FDA Grants AEMD’s Hemopurifier Expanded Access To Treat Ebola

FDA

Nov 19, 2014 Featured: Home Page, MARKET 2 1702 Views

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.

Please do your own due diligence or consult a trusted financial advisor before investing in this or any security.

Share this on: Facebook // Twitter // Delicious // Digg // Reddit // Stumbleupon
Related Posts
Aethlon’s Hemopurifier : An Infectious Disease Game Changer…

Oct 22, 2014


2 Comments for "FDA Grants AEMD’s Hemopurifier Expanded Access To Treat Ebola"


Remarkable

Posted on Saturday 20th December, 2014, 2:54am

Reply

What are thoughts on today’s report in The Lancet by Timo Wolf, et. al.? (Or, et. not al., as Geiger is not a co-author.)

Wolf stated before/after hemofiltration, viral load decreased by 66%, according to RNA PCR assay, but he questioned the validity of the assay, and went as far as saying that Hemopurifier treatment was not responsible for Mawanda’s recovery.

On the other hand, we have Dr. Geiger’s analysis, as reported at the American Nephrologist’s conference and in Time last month. Geiger argued that Hemopurifier was responsible, at least in part, for Mawanda’s survival. He quoted data that showed a much higher rate of viral load reduction before/after — from 40,000 down to 1000 copies/ml, if I recall correctly — and pointed to the elution protocol at Marburg that quantified number of viruses captured in cartridge (242 million copies).

Your thoughts?

    edvapatent

    Posted on Monday 22nd December, 2014, 11:25pm

    Reply

    My thoughts are that AEMD needs a demonstration of its product which cannot be misconstrued by doctors or the press. You might ask how AEMD can control this and the answer is not all that complicated. They have in fact been given direction from the very people who have maligned the Hemopurifier’s impact. They need a patient who is demonstrably ill and whose viral load is accelerating or at least flat (not diminishing) at the time of treatment. They can insist on the use of their device under certain conditions or they can choose not to offer the device at all. At this point for Aethlon it is as much about the integrity of the results as anything else, including saving lives on some level. On first inspection that last line may seem cold but consider that if they keep being maligned or misrepresented, in part because they are not in control of the conditions of use (which of course in their first Ebola patient treatment they can be forgiven for), which will invariably lead to certain types of data points-or openings for critics, then the product itself may not be considered a first line of treatment therapy in future cases or outbreaks. The reality is that after years in the dark Aethlon was just excited to be able to offer the Hemopurifier for treatment to Dr. Mawanda in Frankfurt. Kind of like a pro-team making it to the playoffs for the first time. The problem is you can’t just be excited to be there. You have to play to win and that means thinking of some of the ways (on the front end) a victory may be framed as a loss where you’re concerned. The past month has been a trial by fire for AEMD. They have been blasted by numerous irresponsible authors who either did cursory due diligence or who willfully cherry picked facts to support their stories or both. They also had competing scientists from Emory University offer a bit of backhanded praise for Hemopurifier therapy which left its efficacy less stout than it appeared prior to their comments. The Hep C trials in the U.S. should help as it takes away the “only fraud happens in India medical trials” argument that The Street made. Aethlon needs to consider the minefields ahead as it progresses and have a plan for them rather than simply suffering through them if they come. That is not a strategic plan and it leaves the company and its investors open to vulnerability.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

@ Copyright 2014. EdvaDaily site by Atlanta Marketing Consultants
Top