HEB: Pressure Mounting on FDA to Approve Ampligen for Chronic Fatigue

Today AP reported that Andy Burnham, the British Health Minister, said the UK could have up to 100,000 new cases of swine flu per day by the end of August. Currently we have seen only about 100,000 reported cases worldwide. If the cries of Andy Burnham are anywhere close to accurate, the world may be in for a huge health crisis. The UK won't be the only country that has big problems. The North American countries seem like a sure bet to join in. Japan is very worried. I'm sure many European countries, the former USSR countries, and China will get their share too.

As I understand it, there is a swine flu vaccine. However, the swine flu viruses they are using to make the vaccine provide only about half the normal usable active ingredients. This is apparently such a big problem that they do not think they can have the huge quantities of the vaccine needed by the world ready until the end of 2009. This would likely be too late to prevent much of the damage to both health and economies.

One solution (or ameliorating factor for this problem) may be to use adjuvants. The Japanese Institute of Health has been doing considerable research in this area lately. Japan seems likely to try this. Ampligen (from Hemispherx BioPharma (HEB)), the same factor that is being put forth to combat Chronic Fatigue Syndrome (CFS), has proven to be the most successful adjuvant in trials with flu virus vaccines. It has made the flu vaccines up to 100 times more effective. The Japanese seem likely to use it as part of their flu vaccine (i.e. so they can use less "flu material" per vaccine shot). The US might even be forced to use it, even though the FDA has approved no adjuvant for use with flu vaccines yet.

How does this effect Ampligen for CFS approval? Ampligen has proven reasonably safe for use to combat CFS. It has also been shown to be effective. If the FDA approves Ampligen for use against CFS, it will be much easier for the US (if it has to) to approve the use of Ampligen with flu vaccine. It is my understanding that Ampligen can make the flu vaccine approximately 100 times more effective. If this is so, flu vaccine providers could use much less "flu material" to make up the vaccine (say 1/5 or even 1/10 as much). This would make the vaccine material the US received early go a much longer way. This might help avert a major pandemic. From the HEB studies for Ampligen for CFS, Ampligen is safe. From the Japanese studies, Ampligen is safe; and it is effective as a flu vaccine adjuvant. There does not appear to be a good reason not to use it.

If the FDA denies Ampligen approval for CFS, they will have a hard time approving it for use in a flu vaccine. If the Japanese use Ampligen successfully in their flu vaccines, the US will look extremely foolish if US citizens in the 100,000's or millions get swine flu because they were unable to get a vaccination in time. The FDA will likely want to leave their options open. This latest news from the UK Health Minister should tip the scales in favor of Ampligen approval for CFS (if there was a question in the first place).

There is very limited downside to Ampligen approval. It is apparently safe. It is reasonably effective. The only gripe that I have heard is the price. The FDA should realize their decision is not cast in stone. They can always re-evaluate. They should realize that they may be taking a bigger risk by not approving Ampligen for CFS.

Already there is an 80% chance of aproval for drugs that make it as far as Ampligen for CFS has. It will be an orphan drug. This pushes the odds of approval still higher. The need for Ampligen near term as a flu virus vaccine adjuvant may push Ampligen approval for CFS odds to nearly 100%. The approval decision is overdue by many weeks. The FDA should take action soon. Plus HEB will soon get a big step up in the use of Ampligen as a flu vaccine adjuvant. Both of these things should make HEB a lot more profitable in the very near future. This should positively impact the stock price.

Comments

[David White:]

Jon Doe: I am currently long HEB. However, it is a modest position.

I should clarify that the Japanese and Australian collaboration has been researching Ampligen's effectiveness as both an H1N1 (swine flu) and an H5N1 (avian flu -- killer flu) adjuvant. Ampligen has been found to be very effective as an adjuvant. The researchers have tried other adjuvants. Ampligen has been found to be the most effective.

Jul 14 12:21 PM

[cruelsister:]

As I also follow this stock I would like to know the source of this JIH info. All I've ever come across have been statements from the company which have constituted personal statements and references to older data.

Jul 14 12:38 PM

[jq1234:]

"It is my understanding that Ampligen can make the flu vaccine approximately 100 times more effective. If this is so, flu vaccine providers could use much less "flu material" to make up the vaccine (say 1/5 or even 1/10 as much). This would make the vaccine material the US received early go a much longer way. This might help avert a major pandemic. From the HEB studies for Ampligen for CFS, Ampligen is safe. From the Japanese studies, Ampligen is safe; and it is effective as a flu vaccine adjuvant. There does not appear to be a good reason not to use it."

