Research
http://youtube.com/watch?v=6Q0uQAL_YDA Video of Care To Live member Ted Girgus taken at our nationwide protest in Seattle. Ted has stage IV prostate cancer, that has metastacized to his bones. Ted and his doctor, want him on Provenge NOW!
Provenge Information Sheet (2 page) handout-kw.pdf
Fact Sheet (1 page) handout-1-page-fact-list.pdf
Memorable Quotes (1 page) memorable-quotes.pdf
Phyiscians For Provenge Letter physicians_for_provenge.pdf
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Flowchart showing The FDA Decision on Provenge: Who’s Who and Who’s Connected
Who the players are click to download and read players_provenge_v3.pdf
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Froggmisters research blog
http://www1.investorvillage.com/smbd.asp?mb=971&mn=198604&pt=msg&mid=4846818
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Congress Turns It’s Back on the 27,000 American Men who will Die from Stage IV Prostate Cancer Each Year.
Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings. 2/13/08
micha001.pdf
Three Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.
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FDA’s Reply to CareToLive’s Petition for the FDA To Reconsider the Provenge delay 1/17/08 (click this link) We are officially in FDA Petition Limbo
Summary: In your citizen petition you request the Commissioner of Food and Drugs to reconsider FDA’s failure to grant a biologics license application for Provenge…We are still considering your request and supporting information stated in your citizen petition….we will respond to your petition as soon as we have reached a decision on your request.
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13 pages of Freedom of Information (FOIA) documents received from Commissioner Von Eschenbachs office concerning the Provenge Debacle 3/5/2008.
foi-docs-recvd-3-4-08.pdf
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FOIA FREEDOM OF INFORMATION DOCUMENTS RECEIVED FROM FDA, NCI, HHS CONCERNING PROVENGE
FOIA denial that Andrew Von Eschenbach received any documents concerning the “leaked” letters despite the fact that Dr. Scher & Dr. Maha Hussain CC’ed Von E their letters prior to “leaking” them. 1/30/08 (click this link)
This includes a charge to CTL for $404.75 for finding NOTHING despite proof below (see FOIA 3 “Leaked” Letters and So Much More) whereby on page 23 Dr. Howard I. Scher CC’ed Dr. Von Eschenbach in an email, on page 24 is Dr. Scher’s hard copy of his “leaked” letter which is addressed to, and only to, Dr. Von Eschenbach, including a hand written ANDREW right on it where is says Dear Dr. Von Eschenbach. On page 16 Jesse Goodman forwarded Dr. Maha Hussain’s email to Joanne Binkley. Maha’s email was sent to Von Eschenbach, Witten, Woodcock, Goodman and Pazdur, with Von E listed first.
CareToLive Receives FOIA 3 “Leaked” Letters and So Much More…11/6/2007 (click this link)
Dr. Howard Scher’s Final Version “Leaked” Letter to The Cancer Letter (click this link)
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David Miller of Biotech Research Rebuttal to Dr. Howard Scher’s “Leaked” Cancer Letter (click this link)
Walldiver & Company’s Rebuttal To Scher’s “Leaked” Cancer Letter (click this link)
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Pazdur is consistently inconsistent on approving drugs. Why didn’t he he apply these words to Dendreon and push for its approval?
“Survival is the gold standard of endpoints because it is the most meaningful to all people,” cautioned Dr. Pazdur, who is the Director of Oncology Drug Products at the FDA’s Center for Drug Evaluation and Treatment. He explained that there can be no misinterpretation where it concerns survival–the patient is either dead or alive. “Whereas, the other endpoints, such as tumor response rate, are usually determined by x-rays or scans,” he continued. “There can be variations in the radiologists, the techniques of how the x-rays or scans are obtained, which can make it confusing and unreliable. Also, there is a subjective judgment in reading these x-rays and scans.”
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2/26/07 Dr. Scher, speaks at a symposium sponsored by Novacea. He suggests that when doctors consider whether to prescribe certain treatments, “it may be time we focus less on statistical significance alone, and more on patient benefit.” What hypocrisy he displays when it comes to Provenge, a treatment he stands to lose financially if approved.
5/11/07 Dr. Scher spoke to Marilyn Chase of the Wall Street Journal. “I try to keep to the high ground,” Scher said, adding that he doesn’t work with any companies in direct competition with Dendreon. (At the time of this statement Scher did not disclose that he was the lead chair conducting the Novacea Asentar trials, a direct competitor to Provenge. The Asentar trials were subsequently suspended due to high mortatlity rates, but not before they reaped windfall profits due to a partnership which likely would not have occurred if Provenge were approved.
