By: lovingitall0
13 Jul 2004, 07:56 AM EDT
Msg. 160714 of 160891
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AIDS vaccine years away, researchers warn

17:47 12 July 04
News Scientist news service

A vaccine for AIDS is still years away, warns a new report, with progress being hampered by a lack of scientific, political and economic interest.

Only one vaccine candidate has been tested fully to see if it can work in humans, says Seth Berkley, president and CEO of the International AIDS Vaccine Initiative (IAVI), which released its progress report on Monday. “That is a global disgrace,” he says. “There hasn’t been a serious effort.”

Data on so-called cell-mediated vaccines - which invoke the response of the body’s T-cell system - will be available by 2010. Providing the data are positive, this is the earliest point at which an AIDS vaccine will be close to becoming a reality, Berkley says.

"The world is inching toward a vaccine, when we should be making strides," Berkley said during the launch of the report at the XV International AIDS conference in Bangkok, Thailand. "The single biggest obstacle is that vaccine development is that it is not a top scientific, political and economic priority."

He adds that less than one per cent of global spending on health product research and less than three per cent of all money devoted to AIDS goes towards developing a vaccine for the disease.

Pipeline expansion

However, Berkely admits the 2004 report paints "a more encouraging picture" than previous IAVI progress reports, which are compiled every two years.

"We have seen a tremendous expansion of the pipeline [of vaccine candidates]," adds Wayne Koff, senior vice-president and head of vaccine research at IAVI. He says the number of vaccine candidates is three times what it was at the time of the last International AIDS conference in Barcelona, Spain, in 2002. There are over 30 vaccine candidates currently being researched by drugs companies.

For instance, VaxGen’s gp120 product, AIDSVAC, has been through all testing stages. And a combination approach using Alvac to prime the immune system and VaxGen’s AIDSVAC is to be trialled in Thailand, with data expected in 2007 or 2008. Merck is also carrying out a phase IIB "proof of concept" trial on a product based on adenovirus.

Antibodies and mucus

But a major concern is that all the vaccine candidates being investigated use the same approach to give immunity to HIV. "All of these elicit cell-mediated immunity," Koff told New Scientist, recruiting the body’s T-cells to fight off HIV infection.

These vaccines are either DNA vaccines or use a vector approach. With the latter, a relatively harmless virus, such as canarypox, can be used to ferry in a few HIV genes, which then invoke an immune response.

Koff says other ways of developing a vaccine include invoking the antibody system or the mucosal immunity - resistance to infections across mucus membranes.

Live, attenuated vaccines have been successful in monkeys. "Issues of reversion to the wild type virus have basically taken that off the table at this point," he says. "However, it is critical to try and identify why the concept of a live vaccine works in the SIV model as well as it has."

Shaoni Bhattacharya, Bangkok

By: lovingitall0
13 Jul 2004, 08:52 AM EDT
Msg. 160718 of 160891
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Some HIV Patients Treated During Early Infection Test Negative

12 July '04

UCSF researchers have found that some HIV patients treated with antiretroviral therapy early after infection do test negative, at some point, for the virus.

Study findings showed this result in six of 87 patients.

"First, these patients are not cured. When these patients went off therapy, HIV virus levels rebounded. These results do show that with effective early treatment that reduces the virus to very low levels, the immune system may have less antibody response to HIV," said the study's lead author, C. Bradley Hare, MD, UCSF assistant clinical professor of medicine at UCSF's Positive Health Program (PHP) at San Francisco General Hospital Medical Center.

The 87 patients who qualified for the study must have started antiretroviral therapy within 28 days of entry into the study. They also must have achieved and maintained for at least 24 weeks a level of virus in their blood below the level of detectability using very sensitive viral load testing. At some point during their follow-up, six patients tested negative for the HIV virus using standard HIV antibody tests.

Hare presented the study today (July 12)at the XV International AIDS Conference in Bangkok, Thailand.

Study participants were selected from the Options Project Cohort. Patients in this cohort enter the study in either primary or early infection -- meaning no patient had been infected with the HIV virus for more than six months.

The six patients who tested negative for the HIV virus were tested using standard second- and third-generation Enzyme Immunoassays, which are the most commonly used tests to screen for HIV infection, and Western Blot tests, which are the most commonly used tests for confirming HIV infection.

