FDA stall on diabetes device cost Abbott

[JoeC]

FDA stall on diabetes device cost Abbott


Published: Nov. 26, 2007 at 7:33 AM
Print story Email to a friend Font size:CHICAGO, Nov. 26 (UPI) -- Regulatory delays have prevented Abbot Laboratories' real-time glucose monitor from reaching the U.S. market.

The company's "FreeStyle Navigator" is a pager-like device that constantly monitors diabetics' blood sugar levels. The monitor was initially touted as a potential $1 billion blockbuster, but the delay in reaching the market could make profits fall far short of expectations, Crain's Chicago Business reported Sunday.

A Food and Drug Administration review has been stalled for two years, and though approval is expected in the next few weeks, earnings estimates have been revised to $500 million or less.

Original estimates of the device's earning power were based on the possibility it would be the first to reach the market, but last year San Diego-based DexCom Inc. introduced its own real-time glucose monitor. Since then Medtronic Inc., a Minnesota-based medical device giant, also introduced a similar device.

Analysts are divided on the device's earning prospects, Crain's said. While some say even $500 million is an optimistic figure, others say the Navigator could earn as much as $800 million by 2010 if insurers choose to cover it.

[rickst29]

A Food and Drug Administration review has been stalled for two years, and though approval is expected in the next few weeks....
Looks like more Hype. Unless Abbott has changed the device to solve the problem, i.e. "Navigator V2", I don't expect it to be approved.


They said in July 2006 that Approval was expected in "Early August". Didn't happen!
In August 2006, they said that they'd get approved in September (after eliminating the "total replacement for fingersticks" usage claim. But that wasn't the only problem. Didn't happen!
Then, from September through November, they said "before the end of the year" (2006). Didn't happen!
Then, from December into January, they said something like "we're planning to launch in early February, under revised usage guidelines". Didn't happen!
And now, they magically KNOW that they're gonna be approved "in the next few weeks".


Well, the FDA does not give preliminary hints. Abbott will know they are approved on the same day we know, and not a single day before. If they haven't solved the technical problem, maybe they have a newer study which shows it to be less important than the FDA has thought it to be. But without such a study or a technical fix, they're just spewing more hype through newspapers.

If anyone still believes ANYTHING Abbott says about Navigator dates, after they've "expected" 5 different dates which all turned out to be bogus, you're VERY gullible. Thanks for the post, though. I think that it's just more marketing FUD, trying to keep people from buying Minimed and Dexcom.

BTW, the story also has the competitor's dates wrong-- Minimed was approved FIRST, at the end of 2005; Dexcom was approved in early 2006, so labeling the competitors as "approved last year" is also FUD-ish. The sneaky wording trick is to count only Minimed's "similar device", the current Guardian, and ignore the 522/722 "R/T" system and earlier Guardian device. This is a widely used MarketSpeak trick, and I think it indicates volumes about the rest of the article. :mad: