AIM ImmunoTech Inc (AIM) 2008 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Hemispherx conference call. At this time, all participants have been placed on a listen-only mode and we will open the floor for your questions and comments following the presentation.

It is now my pleasure to turn the floor over to your host, George Neil, with CCG Investor Relations. Sir, the floor is yours.

Thank you, Mandy. Good morning, everyone, and welcome to the Hemispherx Biopharma conference call. My name is George Neil with CCG Investor Relations. We serve as consultants to Hemispherx.

Joining us today on the call is the Chairman and CEO of Hemispherx, Dr. William Carter. He will be joined on today's call by Medical Director, Dr. David Strayer.

Before management begins speaking, we have the following statement. Information contained in this conference call other than historical information should be considered forward-looking and is subject to various risks factors and uncertainties. For instance, the strategies and operations of Hemispherx involve the risk of completion of clinical trials; of competition; changing market conditions; changes in laws and regulations affecting the industry; and numerous other factors discussed in press releases issued by the Company and its filings with the Securities and Exchange Commission.

Any specifically referenced investigational drugs and associated technologies of the Company, including Ampligen, Alferon LDO, and Oragens, are experimental in nature and as such are not designated safe and effective by regulatory authority for general use and are legally available only through clinical trials for the referenced disorders.

Forward-looking statements in this call represent the Company's judgment as of today's date, and the Company disclaims any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection do not imply that the product will ever be specifically approved commercially for other treatment indications.

With that covered, I would like to turn the call over to the Company's Chief Executive Officer and Chairman, Dr. William Carter. Go ahead, Dr. Carter.

Thanks very much, George, and thanks to Diane Will for setting up this conference call. The agenda for today's call before we accept questions will be, first, to give you an FDA update. Secondly, we will comment on new data on the commercial value of the exercise treadmill test, which many of you know is the primary endpoint in the major Ampligen study for the potential treatment of chronic fatigue. And finally or thirdly, we will ask Dr. Strayer, who gave a major presentation at the International Chronic Fatigue Syndrome meeting last week, to provide some brief conference notes on that meeting. And this will be followed by a brief analysis of the new data which was presented on Ampligen at the conference, as well as some new collaborations that have emerged since -- in the last quarter. Finally, we will have an update on our major program in Japan; this is, of course, being conducted with the Japanese Ministry of Health and Biken Research Institute. But first an update, a brief update, on the FDA status.

We are continuing to provide brief reports, especially on animal data, to the Agency as has been requested. A progress note was made in our recently filed 10-K, which I would like to update.

We noted in the K that the New Jersey district office of the FDA had conducted about a nine-day inspection in January and early February of this year of our New Jersey facility. We were very pleased to note that we had less than one page of infractions; typically these may be 25 to 100 pages in length. We noted in the K that we had four method validations which needed to be done.

This basically involved equipment that had been moved from our facility in Rockwell, Maryland, to the New Brunswick location. In the determination of the inspector, this equipment needed to be revalidated. In the K, we actually estimated that this might take up to three months to do. But I am pleased to announce today that we have shortened that period to about two weeks, and we expect to respond definitively to the FDA inspection in the first part of April. So we are very pleased to make that announcement.

We also noted in the K that the FDA had conducted a field inspection at Hollister-Stier Laboratories in Spokane, Washington, in mid-2008 -- actually between June 19 and July 2, 2008. They noted several observations under what we call final fill operations which were not in compliance with the federal regulations. These were basically variations in the process of filling the vials.

Now, we have worked very actively with Hollister to execute specific corrective actions. In fact, very recently, we submitted a proposal to the Seattle office, which was a very definitive program to correct these variations in process filling. We are optimistic that we will be able to correct those in a short time; and indeed, those tests are already under way.

Now in addition to this, as some of you I think know, we have effectively formed a partnership with the FDA to teach and learn about the important differences in the spectrum of new drugs called TLR activators. There are perhaps two dozen of these drugs, and more than $1 billion has been expended by other companies to bring these products to market.

