Thursday morning when Abbott reports second quarter results we suspect a big topic of discussion will be the recent approval of the Libre2. As everyone knows by now the approval came with the iCGM designation but also came with the following warning;
“The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions.”
As we have noted this warning seems to be at odds with iCGM since the device cannot be used with AID systems. We were also surprised with the vitamin C issue as according the National Institute of Health the recommended average daily dose of vitamin C is 90mg per day for a male and 75mg per day for a female. Digging a little deeper we found evidence that taking too much vitamin C can cause gastric issues. None of what we discovered indicated that taking too much vitamin C is life threatening.
Still this issue is seems very concerning to Abbott as according to clinicaltrials.gov the company has initiated a trial called FreeStyle Libre 3 Continuous Glucose Monitoring System Accuracy Study. Full details can be found at https://clinicaltrials.gov/ct2/show/NCT04464772.
While some have speculated that this study is tied to AID our sources indicate the study is designed specifically to deal with the vitamin C issue. Sources have noted that this study is not large enough to fix the AID issue although other studies are planned that will deal with AID. Now to be honest we cannot figure out why the FDA sees this vitamin C issue as a big deal, but they do and that’s all that really matters. Our experience in this area tells us that Abbott will eventually fix both the vitamin C and AID issues it’s just a matter of time.
It will be interesting to see how Abbott addresses this study and the warnings that came with the Libre2 approval. As we noted when the approval first came the company went behind the scenes to analysts stressing that Libre2 is somehow a better system than the Dexcom G6. Having seen what was sent to analysts let’s say the data set used by Abbott was dubious at best. Yet what we didn’t and still can’t understand is why they did this in the first place. The Libre franchise is doing just fine, most experts agree that side by side Dexcom is the more accurate and robust system, yet these same experts would note there is nothing wrong with Libre as it works good enough.
Stranger still is both Tandem and Insulet have noted that even with the AID issue they are confident Abbott will fix it and the Libre2 or some future version will be able to work with their respective insulin delivery systems.
Adding to the confusion Abbott has already note that Libre2 will be priced on par with Libre. This is exactly what we anticipated as the company has made it clear that they no intention of abandoning their value strategy with Libre. A strategy that has served them very well and likely will continue to serve them very well in the future IF they don’t become obsessed with the issues related to the Libre2 approval. This is why Thursdays call has taken on greater importance as it will provide some color as to whether Abbott sees this just as a hiccup or something major.
Now let’s be very clear here the company will not come out and say they are pissed at the FDA nor will they show any outward signs that they are worried about having the warning removed. They will gush over the approval doing their best to position it as a major achievement when in reality it was just another step forward for the franchise. Having become somewhat of an expert in corporate speak it’s not necessarily what they say but how they say it. Listen after 20 plus years of listening to these calls you become very in-tune with bullshit.
It should be noted that since the Libre2 approval shares over Dexcom have jumped almost 16% while shares in Abbott have risen just over 5%. Maybe this is the reason Abbott is pissed. Yes we know this sounds incredibly childish but anyone who’s been around the corporate world knows these idiots sometimes think it’s necessary to whip it out and see whose bigger, rather than act like adults.
Frankly there is no reason for any childish behavior when the CGM market is growing rapidly and the future looks very promising. But then again boys will be boys.