This is a SLEEPER!!! has been for the last 2 years!!!Seen these rare sleepers stocks ..few times before!!!...While its off of everyones radar...especially being a bio-micro cap company..with a very low penny share price..NO-ONE paying attention...THEN it happens, any positive news...as with a FDA approval, it goes "BALLISTIC".....BE WELL INFORMED AND ADVISED!!!!..Strong Belief, this stock will do a hyper price move on FDA announcement..May happen just before with a possible M&A announcement or a big PHARMA involvement of some kind..This is highly possible at this late stage of years of development and near growth revenue potential..Only Then...and with huge price movement ...raises market awareness, and interest to acquire a piece of this highly sought after company...Just My take on events that can lead to a potential 10X bagger... Strong believer that this may be the case here...the risk is well deserved at this price...Sharing my opinion only...please do you DD..and hope you share same opinion..these opportunities only present themselves once in a while or in some cases once in a LIFE time...Good Luck and ...please do not forget to take profits along the way..hopefully at the $2.50/share price...Dont get greedy along the way!!!! Good Luck!!!