By far and away our TLR is the most advanced product in the TLR field; and indeed the only one for which a New Drug Application has been filed and been accepted for review by the Agency.

So we continue to provide what I would call small residual data chunks to the Agency which compare and contrast our product with the spectrum of other TLRs which have been placed into clinical trials. These obviously not only concerned how they work, but they especially concern issues about product safety and unintended consequences, which have been the possible downfall of a number of these products and which to date we have been able to demonstrate that these unintended consequences have not been observed with our product. We feel very positive about that.

Turning to the second, there has been a great deal of economic buzz in the biopharma sector just in the last two or three weeks because of the acquisition of CV Therapeutics. Originally felt it would be a subsidiary of Astellas, the large Japanese company, but at the end of the day, as some of you may know, Gilead purchased CV Therapeutics for $1.4 billion.

Now what is interesting about this product vis-a-vis Ampligen is both products use exactly the same therapeutic primary endpoint, which was the exercise treadmill test.

Remember, your primary endpoint is what goes into the package insert. It is the instructions that are given to the doctor about how to use the drug. In general, you cannot put into the package instructions data that is not either directly in the primary endpoint or clearly connected to the primary endpoint.

Some of you may remember that in the case of our drug, Ampligen, it showed an improvement of about 200% to 300% greater than that which was seen by Cardiovascular Therapeutics' product, which -- the latter case, that was about a 5.9% to 6.9% improvement over the placebo group. Whereas in our case, using similar and indeed identical methods, statistical methodology, we showed improvements of 12.9% to 14.8%. So it's substantially greater improvement.

Now, one of the issues that has come up in the potential marketing of Ampligen, should it be approved, is the issue -- does the ETT allow commercial viability? Because most doctors do not have an exercise treadmill machine in their office, which is expensive machinery and obviously not so easy to operate. I think the recent acquisition of Cardiovascular Therapeutics is basically -- totally driven by this product, indicates that the exercise treadmill test is indeed a test which can be translated into strong commercial viability.

Now obviously, the magnitude of improvement that we had vis-a-vis the CV Therapeutics drug does not imply that our drug will necessarily be approved. This obviously remains to be seen. But the present data from the FDA looking at new medicinal entities indicates that about 80% of these types of drugs will be eventually approved.

Now, certain additional factors may auger well in our favor. For example, two federal agencies have opined favorably on our product to date. One being the FDA, which has provided an emergency right for us to sell the drug under certain restricted conditions to patients who are severely debilitated with chronic fatigue syndrome. And the other federal agency which has opined favorably historically on our product is the agency termed AHRQ, the health research quality organization, which has as its mandate to monitor investigational drugs for potential intrinsic value in medicine. They have stated, quote, that Ampligen -- not yet approved by the FDA -- given intravenously yielded the most promising results in chronic fatigue. So these are additional factors that may be considered.

I want to turn the program over now to Dr. Strayer to comment briefly on the International Association of Chronic Fatigue meeting which he just attended. Go ahead, David.

Yes, just a historical perspective. I have attended half a dozen of these conferences over the last 10 to 12 years, and this meeting had to be the best of all of those that I have attended. They had a lot of good science that was presented by researchers both in the US and abroad. And there were some exciting international collaborations ongoing, which I believe will greatly accelerate progress in this area.

One of these international collaborations is centered in the Reno, Nevada, area and will be studying samples from Ampligen-treated chronic fatigue patients for a battery of immunologic and genetic parameters. The immunologic markers will be comprehensive, and the studies will be performed at the National Institutes of Health in Maryland, as well as by a high-powered group that has been assembled now, immunological group, in Reno, Nevada.

The genetic expression studies will be performed by experts in the UK. In addition to this work, a team of scientists from the Centers of Disease Control and Prevention also attended this conference. And after my presentation, interest was expressed in setting up a collaboration between the CDC and Hemispherx to better understand the molecular basis of the Ampligen response and the pathophysiology of this severely debilitating disorder.

I think in the next few years, with the scientific tools that are now available, that we will begin to see some diagnostic markers for this condition.