Co-authors for the study are Brandee Pappalardo, PhD, MPH, staff scientist at the Blood Systems Research Institute, San Francisco; Bruce Phelps, Chiron Corporation, Emeryville, CA; Steven S. Alexander, Ortho Clinical Diagnostics, Raritan, NJ; Clarissa Ramstead, nurse practitioner at the UCSF PHP; Jay A. Levy, UCSF professor of medicine and director of the Laboratory for Tumor and AIDS Virus Research; Frederick M. Hecht, MD, associate clinical professor of medicine at the UCSF PHP; Michael P. Busch, MD, PhD, vice president, Research & Scientific Services, Blood Centers of the Pacific, and UCSF adjunct professor of laboratory medicine.

Funding for this research was provided by grants from the National Institutes of Health and the Centers for Disease Control.

The Positive Health Program is a component of the UCSF AIDS Research Institute (ARI). UCSF ARI houses hundreds of scientists and dozens of programs throughout UCSF and affiliated labs and institutions, making ARI one of the largest AIDS research entities in the world.

Source: Jeff Sheehy

By: tadly
13 Jul 2004, 10:46 AM EDT
Msg. 160757 of 160891
(This msg. is a reply to 160755 by mind31.)
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ADVR's drug is a successor to a drug that was used in the United States for 25 years (until 1962) for the treatment of influenza, herpes and hepatitis with no reported toxic side effects. Now, the drug has entered Phase II clinical trials in the United States. Patients using Reticulose in the past experienced excellent results (as reported by the patients AND their treating physicians). The reformulated immunomodulator drug, Product R, could be a blockbuster drug for various conditions such as various cancers, HIV, genital warts, (HPV) genital herpes, West Nile virus, lupus and rheumatoid arthritis. Patients have continued to obtain Reticulose through Canada under the FDA Individual Use Program (which requires certain documentation) and have contributed to a wealth of anecdotal evidence that attest to the drug's effectiveness and safety. The anecdotal evidence strongly indicate that clinical trials should go smoothly and rapidly. Product R, the second generation immunomodulator drug based on the science of Reticulose, is Advanced Viral Research's (ADVR) flagship drug that could be in three Phase I and/or Phase II clinical trials for Cancer, HIV and chemotherapy toxicity within weeks.

OLDER News from the Yahoo search engine

(Voluntary Disclosure: Position- Long; ST Rating- Buy; LT Rating- Strong Buy)

By: tadly
13 Jul 2004, 10:54 AM EDT
Msg. 160760 of 160891
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So what if the company focuses on and targets Investigational New Drug applications to the U.S. FDA for therapeutic uses of Product R?

What if this allows the Company to take advantage of FDA programs for orphan drugs and other accelerated tracks for drug approval and attracts significant investment from pharmaceutical partners.

What if....JMHO. I am long and think the news will be substantial for long term holders.

(Voluntary Disclosure: Position- Long; ST Rating- Buy; LT Rating- Strong Buy)

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By: lovingitall0
13 Jul 2004, 11:33 AM EDT
Msg. 160770 of 160891
(This msg. is a reply to 160763 by tadly.)
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Great thoughts. You make sense where others make nonsense.
You have an eye for the future of AVR118 as many of us do, and you do your DD like everyone is supposed to.

There's a small group here who would rather blame their poor investment strategy on others rather than take full responsibility for their own decisions.

"He said, she said, they said....", is their cry.

Mine is: "Keep it goin', keep in flowin'," tadly.

Being a believer does not make one a pumper. But trashing the belief that others have, does make one a basher.

Good job, and good luck to you!


By: lovingitall0
13 Jul 2004, 11:42 AM EDT
Msg. 160773 of 160891
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XV International AIDS Conference

13 July 2004, Bangkok

Access to AIDS medications continues to elude millions around the world. Delegates and speakers at the XV International AIDS Conference in Bangkok, Thailand, called for broader accessibility to antiretroviral treatment. Jim Kim, who heads the World Health Organization project tasked with scaling up treatment, The 3 by 5 Initiative, expressed shame over the six million people who have died of AIDS since the Conference last met two years ago. “By these measures of human life, the ones that really matter, we have failed, and we have failed miserably to do enough in the precious time that has passed since Barcelona,” he said.

Protestors agreed, arguing the availability of cheap generic drugs would remove the biggest barrier to access. But first, advocates say, brand-name pharmaceutical companies must forgo their patents for certain drugs in developing countries. That will dry up innovation, argues Hank McKinnell, CEO of Pfizer. “People living with HIV are going to need a steady stream of new therapies as this virus mutates and currently available treatments fail patients. If ‘Access for All’ is all that we do in the first sense, access for those needing medicines today, then the theme of future IAS Conferences will surely be, ‘Why are treatments failing patients?’”

But maintaining research and development should not keep needed medications from people who cannot afford them, according to Walden Bello from the University of the Philippines. “R & D for HIV drugs and other essential medicines is no longer efficient within a corporate context. Big pharma is more interested in protecting its 20 percent margin, provided by monopolistic pricing based on patents, than in providing drugs to people with little purchasing power.”

