Timeline for NDA, Preliminary Approval, and Approval
So, let me get this straight, in August the clinical data will be available, and shortly after that there should be a partner available if it looks very promising. Then the NDA will be submitted by October to the FDA, in which case the FDA will have 60 days (basically before year end) to reject it, or say that they will have a full review, in which case it could be months to 1.5 years for final NDA approval, and hence first sales won't come in most likely until later in 2014, or 2015.
Hence maybe by August shares trade above $10 on data, and $15 on partnership and FDA submission, and maybe break the $20 upon approval? This could be tricky, but any share price that break through $20 i would sell in the short term, even if the shares can break $50 by 2016.
What is the likely approval time range from October 2013 to Market Authorization by the US FDA ?
If the market generates any buzz, and the shares get above $5, it could be lights out for shorts. This market really could care less about fundamentals. Look at Amazon. This company doesn't make money, has never made money and has no real prospect of making money. It's $250.
In the last 4 years the RUT has gone up 300%. If MNKD actually found itself in some kind of index, it would explode. They would trade for 120X, 2035 earnings estimates.
or like mapp. they came up with an inhaler for migrains...........during the pdufa period,the fda stated that they were to approve it, and that the LABEL was the only hold up. the pps shot up and they were then bought out before pdufa. all the senarios are endless.JMHO