Advanced Viral IS Dr.D's pet project; it's ADVR's projects' laurels that
he seems to be leaning on so as to enhance his own standing in the
scientific community. It also gives him a trip to Italy at the company's
expense to present other peoples's work on AVR118. As long as he does a
GOOD job and presents the drug and the research results acurately and is
able to answer all the scientists' questions about other folk's research
without blunders, there is no harm in Wilner sending Jim for a little
break from the New York winter blues in Firenze. I would really prefer
it if one of the scientists who actually did the work also went to Italy
so as to be able to answer the other scientists' and physicians'
questions accurately. Unless someone has actually done the experiments,
it is not always possible for them to answer all the nit-picking
questions that come up at a conference. If one is ignorant of the facts,
or of one's own purported research, one is easily caught out by other
scientists and that destroys the research's credibility. I've been both
a presenter and audience member at several scientific meetings... I
know. A scientific conference is different from an interview with a TV
station- one cannot fudge or skirt the issue before one's scientific
peers. What I also wonder sometimes is, if Dr. D's such a busy physician
taking care of unfortunate terminally ill cancer patients at North Shore
Hospital, is a professor at NYU as claimed, and as avid a researcher as
the PR suggests, how he has so much free time to do magazine interviews,
radio station interviews, TV station interviews and attend conferences
for ADVR. If ADVR is a cash cow, that would explain it, perhaps. I am
sure he does have a belief in AVR118's role in cachexia, but his readily
availability to ADVR seems a little excessive for a busy physician.
We've had Nowinski milk the company as a cash cow in the past, and have nothing to show for it. At least Dr. Jim is trying to get the word out about the drug and hopefully that will lead to some positive results. If Jimbo gets some personal glory out of that, so be it. If he wishes to skirt the scientific ethics issue by presenting or publishing other people's research, so be it. That's his problem.
In the final analysis, though, it is not attending scientific conferences or magazine interviews that will truly enhance the company's standing in the medical and investment communities. "Spokespersons-at-Large" and touting the drug on the media are fine, but it will only be with the credibility that comes with advancing the drug through the FDA and getting approval which will truly put ADVR on the map, get partnerships with big pharma and get the stock price up. Wilner should focus all his efforts and monetary outlay towards that goal.
- - - - -
You are looking
out 5 to 10 years giving Eli's 3 to 5 years extra time to work.
So 10,000 shares $.14 is a $1,400.00 investment. If the os goes to 2billion as someone suggested you would have to expect a r/s. Say 1 for 10 in which case you would have 1,000 shares with the os at 200,000,000 after the split. If the drug worked and was brought to market and earned $1.00 per share that's $200,000,000.00. Use a conservative PE of 20. The share price would be $20.00 and the market cap would be $4,000,000,000.00.
Your $1,400.00 would grow to $20,000.00 in the decade. 3% inflation would eat away say $3,000.00. 15% income tax would take another $3,000.0 bite leaving you with a 10 bagger.
As was point out yesterday by DIAMONDring and others, the press release
was concerned with remarkable aspects relative to cancer resulting from
“bench research” on AVR118. Also yesterday, Bernie Bildman pointed out
the necessity of somehow transcribing the most important aspects or the
essence of a press release into the title of the press release.
Realizing this, it becomes evident that something more pertinent to the
body of yesterdays press release should have found it's way into the
title. Instead of pontificating as to what should have been done with
the title of that press release, another shareholder [not the puppy] and
I decided to re-write the first part of the press release to demonstrate
what we mean. For what it’s worth, here it is.
- - - - - - - - - - - - - - - - - - - - -
DR. JAMES T. D’OLIMPIO TO PRESENT INVITED PAPER AT INTERNATIONAL CONFERENCE ON CANCER THERAPEUTICS, FEB. 19 - 21, FLORENCE, ITALY, CONCERNING BASIC CANCER RELATED ASPECTS OF AVR118.
