I was also immediately concerned that MNKD may be taking a track different than the FDA had suggested which was to achieve a non-inferior objective. The non-inferior objective is what the management described in previous conferences as the trial design. If they now want to achieve superiority with the trials, it reminds me of the similar risk the company accepted when they tried force mathematical equivalence with inhalers. I just can't imagine taking another risk of this size after the FDA punishment from the last risk.

OK, the financial benefit, if approved, could be a 'hit out of the park'. This same thing could occur after approval by the real drug use with certain controlled physicans.

There almost needs to be other reasons that have been developing that have caused this change, if there really is a change. It may have always been the internal objective, just not the published objective, from the company's view. It may also be that the company is now really listening to the FDA and they are indicating something like insufficient benefit to be a slam dunk approval. I'm very concerned that previously MNKD was simply concerned with approval and now they are willing to delay approval at the shareholders expense. I'm upset again!