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Was this part of the reason why Howard Scher from Memorial Sloan Kettering was handpicked by Pazdur at the last minute to be on the Panel to derail Provenge and leak letters? Scher also had many undisclosed conflicts of interest.
Innocent Casualties, The FDA’s War Against Humanity
by Elaine Feuer — published 1996
The reality is that the pharmaceutical companies make millions of dollars on chemotherapy drugs, and board members of cancer establishments such as the Memorial Sloan-Kettering Cancer Center (MSKCC) are also the board members of the most profitable drug companies. Sloan Kettering’s Chairman of the Board of Overseers and Managers, James Robinson III, is also director of Bristol Myers Squibb, the world’s largest maufacturer of chemotherapy drugs. MSKCC’s President and CEO, Paul Marks, MD, is a director of Pfizer Pharmaceuticals. MSKCC’s Vice Chariman, Richard Gelb, is the Bristol Myers chairman of the Board. Another MSKCC board member, Richard Furlaud used to be president of Bristol Myers.
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Maha Hussain and Survival Endpoint - Consistently inconsistent to her Provenge rant 1/2008 (click this link)
ODAC chair Maha Hussain, MD, wondered if FDA could devise an approval route somewhere between overall survival and PFS. “I respect my colleagues’ opinions about progression-free survival,” said Dr. Hussain, a prostate cancer specialist at the University of Michigan Medical School. “I also come from a field with one or two examples where early positive indications did not translate into a survival advantage.” Indeed, treatment with the drugs resulted in worse survival, she noted. “Therefore, if you ignore survival and just go by progression-free survival, you could actually put harmful drugs on the market.”
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Just last year the FDA approved Gemzar for ovarian cancer despite said drug offering NO survival benefit. An AC voted 9-2 “against approval” in March yet the FDA approved this dubious product made by Eli Lilly in July. This is just one of many questionable products the FDA has aproved over the years. Provenge had FAR more business on the market place then many if not all of these drugs.”
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Dr. Scher’s Conflict of Interest Waiver To Sit on the Provenge Advisory Committee
Dr. Scher’s Conflicts he Failed to Disclose in his Waiver
Dr. Hussain’s Conflict of Interest Waiver
Dr. Hussain’s Sprycel COI Waiver
Dr. Hussain’s Timeline Updated
Bruce Holmes’ Letter to the University of Michigan Complaining about Maha Hussain 7/19/07
Dendreon vs. Novacea Race Toward Approval
Total grants to Howard Scher’s Memorial Sloan Kettering and Dr. von Eschenbach’s
Dr. von Eschenbach is credited with lobbying for the establishment of Department of Defense Congressionally Directed Medical Research Programs PCRP (DOD CDMRP PCRP. Dr. von Eschenbach’s own FDA biography lists him as a as founding director of the Prostate Cancer Research Program http://www.fda.gov/oc/voneschenbach/bio.html
The majority of PCRP consortium doctors who sit in review of PCRP grant applications are consortium doctors to PCF. Notably, Dr. Howard Scher and Dr. Maha Hussain… and many of the same doctors sit on the scientific advisory board of Proquest Investments. .NPCC, which was established and chaired by Michael Milken, lobbies for PCRP appropriations.
NPCC also helped to establish new National Cancer Institute sponsored Specialized Programs of Research Excellence (SPOREs) for prostate cancer. NCI’s SPORE program is the largest source of prostate cancer research funding. Second is DOD CDMRP PCRP and third is the Prostate Cancer Foundation.
C-Change, which was founded by Dr. von Eschenbach, is in partnership with the Prostate Cancer Foundation. Dr. von Eschenbach, the Commisioner of the FDA, is credited with bringing the Bush family into “C-Change”, a non-profit group headed by George and Barbara Bush (also known as National Dialogue on Cancer). Dr. von Eschenbach remains Vice Chairman of the Board to C-Change despite his appointment to the FDA.
When Dr. von Eschenbach was named NCI Director, HHS officials granted Dr. von Eschenbach a waiver to continue to function as a C-Change fiduciary and Vice Chairman of the Board. When President George Bush nominated Andrew von Eschenbach to acting FDA Commissioner, he allowed Dr. von Eschenbach to continue as NCI director. Serving a dual role with NCI and the FDA was particularly shocking to many.
