Buy Hemispherix Before Ampligen's FDA Approval

Hemispherix Biopharma (HEB) is awaiting news from the FDA on its NDA application for Ampligen as a treatment for Chronic Fatigue Syndrome. The stock has soared from about $0.38 in March to a high of $4.54. Ampligen has received rave reviews for its efficacy as a flu vaccine adjuvant lately. No less than the Japanese Institute of Health has raved about it. It will clearly be used as a flu adjuvant. It also has myriad other likely uses, most of which HEB has yet to apply for. Longer term this company looks likely to do well. It may get bought out. Shorter term, it is waiting to hear from the FDA.

To me it seems likely that HEB will gain approval. Are some people selling because there is something wrong? That is always possible. However, it seems more likely that people are selling because HEB made a $150M mixed shelf offering recently. Since the market cap of the stock is only approx. $150M, this would have a tremendous dilutory effect on the stock.

How do you decide what is a good price to get in at? I don't think there is a good solution from a fundamental standpoint. There are a lot of variables. Still the prospects for the company do look good for the future. I would be very surprised to see this company fail. I would be very surprised to see Ampligen flop.

I look for buy signals in this case. Yesterday, we got one. HEB went down to $1.50 at the low today. This was near touching its lower Bollinger Band. It snapped quickly back to $1.80. There is tremendous technical support at approx. $1.50. The future looks bright for Ampligen. Drugs that get to this stage in the FDA approval process historically have an 80% likelihood of approval. Ampligen for CFS would be an orphan drug. This further enhances its chances of approval. If you get a chance to buy HEB at $1.50 to $1.80, it is likely a good risk/reward play. HEB should gain approval within the next couple of weeks. The stock would likely shoot upward on that news.

The downside risks are that the company itself will start selling a lot of stock before it gains FDA approval for Ampligen. The market may completely tank in the next two weeks. This would likely drive HEB down (all speculative growth stocks are hit hard in huge downturns). Finally HEB's NDA for Ampligen for CFS could be rejected. From the evidence I have seen, this is unlikely. The probable worst case scenario is that HEB could be asked to do further tests (provide further informational data). This would hurt the stock price considerably, but fortunately the odds of this are much less likely than approval. Ampligen would be an orphan drug for CFS. It has been shown to be at least reasonably effective. It has been shown to be safe in this case. It has also been shown to be safe in a lot of work done for flu.

One caveat is that a new financial report came out on HEB yesterday morning. I am guessing that this may have had something to do with the negative trend of the stock. You have to pay for this report, so I have not bought it. Still it seems unlikely that it really added anything but another opinion about the stock. The stock is a risk. To me it seems like it might be a good one at its current price. Approval could come tomorrow. HEB expects to hear from the FDA in the next two weeks. The markets should wait until after June ends to really tank (if they do). The mutual funds will likely be doing some window dressing buying at the end of the quarter (the end of this month). That should prevent a near term slaughter from happening.

Good luck investing. This is a very uncertain time. Being in cash on the sideline is not necessarily a bad strategy.

Comments

[horseupdates:]

www.accessdata.fda.gov...

VISIT THAT SITE AND WRITE THE FDA ON WHY YOU THINK AMPLIGEN SHOULD BE APPROVED!

Jun 24 04:08 AM

[User 435971:]

A technical Analysis on HEB with all the key levels to watch out for.
Also very bullish on this stock.

Jun 24 08:07 AM

[chalupa:]

This is a huge buy under $2.50

Jun 24 09:31 AM

[David White:]

Supporting my article, Market Pulse came out with a rating of ATTRACTIVE on HEB this morning.

Jun 24 10:05 AM

[oldetimer:]

Adam Feuerstein of The Street.Com has a completely different take on HEB; extremely negative (please read it). I am very interested to learn other's opinions of his article.

Jun 24 02:57 PM

[rrtzmd:]

...Merck discovered poly I:C around 1967-68, messed with it for a while and then they put it where it belonged -- in the garbage can...HEB's CEO modified it by adding uridylic acid and produced "ampligen" -- a compund which has REPEATEDLY demonstrated its value at separating naieve investors from their money for over 30 YEARS with NOTHING to show for it...more importantly well, perhaps, ampligen has been available in Canada and Belgium for about 13 years now...and some other companies had licensed it to market in Spain, England, and elsewhere...take a look at the revenues on most recent 10Q -- ZERO!...that sums up ampligen's popularity pretty well, I think...walks like a scam, smells like a scam, and goes "SCAM, SCAM, SCAM!!"...

