Identifying Fact vs. Fiction on Hermispherx’s Ampligen
June 7, 2009
Much to the delight of Hemispherx BioPharma individual and institutional investors, a reader and follower of StocksHaven Investments has identified several key points which have been raised recently, decyphering the fact from fiction.
The following article has been submitted by an investor named, Nick DeCesare
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After reviewing my own research, it is time to post some serious points, some of which have already been raised by other investors and some have not.
First of all, Mr. Feuerstein has questioned the safety record of Ampligen. The FACT is, when it began as a compassionate emergency treatment (granted by the FDA several years back), that very agency required HEB to submit monthly safety reports. As of approximately one year ago, the FDA contacted HEB via telephone call, to let them know these reports were no longer needed.
Mr. Feuerstein also questions the legitimacy of CFS as a real disease. Not only is it becoming more prominent and recognized across the country and world, but the CDC has been working closely with HEB to assure treatment of individuals with CFS as a result of their new CFS plan that is in the works (see link: http://www.cdc.gov/cfs/meetings/2009_04.htm). CFS has also been brought to the public’s attention in greater detail via peer reviewed papers touting its potential to cause serious suffering in an individual’s daily life.
Mr. Feuerstein also claims to have tried to contact Dr. Carter. This may be the biggest joke of all of his points. The FACT is, he never tried to get in touch with Dr. Carter via e-mail, phone, or any other means. He did however, get in touch with Dr. William Mitchell, who serves on HEB’s board. Dr. Mitchell is also a professor at Vanderbilt University and highly respected in the field of immunology. Apparently, Mr. Feuerstein had a hard time understanding the details of the conversation. This is no surprise because of his political science background. He is lacking any biological science background and therefore had trouble with the study results that were expressed to him. (see the StocksHaven Investments’ conference call with Dr. Carter).
Mr. Feuerstein also disputes the Phase 3 results from HEB, claiming the data is old and outdated and somewhat fabricated. The FACT is, the Phase 3 results were “consistently positive” as Dr. Carter states, with a final P value of 0.047, well within the 0.052 type range the FDA is looking for a drug to be under. The P value is basically the opportunity for the results to have happened by chance. The larger the P value, the more damaging the results of the study. Also, as Dr. Carter pointed out, Form 483 required by the FDA is filled out as a result of an exit interview for infractions on the drug results. There were no deficiencies in the results and HEB never had to address a Form 483 for the FDA.
Finally, Mr. Feuerstein discusses the failures of HEB, the inability to find a disease for Ampligen and how it has been kicking around for 30+ years. The FACT is, technology changes, technology changes quicker than we can keep up with it. As a result of technological changes, the ability to fine tune Ampligen to meet the needs of CFS has finally happened. What was not possible 5, 10, or even 15 years ago as a result of lack of technology, is available today. HEB has never been this close to bringing Ampligen to market for CFS, they have passed every major hurdle now as a result of these technological changes, it is a matter of time before approval.
A few final points. Many people point to the fact that HEB is not making money. They don’t have real profits. Let me say that the goal of a biotechnology company is to continue years of research which is funded any way possible, in order to one day bring a drug to market that will change the world and patient lives. If you can do this over many years, you have had success, HEB is almost there and will reap the benefits. This is not Pfizer or Merck, just a small biotechnology company with the greatest potential in its history right now. As Dr. Carter has pointed out many times, this is a detailed BIOLOGICAL SCIENCE that no POLITICAL SCIENCE person or anyone can fully grasp unless biological sciences is your background. He also firmly understands that it has taken HEB 15+ years to fine tune the drug for CFS. That is the nature of the beast.
Take into account my final two points. New molecular entities have an 80% approval rate, obviously great for HEB. Also, the HHS, Health and Human Services, which controls the FDA, and CDC, among other agencies), promoted the CFS advisory committee and all of their work. The HHS also supports the Agency Healthcare Research and Quality. Both the CDC and AHRQ both fully support Ampligen as a drug to help CFS.
If you ask my opinion, approval is on its way. Good luck all. Just needed to get some FACTS off my chest.
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Author Bio:
Nicholas DeCesare is an educator of 11 years in the state of Connecticut and holds a Master’s Degree in Education. He has been a freelance journalist for several local newspapers writing about topics ranging from investing to all aspects of technology. Nicholas has been investing in the stock market for the past 15 years with a particular focus on DRIP plans and biotechnology companies.