Neither side denies there’s a need to provide these medications; they just disagree on the best way to get them to the millions of people who need them.


CNN vs. ABC, 12 July 2004

Steven Sinding, director general of the International Planned Parenthood Federation, and Edward Green, research scientist at Harvard School of Public Health and a member of the Presidential Advisory Council on HIV and AIDS, chaired a session discussing two HIV/AIDS prevention models known as "CNN" -- which promotes condoms, clean needles and negotiating skills -- and "ABC" -- which promotes abstinence, be faithful and condoms. Two youth speakers also presented. Although the session was meant to be a debate, the participants agreed that all of the prevention methods could be appropriate depending upon the population being targeted. However, the participants disagreed on how much emphasis should be placed on each prevention method. Following their presentations, the panel members answered questions from the audience.

13 Jul 2004, 11:56 AM EDT
Msg. 160774 of 160891
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TADLY..FACT IS 1986 pps .08 in 2004 pps .10 GO NEW BOSS!!!!!!!
end of story! theres nothing to say!!!!!!
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By: lovingitall0
13 Jul 2004, 12:16 PM EDT
Msg. 160777 of 160893
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The TWST interview with Elma Hawkins looks very interesting. Let's hear from anyone who may have access to it.

Article Profile:


Focus Series: Healthcare
Length: 4025 words (approx. 7 pages)
Doc#: YAL623
Sector: Biotechnology
Type: CEO
Date: 2004-07-05

TWST Questions:

. Please begin with a brief historical sketch of Advanced Viral Research and a picture of the things you're doing at the present time.

. Can you put a very rough timetable on that?

. Have the people in the trials been monitored since that time?

. What will you do regarding alliances and partnerships?

. You said that the typical weight gain over four weeks with the high doses was 2.6 pounds. How does that compare with other experiments that other people have done?

. What about compliance? Would AVR118 be easier to comply with for patients than some of the existing things?

. Do you know whether it will be more effective regarding AIDS or regarding cancer, or is that something that is still to be determined?

. How many types of cancer would this be effective against?

. Are there any other elements in your strategy for the next few years that you'd like to discuss?

. I believe you became CEO in February.

. Were you with a company before that?

. When you became CEO did you change direction for the company at all? Did you institute any new practices, anything new in the culture, etc.?

. What are the elements in your own background that led to the position you're now in?

. When you became CEO, did you bring in any new people?

. What would be the two or three best reasons for the long-term investor to begin to take a very good look at Advanced Viral Research?

. Is there anything that you would wish to add, particularly with regard to the company's long-term objectives?

Thank you. (MC)
Interview Excerpt:

By: CchMiller
13 Jul 2004, 12:33 PM EDT
Msg. 160781 of 160894
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Does anyone know if Advanced Viral is presenting or has representation at the curren World AIDS Conference?

(Voluntary Disclosure: Position- Long; ST Rating- Hold; LT Rating- Hold)

By: CchMiller
13 Jul 2004, 12:33 PM EDT
Msg. 160781 of 160894
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Does anyone know if Advanced Viral is presenting or has representation at the curren World AIDS Conference?

(Voluntary Disclosure: Position- Long; ST Rating- Hold; LT Rating- Hold)

By: CchMiller
13 Jul 2004, 12:37 PM EDT
Msg. 160785 of 160894
(This msg. is a reply to 160783 by kevtod.)
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Then what is the importancce of all the research in reducing the effects of wasting syndrome. Wasn't that supposed to be one of the key uses of the drug.

By: kevtod
13 Jul 2004, 12:43 PM EDT
Msg. 160787 of 160896
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The importance of AVR118 in the treatment of AIDS related cachexia has yet to be proven. And is significantly discouraging to those of us who expected to see antiviral properties from this Old World Immunomodulator.....

By: kevtod
13 Jul 2004, 12:49 PM EDT
Msg. 160788 of 160896
(This msg. is a reply to 160786 by mind31.)
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AIDS Wasting Syndrome Is Declining in US

Fewer patients with HIV infection are being diagnosed with AIDS-wasting syndrome in the U.S., according to data from a large and demographically diverse cohort of 46,678 HIV-infected patients being followed by the Centers for Disease Control and Prevention.

The incidence of wasting syndrome fell from 30.2 cases per 1,000 person-years in the first half of 1992 to 11.9 cases per 1,000 person-years in the first half of 1999. "This trend was especially pronounced after the introduction of HAART in late 1995," researchers note in the July 1st issue of the Journal of Acquired Immune Deficiency Syndromes.

