for this delay is that “questions about the drug were raised at the Advisory Committee meeting.” Of course, the committee meeting is based on raising and addressing questions. There is a mounting body of evidence that there were other motives for the delay. There is reason to believe that there was a power struggle within the FDA about which committee controls cancer drug approvals, there seem to be a group that was interested in continuing the hegemonic role of chemotherapy in cancer treatment, there were specific financial interests of two key dissenting members on the committee, and the National Cancer Institute appears to have had an interest in keeping Provenge off the market in order to protect their prostate cancer drug programs.

There were signs that the delay would occur…especially three letters that were leaked to the public by a widely read newsletter entitled The Cancer Letter during the period between the Advisory Committee meeting on March 29, 2007, and the May 9, 2007, letter delaying the drug. These letters were written by two dissenting members on efficacy from the committee, Dr’s Howard Scher and Maha Hussain, and statistician Thomas Fleming.

The letters, especially Dr. Scher’s, were deeply flawed. David Miller from Biotech Sto