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Disclosure: Long-Term Position
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By reading StocksHaven Investments you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
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June 7th, 2009 at 11:49 am
The biggest problem today is the market manipulations done by
big investment funds!
small investors looking into reap the benefits of a growth in a new coming company could suffer losses because of lack of experience and panic…
We should push for making it illegal for manipulation of market
June 7th, 2009 at 12:08 pm
great post. very imformative, keep up the good work…
June 7th, 2009 at 12:18 pm
Excellent post DeCesare! We appreciate all your hard work for HEB!
June 7th, 2009 at 12:36 pm
Lost in all of this (the Streets Attack) is Ampligen has brought relief to a percentage of CFS sufferers. The testimonials and testing has born this out. A good start for any approved drug and hopefully new technology will come along to improve upon what we have now and CFS will become nothing more then a nusience.
June 7th, 2009 at 12:46 pm
After working in BioTech field for 20 years, I can realize the complexity of drug making and taking it in market. I advice those analyst to work in these companies and later get into drug research analysis profession on wall street.
June 7th, 2009 at 12:58 pm
Great post, nothing but the facts, unlike the articles that have been presented on HEB which tend to focus on fiction. This guys is a very good writer too, great job and thank you stockshaven for publishing this!
Brian
June 7th, 2009 at 1:03 pm
Great post. You didn’t even need to mention HEB’s massive potential for Ampligen with other diseases like influenza, to get the point across :
HEB are well worth the investment whatever way you look!
June 7th, 2009 at 1:07 pm
Good analysis against that *#!:-) AF. Like every statement you pointed out. Hopefully the comimg week will bring a FDA decision – finally.
June 7th, 2009 at 1:49 pm
After all these years the approval is on the doorstep finally. Technology has made the difference this time. This is a exciting time for new investors and a long drawn out time for those long on this.
Good luck for those that don’t panic and wait for the final decision
June 7th, 2009 at 2:09 pm
Adam F is unqualified to judge HEB’s product, Ampligen. Adam F has a degree in political science, not biology or chemistry. Adam F does not understand the language of the science, yet bashes Ampligen. Adam F is ignorant. If you were to ask Adam F how Ampligen does what it does, he would not be able to tell you. Yet, he bashes it. Obviously, Adam F has an agenda. I wonder what that might be, and who else shares the same agenda?
June 7th, 2009 at 2:49 pm
Great post. Thank’s…
June 7th, 2009 at 2:56 pm
Some online news sources can provide accurate information and respond to counter-points rationally. Other sites can provide new information helpful to investors and avoid mischaracterizations of old information. Some can do both. Some can do neither.
June 7th, 2009 at 3:06 pm
Once someone told me to not talk about somethink that I could not understand, and he was right, and that happened with Adam F. Some crap came and published an article, talking about newest technology of Biocience. Have you ever see a farmer talking about corporate finance or a engener about macroeconomical matters? I don’t, it could happen, but without any credibility. That’s how I see Mr. Adam F testemony and oppinion. Keep it to your self Sir.
June 7th, 2009 at 3:20 pm
A.F. is an unqualified analyst for biotech sector. After review his few articles focused on biotech products and research, I can say he does not have even basic knowledge of biotech and biological science and research. He is simply writing articles without any concrete facts. Falsification and manipulation would not last for ever. SEC will start investigation soon.
Please stop following his stupid opinion. Do you DD before investing in any biotech stock and ask some other expert with biotech/medicinal background rather following a political science BS degree holder.
June 7th, 2009 at 4:38 pm
Can we please make sure this gets out to all the main boards and gets the same amount of attention as AF’s mindless rant.
Thank you very much for restating what all of us long Hebbers believe. Great post.
What about all of AF’s ridiculous opinons in regards to Ampligen as an adjuvant?
June 7th, 2009 at 5:00 pm
what about acus,I haven’t heard anything from you since you recommeded it?
June 7th, 2009 at 5:02 pm
@Steven Milo, I believe ACUS has been set back for a long time due to the request for more trials. Due to this, the FDA decision can take some time (a few years)
June 7th, 2009 at 9:44 pm
It has been a long 3 dacades of persistence work by Dr Carter.
He should be dominated the Nobel prize for his believe in Ampligen for CFS.
I have many praise for Dr Carter, irregardless of what’s the FDA outcome for Ampligen. Dr Carter’s medical spirit is a blessing for mankind.
June 8th, 2009 at 8:04 am
[...] identified several key points which have been raised recently, decyphering the fact from fiction. Identifying Fact vs. Fiction on Hermispherx’s Ampligen | hope you all like it [...]