Survival after a diagnosis of wasting syndrome improved during the later 1990s. "This may be another of the many benefits we have been seeing as treatment against HIV has become more effective," lead author Dr. Mark S. Dworkin of the Illinois Department of Public Health in Chicago told Reuters Health.

A CD4+ count of 200 cells per microliter or greater around the time of diagnosis of AIDS-wasting syndrome and combination antiretroviral therapy at or after the diagnosis were significantly associated with improved survival.

Treatment with the endocrinologic oxandrolone also appeared to improve survival but this result did not reach statistical significance, Dr. Dworkin said. "Our study was observational, not a controlled clinical trial, so this finding should be interpreted cautiously and confirmed by other studies," he pointed out. Treatment with testosterone, growth hormone, and megestrol acetate had no apparent impact on survival.

Stressing the importance of early diagnosis of HIV infection, he noted that it can provide "an opportunity to prescribe antiretroviral treatment and hopefully delay or prevent the onset of wasting syndrome, which is associated with many complications such as a higher risk for infections and death."


J Acquir Immune Defic Syndr 2003; 33:267-273.


By: kevtod
13 Jul 2004, 12:52 PM EDT
Msg. 160789 of 160896
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Administration of V-1 Immunitor, an Oral Therapeutic Vaccine, Increases Body Weight and Improves Quality of Life in AIDS Patients

Because AIDS-related wasting is associated with increased mortality, the development of an affordable and safe therapy to reverse the loss of body mass is of critical importance, especially in resource-poor countries.

Researchers in Thailand have demonstrated earlier that an oral therapeutic HIV vaccine, V-1 Immunitor (V1), tested in a small group of AIDS patients in Thailand not only increases T-cell counts and decreases the viral load but also results in weight gain and prolonged survival.

To further expand this observation, the investigators retrospectively analyzed 650 HIV-positive patients who were followed for an average of 23 weeks.

Study Results
The treatment with V1 resulted in a sustained and statistically significant increase in body mass across the whole population. Among them, 384 (59%) patients gained an average of 4.2+/-0.2 kg; 107 (17%) had unchanged weight; and 159 (24%) had lost 3.8+/-0.3 kg.

Thus, the prevailing majority of patients (76%) were able to gain or maintain weight. Treatment was well tolerated; in a survey of health status in a comparable but separate group of 382 patients, about 85% reported subjective improvement after V-1 treatment, 6% reported no difference, and 9% of the patients reported minor adverse reactions, which did not last more than 1 week.

Subjective improvement coincides with the reduction or clearance of oral thrush or mucocutaneous candidiasis in 87.5% of the patients.

In an open label setting, V1 increases body weight, subjective assessment of quality of life, and is safe and effective for HIV patients with weight loss. These data provide the impetus of using V-1 Immunitor as an affordable and easy-to-administer means of treating AIDS-associated wasting and opportunistic infections.

Immunitor Corporation Co., Ltd, Bangpakong Industrial Park, Chachoengsao, Thailand.


V Jirathitikal and others. Increased body weight and improved quality of life in AIDS patients following V-1 Immunitor administration. European Journal of Clinical Nutrition 58: 110-115. January 2004.

By: tadly
13 Jul 2004, 01:05 PM EDT
Msg. 160790 of 160896
(This msg. is a reply to 160765 by jmrhoads.)
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ADVR granted US patent for treatment of AIDS
Advanced Viral Research Corp. [ADVR] has been issued a US patent for the treatment of HIV infections with AVR118 as a combination therapy with other HIV drugs.
27 Feb 2004, 14:39 GMT - ADVR's AVR118 represents a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown a very favorable safety profile, appears to stimulate the proinflammatory responses required to combat viral infections such as HIV and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis.

The agent is currently in clinical trials in Israel for the treatment of cachexia in patients with AIDS specifically.

The Centers for Disease Control and Prevention (CDC) estimates that 850,000 to 950,000 US residents are living with HIV infection, one-quarter of whom are unaware of their infection.

Statistically, over 40,000 new patients are diagnosed with HIV infections each year in the US and of these newly infected people, half are younger than 25 years of age.

"The issuance of this patent allows us to increase our intellectual property protection in an important therapeutic area," said Dr Elma Hawkins, CEO of Advanced Viral Research Corp in a statement to the press.

The candidate was recently granted a similar patent in China.

(Voluntary Disclosure: Position- Long; ST Rating- Buy; LT Rating- Buy)

By: tadly
13 Jul 2004, 01:57 PM EDT
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The Orphan Drug Act (ODA) provides for granting special status to a product/indication combination upon request of a sponsor, and if the product/indication combination meets certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for the tax credit and marketing exclusivity incentives of the ODA.