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PROQUEST INVESTMENTS
Proquest Investments Scientific Advisory Board as of 12/07
I am told they took down this page but you can find the old page here
6 out of 7 Proquest Scientific Advisors have strong ties to the PCF
Dr. Howard I. Scher is a Prostate Cancer Foundation consortium member
Dr. Stuart Holden is Medical Director to the Prostate Cancer Foundation
Dr. Howard Soule is an Executive Vice President to the Prostate Cancer Foundation
Dr. Jonathan Simons is the President of the Prostate Cancer Foundation
Dr. Bill Nelson is a Prostate Cancer Foundation consortium member
Dr. David Argus is a Prostate Cancer Foundation consortium member
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Dr. Maha Hussain is also a Prostate Cancer Foundation consortium member
James Blair of Domain Associates is a Board of Director of both Novacea and the Prostate Cancer Foundation
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James Blair of Domain Associates is on the Board of Directors to the Prostate Cancer Foundation. Blair and Moorin (formerly of Magainin of frogskin oil fame, now Genaera), both have offices in Princeton, both were members of the Board of Directors of Novacea until they hastily resigned shortly after it came to light about the Proquest/Novacea/Scher connections, just prior to Novacea’s shutting down of the Asentar trials for late stage prostate cancer over too high a death rate on Nov. 5, 2007. Scher had led the trials. Blair & Domain Associates sponsors and introduces ProQuest Investments to deals. See the link below for more on Scher and Novacea.
Novacea 6/8/2007
Jay Moorin has served as a member of our board of directors since June 2001. Mr. Moorin is a partner of ProQuest Investments, a healthcare-focused venture capital firm. Previously, Mr. Moorin served as Chief Executive Officer of Magainin Pharmaceuticals, Inc. (now Genaera Corporation). Before working at Magainin, he worked at Bear, Stearns & Co. Inc. as a Managing Director of Healthcare investment banking. Prior to working at Bear Stearns, he held a variety of positions in marketing, strategy and general management at E.R. Squibb and Sons Pharmaceuticals, Inc. (now Bristol-Myers Squibb Company), eventually serving as Vice President of Marketing and Business Development in the SquibbMark Division. In 1996, Mr. Moorin was appointed to the position of Adjunct Senior Fellow of the Leonard Davis Institute of Health Economics of the University of Pennsylvania. Mr. Moorin holds a B.A. with distinction in economics from the University of Michigan.
James C. Blair, Ph.D. has served as a member of our board of directors since March 2001. Since 1985, Dr. Blair has served as a partner of Domain Associates, L.L.C., a venture capital management company focused on life sciences. Present board memberships include Cadence Pharmaceuticals, NuVasive, Inc., Pharmion Corporation, Volcano Corporation, and seven private companies. Dr. Blair has over thirty-five years of experience with venture and emerging growth companies. In the course of this experience, he has been involved in the creation and development of over forty life sciences ventures, including Amgen, Inc., Aurora Biosciences Corporation, Amylin Pharmaceuticals, Inc., Applied Biosystems, Inc., Dura Pharmaceuticals (acquired by Elan), GeneOhm Sciences, Inc. (acquired by Becton, Dickinson and Company) and Molecular Dynamics (acquired by Amersham Pharmacia Biotech Inc.). Dr. Blair currently serves on the board of directors of the Prostate Cancer Foundation, and is on the Advisory Boards of the Department of Biomedical Engineering at the University of Pennsylvania. Dr. Blair holds a B.S.E. from Princeton University and an M.S.E and Ph.D. from the University of Pennsylvania.
Proquest News Release Link
Nov-01-1998 Start-Up 1 The Opportunity in Cancer: Goldberg’s Variation Prostate cancer will be the focus of ProQuest Investments LP, a new venture fund founded by Jeremy Goldberg. With investors the Ann and Robert H. Lurie Foundation of Chicago, Alza Corp., and high net worth individuals, including Michael Milken, ProQuest has raised $40.5 million in its first closing.
May-01-2000 Start-Up Proquest Investments LP Proquest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin. The firm aims to leverage its specialization and focus to create a brand that will make it the preferred VC firm for Internet, device, biotech and pharmaceutical companies with products that advance the treatment and cure of cancer, its founders hope.