Okay, thank you very much, Dave. I would say that if the collaboration with the Centers for Disease Control matures as has been suggested from your meeting, this would represent the third major federal agency -- and indeed, the NIH being the fourth. So you would have four designations of substantial interest in our product, which I think would obviously be remarkable.

I would also say that we are very proud of the new relationships with Harvard University, Stanford University, other relationships which have just started with the National Cancer institute which are separate from the ones that David mentioned. And all these relationships are driven by the unique molecular action of Ampligen as what we call an immunomodulator.

There is a vast need in the field of human therapeutics for immune modulation. Of course, this is most directly seen in the area of cancer vaccines and in the area of infectious disease vaccines. This explains the birth of these more than two dozen products that have come into clinical trials in the last five to seven, eight years.

Unfortunately, the vast majority of them have suffered from what we call unintended consequences -- another phrase that we will use in a moment, a cytokine storm, which is a very severe and potentially life-threatening immune disorder which can be caused by the drug.

So the emphasis in these collaborations is really driven by the unique promise of this product as an immune-based product across a vast field of subject diseases which include not only infectious diseases, not only anti-inflammatory conditions such as potentially chronic fatigue, but also all these new approaches in cancer vaccines. For the most part, they are lacking that critical mobilization of the immune system which may be necessary for a therapeutic response.

Of course, in talking about collaborations, I think one should realize that perhaps our most important collaboration and the one nearest to a commercial application is the application of Ampligen with a vaccine, with especially the flu vaccine, the bird flu vaccines, in Japan. At the end of the year, our collaborators reported positive results across the spectrum of animal studies.

It's important to note here that this is the only -- to our knowledge, and we have representations from our collaborators in Japan to this effect -- to our knowledge, our product is the only product which is being used in conjunction with these vaccines, which have a critical dependency, especially flu vaccines, to have a so-called adjuvant or immune stimulant in order to get the proper benefit.

Also might mention to you that the Japanese research community is very much concerned about the difference between metabolism of drugs in Oriental populations versus Occidental populations. So all their studies are directed to try to study the specificities that would possibly occur in their population. Which basically means that because our studies have been ongoing for several years, have been successful up to this date, it would be very difficult for our product to be crowded out in the Japanese market because of this lead time that it takes to tailor products for the Japanese patient versus the Western -- European or American based patient.

So I am going to turn now to the data that Dr. Strayer presented at the conference. Simply stated, this data deals with two of the overarching challenges in pharmaceutical research today. One of them is basically a challenge to all drugs that are potentially given on a chronic basis. And this I called the Vioxx problem. This, of course, is the problem that has beset not only Merck but many other companies. It is the unintended cardiovascular consequences of drugs given to the chronically disabled population.

So we have some new data in this area that speaks to the potential value of Ampligen. I am going to turn it over to Dr. Strayer in a moment.

The second overarching challenge, which is specific to the immunological class of drugs, are these unintended consequences which can include cytokine storm or other immunological events which are deleterious to the patient. This has been a big problem across the TLR space. Like I say, a multibillion-dollar investment to date has not matured to a commercial approval of any of these drugs. By far the most advanced in that process is Ampligen; and Dr. Strayer is going to highlight why we believe, based on the data we have to date, that Ampligen stands -- is uniquely safe with respect to this issue of unintended immunological consequences. Please continue, David.

Yes, just I think to continue on your thought here, the prototype molecule for Ampligen really was a double-stranded RNA called Poly I:Poly C, which was found to be too toxic for clinical development. It produced what we call these pro-inflammatory cytokines and fevers and some coagulation problems when they tried to use it in clinical trials, and it was abandoned a long time ago. Then Poly I:Poly C12U, which is Ampligen, was specifically designed to avoid the toxicities of Poly I:Poly C.

So what we wanted to do in this study was to look at these proinflammatory cytokines in patients that were receiving Ampligen; measure their levels; and determine whether or not the strategy worked to reduce this modulation of these proinflammatory cytokines with the Ampligen. So we looked in the study, AMP-516 study, which was randomized and placebo-controlled; and we were mainly looking at what we call chronic exposure and these modulations.

