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[McMil]

Happy Sunday all!!!

I've been reading through some of the post re: Ace's calculations for HEB's pps should AMP be approved and although we have all seen different #'s from different sites and post I have a problem with them in general...

Most, but not all, have been based upon the "assumed" number of CFS patients in the U.S. and not other countries at all; and this is all well and fine. In addition the figures have been mostly ALL based upon the more extremely severe cases and sufferers receiving this drug for a specific duration...

Now I believe that the study documentation makes a reference to the AVERAGE duration of treatment being approximately forty (40) months and not just for one year...I could also be wrong, but it is a drug that works through an aggregated process and has to be stored and built up throughout the organism (the body).

Now even if the low ball estimate of treatment is $15,000per year and the higher estimate is $20,000+ per year, and that 5kper year, per patient is no laughing matter as that quickly can become a significant figure with in one day, let a lone a week, then the likelihood of ALL THE PPS ESTIMATES are well off the mark becomes profound...

When making these "guesstimations" EVERYONE, so far, has been basing them on the estimated 4-6million sufferers in the U.S. alone...and then jiggling their numbers...

I say that trying to make that or any kind of estimate for future mkt cap, yrly revenue, or EPS becomes an almost Herculean feat if the global estimate of CFS sufferers is not taken into consideration; even on a low ball assumption.

Along with this line of conjecture is that fact that their mainstream assumption is that ONLY those CFS patients with an extreme set of circumstance will receive AMP treatments and the rest will have to take two aspirin and call their respective physicians in the morning...

That isn't how I see this turning out at all...

Think of this more along the lines of, and I SOOOOOO hate to put it out there like this but, Viagra.

People with various degrees of EDS weren't standing around waiting until things got worse; they were clammering to get their wood-yee on and not taking no for an answer...

I can't, in all of my limited knowledge of human behavior (remember what I did for a living for three decades so I am qualified to generalize social behaviors) believe that the masses in general, around the world, who suffer from CFS in ALL of it's various degrees of severity will not be prescribed varying doses of AMP for a period of time throughout their lives...and in some cases even on and off, if need be and those extremes may never get off of it for life.

And the key to all of these estimates, for me, is the GLOBAL number of CFS patients...not just those here in the U.S.. There is no way that an estimated pps figure can be assumed at, around, above, or below $15-$25 without considering that global need...

What I'm pedantically driving at here guys is that REGARDLESS what the pps estimate is arrived at, it becomes only a STARTING value because they are being arrived at based upon a fraction of the world wide CFS sufferers...

As I read through our postings here, as well as postings from other sites, I keep coming across the same notion: That the OVERALL pps will be these low balled estimates based solely upon the CDC's 4-6million U.S. patient re-estimations.

Now I've seen some pps estimates anywhere from $12-$50-$100pps shortly after an approval as well as a solid $12-$40 for a strong letter of recommendation...

So? What's the bottom line to the pps conundrum?

If I were to take the more global stance into account with the U.S. only estimates, I would would be inclined to believe that this isn't going to be a DNDN situation where the pps shoots way up and then settles back to about $19/$20. Or in this case back down to $15.

There is no competition for Ampligen, there is no other option beyond Ampligen, there is no other drug coming down the pipe to replace Ampligen, at least for the next seven years, to detract from the $ value of HEB; in as far as Ampligen is concerned anyway.

As far as the 30billion Japanese and the rest of the world clammering for an adjuvant for flu and other vaccines is concerned; or the potential for other viral applications of AMP, that, my fellow share holders, becomes just too staggering to comprehend at the moment...

Let's just wait the week out and see what happens...then at that point, in my opinion, it's not going to be an issue of share dilution because there may never be enough shares to go around because Hemispherx will have a hand in, and on, each and every drug that can be made wherein an adjuvant can be added to increase the effectiveness of those drugs: Aids, HEP B & C, cancer, flu, STD's, etc...

I don't think that any of us who currently own shares in this Co. have fully comprehended exactly what has been placed into our respective portfolios only because of the recent price manipulation of outstanding shares...

If I set that to the side for a bit and just look at HEB in it's potential totality, and only that, then I'm not sure that a value, at this point in time CAN be placed upon what will occur if this thing gets approved...I can pretend to know and I can juggle and squash the same beans as these other prognosticators, but in the end, no matter how I come to look at it a pps valued with only the U.S. CFS patients in mind is never going to provide an accurate approximation; I'm afraid very far from it...

And on that note I just keep smiling to myself because it becomes too staggering a figure for me to even want to fathom at the moment...so instead I'm just grateful that I did a little homework while on holiday Memorial weekend...

