Speaking of CGM that's not ready for prime-time, what the heck is the hold-up on Abbott's FreeStyle Navigator, the third continuous glucose monitoring product originally expected to hit the market last year?Navigator_q

In a statement posted last month, the company's website says only: "Abbott's FreeStyle

Navigator

Continuous Glucose Monitoring System was launched in Europe last year

Innovation 2015

and is under active U.S. FDA review. Also in development is a fully integrated

blood glucose monitoring system combining a meter, test strips and lancing

capabilities in one device."

That second bit sounds intriguing. But no sense holding our breath for a combo device from a company whose CGM has been stalled at the FDA approval stage for ages. What could be holding it up, I wonder? Especially since I hear that

technology-wise, the Navigator may be "the best of the bunch."

Turns out that David Kliff, D-analyst extraordinaire of Diabetic Investor, was on this just as my curiosity was peaking. He tells me that a number of fumbles on Abbott's side are at fault, beginning with insisting on an approval for "replacement" therapy vs. the less-aggressive "adjunct" therapy approval that DexCom and Medtronic were able to secure. This means the FDA was OK with approving those CGMs as an addition to, rather than a replacement for, traditional fingerstick glucose monitoring. On top of that, Abbott apparently made a few moves that angered the FDA.

Wow, to think that petty politics might be involved in holding up an otherwise valuable medical device!

Anyway, Kliff is pretty sure that Abbott's not going to meet their latest approval deadline, either -- the end of this quarter, which is coming up fast. And he's sarcastic about it. Check out this little "quiz" emailed to his subscriber base a few days ago (reprinted with his permission):

1. Do you believe Navigator will be approved by the end of the first quarter? Yes No

2. The company will miss another stated dated for approval. True False

3. To save face the company will find another company to file an intellectual property lawsuit against. True False

4. The Navigator will get approval before the end of the first quarter. True False

5. After approval the company will announce they've decided not to launch the product in its present configuration and will launch an updated version later in the year. True False

"Perhaps a better question to ask is whether there is any chance for Navigator commercially," Kliff writes. "Diabetic Investor sees Abbott Diabetes Care at the crossroads. Their conventional glucose monitoring business continues to lose share, they lack a coherent strategy to regain share and the Navigator, even if approved, will do little to help. Using history as a guide, Abbott would try to buy their way out of their problems. Given the current landscape in blood glucose monitoring their choices are limited, there is no Therasense to save the day. The company could go after Home Diagnostics or privately held AgaMatrix but after seeing what they did to Therasense, why would either company want to be acquired by a company with a proven history of turning gold into sand?"

Ouch. In contradiction to its name, Navigator doesn't seem to be heading in the right direction (?)

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