YONKERS, N.Y., Jan. 27 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) today announced that its spokesperson James T. D'Olimpio M.D., a consultant and member of ADVR’s Scientific Advisory Board, has been invited to attend and prepare an oral presentation for the 1st ISC International Conference on Cancer Therapeutics - Molecular Targets, Pharmacology and Clinical Applications - to be held February 19 - 21, 2004, in Florence, Italy.
Dr. D’Olimpio’s abstract is entitled “Use of a Peptide Nucleic Acid Complex in Cancer Regulation and Metastasis: A Preliminary Report of Bimodal Effects in vetro”. The presentation will be concerned with the basic scientific aspects of what has been discovered during active “bench research” on ADVR’s flagship drug AVR118. Findings show that there appears to be specific areas that can impact on a cancer cells ability to “change” into a more normal cell or in the case of tumor cell invasion, hinder the cancer cells ability to spread.
That has been MY impression since the first time I spoke to Eli.
Even when we were on the tour, Eli mentioned that the lawyers had a fit (my words - don't remember his precise verbiage) over the fact that so much was said in the LEADER'S interview.
I responded, to noone in particular, that if the attorneys were unhappy - that's probably a GOOD sign...
A move would be difficult because the only plant producing AVR118 with its associated machinery is at the same Yonkers location as the offices. It would cost much more to rebuild the manufacturing plant at another location than continuing to pay the rent at Yonkers. Also, some of the labs may need to be reactivated and re-staffed if and when funding becomes available. The FDA is very likely to ask for more science on the drug before final approval. The initial IND which the FDA accepted was for a topical application of the drug on the skin. Much more stringent rules apply and additional science is normally needed for an injectable product for AIDS cachexia, cancer, etc. because the drug is internally administered and can potentially have effects on internal organs that don't show up on topical use. You have to do that science to prove it to the FDA.
I have been working in healthcare for years now and I can tell you for
sure that the future of treating illness is in virology...We have maxed
out the science of Bacterias...except for the new ones we create with
mult. use of antibiotics. The fungi are minimal as are the other
bugs....BUT my friend the viruses are the key to many ailments and only
recently have we begun to open many doors. This drug will be the
beginning of a much, much, much wider range of drugs that will treat
many viral and even some non viral related illnesses. ADVR will get the
money for this drug for a time long enough to prosper before science
will find that there are many potential agents that can be produced, and
others will find their own. Remember that the AIDS cocktails were the
catalyst, but ADVR,s drug will be the blockbuster. FOR SURE, Thanks,
FDA Issues Draft Guidance on Providing More Information on
January 27, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration (FDA) today issued a draft guidance designed to make further information about the use of investigational drugs more readily available (see links below).
Clinical trials are research studies designed to test the safety and effectiveness of new therapeutic agents. Sometimes, however, patients with serious or life threatening diseases cannot be treated with existing therapy, or they do not meet the eligibility criteria for enrollment, or they are otherwise unable to participate in a controlled clinical trial. In these situations, when companies are willing, there are a number of programs FDA has in place which allow patient's access outside the clinical trial setting to promising therapies.
The draft guidance is part of the Best Pharmaceuticals for Children Act (Public Law 107-109) (BPCA), and is designed to augment information available in the Clinical Trials Data Bank (ClinicalTrials.gov). Clinical Trials.gov was developed by the National Library of Medicine following passage of the Food and Drug Administration Modernization Act of 1997. It is a publicly available Internet data bank providing information on clinical trials of drug and biological therapies sponsored by the private sector as well as studies sponsored by the National Institutes of Health and other government agencies.
The new information required by the BPCA includes a description of whether, and through what procedure, the sponsor of the research will respond to requests for access to the therapy outside of the clinical trial setting, particularly in children. This draft guidance explains how to provide that information in a straightforward and efficient way.
"This FDA guidance promises to get more information to patients that really need it," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "It represents our continuing effort to work with the private sector to provide information for patients about new treatments in development for serious or life threatening diseases."
ClinicalTrials.gov is the world's largest source of clinical trial information -- currently listing approximately 9,100 federally and privately sponsored trials throughout the United States and abroad - and has proved to be a very useful resource for patients seeking information on clinical trials testing promising therapies for their medical conditions.