Your understanding? It is wrong. Where did you get "from Japanese studies, Ampligen is safe"? Japanese studies were done in vitro, never tested on human. How do you know it is safe?

Your article is mostly based on conjecture. If FDA makes decision based on this type of standard, everyone in this country should be worried.

Jul 14 01:06 PM

[User 447450:]

How does denial for CFS effect it's chances as an adjuvant for flu vaccines? The FDA looks at it separately.

Jul 14 01:10 PM

[David White:]

User 447450: longer term the effect is probably very small. In the shorter term, if Ampligen is approved for CFS, Ampligen is much more likely to get fast tracked for flu. It is also a bit more likely to get approved, when that time comes.

Jul 14 08:15 PM

[David White:]

jq1234: Ampligen has been tested as safe in humans for CFS. Basically it is the same thing in both cases. The CFS dosing would be continual (much heavier overall). If Ampligen is safe in humans for CFS it is extremely likely to be safe in humans for flu. However, they do have a Phase II trial going in humans for Ampligen with flu. The Japanese have conducted studies in animals (very close to humans). Your comment about there only being in vitro studies is a little out of date. The link to that article is below:
www.accessmylibrary.co...

Jul 14 08:20 PM

[David White:]

Here is another link to Ampligen being used as an adjuvant: www.redorbit.com/news/...

And another:www.globenewswire.com/...

Jul 14 08:33 PM

[Jon Doe:]

David,

The first link talks about HEB completing enrollment in the study. That means nothing - the study could show that Ampligen does not work as an adjuvant.

The second link goes back to a study in 2007. HEB has not received approval in that case either.

Jul 14 08:48 PM

[David White:]

Jon Doe:
The animal studies do show it works. I have read other papers, including the one that tells of it improving flu vaccine's effectiveness. I just didn't find it again off hand. The human study by the Aussie's is just getting started. However, they would not even be starting it if they weren't fairly sure it would work. Here are peer reviewed references from the Japanese National Institute of Infectious Diseases from the HEB web site:

www.ncbi.nlm.nih.gov/p...
www.ncbi.nlm.nih.gov/p...
www.ncbi.nlm.nih.gov/p...

The following are appropriate news releases:
finance.yahoo.com/news...
finance.yahoo.com/news...
finance.yahoo.com/news...
finance.yahoo.com/news...
finance.yahoo.com/news...

Also here's another one indicating that the swine flu vaccine tests themselves are just starting in humans: www.abc.net.au/news/st...

Sorry I didn't find the 100 fold more effective article. But I have read it. I believe it was in animals. I hope these satisfy you to some degree.

Jul 14 10:53 PM

[David White:]

Here is an article about use in humans:
seekingalpha.com/artic...

Here is an article attempting to predict the effect of Ampligen approval for CFS to the HEB stock price:
www.stockshaven.com/po.../

I still haven't found the 100 fold enhancement due to Ampligen article. However, the article I read was very scientific in nature. it was not just a news release.

Jul 14 11:10 PM

[Jon Doe:]

I'm only going by what is in the articles you have linked to, David.

Ampligen has been around for ages and is as yet not approved by the FDA for any use (AIDS/CFS/Flu virus adjuvant have all been touted as potential uses).

While I may fall flat on my face if it gets approved tomorrow, I believe that it is just one gigantic scam to con people into giving them money.

I don't think their current product portfolio and their cash burn rates point to HEB being a viable business without additional capital injection. This explains why they have an SEC filing to raise more cash by selling shares and/or bonds.

Jul 15 01:29 AM

[David White:]

Jon Doe: I am not sure you understand how complex and long the approval actually is. One use always has to be the first. HEB has a number of other on going development efforts. There are myriad possible uses. Only at the end of the development effort do you even submit an NDA. HEB is waiting on the approval (or rejection of the NDA for CFS). I was merely saying that some work has been done on Ampligen as an adjuvant for flu vaccine. This could get fast tracked due to the H1N1 (swine flu) and the H5N1 (the avian flu). Approval of Ampligen for CFS would likely speed the process along.

