BriefingWire.com, 8/16/2011 - August 17, 2011 -- Immune Response BioPharma, Inc. Requests Meeting with FDA in Jan 2012 to Discuss REMUNE Approval, Sees Approval of REMUNE the Best Outcome for HIV/AIDS Patients.
Immune Response BioPharma, Inc., Fredericksburg, Virginia Today 8/17/2011 Immune Response BioPharma, Inc. Requests Meeting with FDA in Jan 2012 to Discuss REMUNE, Sees Approval of REMUNE the Best Outcome for HIV/AIDS Patients.
Immune Response BioPharma, Inc. has received a response from the FDA and FDA Officer Kristine Raine regarding emergency approval of REMUNE a vaccine for HIV/AIDS and has offered to meet to discuss approving the vaccine. The FDA has indicated REMUNE would be best classified as a biologic and a BLA maybe the correct course rather than an NDA.
“I am pleased the FDA and the government is prepared to assist Immune Response BioPharma, Inc. in our efforts to get REMUNE approved for HIV/AIDS patients. Approval of REMUNE would be the best course of action and best outcome for them as they have suffered long enough and need real help with this awful disease. We will seek conditional approval of REMUNE pending securing financing and manufacturing on a commercial scale. I have asked many of the old IRC employees to help me with this effort and I welcome those with expertise in this area to assist as well” COO Mr. Buswell.
“Manufacturing will be the biggest hurdle for REMUNE at this point it has been tested safely in over 25 clinical trials and the data is a mixed bag on efficacy there is no perfect solution. REMUNE does many things well and the benefits appear to outweigh the limited risks at this point. It has a low toxicity profile compared to the HAART drugs, it is extremely safe, shows significant CD+8 T Cell counts, and reduces the peak viral load” COO Mr. Buswell.
“The glass is more than half full with REMUNE. We are debt free and have issued no equity we are in a good position to move the ball forward without the noise of the medical community with their many conflicts of interest. Which include the potential loss of billions in government funding, and billions potentially lost by big pharma with a safe alternative to HAART such as REMUNE offers. No one cared about REMUNE or that I restarted this company until I moved to get the vaccine approved, now they come out of the woodwork like termites to attack my efforts. I will get tough with those who try to stand in the way of patients getting REMUNE. Now is the time to put the needs of the patients over conflicts of interest, manufacturing of REMUNE and financing will be the critical obstacles we face” Mr. Buswell COO.
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