...and still the lawn needs a mowing...lol

[discostupid]

30 million Japanese =D

The drug is probably not stored or built up in the body. RNA is very prone to degradation, even in plain water. Usually for the longest shelf life it's kept at -20C as powder. RNAses (enzymes that chew up RNA) are present everywhere in the environment (you always have to be very careful when working with RNA, because it can be destroyed so easily, you have to use RNAse-free water, tubes, etc). Ampligen is double-stranded RNA, so it's a little less prone to degradation. But still, it probably doesn't last in the body more than 1 day after injection. Since it's injected in the bloodstream, where there are lots of RNAses, coupled with a slightly basic pH (promotes RNA degradation), and 37C temperature, it probably really lasts only a few hours. This depends of course on how long the poly I:C12U molecule is; if the chain is 10000 units long, it will last longer than if it was 2000 units long.


On another note, who do you think is most interested in Ampligen and HEB? Is it the 4 million Americans suffering from CFS/ME?

Google Trends: ampligen, hemispherx

[bobshishka]

McMil-

I agree with your assessment, and here is why:

We were talking to our pediatrician about autism, and the sudden 'rise' in cases. He did not agree that there was a sudden rise and here is why- He blamed the insurance companies. He said they will not cover any treatment unless the physician classifies the autism as 'severe'. Physicians began diagnosing even the mildest form of autism as severe, so the parents and children could get the support they needed. As a result, the diagnosed cases have skyrocketed.

Whether you believe in my Dr's assessment or not the point is, once there is a treatment available, more and more people will step out of the woodwork with the disease.

[elmo3]

how much is the PP's going to be and what is its potential
I dont really care
WHEN and IF approval is more important
when we get to that bridge we'll cross it
some people are happy making a dollar profit some want more no one knows
there are no limits if this can used for flu vaccinations.

sorry just a little fustrated cause everyone has opened a gate into why its being delayed. and you do start doubting if it will be apporoved or not come on who wants to lose money . and alot of good reasons im sure if the FDA needs another excuse to delay hearing they'll probably use one of ours...LOL

but one thing for certain which made me relax the Japan thing. If its true I dont think the PPs of this stock will drop like usual bio stocks after rejection which makes me rest easier. Sell and move on or Hold cause this puppy gonna make some $$$ cause if its big in Aisa we wont need North America .They'll come to us

[reddy]

Originally Posted by tdanco Here is an article written a little more recently(yesterday), regarding the big breakthrough Dr. De Meirleir presented at the CFS conference. The Big Breakthrough?

That is a bold claim about H2S. If it indeed is one of the causes for CFS, then more research should be done into it. As we understand more and more about this complex disease, we can then come up with a more effective response. But for now, FDA should give a go ahead to Ampligen immediately, so that millions of people suffering from CFS can get some relief and take control of their lives again. BTW good find.

[tdanco]

Thanks reddy,

I work around H2S all the time too in the oil patch up in northern BC... I wonder how many people up here have symptoms of CFS.

The other article I posted is pretty good too, gives you an idea of what went on in February when they were delayed. More manipulation, and more Dr. Carter...

[Hotchkiss1987]

Hey disco, do we have an epidemiologist on the forums! Nice info! I have a question. Since ampligen is poly 1:poly C12 U, do you think that if it's approved by the FDA other companies would be able to produce the same thing soon too? I'm not too familiar with drug patent law. I know the orphan drug status does give it some protection, but will that status last since there may be up to 4 million CFS sufferers in the US, and Ampligen can (possibly) be used as a booster?

tdanco- I like the articles, but I found a few more about Ampligen's trial with AIDS. It appears that the first trial using Ampligen was very successful, but the second trial with DuPont didn't find a difference between Ampligen and placebo. The articles also have differences on the safety of Ampligen.

The articles didn't go over it in a lot of detail,

Ampligen: The AIDS drug No One Can Have / Oct. 94
Ampligen: Study Stopped After Poor Results
Clinical, immunological, and virological effects o...[Lancet. 1987] - PubMed Result
Poor Results Bring End to Anti-AIDS Drug Study - The New York Times


Anyways, it's weird! However, all the articles seem to agree that Dr. Carter was very hard to work with, and DuPont wanted him replaced.

Here's more info on the shorting:

While we were working on the 1999 article, in September 1998, we had frequent meetings in his office at Business Week. I was present on numerous occasions when Weiss received increasingly desperate sounding telephone call from a man named Manuel Asensio, a notorious short seller.

On several occasions when I was in Weiss’ office, he refused to answer the calls and I could hear Asensio screaming, “I need you to print that HEB article now.”