PROQUEST SCIENTIFIC ADVISORY BOARD
Stuart Holden, M.D. — Chairman
Diplomate American Board of Urology
Warschaw, Robertson, Law Families
Chair in Prostate Cancer
Director Cedars-Sinai Prostate Cancer Center
Howard I. Scher, M.D.
Chief, Genitourinary Oncology Service
Memorial Sloan Kettering Cancer Center
Jonathan W. Simons, M.D.
Director, Winship Cancer Institute
Professor of Hematology/Oncology
Emory University, School of Medicine
David B. Agus, M.D.
Research Director, Prostate Cancer Institute
Cedars-Sinai Medical Center
William G. Nelson, M.D., Ph.D.
Associate Professor of Oncology, Urology, Pharmacology, Medicine and Pathology
Director, Molecular Pharmacology Program
Co-Director, Division of Experimental Therapeutics The Johns Hopkins University, School of Medicine
Howard R. Soule, Ph.D.
Executive Vice President and Chief Science Officer Prostate Cancer Foundation
note: in 2003/2004 was Cap CURE
Web Archive of Proquest Investments Advisory Board Links
PROSTATE CANCER FOUNDATION
View Michael Milken’s Prostate Cancer Foundation’s Board of Directors
View Michael Milken’s Prostate Cancer Foundation’s Leadership Team
The PCF was originally called Cap CURE. It was founded in 1993 it changed its name in 2004.
STUART HOLDEN, MD Medical Director
A urological oncologist practicing at Cedars-Sinai Medical Center in Los Angeles, Dr. Holden has been actively engaged in the field of cancer research and treatment for more than 25 years. Dr. Holden directs the medical and scientific strategy of the Prostate Cancer Foundation, overseeing its grant award programs, consortia activities and scientific meetings. Dr. Holden has held staff positions at Memorial Sloan-Kettering Cancer Center in New York and Georgetown’s Lombardi Cancer Center in Washington, D.C.
HOWARD I. SCHER., MD — Prostate Cancer Foundation Consortium Member
2002 CaP CURE scientific advisory board members Howard Scher, MD. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1531711
2003
CaP CURE has sponsored a significant effort, through the leadership of Howard Scher, MD, to create and standardize clinical trial design scenarios in the clinical state of rising prostate-specific antigens
JONATHAN W. SIMONS, MD — President and Chief Executive Officer
David H. Koch Chair
Jonathan W. Simons, MD, is an internationally recognized physician-scientist, oncologist and acclaimed investigator in translational prostate cancer research. Prior to joining the Prostate Cancer Foundation in 2007, he was Distinguished Service Professor of Hematology and Oncology at the Emory University School of Medicine and Professor of Biomedical Engineering and Materials Sciences at the Georgia Institute of Technology. Dr. Simons is the Founding Director of the Winship Cancer Institute at Emory University in Atlanta and Co-Director of the National Cancer Institute Center for Cancer Nanotechnology Excellence at Emory and Georgia Tech.
HOWARD R. SOULE, PhD — Executive Vice President, Discovery and Translation
Howard R. Soule, PhD, coordinates global academic, government and biopharmaceutical sector research activity and is responsible for the implementation of Prostate Cancer Foundation global research strategies. From 1997 to 2004, he was Executive Vice President and Chief Science Officer of the PCF. Most recently, he was Managing Director of Knowledge Universe Health and Wellness Group, a private investment firm focused on companies in the general areas of disease prevention and treatment. Prior to joining the PCF in 1997, Dr. Soule was a senior R&D executive for nine years at Corvas International, Inc., a public biotechnology company. He was responsible for the discovery and development of innovative products for the treatment of life-threatening cardiovascular diseases. Dr. Soule has considerable experience in medical diagnostic and device industries as well.
MIKE MILKEN Founder and Chairman
Mike Milken established the Prostate Cancer Foundation in 1993 as a continuation of his medical-research initiatives that started in the 1970s. In 1982, he formalized his philanthropic activities by co-founding the Milken Family Foundation, which has been one of America’s leading supporters of cancer research, prevention and treatment. He also serves as Chairman of the Milken Institute, a nonprofit economic think tank, and its Washington, D.C.-based FasterCures - The Center for Accelerating Medical Solutions.
2001 Michael Milken becomes the third chairman of NPCC. NPCC adoptsa public policy platform calling onCongress to pass a cancer savings bond bill and a Patients’ Bill of Rights; create a Medicare oral anticancer drug provision; and establish a centralized oncology division at the FDA. NPCC begins managing the Drive Against Prostate Cancer throughthe sponsorship of Thor Industries,the nation’s largest manufacturer of recreational vehicles. NPCC hosts regional advocacy training meetings in Los Angeles and Philadelphia. NPCC is named one of America’s “100 Best Charities” by Worth Magazine.
