Okay, I just listened to their presentation at Cowen's Health Care conference, and now I am convinced that I didn't miss anything.
1. The device is for adjunctive (or as Rasdal says 'complementary'). This means that to use the device properly, people with diabetes will need to take 3 traditional blood glucose measurements to calibrate the device. Then, if they want to adjust their insulin levels, then they will need to do additional traditional measurements.
2. They have done an 86 patient trial for 21 days that will be a supplement; however, they will still need to do a registry trials for additional changes that were made in the device.
3. They are currently recruiting 400 patients for a repeated use studies, which mean that in the study first submitted to the FDA did not include useability of the sensor. This means that Dexcom has not tested how much fallout will exist from user-directed implant. Based on a study reported concerning the Abbott Navigator system, there needed to be 1.75 inserts per attempt.
4. They have not filed an IDE to conduct the study to obtain replacement labeling. Since they need to file an IDE, it is likely that this will become an entirely new PMA application, which means that a device for replacement is probably at least 3-years away.
5. They compared their results to the J&J Ultra, which is not a gold standard, which means they cannot separate out the error related to the J&J Ultra, which contributes to error. So they have not addressed a key error component related to calibration.
If Cygnus, with their Biographer, a watch-like type device, could not achieve market penetration, I don't see how Dexcom is going to achieve the same.
I intend to find out more about the insertion question, which I think will be key to any initial success of the product.
Right now, I think this stock is over-valued; however, with that said, they will get a $4-5 bump upon FDA approval, they will likely come crashing down as they struggle to find consumers who want their device.
>>...will need to take 3 traditional blood glucose measurements to calibrate the device.<<
Excuse me? Where the f-ck does it say 3 blood glucose measurements were needed to calibrate the device??
All of the SEC documentation and published studies indicate that 2 blood glucose measurements were needed to INITIALLY calibrate the device.
>>This means that Dexcom has not tested how much fallout will exist from user-directed implant.<<
In the FDA clinical trials for the PMA filing, patients inserted the sensors themselves.
>>Based on a study reported concerning the Abbott Navigator system, there needed to be 1.75 inserts per attempt.<<
So what?? Does the Navigator system have the same mechanism for the implant of the sensor. NO!
I have taken profits on most of my Dexcom shares but certainly not for the poorly researched reasons you wrote in your post.
Have you seen the PMA application? I think not, if yes, you will be reported.
Each insertion requires calibration. The mechanism between the Dexcom device, the Abbott device and Medtronic MiniMed are very similar.
The only reason that Abbott hasn't had their approved is because they want replacement. They know there is no market for an adjunctive device.
The market for Medtonic MiniMed is pump users. They have taken the time to titrate a person onto a pump from 45 days to 2 weeks. Dexcom has none of that.
And if you don't think that it there is going to be at least 1 calibration stick per day, you are sorely mistaken, particularly since this is an adjunctive device.
I suggest you try and understand the technology better my friend and don't rely on what is reported in SEC filings.
What you are missing is the big picture. You may have your facts right on this first generation product, but this company is not about a 3 day sensor. The 3 day is a market entry device meant to be marketed and sold to thought leaders and the elites who are a) fanatical about controlling their disease and b) buy anything. The three day is a good diagnostic tool for them and demonstrates the viability of glucose sensing. It is not meant to replace SMBG. That is for their second generation product-- the long term sensor. This first product builds goodwill and credibility for the next one. Remember, it took a long, long time for insulin pumps to get beyond the elites of diabetes world.
From an investment perspective, if DXCM generates even moderate revenues with the first generation and can demonstrate an achievable development path to a long term sensor, they will be acquired.
I am not missing the big picture. The company was founded on the long-term implantable sensor. That sensor has failed miserably (i.e. only 1 doctor could do the implant properly); thus the company had to develop the sub-cu sensor. That's where the problem is. They do not have sufficient money to develop the implant and the 7-day sensor isn't going to attract a lot of users because the values can't be used to adjust insulin levels.
The investors have their out. They are all going to be gone on the FDA approval, sticking the uninformed with a bunch of expensive, useless stock.
That's just my opinion.
As I said before, I would hold until FDA approval and then dump.
I agree with your comments. The big picture is the real story. Neither of the 2 major players in the diabetes self test market have a continuous product ready for commercialization. Dexcom has short and long term platforms. Abbott appears to have similar short-term product capabilities in their Navigator, but the other companies cannot afford to be too late in the game. The big boys will have to pay up for this company. I predict an eventual buy-out at $30 plus per share, based on the potential applications and the fact that there are many competitors that NEED this technology to remain competitive.