Hemispherx Biopharma: Hot and Likely to Get Hotter

Hemispherx Biopharma (HEB) put out a press release.

They announced an invitation, funded entirely by the government of Italy, to present HEB's technology platform for influenza control, at the upcoming 'International Conference on Biotechnologies and Finance' in Rome on July 4-5, 2009. Hemispherx has a broad-based technology platform for confronting the potential of an influenza pandemic, which consists of both preventative (vaccine) components as well as experimental therapeutic interventions. Clinical results from trials conducted in Australia are being evaluated and major vaccine initiatives in Japan are being accelerated in collaboration with the Japanese National Institutes of Health and the Japanese Ministry of Health.

This recognition by the Italian government is obviously great news for the company. The stock surged Tuesday. The surge was apparently industry wide for the swine flu index of stocks. Evidently, those swine flu stocks in the news, such as HEB, got an extra lift. The stock shot up more than $.70 at one point Tuesday from its opening price of $1.74. It has since come down considerably, but is still up $.40+ on the day Tuesday. Considering this is not even the news the market is waiting for, this news (and the reaction to it) is encouraging.

The market is waiting on news about FDA approval of HEB's NDA for ampligen, a treatment for chronic fatigue syndrome. On May 25, 2009 (the original date for an answer), the FDA notified HEB that they would need 1-2 more weeks to finish their evaluation. HEB has been strongly behind their drug publicly. They have been trashed by some people who are not even sure they believe in chronic fatigue syndrome. However, HEB is very insistent. If approved, ampligen would be an orphan drug. This makes it worth even more money to the company.

The acceptance by the Italian government (and the Japanese and Australian governments) of its flu vaccine adjuvant would indicate that HEB is indeed a serious player with leading edge technology. This leads one to believe that the prospects for FDA approval of HEB's ampligen drug are good. Just the positive publicity from the flu acclaim is bound to sway the FDA a little. This story may get better soon. The FDA would not have requested more time, if they were definitely going to reject HEB's NDA. That puts the odds at considerably better than 50% for acceptance.

Hemispherx Biopharma, Inc. is a specialty pharma company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen(r) and Oragens. Ampligen(r) and Oragens represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.

I should note the Dr. William Reeves who heads up the Chronic Viral Diseases Branch of the CDC went on record in 2006 as saying they had found a biological basis for Chronic Fatigue Syndrome.

On May 28, 2009,

Reeves was the ring master of what turned out to be an 'Ampligen love-in' at the Health and Human Services event. Not an insignificant fact when you consider that this was the CFSAC's first meeting under the Obama Administration's and that the HHS is at the top of the food chain and rules the FDA, the CDC, The Social Security Administration, National Institute of Health, HRSA, Etc. (M.E. Garza).

In my book, this bodes well for HEB's ampligen NDA.

Disclosure: Author is long HEB

Comments

[raytayzmd:]

...whether CFS is "real" or not is moot...what is pertinent, as they say on the CSI shows, is the evidence...now apply the advice of your moniker and go read the data:

www.prohealth.com//lib...

...I have a great deal of difficulty accepting a 32 second improvement versus placebo on a treadmill as significant...and I definitely don't think such improvement is worth $14,000...



On Jun 04 05:31 AM thinkb4uwrite wrote:

> To Raytaz md
> ...and any others eager to tell us they neither believe in illness
> per se (its all in your head) but we all know that's because of course,
> they've never had a serious illness.
>
> So... a couple of points that may shed some light upon your callous
> and heartless perspective...
>
> Ampligen is the only drug available for people who have this wretched
> illness (seekingalpha.com/symbo...) and there is little
> doubt among the afflicted and those who treat them, that it should
> have been approved long ago.
>
> The drug works... and it has been shown clearly safe for use in limiting
> many of the debilitating symptoms of CFS.
>
> One way we might significantly improve the FDA would be to require
>

Jun 04 07:55 AM

[thinkb4uwrite:]

Hardly moot. Rest assured its a "real" drug with quite real effects. Lets see now.... Which of these 53 uses so far do you have issue with?