Cap CURE web archives (click this link)
Here we have the 2006 Prostate Cancer Foundation Annual Report with photos of none other than Dr. Hussain, Dr. Scher (2 of the letter “leakers”) and Dr. Eric Small also a PCF consortium member (we were wondering what happened to him) on page 36. David B. Agus, MD, William G. Nelson, MD, PhD Their pictures also appear in the 2006 and the 2007 PCF Annual Report.
page 36 Scher, Hussain, Nelson, Agus, Small, 37 Blair, Holden
2005pcfannualreport.pdf
It is also quite disturbing that the CEGE Founding CEO is a Limited Partner in the Proquest Companion Fund, L.P. So not only is Proquest Investments a major shareholder in Novacea, a direct competitor to Dendreon, but the founding Chief Executive Officer of Cell Genesys, Mark Levin, is a Limited Partner in Proquest Companion Fund, L.P. just like Howard Scher.
Furthermore, Dr. Jonathan Simons, a Scientific Advisor to ProQuest Investments and the President of Prostate Cancer Foundation, has developed a prostate cancer vaccine composed of prostate cancer cell lines transduced to express immune-stimulating cytokines. This vaccine is under development by Cell Genesys for the treatment of advanced prostate cancer.
So while many of us thought Scher was protecting the advancement of Asentar, it now seems he was also protecting the advancement of GVAX.
That is why this statement of his at the Advisory Panel hearing is so telling:
Page 322
“So I say well, what if we think that this (Provenge) really should be available, start thinking about the number of agents (Asentar and GVAX) that are currently under development.”
Then he followed that up with his letter to the FDA and Dr. Thomas Fleming reiterated his main point:
“Reportedly, Scher felt motivated to write the letter after being kept awake the night following the March 29, 2007, FDA Cellular, Tissue and Gene Therapies Advisory Committee by the thought that if Sipuluecel-T were approved, patients may well forego more effective treatment alternatives.” What alternatives? Asentar? GVAX?
That is why we would like the lips of Scher and Fleming to tell us what treatments in development they were specifically worried about. Would they say Asentar? Would they say GVAX? And are they saying there cannot be more than one treatment on the market at the same time? Which one does Richard Pazdur favor? And why? These are the kind of questions we would like real journalists to ask. Not some non-factual line that liar Jonathan Aschoff runs out there so media outlets like the AP can run with it. Jonathan Aschoff of Brean Murray said he thinks the trial will fail - why? Tell us why, Jonnyboy! It’s like me telling my boss I think I deserve a raise. My boss isn’t just going to give me one because I think I deserve it. He will ask why! If I was a reporter, I would have asked Aschoff why! Call his bluff reporters!
So I looked around some more. Millennium Pharmaceuticals is definitely an interesting place connecting Scher and Levin.
Howard I Scher, MD: D Wayne Calloway Chair in Urologic Oncology; Chief, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, New York. Grants/Research
Support: Millennium Pharmaceuticals Inc, Sanofi-Aventis; Consulting Fees: Abbott Laboratories.
http://www.patternsofcare.com/pdf/poc042005.pdf
Mark J Levin Director at Millennium Pharmaceuticals, Inc. Cambridge, Massachusetts
PSA Rising, February 22, 2005. Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced results from a phase I clinical trial of MLN2704 in patients with advanced hormone-refractory
prostate cancer.
A single ascending dose phase I study of MLN2704, led by Howard I. Scher, M.D. at Memorial Sloan-Kettering, New York and Mario Eisenberger, M.D. at Johns Hopkins Oncology Center, Maryland enrolled 23 patients and examined the maximum tolerated dose, dose-limiting toxicity, pharmacokinetics and immunogenicity of MLN2704.
http://www.psa-rising.com/med/chemo/millennium05.html
And then there is this article. It was received on April 5th, about the time Scher was busy working with the others editing his letter. But it was not published online until October and then published in hard copy in December. Look who is supporting this! It is the Who’s-Who of who hates Provenge!