So we looked out at what we call week 32 in the study and compared the week 32 values to baseline to see if there was any change in the modulation of this whole battery of cytokines. What we found was that there was no significant modulation of interferons alpha, beta, or gamma or of cytokines IL-6, -10, -12 or TNF-alpha when we compared the Ampligen group to the placebo group.

We also showed there was no difference in either treatment group with regard to the completion status and change in any interferon or cytokine. That means that people were not dropping out of the study because of any cytokine modulation problems.

Also we looked at the timing of when the samples were taken with regard to the timing of the infusions; and again we found no change related to the timing of the infusions.

Okay. Tell us a little bit about the new cardiovascular (multiple speakers) data.

Yes, we have shown in previous publications and presentations that the Ampligen patients actually can reduce the use of concomitant medications that they take to relieve the symptoms of CSF (sic - see Press Release). CSF patients utilize numerous medications to try to ameliorate their symptoms.

We now wanted to look at a specific class of these drugs that they take to see whether or not we could show that this particular very important class that has cardio toxic effects actually was reduced as well. This class are drugs that prolong the QT interval. The QT interval is part of the EKG complex. And the importance of it is that when this interval gets prolonged, it increases the risk of arrhythmias and of sudden death.

So what we did is we looked -- again in the 516 study we looked at the QT interval in the Ampligen group versus the placebo group. We actually found that the placebo group had a prolonged QT interval compared to the Ampligen group. We began to probe this. We found that it was directly related to the number of medications they were taking that prolong the QT interval.

This was true in both AMP 502, our first randomized placebo-controlled study, as well as the second one, AMP 516.

So these results really from two independent clinical trials suggest that the therapeutic benefit of Ampligen allows patients to reduce their dependence on concomitant medications used to treat the symptoms of CSF, and thereby specifically reducing exposure to these drugs that are known to prolong the QT interval. So we think this is a very important finding, and we have recently submitted this data to the Agency.

Yes, thank you very much. This is, I think, a January submission to the Agency.

So just to reiterate, we found this apparent cardioprotective effect based upon improving the QT problem due to being able to wean patients off these cardio toxic drugs, the Vioxx type drug. We found this in both studies, 502 and 516.

In the earlier study, which had a more debilitated population, we also found a statistical improvement in what is termed suicidal ideations and hospitalizations for suicide.

So the importance of these factors all together is that the two major causes of sudden death in chronic fatigue syndrome, according to Jason and others, the published peer-reviewed papers, are suicidal ideation death and catastrophic cardiac events.

So we have objective, well-controlled data here that suggest that we may be able to ameliorate these issues. Thus it is an additional dimension of efficacy and safety which can be added to the exercise treadmill test which we talked about at the beginning of the conference call.

Now, just prior to taking on questions, I would like to say that we have reported a major cost reduction containment program in the Company which actually began early in the fourth quarter, and obviously to preserve cash resources while maintaining the resources necessary to achieve our commercial objectives, including making further progress on the Ampligen New Drug Application; doing marketing and market development analyses; and engaging a variety of potential strategic partners for the marketing of Ampligen; and also preparing ourselves to reinitiate the commercial sales of Alferon N, which were basically put on hold not only for economic reasons but because of staff had to be redeployed for this major undertaking in the Ampligen New Drug Application.

We feel we are on the cusp of being able to reinitiate the commercial production of Alferon N. To that end, we have engaged the Sage Group, which is a major healthcare organization, to assist us in theses various initiatives. I'm very pleased today that we are in discussions with a variety of parties with respect not only to Ampligen for a CSF potential indication; also Alferon N marketing organizations; and developing a large set of new collaborations which have intermediate and near-term commercial opportunities. These include obviously the vaccine-type initiatives and the collaborations that have been mentioned.

So with respect, by the way, to the cost containment programs, while maintaining resources to do these different important activities, I should say that it has not simply been the management that has participated. It is across the board participation of all staff.