He wanted Business Week to publish his stock prognostication concerning Hemispherx Biopharma (AMEX symbol: HEB). Asensio had taken an extremely large short position in HEB.

Weiss and I had discussed Asensio’s short position. I told Weiss that it could appear that he was assisting Asensio in driving down the price of HEB if the article about Asensio’s negative prognostications ran. Asensio wanted to profit enormously from a decline in the stock price of HEB. Weiss stated that he intended to quote Asensio as stating that HEB had a target value of $0.

At this time I had given Weiss information that Joseph Giamanco Sr., whose firm GHM was the specialist in HEB, was illegally trading the stock of HEB in the accounts of his friends, which he controlled. I also told Weiss that the specialist was manipulating the price of HEB. This was a serious violation of the Securities Exchange Act of 1934.

The article, “Why Hemispherx Could Take Sick,” appeared in the September 28, 1998 issue of Business Week. This article quoted Asensio as stating that Hemispherx had a value of $0.

The problem was that Asensio did not sell HEB stock when Business Week published Weiss’ article. Asensio had already sold stock short; that is, stock that he did not own. Asensio bought back his short stock. Simply put Asensio had used Weiss’ article to cause the price of HEB to fall, so that he could purchase in excess of 100,000 shares that he had sold; and thus earn a profit on his short sales.

Beginning in 2006 there were many voices crying out that short sales involved fraud. Evidence began to be presented that media personalities had assisted short sellers by publishing their verbatim words. Thus, media found themselves assisting short sellers; instead of being neutral in disputes.

Is Naked Shorting Gone? - Floyd Norris Blog - NYTimes.com

And more info on the attempted hostile takeover:

On December 29, 2008, the U.S. Court of Appeals overturned a lower court's
dismissal of Hemispherx Biopharma Inc.'s fraud claims against a group of South
African defendants related to misrepresentations made in an alleged hostile
takeover attempt. "Hemispherx had recently reached a settlement with two of the
South African defendants, Bioclones and its former CEO, Cyril Donninger," said
Thomas Equels, attorney for Hemispherx in the case. "However, the appeal court
ruling allows Hemispherx to pursue its damage claims against the remaining South
African defendants."

The dismissal was based upon an argument by the South African defendants that
the Federal Arbitration Act precluded the lawsuit against them for common law
fraud. The appeals court found that the Federal Arbitration Act did not apply.
Philadelphia-based biopharmaceutical firm Hemispherx, maker of the experimental
drug Ampligen(r), filed its lawsuit in 2004 based upon allegations that the
South African defendants, led by R. B. Kebble, then CEO of JCI, a large South
African public company, catapulted merger talks with Hemispherx in 2002 into a
full-blown attempt at a hostile takeover.


U.S. Court of Appeals Supports Hemispherx in Rebuff of Hostile Takeover Attempt | Reuters

I found those articles awhile ago (before I found out about this site!) or I probably would have posted them! Anyways, the story of HEB (or HEM back then) is really weird.

[Hotchkiss1987]

Oh ya and back to your question disco, it appears that almost all the searches in Belgium were for Hemispherx, and not Ampligen. In Cali it appears that more searches were for Ampligen instead of HEB. I have no idea what this means. I can guess that the Belgium searches are because HEB has a facility there, and people want jobs. I can only state for myself, but maybe it's true for others too. If I do a google search, it's usually to learn basic information about something I did not know about before. Ampligen has been available for testing since December 1996, and google wasn't founded until September 1998. I'm speculating here, but I'd assume that people with CFS have alternate sources of information, and already know a lot about Ampligen if they haven't used it. New info could come from different groups, or from HEB itself.


Edit- Google was started in 1996 I guess, but it wasn't incorporated until 1998, and the domain name google wasn't registered until September 1997. It doesn't really matter though, because it wasn't popular until after 1998 (not sure exactly what time it became popular). Back in '95/'96 if you had net, you'd probably be using Webcrawler. I just used webcrawler and I thought it was the coolest thing ever back then!

Edit again- I just went to webcrawler.com ... and the spider is gone! WTF!

[Hotchkiss1987]

I miss that spider...

[mahmissa]

Bobshiska-

The same is true for many things, most notably ADD and bipolar in the last decade (my hubby and I are in the MH medical field). Though there are many legitimate cases of people in need of medication and treatment, many doctors prescribe without making a true diagnosis. If a patient walks in with CFS symptoms and a medicine is available to help rule out the issue, I'd bet the medication would be prescribed if only because it can't hurt to see if something works to reduce the symptoms. Just my 2 cents.


McMil- Did you see my 1H09 clinical post in the VIP section? There' s a company with a new ED in trials.