"Remember, it doesnt have to be quicker or as quick to give us a REEEEEEAAAAALLY tough time. If it approximates the body's normal functions, it will be a blockbuster."
Any pill form is necessarily going to take 15 - 20 minutes just to begin to be absorbed. There may then be a prolonged release (by design or not) while this whole complex is absorbed in the gut. The only form of insulin I've ever spent time worrying about as a direct competitor is Ora-lyn, which is sublingual. But that company has had its share of problems etc, so it's not on the near horizon.
"As to their situation w fda, isnt it the case that if orals are already available and there isnt substantial difference, the fda path to approval might be streamlined? I dont think theyd be dumb enough to provide such guidance without speaking w fda first?"
There has never been an oral insulin, so they would have to demonstrate safety, efficacy, pharmacokinetics, dosing. And while the insulin is probably safe, they would have to demonstrate safety of their carrier molecule (akin to MNKD's Technosphere). The only study they have provided (although I've not done a literature search), is in 7 rats.
"WE NEED A PARTNER."
I agree; that would probably grease the wheels. Although at this point, I'm willing to wait. The longer we can wait, the better the deal will be for us.