Of course, as you know, the currency being used is restricted stock, which is basically indefinitely restricted due to SEC regulations, et cetera. So I think it shows a significant buy-in from a team of people who are committed to make these opportunities become commercially viable.

Along those lines, I might point out that you notice that the auditors provided a clean opinion to the Company's operations for the next 16 to 18 months. This was based on a serious audit not only of our past but also of our projected programs. In these chaotic financial environments, as you know, this is an achievement.

We know a number of companies with substantially greater cash reserves than we reported on 12/31/08 which did not get clean opinions. So there is a buy-in from the auditors that we have a direction; it is based on a financial and commercial reality; and we are optimistic as we go forward.

So at this point, I am going to turn it over for questions. These have been addressed through Dianne Will. I would say that as the triage officer we are accepting questions which are supportive, neutral, or even hypercritical. We welcome an opportunity to try to provide further insight into our programs going forward. So please go ahead, Dianne, and the operator.

(Operator Instructions) [Bart Cema].

Hi, Dr. Carter, this is Bart Cema from [Bustifs] in Belgium. I have two questions regarding the interleukin-6, -10, and -12 data.

On the presentation you see there, there is a patient, Ampligen patient 5666, who has rather high levels of cytokines. Can you comment a little bit on this? Is there a reason for that?

Dr. Strayer?

Yes, this particular patient actually had the highest level of these cytokines at baseline. So this particular patient, for some reason has a very high cytokine profile.

He did have a little bump in these cytokines when he received the Ampligen, but he tolerated the treatment well; he completed the study. So he had no evidence of any toxicity from these cytokine levels. (multiple speakers) He was one patient out of the total group.

Now also, there were a lot of placebo patients that increased levels of cytokines or of the interferons, actually. So some of these chronic fatigue patients are going to have -- approximately 5% to 10% of these patients seem to have high levels of interferons or these cytokines. And we don't quite understand why yet.

Do you expect the FDA to ask for follow-up studies, meaning after 32 weeks, meaning 48 weeks and longer? (multiple speakers) the evolution of the cytokines?

No, I don't believe so. I think if we wouldn't have seen it by 32, we are not going to see it.

Okay. Also in your presentation, there was the ETT treadmill time. You specifically mentioned the intent to treat patients. Why did you not publish the treated group patients' data?

I didn't understand the question. We have an intent to treat and we have the completers. The intent to treat analysis is a more restrictive and more conservative analysis.

The data on the other group, which is the total patients who completed the study, actually is much better statistically. So both groups are statistically significant; I used the more conservative statistical approach for the presentation.

Okay. Last question that is for Dr. Carter. Can you comment on your partner discussions versus your last conference call? Where are you? What is the timing? Do you already have term sheets in front of you?

We have a number of partnership discussions under way, both with Ampligen for the potential treatment of CSF; Ampligen as a potential adjuvant for vaccine enhancements as would be infectious disease as well as cancer; and also Alferon N related discussions.

Probably in answer to your question have we been looking -- examining term sheets, the answer to that is yes; we have been examining term sheets. At this point, we have not executed any.

Probably our most far advanced commercial discussion at the moment, it would be with the Ministry of Health in Japan and Bekin, where they are now about to embark on human volunteer trials. As you know, there is no bird flu in Japan at the moment, and would of course be unethical to conduct clinical trials in that disease. That is why animals are used.

But in that case, we are in active discussions regarding major supply agreements to the Japanese. They have indicated, although the definitive documents do not yet exist, they have indicated orally that they are prepared to provide us with the vaccine for other parts of the world out of the immediate Pacific Rim area, which would include Japan and Singapore, possibly China.

So we believe that it is simply a matter of time before there is a large commercial agreement in Japan. And it's inevitable, because bird flu is an endemic disease in the Pacific Rim countries. It has been there for about 15 years and at any point there could be a flash fire with tremendous numbers of cases.

As I established earlier, these vaccines critically need an immune stimulant, and the only one that the Japanese have found to be safe and effective in their animal tests is Ampligen. So it's basically a no-brainer.

