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??
All of you must realize that whatever the company says are forward looking statements subject to changes on the fly! So remember this little fact..that last talk said the NDA IS GOING FORWARD AS IT IS!! TO PROTECT IT FROM DERAILING BECAUSE OF SOME STUPID WANNABE PARTNER DEMAND! imo