TSXV:VER.H - Post by User
Post by
herbaciouson Mar 27, 2011 4:24pm
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Post# 18347401
AURA IN THE U.S IN 2013
AURA IN THE U.S IN 2013FDA approval would likely come thru PMA and would likely require additional trial data (additional to the 1,000 + lesion study) However ,until we see the full data st from the 1000+lesion study, it is difficult to determine how much additional data the FDS might require.
MELA Sciences quest for FDA approval of its skin imaging device, the FDA set 95% sensitivity (statistical at 95% conf interval ) as one of the END POINTS for the 1,400 patient clinical trial used to support their PMA application.
The interim data set from Verisante's 1,000+ lesion study showed 100% sensitivity!
Although the full analysis may indicate lower sesitivity , Verisante can ADJUST THEIR DEVICE TO INCREASE SENSITIVITY.
This would comprimise specificity somewhat although likely not nearly anywhere near as low as 9.5% specificity logged with MELA'S device in their 1,400 patient trial (an FDA advisory panel voted by a narrow margin that MELA"S device was effective despite the 9.5% sensitivity)
The Verisante management indicated that they will run a small U.S. based trial (150 patients at each of 3 sites)to supplement the data from the 1,000+lesion study.
THE COMBINED DATA , THEY BELIEVE WILL BE SUFFICIENT TO SUPPORT TO GAIN FDA APPROVAL.
do your own due diligence
herb