June 9th, 2009 at 2:11 pm
Michael when is your buy of the year EESO and NSPT (mega bombed!) going to pay off? Their 70% dropping a month after you called them BUYs is a large concern.
June 9th, 2009 at 2:14 pm
@None, Indeed EESO has been a dissapointment — I no longer hold any positions. NSPT has proved to conduct poor management and has also lost my interest. Others have also questioned my choice on MESA, however those were day trades which I have sold for 20% and 23% respectively. We all make mistakes.
June 10th, 2009 at 11:45 am
MV,
Any news with HEB from your end?
June 10th, 2009 at 11:48 am
@Brad, If there was, I would have posted something.
June 10th, 2009 at 3:54 pm
I am a suffer of cfs for over 20 years. at this time , i am almost bed ridden with this illness. my only hope is approval of ampligen for cfs. if i had a choice of taking it, i would even if it killed me.
June 10th, 2009 at 9:19 pm
MV,
I figured, but you seem to be started towards your next big hit. Unfortunately I don’t have much time to research so I try to pick one that is hitting everyone’s radar and focus my research on that. Between work and family I wake up at 2:30 am and go to sleep 10:00 or 11:00 pm M-F (Vegas) so that does not leave much free study time. Are you planning to day trade “Access” or go in for a while? Again I have not researched it yet but I will begin. I also am not sure if you already posted your plans for this one yet. If you did, sorry.
Thanks for any insight.
June 10th, 2009 at 9:23 pm
@Brad, I see ACCP as a fairly long hold for me, their management has been getting off on the right footsteps as of late, they have key acquisitions and seem to know how to market their product. They are also very up to date when it comes to social media, heck they even have a Facebook application! Very cool!
I am also in on ADLS
June 11th, 2009 at 6:43 am
Thanks again.
Unlike some I do understand that we are all gambling, but any info is a step up. I seen someone on the google board complaining that they lost money because of someone’s advice, they may have been attempting to get a rise out of everyone, but I am sure there are people out there that actually blame others for their loss. If that is how they trade they better get used to losing.
June 11th, 2009 at 11:08 am
[...] Identifying Fact vs. Fiction on Hemispherx’s Ampligen [...]
June 11th, 2009 at 3:21 pm
As posted previously on Yahoo Finance:
A letter was sent to all major news networks worldwide in which investors will be taking on the SEC, FTC and the Office of the President challenging them to reply. It will cover possible stock manipulation and back door disbursement of profits, specific to recent activity of The Street.com and its contributors, namely Adam Feuerstein who was instrumental in using public media and the internet to transmit false reports on several Bio stocks. It should be known that price drop and hedge fund purchases mysteriously coincided with the drops and immediately followed the post articles on The Street.com website. Specific to the demand for a public reply is as follows: Why did monitoring agencies question the CEO of Hemispherx Bio (HEB) about the sudden rise in stock price 8 days ago, while when the stock experienced a loss at greater than that rise rate, did not question the “reporter” at The Street.com as to their involvement in possible short selling, hedge fund involvement and price manipulation. Ironically Jim Cramer has recently begun a formal “short selling” petition that he publicly touted on his Mad Money CNBC show. Is this a ploy to mask his own activity and those of his financial circles to hide behind? ( see video for reference http://www.youtube.com/watch?v=HRa0B34jM... The clips seemed to strike a sour tone to CNBC and many of the clips were removed. Is CNBC actively aware of background manipulation tactics used by The Street and many who are within their circles? Could it be very possible that stock manipulation goes further than the halls of wall street and those involved were able to get embedded deep into the SEC and FTC so that only the privileged who hide behind the “Freedom of Speech” clause can avoid prosecution? It is time that the oval office become more aware of issues that go further than the political sectors and begin cleaning house where it’s needed. I say, yes, Mr. President, I will challenge you as well to reply to me via this board. Your platform is change; I myself voted for you and have no fear of making that public. I too see the future as one that requires change, and not only from the bottom up but also from the top down. My goal on Monday will be to make these challenges very public in whatever means it takes to achieve it. If it means that entities and individuals and The Street.com become the pinnacle of an in-depth investigation, so be it. It is owed to the American people for the President to become responsive to issues that make a difference to all people in America, regardless of class, celebrity status, or political affiliation. To this end, I will see that this exercise does not fall on deaf ears and mark my words, these events will be investigated and should Adam Feuerstein or Mr. Cramer be found guilty of any charges on a federal level it would be incumbent on all who have experienced financial losses to bring charges against these same individuals and the vehicles of media they are employed by, specifically NBC, GE (Owner of NBC and its affiliates. This notion is made on the basis that enough posts were made on this and other financial boards to make it so that CNBC and other management of NBC affiliated media sources were apprised of possible illegal movement within their organization and if it was not addressed or can be proved to have been addressed, that NBC and its owners and affiliates will be held liable for the compensation of all losses to shareholders and be held accountable for and not limited to criminal and civil penalties. Copy and communicate this release to as many of the boards or media sources that you are associated with on or before Monday. Thank you all in advance for your support and hope that we can begin to rid Wall street of criminals who are at the forefront of the corruption that helped put the United States in the unwanted financial crisis we are all experiencing.
