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Post by Deleted on May 29, 2014 13:07:59 GMT -5
Afrezza holds the promise of reducing or eliminating bouts of life- threatening hypoglycemic events as well as the need for injection. I therefore envision possible chaos in the diabetic community if MNKD is unable to satisfy World demand if approval is achieved prior to forming a solid marketing/manufacturing partnership with a major company. Could this have an affect on the FDA’s decision?
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Post by 4Balance on May 29, 2014 13:44:42 GMT -5
No...IMHO, I don't think the FDA cares about the ability to satisfy demand in a timely way; that part would be up to the company to solve. Furthermore, if MNKD is able to use the stored insulin supply, that part of the equation is probably solved...of course, there are more steps to placing product in the hands of users.
I truly believe the larger issue with timing of partnership is whether the drug will be approved. Prior to approval it's a huge risk....plus, Al can get far more in return, post approval...and he is looking for return on his investment.
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