Navigtor in 2006????

[BrendaK]

I sent Abbott Labs an email seeing if Carson could get in a trial study for the Navigator. They just sent me back an email, not addressing the study question I asked, but they did say it's awaiting FDA approval (obviously) and they hope to have it available in the US sometime in 2006. Wouldn't that be just in the next 6 weeks?

I'm kind of thinking they sent me out a generic response that was written sometime last year or something. But, how cool would that be if it was available this year!!!

Trying not to get my hopes up....

[rickst29]

The FDA absolutely, positively DOES NOT give hints about when an Approval will be made. Abbott will find out on the same day I do-- there's a bunch of people who watch the FDA Approvals site like EAGLES, almost 24x7, over at Insulin Pumpers.

In June and July, they were saying the exact same stuff about "we're planning to go on Sale in August". August came and went, so did Sep.

Then they started talking about how they plan "to be on the Market before the end of the year". And that went on for a while... but even that story is now old.

The "new date" which I hear people saying their Abbott contacts are working with, A GUESS, is January. (I hear this over on IP.) Is there any reason to believe this one? Well, maybe: The "terms" of the new Date are rumoured to be "Even if we're only approved for a 3-day Sensor wearing period, we'll run with that Approval and release the product."

Before August, they were definitely asking to be a total replacement for blood testing: When the Navigator says that you're low or high, go ahead and treat it WITHOUT using a finger-stick meter to confirm the reading. (Dex and MiniMed both officially REQUIRE you to do a finger stick before treating.) The FDA denied the Application, and Abbott resubmitted a little bit later-- apparently thinking that the "no-confirmation" part was the only thing the FDA had problems with. And so they started giving stories to Neswpapers (Wall Street Journal had one), basically ANNOUNCING the "before the end of 2006" which you heard.

Well, they were DENIED again. The FDA has a big problem with end users stabbing something into their skin and leaving it there for more than 72 hours--- without professional medical poeple doing the insertion, the FDA worries that infections could develop and remain untreated for way too long, becoming well-entrenched and dangerous.

Abbott has re-submitted again, this time for only 72 hours (same as MiniMed and Dexcom, which I've heard has an "eight day" Sensor ready to go if the FDA give an OK). Will they be approved before the end of the year?

MAYBE. And Abbott DOESN'T KNOW, either *IF* or *WHEN*. They can go ahead with Marketing plans and setting prices and manufacturing devices, but they don't KNOW any more than I do.

BTW, both MiniMed and Dexcom can be easily "tricked" to use the same old Sensor when the timer goes off. The average usage (SWAG) appears to be about 8 days for MM, closer to about 10 days for Dex. In the real world, "off-label" usage is the rule. We actually find that the "unapproved" second and third 72-hour periods are MORE ACCURATE than the Approved first period!

[rickst29]

So yeah, you got a Generic response based on the September/October Marketing plan (before the application with 5-day Sensor life was denied).

FDA can't give hints without creating huge problems for "insider information" invalidating zillions of stock market trades... and so they don't. Before the application is confirmed/denied on their Register, they say NADA. ZILCH. NULL. ZERO. NOTHING. !!!