The draft guidance will be posted in the Federal Register on January 27, 2004 with a comment period of 60 days. Those interested in submitting written comment can send them to the following address:
Division of Dockets Management (HFA)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Further information about clinical trials of medical products is available on FDA's Web site at http://www.fda.gov/.
Credentials of ADVR Scientific Advisory Board Members
Internet investigations helped me compile these profiles:
James T. D’Olimpio: M.D. University of Guadalajara (Mexico) (1978); Clerkship and Residency, Mt. Sinai Medical Center (1978-1982); Montefiore Medical Center (1982-1992), Medical Director- Hospice Care of Long Island (1992-1997); Director of Palliative Medicine, North Shore Hospital, long Island (1997-Present)
Publications listed in PubMed: 8 (3 on clinical trials in cancer patients, one on testing a nutraceutical product, one laboratory study with Albert Einstein Med school researchers, an essay each on Physician assisted suicide, Hospital Ethics and Palliative Care)
No record of being a Principal Investigator on NIH grants found on the NIH CRISP website (Computer Retrieval of Information on Scientific Projects).
An authority on cancer palliative/hospice care, cancer cachexia.
George Canellos: M.D. ,Columbia U. (1960), Residency at Mass. General Hospital; > 25 year association with Harvard Medical School/Dana Farber Cancer Institute, was Chief of Medical Oncology at Dana-Farber 1975-1995. Has been Acting Clinical Director of the National Cancer Institute, Member of FDA Oncology Drug Advisory Committee, Past President of American Society of Clinical Oncology (ASCO); Former Editor-in Chief, Journal of Clinical Oncology.
Publications listed in PubMed : 261 (Mainly clinical trials and basic science studies relating to chemotherapy of a variety of cancers with an emphasis on lymphomas and leukemias).
Principal Investigator on 29 National Institutes of Health grants since 1976.
An authority on cancer drug development and clinical trials, particularly for Hodgkins’ disease, lymphomas and leukemias. Canellos literally wrote the book on “Lymphomas”.
Michael Harris: M.D. Albert Einstein School of Medicine, New York, Worked in Pediatric Oncology at Children’s Hospital Philadelphia. Currently Chief of Pediatric Oncology at Hackensack University Medical Center, New Jersey and Professor of Pediatrics at UMD-NJ.
Publications listed in Pub Med :41 (on childhood leukemias, osteosarcomas, drug clinical trials in pediatric oncology).
Principal Investigator on 12 grants from the NIH.
An authority on childhood cancers, particularly leukemias and osteosarcomas. Extensive experience in clinical trials for pediatric cancers .
Sidney Pestka : M.D. University of Pennsylvania (1961), Currently Head of Molecular Genetics at UMD-NJ. Awarded the National Medal of Technology by President Bush (2001). Founder of a company, PBL Medical Labs, NJ.
Publications listed in Pub Med : 311 (antiviral interferons, molecular immunology, interleukins and cytokine biochemistry).
Principal Investigator on 59 NIH grants
An authority on antiviral interferons, interleukins and peptide/protein drugs.
Howard A. Young: Ph.D. University of Washington (1974); Postdoctoral Work- National Cancer Institute; Member Laboratory of Molecular Immunology (1983-1989); Director of laboratory of Cellular and Molecular Immunology, National Cancer Institute (1989-Present).
Publications Listed in Pub Med: >170 (Basic lab research on immunology, cytokine actions)
Principal Investigator on 5 NIH grants (source-CRISP)
An authority on cellular and molecular immunology, cytokine action.
