Hemispherx BioPharma, Inc. (NYSEMKT:HEB)

CAPS Rating: 1 out of 5

A biopharmaceutical company engaged in the clinical development, manufacture, marketing and distribution of new drug entities based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders.


Player Avatar cfsguy99 (53.56) Submitted: 10/11/2007 2:01:11 PM : Outperform Start Price: $1.77 HEB Score: -37.87

HemispherX Biopharma is the ONLY drug company to develop and fully test a treatment drug for the disabling, devastating illness with the silly name: "Chronic Fatigue Syndrome (Myalgic Encephalomyllitus or M.E.)" I know just how devasting this illness is, as I am disabled by iit. Today, HEB has submitted a new drug application (NDA) to the FDA for approval. HEB owns dozens of worldwide patents on "AMPLIGEN". It might still be considered specualtive since the FDA has yet to approve the drug, however, as a person with CFS/ME who participated in the drug trials...I know it helps. It will help the majority of the 1-2 million people sufffering from this illness in the US alone. AND it may have helpful immune system benefit for other diverse conditions such as bird flu, AIDS and even toxic chemical exposure.

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Member Avatar cfsguy99 (53.56) Submitted: 12/13/2007 12:15:23 AM
Recs: 1

The recent FDA letter to HemispherX outlining 11 clinical and 3 pre-clinical questions was interpreted by institutional investors as a failure and they dumped HEB, dropping the price down about .50. Individual, small, investors panicked the next day and stock price dropped another .10-.15. I listened to the conference call HemispherX promptly scheduled and, for better or worse, believe what they are saying.Although all of the questions posed by the FDA are legitimate in analyzing and evaluating the Ampligen NewDrugApplication, the answers to their questions exist and were presumably submitted with the tens of thousands of documents that is the NDA package. The problem, as indicated by HemispherX, was a "poor table of contents". Critical documents were attached as addendums to other documents and not cross-referenced to be easily found.Apparently, the NDA submitted includes all the test results, statistics, patient information and clinical records requested by the FDA, but not easily found. On the surface, this sounds like a lame excuse, however, knowing that this process has been ongoing for HEB for almost 20 years and knowing that almost everything had to be hand written on forms and documents (no computer data entry on initial data capture) and learning that an unprecedented 4 different divisions have been charged over the years with evaluating and judging HEB's submissions (because FDA didn't know how to classify the first double stranded RNA drug submission), I believe there is a high probability for confusion in prioritizing and referencing material anyone would have assumed was already evaluated and approved in years past. This is not to excuse HEB, and its agents, for any omissions or organizational mistakes, obviously, HEB is responsible for not only getting all the info to the FDA that the FDA needs, but making it easily accessible so they don't have to wade through every box of papers. I believe HEB will get their ducks in a row, work through the holidays and provide the FDA EVERYTHING that was promised in a timely fashion so as not to delay the process any further.This drug needs to be approved, people need the help. No paperwork snafu should be allowed to delay this process any further. My commitment has not wavered, but like other shareholders, my patience is stretched thin.In the mean time, a buying opportunity exists, for those who can stomach the ride.

Member Avatar cfsguy99 (53.56) Submitted: 3/14/2008 1:33:47 PM
Recs: 0

Recent FDA response from the HEB submission was made public bearing out that ALL major medical and Biopharma issues were addressed to the FDA's satisfaction and all that remain are, essentially, administrative, paperwork "dot the i's" and "cross the t's" issues that should be cleared soon. HemispherX continues to solicit investors and move forward with production/marketing/distribution tasks and I take this as a very good sign. Look for price/sh bounce when FDA approves AMPLIGEN, and again, when HEB contracts with some company moving AMPLIGEN closer to market.

Member Avatar cfsguy99 (53.56) Submitted: 2/27/2009 3:27:47 PM
Recs: 0

During this economic downturn, biopharma seems to be the best investment. HEB still waiting on FDA approval. The politics of delay are frustrating, but with the change in Administrations, there is renewed hope we will see the positive result we've been waiting so long for in May.

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