After 16 years of hard work, we have almost reached the finish line for FDA approval of AFRESA! A mere 25 trading days remain until we cross that finish line. 01/16/10.
A word of thanks to all who have played a role in getting us to this point. It's almost time to harvest what you have sown. And the lives of many millions of patients will soon be made easier, and safer. Thanks again!
Al Mann publicly stated that the Dreamboat acceptance and approval by the FDA would be a major issue (Morgan Presentation) and that MNKD would not launch until the Dreamboat Delivery Device was approved (because of the compelling cost and usage/drug delivery advantages).
So go into the PDUFA date with proper expectations, unless it is 100% positive, we will more than likely trade down.
The PDUFA is a MAJOR milestone but expect set backs and expect that shorts (and others) will CONTINUE to exploit every possible angle to push this company down.
Just my generally pessimistic outlook toward development stage biotech stocks...