If you read the articles I referenced for you, you will see that at least three major governments (other than the US) are seriously interested in Ampligen for a flu vaccine adjuvant. HEB is not a fly by night company. It is getting worldwide recognition. It is getting recognition from the CDC. On the other hand it is still in a development stage. The Ampligen approval for CFS would make it much more profitable. This might make the stock soar like Dendreon's. It is still a high risk company, if that is what you mean. It is also a high reward company. From its current price, the stock would likely at least triple on approval. On of the articles above estimated a $15 share price. Still that is only the first step. As you noted HEB has many more approvals to get. It is all a question of risk and reward. If you think the risk of a rejection is only say 20%, it may be a great risk to try to triple you money in the next month by investing in this stock. As long as you don't bet everything on this one stock you're fine. An 80% chance of a 200% profit in the next month or so is good. If you kept making such statistically good investments, you would on average make 160% on your money in what might average a few months each time. That is good in my book. If you are uncomfortable with this type of investment, don't make it. It's as simple as that.

By the way most Biotech companies do require cash injections to get them going. In fact you could say that of most start ups. Biotech start ups with important NDA approvals pending are much better bets than simply betting on a start up.

I should add that I never said that Ampligen had been approved for anything else. You are quite simply puting false words in my mouth. It is inappropriate. I have contended that the FDA might wish to quickly approve Ampligen as a flu adjuvant soon after the Ampligen for CFS approval. This latter approval would make it easier to fast track Ampligen as a flu adjuvant. It would also make it slightly easier to approve Ampligen as a flu adjuvant.

If your contention that this is entirely a scam were true, it is unlikely that the government health organizations of 4 major countries would be heaping praise on HEB. These four main culprits are the U.S., Japan, Australia, and Italy. This does not mean others do not recognize HEB's work as significant. I believe Russia is interested.

Naturally all this does not guarantee approval. However, it certainly makes one believe that this is a lot more than a scam. Your wording in that case was inappropriate or uneducated. I am not sure you even bothered to read the articles I took the time to reference for you.

I make no claims to being absolutely sure that Ampligen for CFS will be approved. I am merely playing the odds and the profit potential. I do not have all of my money wrapped up in it for the simple reason that it could be denied approval, or approval could be postponed. On the other hand, I believe it is a great risk/reward opportunity.

Jul 15 02:51 AM

[dreamdivers:]

David, you state that "at least three major governments (other than the US) are seriously interested in Ampligen for a flu vaccine adjuvant." and that "government health organizations of 4 major countries would be heaping praise on HEB. These four main culprits are the U.S., Japan, Australia, and Italy. This does not mean others do not recognize HEB's work as significant. I believe Russia is interested." Other than some work done in Japan, I have never seen anything like "heaping praise" from the US, Italy, or Australia. What do you base these claims on? And you believe Russia is also interested? Why? On what basis? I am frankly very surprised at how little basis you have provided so far for such sweeping claims.


On Jul 15 02:51 AM David White wrote:

