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Alias Born 03/03/2005

Re: None

Sunday, 10/30/2005 1:36:16 PM

Sunday, October 30, 2005 1:36:16 PM

Post# of 30387
what we need to see is ABBOTT make some moves. they have had RECAF in their labs for around 7 months now. when will they go public with something? (other than the email to HALF_FULL or Headache or whoever it was)

the problem with the 510k process is that all testing, etc is done out of the public view and the application is simply submitted to the FDA. so, we may not hear much from abbott until they actually file the 510k. for those indications that a PMA will be required, we can expect dockets to be posted at clinicaltrials.gov so we will definitely know when they start recruitment/enrollment.

obviously, one would expect them to initiate some sort of medical PR campaign before product launch -- ie; peer reviewed publishing, the conference circuit, etc. but they may choose to do this AFTER fda approval, or during the 510k review period. all of that is up to Abbott, not BioCurex...which is kind of a pain in the a**.


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