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Post by trondisc on Jul 21, 2016 9:47:00 GMT -5
Just read the entire article assessment over at MassDevice.c0m (if I post the link here this thread will be moved over and transferred to the articles, blog, media, etc. page so just do a damn search to find it).
This information caught my attention...
With all of the data provided for the G5 CGM, Dexcom is likely to win a favorable vote in the panel, according to Leerink Partners analyst Danielle Antallfy.
“In our view, the panel docs are largely benign and support our belief that the panel will vote favorably that the benefits of a nonadjunctive claim outweigh the risks,” Antalffy wrote in a letter to investors. “As a reminder, the importance of a dosing claim centers not only around increased convenience to the patient — potentially further accelerating patient adoption — and validation of the technology, which could drive a higher number of physicians to prescribe, but also the possibility of securing CMS coverage, which would provide access to the 20%+ of Type 1 patients currently covered by Medicare.”
The roster of authorities sitting on the panel will work in Dexcom’s favor as well, Antallfy said, as it includes 6 endocrinologists and diabetes authorities, who the analyst thinks would “likely be more postively biased towards CGM.”
When Dexcom's G5 CGM is approved as an FDA standard, what would be next for MannKind? Positive possibilities? People please share your domino effect hypotheticals...
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Post by Deleted on Jul 21, 2016 10:01:20 GMT -5
Its great for diabetics but means nothing to MNKD. Sell Afrezza, its that simple.
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Post by dictatorsaurus on Jul 21, 2016 10:31:03 GMT -5
Dexcom and Mannkind are not linked together in any way.
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Post by Deleted on Jul 21, 2016 10:35:06 GMT -5
Dexcom and Mannkind are not linked together in any way. Oh, but they are. Here is one example: Suzanne Stone - Worked for MannKind from 2003-2014 - Started working for Dexcom in 2014-present - She is currently the Senior Director of Sales Operations |
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Post by johnhindepost on Jul 21, 2016 10:46:00 GMT -5
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Post by matt on Jul 21, 2016 10:48:37 GMT -5
Not sure there is much overlap. Certainly it is good to have a device that monitor glucose continuously, but all that does is tell patients how effective their insulin regimen is and whether is needs tweaking. It is not going to be obvious to the average patient that some insulins will be better or worse for their condition, or that some are more convenient to use. The task at hand remains the same: convincing doctors to write scripts for Afrezza in preference to other alternatives, of which there are many.
Ideally MNKD would run a large trial putting Afrezza + continuous monitoring up against the other insulin regimens + continuous monitoring to see which patient cohort is better controlled. However, that would required a large number of patients, which are easy to find, and a large amount of investment, which might prove more tricky.
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Post by Deleted on Jul 21, 2016 11:46:21 GMT -5
Dexcom and Mannkind are not linked together in any way. Oh, but they are. Here is one example: Suzanne Stone - Worked for MannKind from 2003-2014 - Started working for Dexcom in 2014-present - She is currently the Senior Director of Sales Operations My friend you have quite the imagination! |
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Post by sportsrancho on Jul 21, 2016 12:55:12 GMT -5
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Post by Deleted on Jul 21, 2016 13:10:52 GMT -5
Dexcom and Mannkind are not linked together in any way. Oh, but they are. Here is one example: Suzanne Stone - Worked for MannKind from 2003-2014 - Started working for Dexcom in 2014-present - She is currently the Senior Director of Sales Operation you missed the important one DEXCOM MANNKIND One starts with a D and the other ends with a D |
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Post by sportsrancho on Jul 21, 2016 13:14:48 GMT -5
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Post by kbrion77 on Jul 21, 2016 13:16:41 GMT -5
Dexcom and Mannkind are not linked together in any way. Oh, but they are. Here is one example: Suzanne Stone - Worked for MannKind from 2003-2014 - Started working for Dexcom in 2014-present - She is currently the Senior Director of Sales Operations Ah the old Kevinmik connecting the dots theory. |
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Post by Deleted on Jul 21, 2016 13:28:40 GMT -5
lol i was joking when I posted that. My dot connecting is a bit more indepth than that
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Post by compound26 on Jul 21, 2016 13:29:04 GMT -5
If this is approved, this will no doubt be a positive development for Mannkind. But we will see how much Mannkind can take advantage of such a development.
What CGMs provide to PWDs is "real time monitoring". So if, based on real time data provided on CGM, a PWD noticed that his BG level is rapidly climbing, he would naturally want a "real time treatment" to bring down his BG level as fast as possible. And Afrezza is the only ultra rapid insulin out there that you can deem it as a "real time" treatment.