> Jon Doe: I am not sure you understand how complex and long the approval
> actually is. One use always has to be the first. HEB has a number
> of other on going development efforts. There are myriad possible
> uses. Only at the end of the development effort do you even submit
> an NDA. HEB is waiting on the approval (or rejection of the NDA for
> CFS). I was merely saying that some work has been done on Ampligen
> as an adjuvant for flu vaccine. This could get fast tracked due to
> the H1N1 (swine flu) and the H5N1 (the avian flu). Approval of Ampligen
> for CFS would likely speed the process along.
>
> If you read the articles I referenced for you, you will see that
> at least three major governments (other than the US) are seriously
> interested in Ampligen for a flu vaccine adjuvant. HEB is not a fly
> by night company. It is getting worldwide recognition. It is getting
> recognition from the CDC. On the other hand it is still in a development
> stage. The Ampligen approval for CFS would make it much more profitable.
> This might make the stock soar like Dendreon's. It is still a high
> risk company, if that is what you mean. It is also a high reward
> company. From its current price, the stock would likely at least
> triple on approval. On of the articles above estimated a $15 share
> price. Still that is only the first step. As you noted HEB has many
> more approvals to get. It is all a question of risk and reward. If
> you think the risk of a rejection is only say 20%, it may be a great
> risk to try to triple you money in the next month by investing in
> this stock. As long as you don't bet everything on this one stock
> you're fine. An 80% chance of a 200% profit in the next month or
> so is good. If you kept making such statistically good investments,
> you would on average make 160% on your money in what might average
> a few months each time. That is good in my book. If you are uncomfortable
> with this type of investment, don't make it. It's as simple as that.
>
>
> By the way most Biotech companies do require cash injections to get
> them going. In fact you could say that of most start ups. Biotech
> start ups with important NDA approvals pending are much better bets
> than simply betting on a start up.
>
> I should add that I never said that Ampligen had been approved for
> anything else. You are quite simply puting false words in my mouth.
> It is inappropriate. I have contended that the FDA might wish to
> quickly approve Ampligen as a flu adjuvant soon after the Ampligen
> for CFS approval. This latter approval would make it easier to fast
> track Ampligen as a flu adjuvant. It would also make it slightly
> easier to approve Ampligen as a flu adjuvant.
>
> If your contention that this is entirely a scam were true, it is
> unlikely that the government health organizations of 4 major countries
> would be heaping praise on HEB. These four main culprits are the
> U.S., Japan, Australia, and Italy. This does not mean others do not
> recognize HEB's work as significant. I believe Russia is interested.
>
>
> Naturally all this does not guarantee approval. However, it certainly
> makes one believe that this is a lot more than a scam. Your wording
> in that case was inappropriate or uneducated. I am not sure you even
> bothered to read the articles I took the time to reference for you.
>
>
> I make no claims to being absolutely sure that Ampligen for CFS will
> be approved. I am merely playing the odds and the profit potential.
> I do not have all of my money wrapped up in it for the simple reason
> that it could be denied approval, or approval could be postponed.
> On the other hand, I believe it is a great risk/reward opportunity.

Jul 15 10:45 AM

[cruelsister:]

The only basis for the claims has been from the company, which, as I posted previously, provides links to old animal studies and anecdotal asides about how much organizations love the drug. Mr White would certainly not be the first person fooled by Company propaganda.

Jul 15 11:21 AM

[dreamdivers:]

Yes, but in some cases I don't think there is even company propaganda for Mr. White to claim as a basis. Australia? Russia? Attending a conference in Italy?

Jul 15 12:24 PM

[cruelsister:]

I've heard (haven't read) of a recent interview with some penny-stock rag by the CEO which seem to parallel these statements.

Certainly nothing via an Index Medicus search.

Jul 15 01:42 PM

[oldetimer:]

David, how do you respond to all the negative comments specifically
espoused by Adam Feurstein of "The Street.com"? I have been a shareholder of HEB, on and off, for 2-3 years. His comments do not seem to be unreasonable, and he sounds "authoritative". If it was not for him I would take a larger long position.

Jul 15 01:59 PM

[Jon Doe:]

David,

Don't get me wrong. I appreciate you taking time to research this stuff and write up your articles for everyone to use as fit. I also *completely* agree with your statement of investing per one's personal comfort level with the level of risk.

My comments were not directed against you (or anyone else, for that matter). They are just my opinions. (Yes, I know the truth - opinions are like arseholes, everyone has one).

What I am questioning though is that if HEB will even be around till FDA approval or will they run out of money and someone expose their CEO's fake(?) promises so far.

Jul 15 04:24 PM

[fortunate1:]

i believe their stratedgy is well conceived, the company needs to prepare for their growth , stability, and 'Our ' ultimate prosperity.
The revenue needs to be generated in order to insure maximum
producitivity and profitability. I would be more concerned if the company failed to properly prepare for the future and neglected the
'big' picture of success and wealth.



On Jul 15 01:29 AM Jon Doe wrote:

> I'm only going by what is in the articles you have linked to, David.
>
>
> Ampligen has been around for ages and is as yet not approved by the
> FDA for any use (AIDS/CFS/Flu virus adjuvant have all been touted
> as potential uses).
>
> While I may fall flat on my face if it gets approved tomorrow, I
> believe that it is just one gigantic scam to con people into giving
> them money.
>
> I don't think their current product portfolio and their cash burn
> rates point to HEB being a viable business without additional capital
> injection. This explains why they have an SEC filing to raise more
> cash by selling shares and/or bonds.

Aug 01 12:47 AM

[fortunate1:]

HEB is soon going to flourish with FDA approval,
it wont be long now...

Aug 03 07:29 PM