One of the reasons we are optimistic that the facility that we have in New Brunswick, New Jersey, which is the core manufacturing facility for Ampligen, that we will not only have potential promise in chronic fatigue, but there is a spectrum of spokes that go out from this facility which mean major economic opportunity across a broad spectrum of diseases.

That is why we are so optimistic about continuing to make sure that that facility not only fulfills its immediate promise, but also that it has the capacity to grow and to provide really large, industrial amounts of Ampligen for multiple uses around the world.

Indeed, all the research that we are doing there indicates that that facility could be fine-tuned for modest capital improvements to be able to make Ampligen on a really significant industrial scale.

Next question.

Okay, thank you.

(Operator Instructions) [Roberta Kraus].

Excuse me, this is her husband. She asked me to speak for her. First of all, I would like to know, concerning your Ampligen, are there any other people that are making Ampligen besides Hemispherx? Do you have any other competitors?

We know of no present competitors in the manufacturing of Ampligen. At one point a couple of years ago, our partner Bioclones had what seemed to be leading towards an independent Ampligen production program. There was a litigation. The litigation was settled in our favor, and all their records and Ampligen stocks were returned to Hemispherx, where they now reside at the New Brunswick facility.

I think importantly -- and I am not sure how much it is mentioned in the 10-K -- there is a whole new set of patents, up to eight major new patent applications on Ampligen as well as on Alferon N, including composition-of-matter patents, which if issued would make it virtually impossible to compete with us in any area where patent treaties are recognized.

Historically, the Company has had a very good record, probably better than 95% patent issuance, because of the unique features of Ampligen. So we think we are in a strong position with respect to intellectual property.

Obviously, our manufacturing procedures are closely guarded, and we do plan for the indefinite future to use our own facilities for the manufacture of the products, so that we have the additional proprietary protection which relates to that fact.

Dr. Carter, I wanted to ask you also, do you have enough cash on hand, let's say, to go forward for the rest of this year?

You have to -- would you talk a little louder? I could not hear your question.

Pardon me. Do you happen to have like enough cash to go forward, let's say, for the rest of this year?

I think again the question unfortunately is a little bit muddled, I couldn't hear it, but --

I said enough cash to go forward.

I think you said do we have enough cash.

Cash to go forward?

Yes, the answer to that is yes, we do. We are looking at various additional funding opportunities which are on the table. We have not chosen any yet, but we have several funding opportunities should we need additional cash.

But both the senior management, the Board of Directors, and most importantly the auditors have all concluded that the Company has an adequate cash position for the next 16 to 18 months.

Okay, that's good. That's good. Now from what I understand, you're supposed to go in front of the FDA or like the board before the main FDA to see if they are going to approve the Ampligen or if they are not going to approve it. Is that supposed to be like May 24, May 25 rather (inaudible) in front of the board, the board of advisors, before the FDA? Like the panel, or whatever they call it.

Again, I think I heard some of your words, but unfortunately, not completely. I think you commented on the May 25 date for FDA --

Approval.

Review and report.

Right. Is that the preliminary panel that you have to go in front of?

We believe that we have answered all the major questions that have been put forward with the Agency. Now under federal law, they can continue to ask questions as long as they want.

But we believe that the major questions which they have asked have in our opinion been retired. Obviously, we are trying to anticipate questions that might come up in the future so that we can be prepared should there be further questions.

That is May 25 that is going to come up?

Yes, May 25, we would expect definitive response letters at that point.

Now you mentioned you are trying to get partnerships. Now would this include like, what do you call, big pharma? Or like small drug companies or pharmas, as well as small companies as well as large that you are trying to get partnerships with?

Right. Right now, we are looking at a spectrum of potential partnerships which include the multinational companies as well as the middle-tier pharma companies. The middle-tier pharma companies may have the advantages that they can move somewhat more quickly and that they can field in conjunction with us what we would call a specialty sales force. A force that would, for example, be directed at rheumatologists or neurologists and would be in the range of several hundred, perhaps up to 500, 800 people.

