"They believe MNKD's actions are unprecedented by releasing data on only two of three arms of the AFFINITY 1 trial. They released the results on the injectable insulin and Dreamboat arms but withheld the results on the Medtone C-arm. Firm says that if the inhalers are not equivalent, then there is not enough safety information to approve Dreamboat."
They may have opened a new can of worms with the medtone a1c out performing the othe inhaler. It would inadvertently bring up a bio equivalence issues, the 30 % of lost insulin in the medtone likely had a long acting effect through absorption through throat and bronchi absorption. New trials can generate new complete response issues. Why they doing a dosing study clinical before results came out? They have a new dosing issue. Al Manns clinical team are likely not as competent as they need to be.. My wife the doc told me to be aware of this outcome. We bought at 1.90 and sold half before data, and sold the rest the day news was posted. We just are not sure what will be next may get back in when bottoms. .??..
Summer Street is distorting the facts. The only reason the FDA asked Mannkind to include Medtone in the study was to compare the Pulmonary Lung Safety between Medtone and Dreamboat. The FDA did not ask for an efficacy comparison to be done between Medtone and Dreamboat and Mannkind and its only concern was the pulmonary safety for Dreamboat compared to Medtone, The results came out positive and Mannkind can now bridge all prior pulmonsary safety clincal data from all of Medtone's previous trials into the Dreamboat regulatory application. The only efficacy comparison the FDA asked for was for Dreamboat to demonstrate non-inferiority compared to Aspart. Summer Street has it all wrong.
"Early today, we released preliminary results on these studies and reported that both studies met their primary endpoints, and that the trial type 1 trial achieved its other main objective of bridging the Generation 2 inhaler to the pulmonary safety data collected with the MedTone inhaler"
I have always suspected their trial results regarding respitory and safety. I am sure it is why it was not told by MNKD corp. I believe that Afreeza if approved will get an FDA Label, limiting users. This could be very bad for sales. Another problem with MNKD is that you cannot ask any negative questions here, you have the MNKD followers bashing you down.