Supported by Millennium Pharmaceuticals, National Cancer Institute Grants CA102544 and CA05826, Prostate Cancer Foundation, the Sacerdote Fund and the PepsiCo Foundation for Prostate Cancer.
http://www.jurology.com/article/PIIS0022534707019866/abstract
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Provenge’s FDA Biologic’s License Application Advisory Committee Transcript March 29, 2007 - click here to view pdf
On Safety - Voted 17-0 Safe including Dr. Scher, although Scher stated in his “leaked” letter that it had safety issues.
DAPOLITO: OK, for the record, the vote was 17 yes, zero no, zero abstain for Question 1.
MULE: OK, we’ll move on to Question 2. Again, I’ll read it. Does the submitted data establish the efficacy of sipuleucel-T in the intended population?
2 of Provenge’s conflicted naysayers had trouble answering the corrected efficacy question which had been bastardized, even after it was changed back to the FDA regulatory standard.
WITTEN: Yes. The regulatory definition is “provide substantial evidence.” So that’s our standard. Is there substantial evidence that it works? Is there substantial evidence of efficacy, if that helps. So, is there substantial evidence?
MULE: OK. So just to clarify what you’re asking, is there substantial evidence that the product is efficacious?
WITTEN: Yes.
MULE: OK. OK. So for the sake of time, I’d like to finish this voting.
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Scher, Hussain, Woo all signed waivers and voted no.
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Chappell - voted no to the original question and Mule never corrected him like he did with Scher and Hussain
page 382
DR. MULÉ: Dr. Chappell?
15 DR. CHAPPELL: No. Regretfully
16 and very sympathetically, I don’t believe
17 that the data establish efficacy. I dearly
18 hope that the next trial does, but — and I
19 realize the need for hope, but I don’t want
20 to give that hope on a false premise.
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page 386
DR. MULÉ: Dr. Scher?
2 DR. SCHER: I think we are really
3 poised at the beginning of what will be
4 hopefully an outstanding era of
5 immunotherapy. I think there is sufficient
6 evidence demonstrated which justifies the
7 definitive study, and obviously there are
8 investors in that who concurred, but I think
9 it does not meet the — as the question was
10 phrased, to establish the efficacy. I think
11 this is still an open question.
12 DR. MULÉ: So I take it you’re
13 saying yes with these provisos?
14 DR. SCHER: We have two
15 questions. I would say yes to one, no to
16 the second. The first question as posed, as
17 established, I say no.
18 DR. MULÉ: No, it’s substantial
19 evidence.
20 DR. SCHER: I will say no.
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page 382
DR. MULÉ: Dr. Hussain?
22 DR. HUSSAIN: So to me
1 “substantial” and “establish” are the same,
2 and no to either. So no to both.
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page 307 Hussain
10 DR. MULÉ: Other comments? Okay.
11 Number 5, Maha.
12 DR. HUSSAIN: So the essence of
13 the question is the survival data that’s
14 presented. The intent is to discuss the
15 persuasiveness of the efficacy evidence
16 reported in the BLA application and in the
17 table. And as I read this, it is clear that
18 there is a survival difference, so we’re not
19 disagreeing on that. The question is does
20 one believe that the survival difference is
21 related to a therapy effect. Am I
22 interpreting that correct? Okay.
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Dr. Scher, in his “leaked” letter which he allegedly wrote, with help from at least Alison Martin that we know of from the National Cancer Institute (NCI) according to FOIA documents received (see above), Scher stated in one version of his emailed letter that the efficacy question was changed to “Do the data show significant benefits?”, which he then emailed Goodman saying that he had made a mistake when he wrote that, and that he was going to correct it in the hard copy of his letter, which would follow. He also was confused in his FOIA letters about the date of the Advisory Committee.
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Page 8 -Waivers
FDA has determined that members
9 of this advisory committee are in compliance
10 with federal ethics and conflict of interest
11 laws, including but not limited to 18 USC
12 208 and 21 USC 355(n)(4). Under 18 USC 208,
13 applicable to all government agencies, and
14 21 USC 355, applicable to certain FDA
15 committees, Congress has authorized FDA to
16 grant waivers to special government
17 employees who have financial conflicts when
18 it is determined that the agency’s need for
19 a particular individual’s services outweighs
20 his or her potential financial conflict of
21 interest, Section 208, and where
22 participation is necessary to afford
9
1 essential expertise, Section 355. Members
2 and participants of the committee who are
3 special government employees at today’s
4 meeting, including special government
5 employees appointed as temporary voting
6 members, were screened for potential
7 conflicts of interest of their own as well
8 as those imputed to them, including those of
9 their employer, spouse, or minor child
10 related to the following: Topic I, the
11 discussion of Provenge sponsored by
12 Dendreon; Topic II, an overview of research
13 programs in the Division of Cellular and
14 Gene Therapy’s Center for Biologics
15 Evaluation and Research; Topic III, draft
16 guidance for industry, minimally
17 manipulated, unrelated allogeneic placental
18 umbilical cord blood intended for
19 hematopoietic reconstitution in patients
20 with hematological malignancies; and Topic
21 IV, a discussion of scientific issues
22 regarding minimally manipulated unrelated
10
1 allogeneic peripheral blood stem cells.