(Voluntary Disclosure: Position- Long; ST Rating- Buy; LT Rating- Buy)

By: lovingitall0
13 Jul 2004, 02:12 PM EDT
Msg. 160798 of 160896
(This msg. is a reply to 160795 by kevtod.)
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WOW!..."This makes AVR118 look to be a potential candidate for orphan drug status.....IMO"

Now THAT'S a blockbuster it itself!

By: lovingitall0
13 Jul 2004, 02:13 PM EDT
Msg. 160799 of 160896
(This msg. is a reply to 160798 by lovingitall0.)
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correction: IN itself!

I'm soooooo excited! Kevin said it!

By: kevtod
13 Jul 2004, 02:18 PM EDT
Msg. 160801 of 160897
(This msg. is a reply to 160797 by tadly.)
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Also, "there is no reasonable expectation that costs of research and development of the drug for the indication can be recovered by sales of the drug in the United States as specified in § 316.21(c)."

This is precisely why touting "Orphan Drug Status" for a fledgling Biotech like ADVR is soo "Reticulous".....For one thing, they have no other income to make logical use of the offsetting tax credits that are provided by the designation.

By: mind31
13 Jul 2004, 02:20 PM EDT
Msg. 160802 of 160897
(This msg. is a reply to 160795 by kevtod.)
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Kevin, now I think both our numbers are off.

"1,000,000 estimated HIV+ cases in the USA, you would arrive at approx. 12,000 who may suffer with AIDS related wasting (cachexia)"

Correct me if I am wrong but of those 1 million only a certain percentage have full blown AIDS. Those that are HIV+ but in sucessful treatment do not shown cachexia symptoms. Indeed I think, (can't prove it), that there are fewer than 12,000 cachexia cases a year - much fewer.

I got my 12,000 in a different way. Of 15,000 deaths, I have read in ADVR company literature I believe, that 80% will develop cachexia in the terminal stage. That is 12,000.

By: kevtod
13 Jul 2004, 02:57 PM EDT
Msg. 160810 of 160897
(This msg. is a reply to 160806 by mind31.)
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Wasting Syndrome (cachexia) is one of many AIDS defining illness. So, technically speaking, it is precisely person that are HIV+ who may now be defined as having AIDS if they were diagnosed with Wasting Syndrome.

You are correct that many (if not most) people that are HIV+ will not develop AIDS. And, that most people that develop cachexia will have been previously diagnosed as having AIDS, due to other opportunistic disease.

I know that makes sense.....-kev

By: SUE32073
13 Jul 2004, 03:08 PM EDT
Msg. 160811 of 160897
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Concerning Orphan Drug status, I believe the qualifying number is 200,000 or less affected by any type of disease. Does this also include drug status for animals? many weepy-eyed dogs are there in the U.S.? How many cases of feline leukemia are there reported in the U.S.? How many cases of doggie distemper are there reported in the U.S. each year?.....Hmmmmm.

By: kevtod
13 Jul 2004, 03:19 PM EDT
Msg. 160812 of 160897
(This msg. is a reply to 160811 by SUE32073.)
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Sue- And why is there never the same level of enthusiasm for all those useless animal patents as there is for the others ???

By: mind31
13 Jul 2004, 03:19 PM EDT
Msg. 160813 of 160899
(This msg. is a reply to 160810 by kevtod.)
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kev, that is clear to me. I am interested in the exact incidence of AIDS related cachexia in the USA. I know you do not have the number in your pocket but I think we agree that it is relatively low in the thousands not the tens of thousands perhaps.
So why the hell did ADVR target that application in the first place? Contrast that fact to the huge incidence of cancer related cachexia.
I think Hirschman though that if he could orphan it in with AIDS cachexia then it would find the market with cancer.
This would not be an alltogether stupid plan.
The thing is, they have about as much chance of getting this through the FDA process as luvitup does getting elected president.

By: Ourobouros
13 Jul 2004, 03:26 PM EDT
Msg. 160816 of 160899
(This msg. is a reply to 160760 by tadly.)
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Reticulose was denied orphan drug status, I believe.

And your note of anecdotal stories has not impressed the FDA in the least.

Thus a price of 10 cents is probably overstated.

By: mbengineer
13 Jul 2004, 04:52 PM EDT
Msg. 160827 of 160899
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KEV. approval as an orphan drug may not get the sales required for continued operation but off label use should be considerable and make the co profitable.
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By: lovingitall0
13 Jul 2004, 06:39 PM EDT
Msg. 160840 of 160900
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Orphan drugs

Q & A