A few interesting news items today for everyone keeping watch on HemispherX Biopharma (Amex: HEB) as they await their FDA decision on approval of Ampligen(r) NDA for the treatment of Chronic Fatigue Syndrome.

First, the Sage Group, a privately held international health care consulting group, announced today that HemispherX Biopharma has expanded the mandate for The Sage Group to include, in addition to the strategic partnering efforts related to Ampligen (an experimental immunotherapeutic) for Chronic Fatigue Syndrome, additional partnering efforts related to Ampligen's use to increase the effectiveness of preventative pandemic flu vaccines and the additional role of Alferon LDO (an experimental therapeutic) for treating various types of pandemic flu.

In addition, officials at Hemispherx announced today that last week- May 20, 2009- their Board of Directors awarded bonuses to the following executives in relation to 2008 corporate goals and objectives: W.A. Carter, M.D., CEO and Chairman of the Board, was awarded $300,000 and Dr. David Strayer, Chief Medical Officer, was awarded $150,000.

The Compensation Committee and Board of Directors reviewed corporate goals established in March 2008 and determined that significant progress has been made in terms of 1) preparation and filing the Ampligen(r) NDA with the Federal Drug Administration; and 2) with the receipt of recent funding for operating activities, funds previously reserved for operating activities could be used to pay 2008 bonus.

On a down market day, shares of the company are up 6.29% on nearly three times daily volume average in anticipation of that FDA decision. In addition, biomedical developers like Novavax and Hemispherx BioPharma have had big jumps in share price recently in reaction to that H1N1 flu breakout.

Besides the Point

Mr. M. Holler, a Senior Credit analyst from Arlington, TX was kind enough to send us this note:

I appreciate that you are attempting to keep people current on the situation with Hemispherx, however I think it’s important for you to separate fact from speculation. In your article you note that, “Interestingly, a hedge-fund sponsor Renaissance Technologies, where Mr. Brown works owned 34,500 shares in HEB and added 23,000 more recently according to the latest Mutual Fund Facts report,” however you fail to mention that the same company also owns several thousand shares of OCLS (http://www.mffais.com/OCLS) which received approval today.  I think this would be important to note in your article as many are taking this information and drawing unfounded conclusions.

Yes, it's true. The fund also owns Angiotech Pharmaceuticals (NASDAQ:ANPI) which shot up Wednesday, as the company announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX) has received approval from the U.S. Food and Drug Administration to market its TAXUS Liberté Atom Paclitaxel-Eluting Coronary Stent System.

As I scan the list I can see that in addition to HEB, the fund has quite a few shares of at least one other company that has a pending FDA decision from our Exclusive FDA and Clinical Trials Calendars.

We did some research and what we're able to find out  regarding the Wall Street Journal Article (New FDA Chief Must Divest Several Stock, Fund Holdings) is that new New Food and Drug Commissioner Margaret Hamburg and her husband, hedge fund executive Peter Fitzhugh Brown, reported an income of at least $10 million in 2008, according to financial disclosure forms filed with the White House. Her husband Peter is an expert on artificial intelligence and works with James Simons, the country’s top hedge fund earner last year. Margaret, will make $150,000 a year at the FDA and has resigned her board position at medical supplier Henry Schein, Inc., she sold off nearly $3 million in company stock over the past several days according to Muckety.

We certainly welcome comments, but as far as we can tell, the same fund in question can trade any biotech stocks so long as the FDA Commissioner or her husband do not own any shares in the actual fund itself. The fact that her husband is still actively involved in managing and is compensated for those funds has some investors wondering if that is a conflict of interest. Others, however, say that liquidating their direct holdings is good enough to move ahead.

For what it's worth, the couple will be allowed to retain their interest in Renaissance's Medallion fund. An administration official told the Wall Street Journal that Medallion was exempted because its computerized quantitative model trades rapidly and holds shares only briefly, creating the equivalent of "a very blind trust." Its programming does not allow for human tracking or input except in rare instances, meaning that neither Dr. Hamburg nor her husband would be in a position to direct their Medallion account to companies or areas affected by the FDA.

Said Medallion Fund paid Dr. Hamburg between $1 million and $5 million last year, and more than $4 million to trusts held by her and her family. There are reports that shares of Cell Therapeutics, Inc. (NASDAQ: CTIC) are owned by that fund, although we have not been able to confirm that.

Another reader sent us this link to a fairly recent interview with Dr.William Carter, Chairman and CEO of HEB. It's hosted at SmallCaps.us if you haven't heard it and would like to listen to it.

In the meantime, know that the folks at Fool.Com, who had been called out for reporting that that HEB was "Poised to Plunge" has apparently changed their tune. Now HEB is one of the stocks on their new "10 Stocks to Shake the Market" list.

Go figure.

Thursday is Day 2 of the Chronic Fatigue Syndrome Advisory Committee Meeting.  The Chronic Fatigue Syndrome Advisory Commitee was established to provide science-based advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS).  There will be streaming coverage of the meeting at http://videocast.nih.gov starting at 9 a.m. EST. For more information and agenda notes, go to:  http://www.hhs.gov/advcomcfs/

BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section

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