RE: FDA approval my guess is FDA approval will be very late 2014 or early 2015 - this will likely be a full PMA application with required US clinical trials as a class III device - anything less would be a pleasant and unexpected surprise. I expect that once the company announces the confirmed FDA process with timelines the market should start taking notice and valuing accordingly.
IMO - comparing melafind to verisante aura for FDA approval process is apples to oranges for the most part - as the devices are entirely different as are the uses. Very generally they are both to assist in the identification of melanoma - but that is a very broad based analysis when looking at the background science of each device.
I wrote about my opinion on the Melafind FDA process in an earlier seekingalpha blog post - interesting bits as follows:
(Melafind)Statistical method used to calculate the device sensitivity at 98% was chosen by Mela Sciences as a one-sided exact Mid-p binomial method. Some view this as a weaker statistical evaluation. The FDA certainly voiced this concern despite approving. Comparing this method to the Clopper-Pearson, Score methods and the two-sided Mid-p method the FDA showed much lower results.
Please see: www.fda.gov/downloads/AdvisoryCommittees...
and
www.fda.gov/downloads/AdvisoryCommittees...
Most importantly in my mind, is the issue of Melafind Non-Evaluables- these were not included in the assessment of melafind's accuracy but should be taken into consideration. Let's put this into perspective: in Melafind's clinical study, of the 1831 enrolled lesions, 162 were deemed to be non-evaluable, meaning scanned with no result given, of which included 27 pathology confirmed melanomas. Once hair is shaved, alcohol applied and suspicious lession scanned using the Melafind device, approximately 9% of all these scanned lesions were non-evaluable by the device and of those lesions, 16.7% were confirmed melanomas.
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Again just my thoughts & personal opinions, nothing more. Those FDA links about melafind are good reads - better than any NR link on the company website.....
good luck & do your own DD.