|FDA Calendar Extreme Trades: Aethlon (AEMD.OB), Lifeline (LLBO.PK)|
|Monday, 03 August 2009 17:10|
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 299 entries as of 8/3/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 8/3/09, Lifeline Biotech (LLBO.PK) announced that it has made its initial filing of its First Warning System with the FDA. The Company's CEO, Jim Holmes, said that "through its consulting firm, Lifeline has submitted the First Warning System process and technology to the FDA. The purpose of this filing is to obtain the FDA's opinion requesting a classification of this device. The opinion as to the classification is expected to determine the subsequent filing and registration required to clear the First Warning System for marketing in the United States. The FDA's response is expected to take several months."
The Company previously received two patents on its First Warning System hardware and has in the past year filed for a patent on the technological advancements of the First Warning System software. The software has achieved the robust capability of identifying and classifying tissue abnormalities of the breast with sensitivities (ability to identify) of 95% to 100% and specificities (verify) of 87% to 90%. Currently, it is widely recognized that mammograms miss an estimated 20 to 30% of the breast cancers. As stated by the CEO in the PR today, this filing by LLBO.PK is NOT for marketing clearance of the First Warning System as the Agency is expected to classify the device (i.e. I, II, or III) to guide a future submission for marketing clearance.
Aethlon Medical (AEMD.OB) is developing the Hemopurifier filter cartridge as a potentially new and additive treatment for chronic infection with the hepatitis C virus (HCV), in addition to other viral infections (HIV, influenza-pandemic flu), bio-terror agents, and cancer. The Company's filter technology platform combines principles of both dialysis and affinity chromatography to selectively remove unwanted substances from the blood (e.g. viruses) with a coating of a plant protein called a lectin that binds to specific carbohydrate molecules on the surface of some cell membranes which are not normally present in humans.
To conduct human studies in the U.S., AEMD.OB must receive approval from the FDA based on the Company's Investigational Device Exemption (IDE) application, which must be amended for the Company's proposed use in HCV therapy. The Company hopes to schedule a meeting with the FDA during Fall 2009 (11/15/09 is just an estimate for this entry) based on study data generated in India that includes two small clinical trials demonstrating the ability for the Hemopurifier to bind/remove HCV from the blood of infected patients. AEMD.OB has completed safety and efficacy studies including 12 collaborative in-vitro studies, animal studies, and human studies. In addition, the Company has conducted five years of research + proof of principle studies on the Hemopurifier and is moving towards commercialization on a named-patient basis in India.
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