HEB Proposed Ampligen Uses Per Company Press Releases, Interviews and Patent Applications

1. Alzheimer's Disease (1999 Patent No. 5958718)
2. Anthrax Vaccine (Through Leverage - Immune Enhancement) (November 5, 2007 Conference Call)
3. Arthritis (1995 United States Patent 5683986)
4. Avian Flu - when combined with the neuraminidase inhibitors Oseltamivir, (brand name Tamiflu) and with Zanamivir (Relenza) (June 2007)
5. Bioterrorism Rapid Response Tool (June 2006)
6. Bladder Cancer (November 5, 2007 Conference Call)
7. CFS/ME (NDA Accepted for Review July 2008, further animal studies due March 2009, FDA to respond May 2009 per Carter)
8. CFS – Heart Attack Mitigation Measure (February 22, 2009 Interview)
9. CFS – Reduction in Dependence on Concomitant Medications (Strayer – March 13, 2009 Presentation)
10. Chronic Obstructive Pulmonary Disease (1987 via Tobacco)
11. Colon Cancer (November 5, 2007 Conf Call)
12. Common Flu (Carter Quote 3/2006 as vaccine adjunct)
13. Coxsackie Virus
14. Dengue Fever virus (October 2003)
15. Ebola
16. Emphysema (1987 via Tobacco)
17. Equine Encephalitis Virus (October 2003)
18. Fibromyalgia (January 28, 2009 Interview)
19. Gulf War Syndrome (January 1997)
20. Hepatitis B
21. Hepatitis C
22. HHV-6
23. HIV/AIDS
24. Influenza (as a Vaccine Immune Enhancer) (December 14, 2007 Press Release).
25. Japanese Encephalitis Virus (October 2003)
26. Lung Cancer (1987 via Tobacco)
27. Malaria Vaccine (Through Leverage - Immune Enhancement) (November 5, 2007 Conf Call)
28. Malignant Glioblastoma (Brain Tumor) (November 5, 2007 Conference Call)
29. Malignant Melanoma
30. Monkey Lung Inflammation (June 2006)
31. Multiple Sclerosis (Carter 1995)
32. Myocarditis
33. Ovarian Cancer (November 5, 2007 Conference Call)
34. Panoramic Flu Protection (to fight flu mutation – Swine Flu) ( April 28, 2009)
35. Prostate Cancer (November 5, 2007 Conference Call)
36. Renal Cell Carcinoma
37. SARS
38. Septic shock subsequent to trauma, burns, surgery, transfusion, radiation therapy or chemotherapy (US Pat 5763417 - 1995).
39. Small Pox
40. Solid Tumors (November 5, 2007 Conf Call)
41. Swine Flu (in the Intranasal Dosage for Mucosal Administration) (April 27, 2009 Press Release)
42. Tobacco Mosaic Virus infection (1987 on the Tobacco itself)
43. Tuberculosis (Ampligen with AZT 1996 presentation)
44. Vascular Disease (1987 via Tobacco)
45. West Nile Virus
46. With DOGS [not the animal] - Vaccine Technology Platform (VACCINE ENHANCE) [This is a “refinement/enhancement” of proposed Use Number 5]
47. “911 Project” (November 20, 2001) – To Combat Small Pox and Terrorist Threats

Diseases Identified in 1995 Patent Application to be treated via topical cream or condom coating

48. Cytomegalovirus or CMV (sometimes classified as a herpes-type virus)
49. Herpes Simplex
50. Herpes Zoster
51. Localized skin cancer w/wo vital etiology
52. Susceptible sexually transmitted viral conditions and venereal infections including Chlamydia
53. Venereal infections in which the causative viral agent is primary or secondary to another venereal infection insensitive or less than adequately controlled by mismatched dsRNA - which secondary infection is being treated by another therapeutic modality (such as a concurrent gonorrheal infection for which the patient is receiving tetracycline therapy).

Oh by the way...

Your link lists small though significant improvements in one trial parameter which did show the drug's efficacy was evident. In other words the link supports the drug.

Here's a challenge for you or any others. Find any actual research that doesnt support any of the claims listed above.

And I always thought HAW HAW was one of the other noises donkeys make.