Now to reach the primary care physician, which is part of the present equation by which chronic fatigue syndrome patients are diagnosed, that would require thousands of people. And that necessarily is a multinational organization.

So we're looking at both iterations, the specialty-based sales forces as well as primary care-based sales forces.

In order to be intelligent in this area, we are doing market development studies trying to understand better where these patients are, who they go to, where does the economic advantage to the doctor and the healthcare provider lie. This is a work in progress, but certainly we have already executed several market development studies, and these are providing a direction which is helping us in our negotiations.

I see. I have an idea if it would help you, Dr. Carter. Did you ever think about trying to break into the Indian market as well as the Chinese market? Because you've got in China alone 1.3 billion people; India you got like about 1 billion people. The populations are huge over there.

We are in discussion actually with Indian-based companies --

Oh, you are in discussions?

For the reasons that you cite. We like you very much the Indian opportunity because they operate more at, shall we say, a Western European FDA type level.

(inaudible)

In China, as you know, it is a little bit more spotty.

Yes, I know.

And we have not put our toe in the water in China.

It's a little more difficult in China.

It's a little bit more difficult. Probably going to be a few more years before the Chinese regulatory process is more similar to that in (multiple speakers).

But like you said, if you can get it to the Indian market, that is just as good because there is like about 1 billion people.

Exactly, and we are having active discussions in that area.

That's good. Also, one more. I wanted to ask like what is the -- (inaudible) how much is this drug -- in other words, like what is the market capitalation for this drug and this -- I mean, Ampligen, let's say, God willing, if the FDA approves it?

As you know, there are between 4 million and 6 million Americans who have the --

Chronic syndrome.

-- the disorder, and let's say 25% of them, more or less, are very, very ill. These would be the first patients who might qualify when and if the drug is approved. Under the emergency regulations, we presently provide the drug on a cost reimbursement basis for $16,000 to $20,000 a year. So obviously, there would probably be a step-up in that pricing if the product receives a full approval.

But in essence, you can run the numbers yourself. As you know, there are no other products on the market that are approved.

That's true.

A drug in this class would certainly have the potential to be a $1 billion product assuming that it was accepted in the marketplace -- and which was one of the reasons that I talked at the beginning about the cardiovascular therapeutics and the use of the treadmill. The treadmill, at least with respect to that drug, that data was accepted as something that was very significant, not only by the FDA but also by the physicians and presumably by the reimbursement specialists. Let's try one more question.

Okay, one more and that's it. I'll leave you alone. What's the chances of this getting passed by the FDA? What is the chances?

I could not hear that question, sorry.

In other words, what's the chances that the panel, FDA, might approve Ampligen?

Well, all we can do is cite historically data because obviously no one can read the future.

That's true. Nobody has a crystal ball.

Historical data from the FDA in 2008 was around 80% probability. That is looking at a spectrum of drugs called new molecular entities.

We think there may be some advantages to our program, and I highlighted them. Especially the federal agencies that have opined favorably about the product in different areas. And also as Dr. Strayer mentioned, the new potential federal collaborations which are building a basis of knowledge. Of course, knowledge is power.

That's true.

The FDA likes knowledge, so the more knowledge you have the more probability that you may receive approval. So we think that there is a rising tide of insight and enthusiasm in this disease and that it may auger favorably.

All we can do is cite the historical data. And obviously, the fact that we are committing these resources to it -- management, staff, et cetera -- is evidence that we believe there is a promising opportunity here.

Sounds good. You know, Doc, you sound like you've got a Georgian accent. Are you from Georgia?

Okay, I will take one more question.

Okay, thank you very much, Doctor.

We will take one more question if there are any more questions in the queue.

(Operator Instructions) We have no further questions at this time.

There's no other questions at this time? Okay, thank you so much. If there are any further questions, simply direct them by e-mail to Dianne Will and we will undertake to answer them. So thanks so much for your participation and have a good day.

Thank you, ladies and gentlemen, this does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.