Jun 24 03:33 PM

[littlebuffet:]

I took a quick look at this about a month ago and decided to pass. I'm glad I did. CFS is a name for a complex of symptoms with a large and somewhat indeterminate set of causes. Attempting to get the statistical significance the FDA requires (to show efficacy) for an indication with many causes is a fools errand...

I will be surprised beyond belief if it is approved

Jun 24 11:51 PM

[David White:]

HEB is being added to the Russell 3000 Index at the end of this month. If people believed this stock was going to be a flop, it would not have gained enough acclaim to be added to the Russell 3000 Index. This status will also mean that a number of funds will be forced to buy the stock. This should push the stock higher.

Obviously the approval of Ampligen for CFS is still of primary importance to a major move upward in the stock.

Jun 25 12:17 AM

[David White:]

littlebuffet:

From "The World Journal of Biological Psychiatry":

"Chronic fatigue syndrome (CFS) is now recognized as a medial disorder. In contrast to recent related reports, the present review focuses primarily on aetiological aspects of CFS. Four major hypotheses are reviewed. (1) Although CFS is often associated with viral infection, the presence of viruses has as yet not consistently been detected. (2) It is not clear whether anomalies of the HPA axis often observed in CFS, are cause or the consequences of the disorder. (3) Immune dysfunction as the cause of CFS is thus far the weakest hypothesis. (4) The psychiatric and psychosocial hypothesis denies the existence of CFS as a disease entity. Accordingly, the fatigue symptoms are assumed to be the consequence of other (somatic) diseases. Other possible causes of CFS are oxidative stress and genetic predisposition. In CFS cognitive behavioural therapy is most commonly used. This therapy, however, appears to be ineffective in many patients. The suggested causes of CFS and the divergent reactions to therapy may be explained by the lack of recognition of subgroups. Identification of subtypes may lead to more effective therapeutic interventions."

There are probably more definitive articles. However, this should give you a clue that they have found a strong correlation between CFS and viral infections. Since we know from the flu virus vaccine with Ampligen adjuvant that Ampligen is terrifically helpful in engendering flu immunity, it is not much of a leap to believe that it would help immensely in treating CFS. Ampligen has also been shown to improve immune funtionality. Another of the posible causes of CFS that have been suggested. I could go on. Basically the breadbasket of possible causes of CFS all seem to be things which would likely be improved by treatment with Ampligen. Since Ampligen does not seem to be harmful, it would seem to be something that should be approved for use to treat CFS symptoms.

In another study:
"If you have chronic fatigue syndrome (CFS) and you're female, you probably woke up this morning with a really low cortisol level. A study accepted for publication in the Journal of Clinical Endocrinology & Metabolism (JCEM) links low levels of the hormone to severe fatigue in female CFS patients - but not in male patients. "

Whether or not Ampligen is effective against all possible causes of CFS is not necessarily at issue. If it has been shown to be generally effective against CFS (or some large percentage of CFS patients), the actual cause does not necessarily have to be proven. HEB only has to prove effectiveness and safety. From what I understand, they have done this. Plus the possibility of viral and immune system causes for a good percentage of the CFS cases links in well with the research done on Ampligen as an adjuvant for flu vaccines. That work provides further indirect evidence that Ampligen should be approved. Medical scientists have often in the past developed treatment regimens without knowing the precise cause of a disease. That is quite simply nothing new. The big issues are efficacy in a substantial percentage of cases and safety.

In sum I think the odds are excellent that Ampligen for CFS will be approved.

Jun 25 12:51 AM

[David White:]

I have found yet another article on CFS. This one seems to provide the best overall explanation of CFS and its causes that I have seen.

chronicfatigue.about.c...

