3SOF

Quote from: danman3459 on October 07, 2005, 11:23:42 AM
Falling like a rock.

Buy more or sell?

HEB has been a sleeping baby compared to SVA!  Talk about falling like a rock!  Wow! 

President Bush will host Avian Flu conference at 2PM EST.

I found this post in one of the MB this morning:

"Shares of "Pandemic Summit" Names Advance [delayed]
09:43 a.m. 10/07/2005 Provided by Ridgeland, MS, OCT 07, 2005 (EventX/Knobias.com via COMTEX) -- President Bush hosts a Pandemic Summit today where he will meet with execs from CHIR, MEDI, GSK, MRK, SNY & WYE. Shares of these summit participants are mostly higher in pre-market trading. Other companies tied to the vaccination industry that may have already seen "bird flu rallies" include: DVAX, GMED, HEB, NNVC, NVAX, VRA & VXGN. "

Interestingly, it appears to me that HEB is further along in its anti-Avian Flu trials than some of the big pharma companies that were invited to the White House on Friday. Indeed, I spoke to investor relations at HEB on Friday, and she mentioned that their Ampligen product (effective against not only the avian flu, but also against chronic fatigue syndrome -- just another reason to like this small speculative company) has already undergone many successful safety tests.  Additionally, the company has applied for fast track approval with the FDA, and is expecting an answer any day.  The bottom line is that with the incredible need for vaccines should the outbreak reach pandemic levels, even small companies like HEB, NVAX, and VICL will likely benefit.

Recent article:

Ampligen enhances the effectiveness of Tamiflu against Avian influenza 
Virus Weekly via NewsEdge Corporation :. 
2005 OCT 4 - (NewsRx.com) -- Hemispherx Biopharma, Inc., (HEB) reported two new preclinical studies on double-stranded RNA (dsRNA), including Ampligen, one of its flagship experimental immunomodulators. 

Both preclinical studies suggest a new, and potentially pivotal, role of dsRNA therapeutics in improving the efficacy of the present standards of care in both influenza prevention and treatment of acute disease. 

The first preclinical report, conducted by research affiliates of the National Institutes of Health at Utah State University, compared the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen (dsRNA, Hemispherx), alone and in combination against the Avian flu virus (H5N1).  Cell destruction was measured in vitro using different drug combinations. 

Both drugs, given alone, were effective in inhibiting cell destruction by avian influenza, but viral "suppression with the combination was greater than either drug alone." The researchers reported, in summary; "The overall assessment is that there was improvement in cell protection when Ampligen was combined with oseltamivir carboxylate" (Tamiflu).  Further immediate experimental tests are planned. 

At present, a narrow window of opportunity (approximately 48 hours) exists for effective utilization of Tamiflu after exposure to influenza.  By providing a new mechanism of inhibition of avian flu, (i.e.  immunologic/host defensive immune cascades), Ampligen, an experimental immunotherapeutic, may afford a new approach to help combat influenza virus. 

Double-stranded RNA (dsRNA), such as Ampligen, are also specific inducers of broad-spectrum antiviral/immune response.  Recently, Japanese researchers ( Journal of Virology page 2910, 2005) have also found that dsRNA's increase the effectiveness of influenza vaccine by more than 300% and may also convey "cross-protection ability against variant viruses" (mutated strains of influenza virus).  Ampligen recently completed phase III testing in the chronic disease, chronic fatigue syndrome. 

Hemispherx Biopharma recently disclosed in a letter to shareholders that it has increased the capacity of its facility in New Brunswick, New Jersey, to manufacture Ampligen, as well as advancements in the application of Alferon LDO for potential treatment of Avian influenza. 

This article was prepared by Virus Weekly editors from staff and other reports.  Copyright 2005, Virus Weekly via NewsRx.com. 

<<Virus Weekly -- 10/05/05>>. 



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Source: Virus Weekly via NewsRx.com  Indexing Date: 05/10/2005
Harvested Date: Oct 4 2005 10:15AM     

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Here I am with the wet blanket again, but too much bulishness can be dangerous to your financial health!

In 2002, patients in the CFIDS trial were charged $200 per dose for twice-weekly doses.

http://www.immunesupport.com/library/showarticle.cfm/ID/3315/

Mary Schweitzer kept an online journal of her successful CFIDS treatment on Ampligen in 1999. The total cost for her was $40,000, and her twice-weekly infusions took a half-hour each to be administered.

http://www.cfids-me.org/marys/ampdiaries.html

For Ampligen to be a meaningful answer to bird-flu, it needs to be much cheaper and more easily administered. I don't know what progress has been made on these fronts.

