Battelle contract goal is an IDE device for sepsis.
If AEMD obtains the IDE FDA go ahead it would also support the Battelle contract goal for an IDE device for sepsis. That would be a real feather in their cap. The only thing holding the FDA back from granting any device IDE testing, is the assurance that any device is safe enough for use, FDA is 1 in 10 million use cycles. The biggest issue is how does the HP stop any of the fiber doping materials from entering the blood stream and that the delta pressures from the dialysis machines don't over pressure the HP device and cause failures. The HP filter should not have any problems if the dialysis machines operate properly. What measures has AEMD devised to insure that the over pressuring can not occur. This is an interesting problem.
Just out of curiosity, does this knowledge come directly from Aethlon's communications with the FDA, or more from a general knowledge of FDA concerns in the dialysis and filtration fields, combined with supposition?
No communication from AEMD and the FAA isa used in my analysis. General knowledge from others who are dealing with the FDA approval process and from the FDA website on IDE submission and reliability requirements. General failure modes and effects analysis on what is described of the HP system and how it works by AEMD provides enough information as to what the FDA is looking for in their critical analysis.
Extremely interesting insight - much further beyond anything I know regarding the HP and IDE/FDA approval processes. Hopefully we hear within the next few days whether or not we have gotten IDE approval.