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.
After reviewing my own research, it is time to post some serious points, some of which have already been raised by other great posters, 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 the company 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 here). 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 Feuerstein also disputes the Phase 3 results from HEB, claiming the data is old and outdated and somewhat fabricated.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 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, and it has 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. It doesn’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 (PFE) or Merck (MRK), 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.
Disclosure: Long-Term Position in HEB.