10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear FDA Commissioner Margaret Hamburg,
I am writing you concerning REMUNE the HIV/AIDS Vaccine and RemuneX formerly IR103 REMUNE with Adjuvant and the reorganization and restart of the Immune Response Corp under the Immune Response BioPharma, Inc. name and umbrella. The unfortunate events which led to the downfall of the old IRC and lack of access to HIV/AIDS patients to REMUNE and RemuneX are of a tragic nature and very sad to say the least.
Perhaps a civic good was done by the failure of the old company and was the best course of action in the long run. It takes great courage, leadership, and responsible actions to bring this company back and while the former management was unethical and irresponsible and cared only about their wallets and stock price, I see light at the end of the tunnel for the science which is sound and can save many lives.
Today we have an opportunity to help eliminate the HIV/AIDS pandemic that plagues society. I am notifying the FDA and your office that I have restarted the company and will seek FDA approval and an NDA for REMUNE on the behalf of patients who have been denied access to the vaccine. REMUNE offers partial immunity of the disease and is perhaps the safest and best treatment option for patients.
Additionally REMUNE will give their immune systems a break from HARRT and the toxic effects of the anti-retroviral drugs. REMUNE has been tested extensively and at this point it would not serve the public’s interest to require further testing in order to approve the vaccine as safe and effective. Data from the numerous trials show increased CD8 + T cell counts which are a key biomarkers and the better metric to evaluate the effectiveness of the vaccine.
Patients need immediate help and it is the responsible thing to do to move towards a marketing NDA approval for REMUNE and RemuneX as the humane, ethical, moral and honorable path to take to eliminate HIV/AIDS. The whole killed approach for virus’s including the flu to polio, is a tried and true proven method for defeating the virus and providing immunity to those who get the vaccine. REMUNE still has the potential to become treatment of choice for patients. Increased dosing of REMUNE in future clinical trials may offer increased immunity; it appears to be a dosing and frequency issue to achieve full immunity for patients.
It will take a coordinated effort by the Government, the FDA and financing from both private and public funds to achieve a commercial ramp up and manufacturing of enough doses and quantities of REMUNE for the infected patients here in the USA and across the globe. I have contacted big pharma including Merck and they have no capability or know-how or manufacturing ability to make REMUNE in commercial quantities. Thus I am asking for your help and financial assistance from the government to provide financing for a manufacturing plant for REMUNE. I estimate we will need between $10-50 million for the REMUNE manufacturing plant for which I am asking the White House to provide help with as well.
Finally if the government and the FDA are sincerely committed to eliminating HIV/AIDS from the world, I would recommend that the FDA approve an NDA for REMUNE on an emergency basis.
Complete Letter Available at www.immuneresponsebiopharma.com
