Finally this past Friday the FDA did what everyone expected and approved the Control IQ, creating lots of happy dancing for the folks at Tandem, not to mention the large and growing group of patients who were also anxiously awaiting its approval. Before we get into what this means a few quick thoughts.
1. Ok I know there is nothing we can do about this, but these Friday afternoon approvals have got to go, has the FDA never heard of Happy Hour.
2. While shares of Tandem did increase with the announcement the reaction was rather muted. This is largely due to the fact that everyone anticipated it would be approved and the approval came very late in the quarter. Simply put the approval was pretty much priced into the stock.
3. Yes this is obvious but now it’s up to Tandem to execute, they have known this is coming, they have been getting ready but now it’s time to move from planning stage to execution. Best as we can tell the company has done everything they can and based on communications with the company they are ready.
The fact is Tandem now owns the Death Star, the coolest toy in the toy chest, the most whiz bang tool in diabetes. Given that Evil Empire is struggling, has come under new leadership it’s possible that the rebels who now have the Death Star could use this weapon against its former owner. With this approval all the focus all the bright lights will be shinned not just on the Control IQ but the Dexcom sensor.
As we have said a thousand times while the 670G may not be the greatest thing invented but when the damn thing works patients love it. The problem which is well documented and well known in the diabetes community is the damn thing doesn’t work as designed and the biggest issue is the crappy sensor. A sensor which is not reliable nor accurate on consistent basis.
The reality is that Medtronic is down to their last bullet in the chamber, formulary position. That without that one advantage the choice for patients wouldn’t even be a choice, Control IQ would beat the 670G like a rug. This could happen anyway given the anticipation from the diabetes community and the reaction to the approval on social media.
And just to be clear there is NOTHING in the Medtronic pipeline that will be here soon enough to counter the enthusiasm for the Control IQ and quite frankly given their track record we have no idea when or if these new systems will get here.
We don’t see this approval adversely impacting Insulet too much although it does put added pressure on the company. Control IQ is the new standard in hybrid closed loop insulin delivery and Horizon now must meet this new and thankfully higher standard. Thankfully like Control IQ the Horizon works with the Dexcom sensor and just in case you haven’t figured it out by now Dexcom is also a big winner with this approval.
Before we close today a huge shout out to Tandem, this company which admittedly was on the verge of bankruptcy for the moment is now King of the mountain when it comes to insulin pumps. This turnaround will go down in diabetes history as one of the greatest turnarounds ever. This tops Bayer’s comeback in BGM although that was pretty damn good as well but was unfortunately unsustainable.
In the words of Momma Kliff “Damn good job now don’t screw it up.”