Jun 04 11:08 AM

[pr1:]

Funny, read the same BS hype about HEB and its wonder drug 13-14 years ago when I was trading it up and down. Guess Ampligen is the drug for the next decade - and always will be!

Jun 04 11:29 AM

[David White:]

Heb has continued its run up today. It is currently up about $.40 on the day. A DJ news item out today has likely helped.

Japanese National Institute of Infectious Diseases Scientists Identify Hemispherx Biopharma's Drug Technology As The "Most Promising Mucosal Adjuvant for Influenza"

Jun 04 01:53 PM

[Whippet:]

Great point. I work in the industry, on molecules that are actually efficacious. Here's two pieces of their "outstanding reputation with the FDA":

<On December 3, 2007, the FDA deemed the NDA submitted by the company on October 10, 2007 to be incomplete. Specifically eleven deficiencies were noted in the Clinical Section and three in the Pre-Clinical Section.>

<Hemispherx has on two occasions received warning letters from the FDA regarding its promotion of Ampligen as safe and effective before approval from the FDA.>

(both from Wikipedia listing for Ampligen)

Take profits back to your basis, at least, and let the rest ride if you're bullish. I do believe shorting would be foolish as well (especially because there are no options to hedge gap ups)- we just saw DNDN fly. My "gut" tells me this company is a fraud.


On Jun 03 11:10 AM jq1234 wrote:

> "The FDA has notified HEB that they need more time. If the FDA were
> certain of a rejection, they would not need any extra time. They
> could be running behind, but the FDA has taken a good look at the
> NDA by now."
>
> I read so many comments like this. It just showed these people do
> not know FDA process that well. Do you need a few examples that FDA
> asked for more time, then came back with complete response letter
> (seekingalpha.com/symbo...)? CRL could simply ask for clarification,
> could also ask for new clinical trial.
>

Jun 04 02:20 PM

[thinkb4uwrite:]

My intuition likewise is the FDA is not going to completely approve - probably due to cumulative history and agency's obligation to not support any dubious use. But I believe the CFS use will be approved. With the Japanese news and potential for enhancement of vaccines amidst a potential pandemic and all thats in the offing on Ampligen this now makes a different call for them. The drug represents too much potential for many parties and for varied reasons. So even if it does not get complete approval, it is likely to have a complete approval shortly after minor further requirements are met by the company.

Also, I believe, the share price will not likely fall.

Jun 04 03:09 PM

[David White:]

The W.H.O. data on the Swine Flu virus, Influenza A(H1N1). as of June 3 indicate 19,273 reported cases worldwide. Plus don’t forget to consider that a several fold multiple of these cases have likely gone unreported. Of the 19,273 reported cases, only 117 resulted in deaths. Still there are a number of countries that are having severe problems with it such as the U.S. (10053 cases), Mexico (5029 cases), and Canada (1530 cases). Perhaps of greater concern are the countries in the southern hemisphere where it is just starting to spread. They are in late fall, early winter (the traditional flu season). They have the potential to have severe problems before most people could be immunized. Some countries on this list are: Australia (501), Argentina (131), and Chile(313). They are perhaps the likeliest areas for the H1N1 to spread quickly. The W.H.O. is at alert stage 5. The pandemic stage is 6. The W.H.O. definitions are as follows:

Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.

Phase 6, the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way.

It seems to me that we are very near stage 6.


However, this is not the most worrisome thing to the W.H.O. They have been tracking the Avian Flu (H5N1) since 1996 (more seriously since 2003). There have been a number of cases of this in Egypt, India, Vietnam, etc. this year (2009). As far as I understand, they still don't think there is human to human infection. However, they are very worried. The statistics on Avain Flu are considerably worse than for the H1N1 (Swine Flu). There have been 433 reported cases of Avian Flu. Of these cases 262 of them resulted in death. This is considerably worse than the roughly 1 in 200 ratio of the Swine Flu so far.

Flu strains are very prone to mutate. It may only be a matter of time before the Avian Flu mutates to allow for human to human infection. If this happens, it sounds like people will be very glad to have the adjuvant, ampligen (from HEB), to take along with the vaccine. The acclaim it has gotten from both the Japanese and now the Italians is hard to ignore. The FDA may be evaluating ampligen for CFS efficacy, but they will likely think twice about giving it a bad name. It may be a critical drug for flu in the very near future. Ampligen’s promise for use against flu should give it a huge edge in its bid to get FDA approval for CFS. Let's not forget that there is the possibility that the Swine Flu may mutate into a more deadly form.

