If you listen to the last JMP you will clearly hear that the Medtone inhaler is the one that is in the NDA and that they are not putting the Dreamboat in it..because they do not want to disrupt the current NDA's approval track.... The Dreamboat will come later...and that my friends is what I believe the wannabe partners are upset about..well..when Al launches with Medtone..realize that in an early talk the company said they were Pre-pared to go it alone..REMEMBER MINIMED!! WALLSTREET DARLING!! Walked away from those wannabes..and then made BILLIONS!!!!! And Mannkind is many magitudes larger then Minimed...If I was in charge at that wannabe partner...I would be shutting up my demanding attidude before I lost the partnership..well to late..NEXT partner?? SNY? 15Billion Euros and copromotion, and launch with Medtone..if you want!?
Will NOT LAUNCH with medtone inhaler. Mr. Mann stated during the Morgan Preso that MNKD will only launch with Dreamboat - and that FDA approval of the Dreamboat could be a major hurdle to overcome for a January launch date (2010) - IF THE FDA doesn't approve Dreamboat by the PDUFA date.
As of the Morgan Preso, MNKD had submitted additional information to the FDA regarding the Dreamboat, but had not been given an indication as to whether or not the Dreamboat was going to be approved by the FDA nor was MNKD made aware as to the manner in which the approval would be granted.
MNKD shareholders (and shorts alike) have two distinct issues to stay on top of:
1. the FDA approval of Afresa and the technosphere delivery of the insulin. (1/16/2010 - PDUFA date)
2. the FDA approval of the dreamboat inhaler - delivery method. (No approval date or approval track has been reported by the MNKD or the FDA)
Amazing how few do their research..I guess that the panic caused them to stop listening to the talk after they read the k form?
The Medtone is great! the Dreamboat is even greater!..I am suggesting that it is possible that only one inhalation is required regardless of the inhaler...listen to the last talk and tell me you can not hear that message??
you are to in love with al...this is a great product and delivery system...the cancer studies are to new,phase one...don't get crazy about that,not until you see great results in phase 2...and until afresa is approved without further testing this can implode...jmho