DarioHealth Corp (DRIO)

[Vaffan-Coulo]

Busted a gut laughing!

Say what:

"This interaction has led us to recently finalize plans for a new U.S. study aimed at evaluating the usability of the Dario™ and its accuracy in the hands of end-users, and we are commencing this study imminently."

Seiously??? Does Erez understand that a 510K study under NO CIRCUMSTANCES requires a "study"? Does he understand that NO study will affect the FDA decision process? Not to mention that apparently it took them almost a YEAR to figure out this alleged "study" was "needed" for approval.

For a 510K, the ONLY thing the FDA does is COMPARE the device to OTHER similar devices! Given Labstyle's near bankrupt condition, what kind of idiot management would spend money to initiate a "study" that WON'T have ANY effect on the approval process?

Indeed, if you think about it, WHAT "evidence" would they be seeking? The thing is a GLUCOMETER, for godsakes! It operates like every other glucometer -- presumably! What's "different" about dario that makes "usability" an issue that needs "evaluating"?

Sounds to me more like DRIO is just preparing excuses for further delays BEYOND this year and for reasons to execute yet more PIPES.