Jun 05 09:07 AM

[David White:]

The W.H.O. data on the Swine Flu virus, Influenza A(H1N1). as of June 3 indicate 19,273 reported cases worldwide. Plus don’t forget to consider that a several fold multiple of these cases have likely gone unreported. Of the 19,273 reported cases, only 117 resulted in deaths. Still there are a number of countries that are having severe problems with it such as the U.S. (10053 cases), Mexico (5029 cases), and Canada (1530 cases). Perhaps of greater concern are the countries in the southern hemisphere where it is just starting to spread. They are in late fall, early winter (the traditional flu season). They have the potential to have severe problems before most people could be immunized. Some countries on this list are: Australia (501), Argentina (131), and Chile(313). They are perhaps the likeliest areas for the H1N1 to spread quickly. The W.H.O. is at alert stage 5. The pandemic stage is 6. The W.H.O. definitions are as follows:

Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.

Phase 6, the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way.

It seems to me that we are very near stage 6.


However, this is not the most worrisome thing to the W.H.O. They have been tracking the Avian Flu (H5N1) since 1996 (more seriously since 2003). There have been a number of cases of this in Egypt, India, Vietnam, etc. this year (2009). As far as I understand, they still don't think there is human to human infection. However, they are very worried. The statistics on Avain Flu are considerably worse than for the H1N1 (Swine Flu). There have been 433 reported cases of Avian Flu. Of these cases 262 of them resulted in death. This is considerably worse than the roughly 1 in 200 ratio of the Swine Flu so far.

Flu strains are very prone to mutate. It may only be a matter of time before the Avian Flu mutates to allow for human to human infection. If this happens, it sounds like people will be very glad to have the adjuvant, ampligen (from HEB), to take along with the vaccine. The acclaim it has gotten from both the Japanese and now the Italians is hard to ignore. The FDA may be evaluating ampligen for CFS efficacy, but they will likely think twice about giving it a bad name. It may be a critical drug for flu in the very near future. Ampligen’s promise for use against flu should give it a huge edge in its bid to get FDA approval for CFS. Let's not forget that there is the possibility that the Swine Flu may mutate into a more deadly form.

Jun 05 09:08 AM

[Wisty:]

On Jun 04 01:42 AM Michael Murphy wrote:

> I don't own the stock, because the only published data on their Phase
> III trial showed it did not meet statistical significance over the
> placebo. But I am interested to know why others think it will be
> approved anyway. Patrick #797, thanks for the Biomed Reports link.

Can you give more information on this claim of no statistical signficance? Feuerstein also claimed that in his article a week ago, but the abstract he cited did not support his claim.

Jun 05 09:56 AM

[ladders11:]

You could drive a truck through the holes in this story.

Jun 05 01:22 PM

[frogmatic:]

Based on today's price action (down 27%, plus another 6% after hrs so far) I'm guessing the "pump" is complete, and the "dump" has begun. But if you bought at the top, don't worry; you can just wait until HEB puts out another press release in 3 years or so, claiming that a study (from a research group in Papua New Guinea no doubt) shows Ampligen is efficacious as a fat burner, wrinkle smoother, cancer cure, pain reducer and legal psychadelic drug. And it's less filling AND tastes great.

Jun 05 05:55 PM

[David White:]

frogmatic: There is very little doubt from comments by the Japanese/Australian collaboration that ampligen is a valuable adjuvant for flu. Dr. Reeves (CDC) would seem to think that it is valuable for CFS. What the decision of the FDA will be, I have no inside information.

Adam Feuerstein wrote two negative articles about HEB that appeared on Yahoo finance on Friday. It is likely that those articles were responsible for the stock sell off Friday. Several commenters above have had very negative things to say about Mr. Feuerstein (both his opinion of HEB and his level of biomedical knowledge). They have also disputed his previous negative comments. I am not that familiar with Mr. Feurerstein, so I don't want to speculate about him. I also have not read the articles (only the titles). I have not paid for the Street.com service. When I click on the articles, I get junk.

