Why Afrezza Doesn't Need Precise Titration

[capnbob]

May 28, 2016 5:52:53 GMT -5 mnholdem said:

That last comment brings up a point I've been meaning to ask the pharmaceutically knowledgeable / experienced members here:

If the recent post-marketing trials required by the FDA involved the use of Continuous Glucose Monitors, would it be conceivable that the FDA could permit MannKind could use screenshots of CGM's from these latest trial in their marketing of Afrezza to physicians?

I'm reminded of how powerful Sam Finta's "before & after" CGM photos are. His CGM would be consider anecdotal and unusuable for direct marketing by MannKind. But what about CGM photos taken from a controlled FDA-protocol trial?

I'd prefer somebody with experience in these matter to answer my questions, please, rather than wild-ass guesses.

Thank you!

If the screenshots were published in a journal article, they could distribute the article.  But, again, selecting out screenshots to present as a sales tool falls into marketing and promotion, and since they aren't a part of the insert, they would not be allowed as I interpret the rules. Pretty much anything that is contrary to or different from or not mentioned in the insert has to be approved by the FDA before being used as a sales tool as I interpret the rules in that link I provided earlier.