Sam Finta has made this statement a year ago, that, CGM+Afrezza="real time monitoring" + "real time treatment".
Matt P. and Mike C. have now repeated in several occasions that their market research has revealed that, among all the users of Afrezza, people with CGMs as a group have had the greatest success with Afrezza.
Mike. C also noted that since Afrezza came to market, CGM user population has greatly increased. Apparently, he deems this to be a positive thing for Afrezza. (Even though apparently, Sanofi has not take any measure to take advantage of such a development). However, with Afrezza marketing rights now back to Mannkind, Mannkind certainly would be expected to design their marketing strategy to take advantage of such development.
Personally, I believe when Mike C. was referring to "co-promoting opportunities" in his latest presentations, he was thinking about co-promoting CGMs and Afrezza. However, as Afrezza's sales are still minuscule, at this particular point of time, Dexcom would not be interested in considering such co-promoting opportunities. On the other hand, if Mike and his team can show positive and significant growth of Afrezza scripts within the next few months, with all the social media reporting postive results with CGM+Afrezza combination, it would not surprise me a co-promoting agreement is reached between Dexcom and Mannkind down the road. Also, note that Al Mann was the mentor of Dexcom's current CEO, Kevin R. Sayer.
In Mike C's recent presentation, he mentioned that there are currently 150,000 CGM users worldwide (if I recall correctly). Assuming 50% percent of them are in the US, that will get us to 75,000. If we can convert 10% of them into Afrezza users, that will be 7,500 users, with 584 weekly Rx (assuming everyone gets a Rx every 90 days) and a 20% conversion will be 15,000 users and 1,167 weekly Rx.
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Post by mnholdem on Jul 21, 2016 14:12:57 GMT -5
Forgive my ignorance, but could a patient rent a CGM, for titration purposes? They would, of course, have to pay for the consumables used with the device.
I've often wondered if more patients with Type 2 diabetes would consider using CGM's short-term when they initiate diabetes treatment if CGM's where available for rent, rather than shelling out the big $$$.
I would think that 3rd-party payers would like this idea if it resulted in better control of the disease.
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Post by compound26 on Jul 21, 2016 14:23:13 GMT -5
Forgive my ignorance, but could a patient rent a CGM, for titration purposes? They would, of course, have to pay for the consumables used with the device. I've often wondered if more patients with Type 2 diabetes would consider using CGM's short-term when they initiate diabetes treatment if CGM's where available for rent, rather than shelling out the big $$$. I would think that 3rd-party payers would like this idea if it resulted in better control of the disease. I think the renting idea is basically what FreeStyle Libre Pro (currently under review by FDA) offers. Hope the same concept can be applied to regular CGMs. FreeStyle Libre Pro is a bit different from the patient version of FreeStyle Libre (available in Europe) that we tested in diaTribe in January. Libre Pro allows physicians to get continuous glucose data from patients over a two-week period. It consists of a small sensor (a bit larger than a US quarter dollar coin) worn on the arm. After applying Libre Pro in the doctor’s office, it is worn for two weeks, and the sensor automatically records glucose values every 15 minutes. Patients then return to the doctor’s office, where the sensor is downloaded. Abbott has done a really good job of making the glucose data download easy to interpret, meaning healthcare providers and patients can quickly grasp what is going well and what may need improvement. Unlike the FreeStyle Libre system currently available in Europe, the Pro version does not give patients a reader device to look at glucose values in real time. While that seems like an obvious drawback, it’s a key design choice for a few reasons: Many patients don’t want to wear a sensor all the time; wearing this product occasionally (i.e., twice a year) could offer many of the benefits of more continuous glucose monitoring (i.e., more comprehensive glucose data to change therapy), but without having to wear a sensor all the time.
Professional glucose monitoring systems like FreeStyle Libre Pro are generally reimbursed well by insurance, including Medicare. Medicare does not currently reimburse real-time CGM.
Many patients change their behavior in response to seeing the real-time data. A blinded sensor like FreeStyle Libre Pro makes it more likely patients will stick to their normal routine – allowing providers to get a more realistic view of a patient’s day to day management.
The FDA approval process for FreeStyle Libre Pro should be easier than the real-time version, since patients can’t make insulin dosing decisions off the blinded system. - See more at: diatribe.org/freestyle-libre-pro-submitted-fda-approval-potentially-coming-us-2016#sthash.VD3MIJqq.dpuf |
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