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Re: kidnova post# 19562

Wednesday, 02/15/2012 11:25:29 AM

Wednesday, February 15, 2012 11:25:29 AM

Post# of 330175
Thanks very much for the message and link Kid. I checked out the correspondence from the FDA on the first device, the infrascanner, and it is interesting to note in the Decision Summary link in the right column that the applicant was turned down in March of 2010 when FDA issued its rejection letter. The applicant then re-applied, presumably fairly quickly, for Class II de Nova classification after that March 2010 rejection and was approved in December 2011, some 20 months later, from the rejection date. How does that stack up with BIEL's status although the two are completely unrelated? I still believe the logic found in BIEL having already been approved for the post eye surgery Recovery Rx and that the process the company is in now is just a procedural one. Thanks