Mr Feuerstein is one voice. Several of the commenters in this article at least claim to be much more knowledgeable than Mr. Feuerstein (and they likely are). Dr. Reeves is almost certainly more knowledgeable. It seems unlikely the FDA will reject the NDA for ampligen for CFS outright. They might ask for more information before approval, or they may approve ampligen. We will have to wait to see what happens. The good PR recently should help. The fact that ampligen would be an orphan drug for CFS should help. The fact that HHS held an event described as a "love-in for ampligen" on May 28 should help. I think HEB probably has a floor af about $1, after the good PR it has received for ampligen as an adjuvant in flu treatment. It may have a ceiling of $10 to $20. It is hard to say. I still think the odds of approval are better than 50%. You must decide your own course for youself.

Jun 06 10:36 PM

[med-buy@hot...:]

I just bought in the stocks of HEB. It is weird for me to read so much controvercial comments on the company. It is very easy for publics to find the credit problems of the company if it is true the that the company/its CEO is intended to manunipulate the news releases. Would the company be so idiot to do it? I also found that all negative comments are based on some logicals. I had some experiences in applying for new drug application in other countries. It is very hard to predict the exact time when the government will give you the final decisions on the new drug application although they give companies time frame. It does not make sense to probe if the applicaiton will be approved or not unless you were an insider and knew the details of the application contents. In terms of the result of clinical trials, it is very scientific and there are lot of different explanations from diffferent prospectives. It totally depends on how to read it. I read the reports from some websites and was ever very concerned about my investment.

I am not a fan of the company but just wondering if some negative comments have value to investors.


On Jun 03 07:01 AM herememoney wrote:

> I am Long HEB. However, I was doing some research into how "invitation
> by italian government" could be spun and tried to find out if other
> companies also have gotten invited (funded invite) to this conference.
>
> 1. I am yet to find a website for this conference with a simple search
>
> 2. An "invitation" could mean, travel funding scholarship for one
> scientist from the company, which the company is putting out as a
> press release and making it sound as if the entire company is being
> invited for major drug production operations. NOT YET.
> Guys I spent two hours (and I am VERY good at locating info on the
> net) and I still cannot find how much funds were released in Japan
> or the actual conference in Italy. If any of you know the real info
> (not HEB press release) how about posting it here...?

Jun 07 12:23 PM

[MIK1:]

Some people ask for links about research from Japan. Here attached a link about a paper published on May/09 from National Institute of Infectious diseases of Japan

www.dovepress.com/getf...

What about Italy? I found the program of the conference in Rome. HEB is named as a guest, as any other companies. I dont believe its presence was relevant.

Jun 08 08:07 AM

[David White:]

Here's some informative information I got from my new InfoNgen account:

First, Reuters reported that Japan plans to produce enough H1N1 flu vaccine to treat 20 million people by the end of year. The company has been in discussions and testing their flu platforms with that country for quite some time.

“The highest level of the Japanese government and public medical community is now focused exclusively on our product,” Carter told BioMedReports last week. “They stopped working on all other adjuvants (boosters) and are only working with this one because they’ve found that it enhances the vaccines by 100 fold.”

Second, Prohost Biotechnology, an independent publication which evaluates biotechnology companies, their products, technologies, scientists and managers, as well as their finances for fund managers, investors, medical professionals issued a report on Friday calling both Hemispherx's Ampligen and Antigenics’(Nasdaq:AGEN) QS-21 Stimulon the two most indespenable vaccine adjuvants. "We need adjuvants and Ampligen is among those whom we really need to have available to infectious disease and oncology specialists" said the report.

Peer-reviewed medical publications, have reported key findings with a view to offering a rationale for the use of Ampligen as a potentially safe adjuvant- one recently published one from Cardiff Univeristy even summizes that the drug is capable of overcoming tumour-related immune tolerance mechanisms in a clinical setting.

The company is waiting for an approval decision for Ampligen's application to treat Chronic Fatigue Syndrome from the FDA. That decision should come on Tuesday, if not sooner according to previously released news.


