Exit partnership, sell Afrezza IP + manufacturing plant, rebrand as a TS technology company, then sell TS to the highest bidder after the first successful product release.
Let me guess, you're a member of the senior leadership team at MNKD? Just wait for the magical fairies to descend and fix everything, right?
Stunned silence from the peanut gallery.
They gambled and lost. Simple as that. It's amazing that Shkreli knew this as MNKD mgmt did not. When he went to the FDA to challenge the bio-equivalence clinical trials comparing MedTone to Dreamboat, he knew the FDA would be forced to issue a CRL because of FDA guidelines requiring In Vivo clinicals. MNKD management did not know this. So, yes, they screwed up.
'the best thing that you can hope for is that they sell the entire company.' Exactly, that is the best possible outcome.
They had no choice about changing the inhaler - Medtone was not going to be approved, and the cost and time to address it with Dreamboat already developed would have been a worse decision. The mistake was short cutting clinicals using in vitro vs in vivo protocols. They may have been misled by the FDA, but it was a huge gamble that resulted in a 3 year delays and another 150 million shares.
Good post OPC, your last sentence sums it nicely. Not much else to say.
SNY just reduced sales estimates based on current information. Whatever estimates RBC generated 'long ago' are irrelevant today.