MY NEW UPDATE ON LLBO
they just entered into a contract with salesforce, 2 weeks ago,to handle all the documentation for each patient to be downloaded/recorded ,which is very important if the FDA wants to come in during the trials and examine any patient .All the forms that needed to be created for the patients have all been done,next thing that happens in the hospital, it goes to the legal department ,which went back and forth between our legal(CH) team and the hospitals about 2 or 3 weeks ago,then the agreement is signed then goes to the president of the hospital who signed the clinical trials agreement a week ago,that's all done now ,
now we focus on Flextronics to get the patches and recording devices delivered ,estimated production and shipment date of June 15,soon after the trials will be started .(delays happen so to be safe let say + another week or two,jmo)
once the trials are completed and summarized they will file for the 501k(investigational device) ,probably wont happen till October ,and at the same time they will file for the CE mark to sell over seas ,Ce mark takes 90 days to get fda 6-9 months from the date filled .
they will be meeting with FDA in July in Washington bringing them up to speed ,and applying for fast track which we may get lucky and see 4-6 months ,but no guarantee i want stress that just cause they apply for fast track wont mean it will happen , safer to say 6-9 months
in the trials
the process is the woman has a mammogram, then she has our test and then the biopsy ,we know the results of the woman as soon as the information of the biopsy is available, we then know how we compared to the mammogram.
were going to test the first 50 women for 12hrs ,if the correlation is coming up to what we except it should ,then were going to drop our test from 12hrs to 6 hrs ,then test another 50 women and if the correlation is there at 6 hrs ,then we drop it down to 2 hrs.
the other thing thats going to happen is they are going to get publication from peer review journals of the results of the test
this my DD do your own DD
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$LLBO MY NEW UPDATE ON LLBO (from change-for-a-buck)
$Pistol Pete$ on 6/9/2015 12:41:11 AM
excerpt/ LLBO
mick on 6/9/2015 12:49:27 AM
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