2 These interests may include investments,
3 consulting, expert witness testimony,
4 contracts, grants, credits, teaching,
5 speaking, writing, patents and royalties and
6 primary employment.
7 For today’s agenda regarding
8 Topic I the committee will discuss and make
9 recommendations on Provenge sponsored by
10 Dendreon in accordance with 18 USC
11 208(b)(3).
Waivers were granted to Drs.
12 Maha Hussain, Howard Scher and Savio Woo.
13 Dr. Glenn Dranoff was granted a limited
14 waiver to permit his participation in the
15 discussions. Dr. Dranoff will not vote on
16 this topic.
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Novacea & Proquest Investments INITIAL STATEMENT OF BENEFICIAL OWNERSHIP OF SECURITIES UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 5/3/06
Series A-1 Preferred Stock ( 1 ) ( 2 ) ( 3 ) Common Stock 279,364 0 I See footnote ( 4 )
Series A-2 Preferred Stock ( 1 ) ( 2 ) ( 3 ) Common Stock 279,364 0 I See footnote ( 4 )
Series B Preferred Stock ( 1 ) ( 2 ) ( 3 ) Common Stock 435,539 0 I See footnote ( 5 )
Series C Preferred Stock ( 1 ) ( 2 ) ( 3 ) Common Stock 476,393 0 I See footnote ( 6 )
Stock Option (right to buy) ( 7 ) 3/2/14 Common Stock 34,285 1.295 D
Stock Option (right to buy) ( 8 ) 11/29/15 Common Stock 8,928 5.25 D
Stock Option (right to buy) ( 9 ) 5/3/06 Common Stock 12,500 ( 10 ) D
Explanation of Responses:
1. Each share of preferred stock will automatically convert into common stock upon the closing of the Issuer’s initial public offering.
2. The securities are immediately convertible.
3. The preferred stock is convertible into the issuer’s common stock on a 1-for-1 basis and has no expiration date.
4. Of such shares, 267,994 are owned by ProQuest Investments II, L.P. (”Investments II”) and 11,370 are owned by ProQuest Investments II Advisors Fund, L.P. (”Advisors”). ProQuest Associates II, LLC (”Associates II”) is the general partner of each of Investments II and Advisors. The reporting person is a managing member of Associates II and disclaims beneficial ownership of the reported shares except to the extent of any indirect pecuniary interest therein.
5. Of such shares, 417,813 are owned by Investments II and 17,726 are owned by Advisors. The reporting person disclaims beneficial ownership of the reported shares except to the extent of any indirect pecuniary interest therein.
6. Of such shares, 457,005 are owned by Investments II and 19,388 are owned by Advisors. The reporting person disclaims beneficial ownership of the reported shares except to the extent of any indirect pecuniary interest therein.
7. Such options are immediately exercisable. However, all unvested shares of common stock underlying the option are subject to a right of repurchase held by the issuer, which right will lapse as the underlying shares vest in 48 successive and equal monthly installments measured from March 3, 2004, such that all underlying shares will be fully vested on March 3, 2008.
8. Such options are immediately exercisable. However, all unvested shares of common stock underlying the option are subject to a right of repurchase held by the issuer, which right will lapse as the underlying shares vest in 12 successive and equal monthly installments measured from November 30, 2005, such that all underlying shares will be fully vested on November 30, 2006.
9. Such options are immediately exercisable. However, all unvested shares of common stock underlying the option are subject to a right of repurchase held by the issuer, which right will lapse as the underlying shares vest in 12 successive and equal monthly installments measured from March 22, 2006, such that all underlying shares will be fully vested on March 22, 2007.
10. The exercise price is equal to the sale price per share of the issuer’s initial public offering.
/s/ Pasquale DeAngelis as Attorney-in-Fact 5/3/06
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