Revenge of the Navigator
While it seems like ages ago there was a time when Abbott (NYSE: ABT) had the hottest product in continuous glucose monitoring. Yet thanks to numerous mistakes made by management the Navigator took forever to receive FDA approval allowing Dexcom (NASDAQ: DXCM) to establish a firm grip on the CGM market. Given that the FDA still has not approved the FreeStyle Libre we’re beginning to wonder whether history is repeating itself.
Let’s be honest the Libre has surpassed expectations and continues to gather growing usage overseas. Yet even with this growing international acceptance the product is still not approved here in the USA. The PRO version was approved back in September of last year but the patient version is still awaiting approval. The question has become is history repeating itself?
Now we will not review the many missteps the company made with the Navigator. (Although for those new to Diabetic Investor we would recommend searching the archives section of the web site as in all honesty we produced some truly outstanding copy on this subject.) And thankfully for Abbott the team that screwed the pooch when it came to Navigator are long gone. So, this latest delay cannot be blamed on the old team and rests squarely on the shoulders of the new team running diabetes care.
To be clear we see no reason why the system should not be approved. No, it may not be as accurate as the Dexcom system, but then again, no system has yet to match Dexcom’s accuracy, the Libre does work just fine and patients seem to like it.
Abbott’s issues with Libre are much like Medtronic’s (NYSE: MDT) issues with their new Enlite sensor, the ability to manufacturer sensors on a large scale consistently. The issues with Enlite have become so bad that they cannot supply patients and have stopped telling patients when sensors will come off “back order.” But like the Libre when the system works patients like the Enlite.
Yet this manufacturing issue cannot be ignored as it goes directly to a major advantage Dexcom has. Besides keeping patients happy by producing accurate reliable sensors, the company’s manufacturing prowess lowers costs. Dexcom is not unaware that soon Abbott and Medtronic will use price as a weapon to gain share in the growing CGM market. But even at a lower price point patients, physicians and CDE’s don’t like it all that much when the damn thing doesn’t work.
Which makes us wonder is that’s what the FDA is looking at. Could the FDA be concerned that yes, the system works but the company cannot manufacture them consistently.
Honestly, we have no idea why the FDA is taking so long, nor does anyone else for that matter. Heck based on Abbott’s own public comments they also are at a loss to explain what’s taking so long. Given we’ve been around the block more than once and given Abbott’s history with the Navigator it does make us wonder.
As Momma Kliff used to say; “Just when you think that someone has learned their lesson, that they will not make the same mistake twice, they go out and repeat the same mistake all over again.”