Yes it does matter

To be honest we’re not sure who said “Those who cannot remember the past are condemned to repeat it” but we know it wasn’t anyone at Abbott. Yesterday the company continued to backtrack from their initial comments that Libre2 would not just receive FDA approval but would garner this approval with an iCGM designation. Since Libre2 was submitted to the FDA the company who initially expressed supreme confidence has been backtracking off this initial confidence.

Now we really hate to do this, first because it makes us feel old and second because so many forget the past but it’s important that the facts, yes, those pesky facts, are resurrected. This is not Abbott’s first rodeo with CGM, far from it. Back in October 2004 they submitted the FreeStyle Navigator to the FDA. Back then the Navigator was considered not just the coolest toy in the toy chest but the best toy in the toy chest. Even better it was way better than another CGM from some little company called Dexcom.

Yet it wasn’t until March 2008, a span of over 1200 days, that the FDA finally approved the Navigator. A span which allowed Dexcom to launch their system and become the leader in CGM.

Some 900 days later Abbott pulled the Navigator from the market.

Let’s be very clear here we don’t anticipate the FDA taking another 1200 or so days to approve the Libre2, although one never knows. Nor do we anticipate sale of the Libre suffering much because the Libre2 isn’t here yet. However Dexcom has the G7 warming up in the bullpen, a system which will not just be cheaper to build, but cheaper for the patient as well. A system which we have described in the past as a possible Libre killer. Basically it does everything the Libre does only better and at a price point competitive with Libre.

Libre2 was supposed to be Abbott’s answer to the G7, it was supposed to be here before the G7, it was supposed to have everything the G7 has including an iCGM designation. But it isn’t here, no one not even anyone at Abbott seems to know when or even if it will get here and whether or not it will come with an iCGM designation.

Will this delay cost Abbott? Ya think! Could this delay have been avoided? Based on everything we know we think so. Had Abbott submitted Libre2 and not sought the iCGM designation we believe it would have been approved already. But they did and this decision is costing them dearly and worse they cannot go backwards. While going backwards might get Libre2 to market sooner it would also be a major embarrassment for Abbott and we can’t have any of that can we.

Is it possible that history is not just repeating itself for Abbott in CGM but in glucose monitoring? Remember Abbott bought Medisense in in 1996 for $876 million, then proceeded to run this company into the ground. The company not content to run one glucose monitoring company into the ground doubled down buying Therasense in 2004 for $1.2 BILLION and then ran that company into the ground. Honestly, we wish we were making this up but sadly we aren’t.

Is it even conceivable that Abbott could turn gold into sand one more time? Is it possible that as well as they have done with Libre, a huge success by any measure, this billion-dollar product will go from the penthouse to the outhouse? Could the delay with Libre2, their insistence for an iCGM designation which no one really cares about be the beginning of the end? Will this delay allow Dexcom to regain their leadership position in the expanding CGM market? Will Libre and Libre2 should it ever get here be relegated to a second-tier status?

These are the questions that are going through our mind. Honestly, we wish they weren’t as up to this point Abbott has done an outstanding job with Libre. They have proven, like Insulet has in the insulin pump space, that price is a major factor for patients when it comes to diabetes device technology. Also like Insulet, they have shown the benefits of using the pharmacy distribution channel. They have also forced Dexcom to get better which is no small feat given how well run Dexcom is.

As we noted before up to this point Libre has been a huge success. It also looked that Abbott had learned from past mistakes and would not turn gold into sand for a third time. Yet this situation with Libre2 makes us wonder. We hope we are dead wrong, that the Libre2 delay won’t be the first domino to fall, that it won’t mark the beginning of the end. Yet as Momma Kliff used to say; “Just when you think a lesson has been learned you have to send the children back to school.”