Quote from: robt on October 09, 2005, 10:36:06 AM
Here I am with the wet blanket again, but too much bulishness can be dangerous to your financial health!

In 2002, patients in the CFIDS trial were charged $200 per dose for twice-weekly doses.

http://www.immunesupport.com/library/showarticle.cfm/ID/3315/

Mary Schweitzer kept an online journal of her successful CFIDS treatment on Ampligen in 1999. The total cost for her was $40,000, and her twice-weekly infusions took a half-hour each to be administered.

http://www.cfids-me.org/marys/ampdiaries.html

For Ampligen to be a meaningful answer to bird-flu, it needs to be much cheaper and more easily administered. I don't know what progress has been made on these fronts.

First, I would recommend going back and looking at some of the more recent press releases from the company on the development of Ampligen, including a recent release on the expansion of their manufacturing facility for the making of Ampligen (http://biz.yahoo.com/bw/050901/15685.html?.v=1).  The relatively dated links you refer to are for costs during the clinical trial phase, before the drug is mass produced.  Of course, when a drug is mass produced, the costs will be contained.  Second, and more important during the near term with the pandemic threat, the U.S. Government is going to spend somewhere between $4 to $6 BILLION on the mass production of a vaccine.  So, while the costs will be contained during mass production, I don't think the government is going to be an overly frugal shopper -- they need quick access to A LOT of effective Avian Flu vaccines.

Investing in speculative plays is not for everyone, but, as David points out, NVAX, HEB, and VICL are theme stocks that are currently in play, and, I believe, will continue to be during the evolution of the Avian Flu story.  I am currently invested in all three.

I would like to clarify to those that are interested.

NVAX produces the vaccine, but HEB produces the treatment.

To my knowledge, $4+ Billion allocated is for vaccine stockpiling, which is only effective if the virus DOESN'T mutate.  The article I posted earlier addresses the concern for virus mutation, which may be already happening.  This morning's newspaper estimates that if virus mutates and goes human-to-human instead of current animal-to-human, deaths in US alone will be 1.9+ million in 12-18 months.

http://news.yahoo.com/s/ap/20051009/ap_on_he_me/flu_pandemic

I am not aware of any money allocated for treatment.

Like David mentioned already, HEB and NVAX should be good Avian plays.

FYI.

Quote from: Stocksquire on October 09, 2005, 11:17:04 AM

First, I would recommend going back and looking at some of the more recent press releases from the company on the development of Ampligen, including a recent release on the expansion of their manufacturing facility for the making of Ampligen (http://biz.yahoo.com/bw/050901/15685.html?.v=1).  The relatively dated links you refer to are for costs during the clinical trial phase, before the drug is mass produced.

The reason some links are old is that these tests have been conducted for years, and the drug is still not approved. Use has been permitted in Canada for nearly a decade, so the 2002 price cited is relatively recent; if any economies of scale entered the picture through Canadian use, these would surely be reflected by that year.

The relatively small Canadian market may not have spurred true economies of scale -- but if that is the case, how quickly can manufacturing capacity be placed online? In the case of a medication as complex as this one -- a modified RNA molecule -- I think a year is a very conservative guess. This presents another obstacle to any usefulness of Ampligen in the near term.

Quote
Of course, when a drug is mass produced, the costs will be contained.  Second, and more important during the near term with the pandemic threat, the U.S. Government is going to spend somewhere between $4 to $6 BILLION on the mass production of a vaccine.  So, while the costs will be contained during mass production, I don't think the government is going to be an overly frugal shopper -- they need quick access to A LOT of effective Avian Flu vaccines.

An important distinction needs to be made, in that Ampligen and Alferon are antiviral treatments, not vaccines. In conjunction with Tamiflu, Ampligen is proposed as an adjuvant, or "enhancer." Again, not a vaccine. There's some question as to whether such drugs will automatically qualify for these vaccine-earmarked billions.

I am not arguing against the speculative trade proposition David has put forth. I am only pointing out certain reasons why HEB, among these picks, is most likely to drop whatever gains it makes as bird flu hype gives way to bird flu realities.

