Most anyone watching this company knew that this news was coming but it is great that we are greeted with it this morning. Essentially what it does is remove layers of red tape so that someone suffering from Ebola in the U.S. can get treatment right away. We believe the speed of this announcement on the heels of both the positive results of the Hemopurifier therapy on Dr. Mawanda in Frankfurt, Germany and the tragic passing of Dr. Martin Salia in Nebraska is not coincidental. A excerpt from this morning’s press release on the announcement follows for those trying to understand the implications. This is tremendous news for anyone coming to the United States for treatment or for those who may contract the virus here. In the coming days and weeks we expect to see more requests outside the United States to treat patients with the Ebola virus.
“Aethlon previously disclosed that it would provide Hemopurifier® therapy on a humanitarian basis through FDA compassionate use access provisions, which allow for the use of an investigational device to treat an individual patient or small group based on clearance by FDA prior to treatment.
Based on FDA guidance, Aethlon will now provide Hemopurifier® therapy to treat Ebola infection through expanded access “emergency use” provisions in the United States. Expanded access “emergency use” of an investigational device does not require advance FDA approval for life threatening circumstances for which an alternative therapy is not available. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans.”
Important: Aethlon will announce the results of its Medanta Medecity HCV Study which utilized Hemopurifier therapy on patients with Hepatitis C (HEP C) in various Genotypes. There are currently over 3 Million Hep C cases in the United States and over 170 Million worldwide. It is important to remember that Hep C is but one of dozens of indications which may be treated by the Hemopurifier.
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