Shares $ of Shares Beneficially
Beneficially Beneficially Owned
Owned Owned Beneficially After
Before Before Shares to be Sold in Owned After Offering
Selling Stockholder Offering Offering (1) the Offering (2-6) Offering (7)
- ------------------- -------- ------------ ------------------ -------- ------------
Angela Amato 480,000 * 480,000 2 0 0%
Ralph Albergo 300,000 * 300,000 2 0 0%
AVIX, Inc. 573,750 * 105,000 3 468,750 0%
Elliot Bauer 3,250,000 * 750,000 2 2,500,000 0%
John Billard 1,500,000 * 1,500,000 2 0 0%
Phillip Brennan 1,850,000 * 1,350,000 2 500,000 0%
Dorothy Christofides 2,035,000 * 1,155,000 2,3 880,000 0%
Michael Contillo 1,000,000 * 750,000 2 250,000 0%
Joseph Deglomina 961,364 * 750,000 2 211,364 0%
Edward Gorkes 1,500,000 * 1,500,000 2 0 0%
Benjamin Kirsch 750,000 * 750,000 2 0 0%
Russell W. Kuhn 6,000,000 1.1% 6,000,000 2 0 0%
Mark Levine 1,800,000 * 1,800,000 2 0 0%
Steven Levitt 2,509,090 * 1,199,999 2,3 1,309,090 0%
Barry & Marci Mainzer 450,000 * 450,000 2 0 0%
Robert Nowinski 1,159,125 * 1,159,125 4 0 0%
Lawrence Pomerantz (Harbor View) 19,592,388 3.4% 6,615,533 2,3 12,976,855 2%
Gerald S. Schuster 2,422,500 * 1,200,000 2 1,222,500 0%
Roberta Schwartz 750,000 * 750,000 2 0 0%
Avraham Sibony 1,500,000 * 1,500,000 2 0 0%
Robert Franklin Smith 1,022,549 * 900,000 2 122,549 0%
Xiao Yuan Tang 1,350,000 * 1,350,000 3 0 0%
Michael Tannenhauser 450,000 * 450,000 2 0 0%
Frank Vigliarolo 5,251,250 * 2,970,000 2,3 2,281,250 0%
Michael Villani 750,000 * 750,000 2 0 0%
Scott Weil 900,000 * 900,000 2 0 0%
Mike Weiner 600,000 * 600,000 2 0 0%
Eli Wilner 33,012,500 5.6% 27,200,000 5a,b,c 5,812,500 1%
David Seligman 9,200,000 1.6% 5,250,000 5a,b 3,950,000 1%
Nancy J. Van Sant 6,050,000 1.1% 4,100,000 5a,b 1,950,000 0%
Roy S. Walzer 8,228,800 1.5% 5,650,000 5a,b 2,578,800 0%
Elma S. Hawkins, Ph.D., MBA 1,500,000 * 1,500,000 5a - 0%
George P. Canellos, M.D. 750,000 * 250,000 5a 500,000 0%
Michael Harris, M.D. 750,000 * 250,000 5a 500,000 0%
James D'Olimpio, M.D. 950,000 * 450,000 5a 500,000 0%
Howard Young, M.D. 750,000 * 250,000 5a 500,000 0%
Sidney Pestka, M.D. 750,000 * 250,000 5a 500,000 0%
DeDiego, Maribel 1,100,000 * 1,000,000 5b 100,000 0%
Garcia, Maritza 12,000 * 10,000 5b 2,000 0%
Marino, Maria 530,000 * 500,000 5b 30,000 0%
Szalkiewicz, Andy 655,000 * 500,000 5b 155,000 0%
Taraporewala, Irach 1,150,000 * 1,000,000 5b 150,000 0%
----------- ---------- --------- ----------- ---
SELLING STOCKHOLDERS TOTAL SHARES 126,095,316 19.4% 86,144,657 39,950,658 7%
SHARES OUTSTANDING AFTER OFFERING (2-6) 621,991,449
Call me cynical, but one must wonder why Eli in particular would be
selling 27,200,000 at this stage of the "game".
Go to page 15 of the S-1 and you
will see 86M shares being sold by certain individuals, some of which have
exercised their warrants/options.
Eli, among other, is selling the majority of his holdings.
I don't know. There must be some time frame associated with this type of
intent to sell notice...maybe shaggy knows this.
It's so nice to see Eli selling; that must really bring up investor
morale and encourage anyone sitting on the sidelines. Sad to see really.
As BillBlue said, it's a real eye opener.