I know this is a dead horse but with 5 internal committees being involved in an FDA approval the story Al told of getting guidance from the FDA to change the device makes sense. Much has been said about crystal clear hindsight to gain approval with the MedTone inhaler. The fact of the matter is MedTone had more issues that may have led to a CRL than switching to Dreamboat midstream. Included in those are complexity and clogging. The FDA was not interested in seeing this product introduced on MedTone. It would have required too much training and maintenance to keep it clean. If the device was not clean it would have been normal to vary the amount inhaled making dosing a nightmare.
Add to that the fact it used 23% more insulin to get an equivalent dosage (Dreamboat requires 30% less which equates to MedTone using 23% more insulin). Nobody can say for sure but I like where we are now than betting on a MedTone approval for Type 1 only.
Swing