Jun 25 01:11 AM

[David White:]

Yet another (more recent article) from the CDC. this one suggests that genetics may be the root cause of CFS. However, this does not take away from the fact that Ampligen still does a good job of helping to ameliorate (or cure) the disease. The link is below.

www.bio-medicine.org/m.../

Jun 25 01:23 AM

[User 436462:]

It amazes me what some people believe. F boy are you kidding. Look at his boss Cramer on Youtube and then come back and say you want to know what he's saying. Full of lies. F boy's articles are full of them. Dr Carter conducted an interview answering each of F boy's comments point by point and the boy cries "He didn't answer me", oh please. Other false and misleading statements by F boy or Lykes, "The FDA must send a candidate thru an Advisory Committee" Patently false. "The FDA hasn't delayed it's decision it was made up by HEB attorney's" That would put the company in a very bad position legally. If these are the people you want to listen to, you might get a small downward move since they only tear down stocks, but don't get left holding the bad when approval comes.

Jun 25 06:08 AM

[rrtzmd:]

...talk about "begging the question"!...as pointed out, ampligen has been approved for use for 13 years in Canada and Belgium...ampligen sales?...ZERO!....other companies had licensed it for sale in other countries...ampligen sales?...ZERO!...what do you want -- a hundred foot high blinking neon sign saying "SCAM!"?!

Jun 25 08:05 AM

[User 436517:]

I used to be a broker, and had the CEO of this company come through our offices to do his dog and pony show. Nice brochures, great story about Ampligen and CFS, very exciting stuff. Good to see nothing has changed and they're still at it fourteen years later. There aren't a lot of outfits that can milk one dry cow that long. Good job by them!

Jun 25 08:39 AM

[David White:]

The specific cause of CFS is not the biggest issue. For instance, CFS could be purely genetic. However, this may then predispose individuals to greater viral susceptibility, etc. If Ampligen's only role is in fighting off these essentially secondary problems, which are often present, it is still a good treatment. It should be approved.

I have often taken antibiotics, when I am very sure I have a viral infection. The reason is simply that I often get secondary bacterial infections in my lungs during a bad viral infection. When the antibiotics help to cure the secondary infections, they make it easier for my body to recover from the viral infections. If all Ampligen does is help in this indirect way, it is still helpful. It should still be approved.

Jun 25 11:25 AM

[ladders11:]

David, HEB is a sick joke. Sorry. Anyone who buys this stock will lose money.

Jun 25 12:08 PM

[rrtzmd:]

...do your antibiotics cost $15,000 for the treatment of your "possible" secondary infection?...and you're still begging the question...ampligen is available in Canada and Belgium...other companies have licensed it to sell in other countries...current revenues from ampligen -- ZERO!...hint, hint: SCAM!!!!


On Jun 25 11:25 AM David White wrote:

> The specific cause of CFS is not the biggest issue. For instance,
> CFS could be purely genetic. However, this may then predispose individuals
> to greater viral susceptibility, etc. If Ampligen's only role is
> in fighting off these essentially secondary problems, which are often
> present, it is still a good treatment. It should be approved.
>
> I have often taken antibiotics, when I am very sure I have a viral
> infection. The reason is simply that I often get secondary bacterial
> infections in my lungs during a bad viral infection. When the antibiotics
> help to cure the secondary infections, they make it easier for my
> body to recover from the viral infections. If all Ampligen does is
> help in this indirect way, it is still helpful. It should still be
> approved.

Jun 25 12:20 PM

[AssetReset:]

Thestreet.com (Kramer) is Negative?
The Signal: BUY BUY BUY BUY BUY

Thestreet pushes hindsight like it is investment advise


On Jun 24 02:57 PM oldetimer wrote:

> Adam Feuerstein of The Street.Com has a completely different take
> on HEB; extremely negative (please read it). I am very interested
> to learn other's opinions of his article.

Jun 25 03:13 PM

[AssetReset:]

Thestreet.com (Kramer) is Negative?
The Signal: BUY BUY BUY BUY BUY

Thestreet pushes hindsight like it is investment advise


On Jun 24 02:57 PM oldetimer wrote:

> Adam Feuerstein of The Street.Com has a completely different take
> on HEB; extremely negative (please read it). I am very interested
> to learn other's opinions of his article.

Jun 25 03:13 PM