The extreme bull view of HEB may ultimately prove correct, especially in the case of an actual, high-profile outbreak. But it is important to consider what factors may prevent that from being the case.

Excellent points and views around HEB, congratulations 

My take on the company is as follows:

1) Ampligen will probably be approved by the FDA soon;
2) The drug serves as a treatment to the Bird Flu virus but its primarily focus is on the treatment of the chronic fatigue syndrome;
3) The stock recently made a breakout of a resistance zone, which value is $1.96;
4) Now it is pulling back some of those gains.

I've read your analysis and enjoyed them much, but reading them doesn't tell me if I should buy or sell. In fact, I'm pretty sure that I can read everything available about HEB and still I wouldn't know if I should hold or sell at this point.

So I have to trust the market, on an objective way, to know what to do. I figure that the recent breakout shouldn't be a false one if HEB is to continue with a bullish trend. It will be false if we ever get a close below $1.96.

So my plan is easy:

1) Hold the stock for the medium term (the flu season is coming  )
2) Sell if HEB is set to close below $1.96. If that were to happen it would mean the market doesn't agree that this is a good speculative play, and the market always knows better.

Hemispherx Biopharma Signs Letter of Intent with HollisterStier Laboratories LLC for the Production of Ampligen(R)
Business Wire - October 10, 2005 08:30

PHILADELPHIA, Oct 10, 2005 (BUSINESS WIRE) -- Hemispherx Biopharma, Inc. (AMEX: HEB) has signed a Letter of Intent (LOI) with HollisterStier Laboratories of Spokane, Washington, for the contract manufacturing of Hemispherx's experimental drug, Ampligen(R). The achievement of the initial objectives described in the LOI, in combination with the Polymer production facility under construction in New Brunswick, N.J., will enable Hemispherx to manufacture the Active Pharmaceutical Ingredient (API) for approximately 10,000 doses of Ampligen(R) per week. Based on the LOI, HollisterStier Contract Manufacturing has agreed to fill the Ampligen(R) API from Hemispherx. Production for significantly larger quantities of product are planned thereafter. Hemispherx has already commenced the process of transferring manufacturing technology to HollisterStier.

Doug Hulse, Chief Operating Officer and President commented, "We are pleased to be working with HollisterStier, a highly professional group who can support the full commercialization of Ampligen(R) upon FDA approval. We selected this group from a qualified pool of manufacturers and look forward to executing our manufacturing strategy with them."

Anthony Bonanzino, President and CEO of HollisterStier noted, "The new relationship with Hemispherx Biopharma represents an exciting addition to our well established client portfolio. We are pleased with the Hemispherx decision, and strongly believe the Hemispherx manufacturing strategy is an excellent match to HollisterStier's core competencies."

Hemispherx recently completed Phase III testing of Ampligen(R) for Chronic Fatigue Syndrome (CFS).

About Hemispherx Biopharma

Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx's flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net

About HollisterStier

HollisterStier Contract Manufacturing provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The company has specialized competencies essential for compounding and filling sterile products. Outsourcing services include vial and syringe filling, as well as commercial and clinical scale capabilities for lyophilization. HollisterStier Laboratories LLC is privately held and located in Spokane, Washington. For more information go to fill.hollisterstier.com.

I sold my position in HEB with a nice gain (I bought in at $2.14) and bought NVAX for faster gains this week.

I plan on buying back HEB when rebound of this pullback is evident.

Good trading!

Thanks for posting the news aussietrader 

As it happens many times, the news didn't help the stock. It opened too high because of the news and then short term profit taking kicked in.

Not a problem, there was no damage to the technical bullish setup. It feels like the stock is consolidating for another leg up, like the other stocks on the Avian Flu group.

But, there maybe be some losers on this field too. I want to lose small on the losers and win big on the winners, that's why I have 4 Avian Flu plays instead of just one or two, I could miss the big winner (as I'm sure there will be at least one - but maybe there's a speculative tide to lift all stocks on this specific group).

The future is still not clear for HEB, I will take a loss if the stock is set to close below $1.96. In the meantime I will continue holding and waiting for a new bullish move.

While other vaccine stocks run well, HEB will have another run soon.

I bought it this morning at support of $2.06.

It got to what should be support and so far a little bounce

http://tinyurl.com/9vkv3

It was pretty difficult to decide whether to stop out at close or not .. the bid ask was on either side of 1.96..

If my info is correct, it closed at 1.93!?