My position: Long on HEB … I know it is important to all of us as Americans for Ampligen to be approved however we must put the FDA approval into a global perspective. Even if it is not approved for US distribution I believe short term it would be of no consequence to the value behind HEB. I make this presumption simply based on the inherent distribution probabilities outside our shores and the populations demand therein. The US population is a mere 4.53% or the world. The Asian rim and other countries that have already focued on Ampligen as a viable drug for various ailments constitue over 38% of the world population. (http://en.wikipedia.org/wiki/List_of_countries_by_population ) As Americans we should be used to our Admins and Commissions to sit in a bath of political rhetoric which stifles progress on the US. Too often we rely on outside countries to excel and later ponder what we did wrong and probably assign a new useless commission to do that. I think HEB and the Ampligen product will prevail, if not in the US, then for other countries.
There are 38 people in the NJ- HEB facility alone. I’ve managed an FDA and EPA certified manufacturing company which attained Malcolm Baldrige National Quality Award and ISO status with full utilization of GMP and MRP 1 & 2 production methods. My staff was half of what is listed as the manufacturing employees that HEB has in the NJ location and we were able to support orders received from company in the USA, Asia, Europe, South America and Canada. For those of you who don’t know the mechanical process of fill and seal machines, the typical machines used are Circle Line Form fill and Seal caddy stations capable of over 40,000 units per hour output. The manpower requirement for each shift per machine is 2 units with a staff mechanic covering the floor as needed all in a Class 100 or better environment. With that said, HEB has ample staffing for a full 3 shift schedule. The balance would be supervisory management, quality control and second tier management. For those of you who do not have a manufacturing background, the Baldrige Award is one of the highest honors a manufacturing company can receive. Thank you…Vinthetoolman@yahoo.com .
June 28th, 2009 at 6:46 am
After the last few days before the the share holders meeting I was about to give up on HEB. I’m now going to hold I feel more confident that ampligen will get approved. Investors are starting buy into HEB as I notice thurs & friday. Monday we will probably see $3+/-.
July 2nd, 2009 at 11:51 am
[...] nothing else Ampligen appears to be safe and effective. Here is a great article that separates the fact from fiction. Hemispherx BioPharma One Penn Center 1617 JFK Blvd., 6th Floor Philadelphia, PA 19103 Phone: [...]
July 10th, 2009 at 11:49 pm
If the p value is .047 then WHY is it .052 on the NEWEST PR regarding the ampligen trial??????????
http://www.hemispherx.net/content/investor/default.asp?goto=298
August 2nd, 2009 at 5:59 am
i don’t know why all you hate A.F so much! the first artical he wrote i was a bit pissed becuase of the drop to the$1,50 to $1.70 range but now i can’t wait for the next one becuase i need to buy back the share i sold last week for 3.40. if you did your homework on HEB, you know what the range of the stock is. so next time A.F writes some hate mail on HEB buy like crazy because you know a week after the stock will come back to the $1.90 to $2.50 range. When he writes by now you should know exactly what he’s doing so make the manipulation make you $ too. THANKS ADAM I’M LOOKING FORWARD TO YOUR NEXT ARTICAL!!!!
August 31st, 2009 at 12:47 am
Speaking from the perspective of a CFS patient who has known and read of many others with CFS who have tried Ampligen, the drug is an expensive joke, and a cruel one at that.
Like most pharmaceuticals, Ampligen does nothing to permanently correct the immune dysfunction in CFS, because it does not address the causes of said immune dysfunction, which can be many, and differ from patient to patient.
Sure, some patients have had remarkable improvement while on the drug, but as soon as they have stopped, their CFS relapses to a state even worse than the original condition they were so desperate to recover from. From wheelchair to a full life, and then bedridden again.
This is a fact. Google Mary Schweitzer, just as one example. Her 10 year history with this drug shows what a miserable and cruel failure it is, and an incredibly expensive one at that, fortunately putting it out of the reach of most CFS patients.
And we wonder why health”care” is so expensive.