I think the key might be that the Medtone inhaler was not approved. To use in vitro bioequivalancy tests to replace an approved device with a better one is one thing. To use in vitro testing to show that the new device performs as well as one that was not approved is another.

Of course Medtone was denied approval because of device maintenance issues and cartridge labeling concerns, not how it delivered the drug. But this still leaves plenty of justification for the CRL.

At the end of the day it is clear that the FDA could have approved the device if it wanted to, but someone in the device division made a decision that was not based on concern for diabetics.

Shortly thereafter the head of the FDA device division resigned to take a job with the State of Maryland. "I guess my job is done here."

BTW trading volume has subsided today. The traders must be done for the moment.