You should also be aware that Michael Catalin Vlaicu (seekingalpha contributor) wrote a new, informative article about Adam Feuerstein's articles on HEB from last Friday entitled, "Hemispherx's Ampligen: Fact vs. Fiction". It is worth reading.

seekingalpha.com/artic...

Jun 09 05:35 PM

[David White:]

I should add HEB is tanking after hours a bit today because the company announced that they filed a shelf registration with the SEC to sell $150M of common stock, preferred stock, debt securities, ans warrants. No doubt the stock is down on dilution concerns. This has no bearing on the FDA approval. If anything it may mean that the company expects FDA approval (i.e. a higher stock price in the near future).

Jun 09 05:39 PM

[David White:]

WHO is holding a meeting today, June 10, to determine if they are going to raise the Swine Flu threat level to 6 -- a pandemic. Australia now has reported more than 1200 reported cases. The US has reported more than 13,200. Mexico has reported more than 5700. Canada has reported over 2400. Chile has reported about 1700. This looks like it meets the criteria for moving from stage 5 to stage 6. Plus the outbreaks in Chile and Australia are particularly significant as they are about to enter their winter season (flu season).

The criteria are:
Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.

Phase 6, the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way.

If you consider Mexico, the US, and Canada as one region, you now see there are significant outbreaks in two other regions -- Australia and Chile. I expect the W.H.O. will raise the threat level to 6 -- a pandemic.

Jun 10 02:53 PM

[David White:]

Today the W.H.O. declared the Swine Flu a pandemic. This is actually very good news for HEB. First one of the applications for ampligen is as an adjuvant for flu vacccine. The Japanese Institute of Health has given it rave reviews in this regard. The Swine Flu pandemic will no doubt bring HEB some more business.

More than that though, this really puts a lot of pressure on the FDA to approve ampligen for Chronic Fatigue Syndrome. Really there is no doubt that it is at least somewhat effective. Additionally it would be an orphan drug. It is expensive, but it would help a lot of people who suffer from the illness. Then the real question is, "Is it safe?" From what I understand it is. However, the FDA still has to decide this (in conjunction with its efficacy).

Still the FDA is a bureaucracy among its other traits. If you were a bureaucrat, would you want to be on record as turning down an orphan drug, especially when large numbers of people in the world take it safely for flu??? I don't think I would. The FDA likes to err on the side of caution. This pandemic declaration will likley make them a little less cautious. Ampligen is clearly an effective adjuvant for flu vaccine. There is little doubt it will be used for that by large numbers in the very near future.

Jun 11 06:13 PM

[David White:]

Good news for HEB again today. HEB's partner in Japan, Biken, has decided to expand their flu vaccine manufacturing facilities 5-fold as a result of the pandemic declaration for Sine Flu. This should translate into more ampligen sales for HEB.

Jun 12 10:09 AM

[David White:]

The Street.com/stockpkr is at it again. This time they are saying that HEB made the $150M shelf filing so they can take advantage of the run up in price. The thought seemed to be that they wouldn't need it if the product was approved. This is obviously not the case. HEB needs the money. They likely are hoping for a good pop on ampligen for CFS approval. This would likely double or triple the market cap. Then $150M would not be as big a part of the total company worth. HEB has many more uses for ampligen that need approval. They will need studies. This is just the first. It is a valuable first step. If it gets approved, it will greatly help to expedite the many other approvals necessary for ampligen (see comment above for a list of uses). The guy doing the shorting will likely do great until a stock finally explodes on him more quickly than his stop can cover. He was not impressive. Even James Altucher said he had disagreed with Adam Feuerstein about DNDN. The implication was that James was not signing up for the shorting nonsense. If the stock rises dramatically, the dilution factor will be much less. My thinking is that there is a 75% chance or better of approval. If approved, the stock may well triple or more in value. If rejected, the stock may lose $1.50 or so. There has been a lot of positive flu news lately. To me this seems like a calculated risk that should work in my favor if continuously taken over the long run.

Loss: 0.25 X $1.50 = $0.375
Gain: 0.75 X $5.00 = $3.75

In short the risk to reward ratio is about 1 to 10. That's usually a good bet in my book.

Jun 12 06:47 PM