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Post by compound26 on Jul 25, 2016 11:51:14 GMT -5
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Post by compound26 on Jul 25, 2016 11:40:58 GMT -5
While I can't find that picture. I'm 100% sure it exists. I want to say it might have been demo'd at the annual shareholders meaning. I think it's in the ADA pictures in the ADA thread but I'm still looking. Yes, Mike. C showed a sample of the device in his presentation at the ASM. It is at around 27'20" of the presentation. It is a very small device. vimeo.com/167332167Also, there is a picture of the device in this article: www.healthline.com/diabetesmine/afrezza-news-updates#2 |
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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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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 compound26 on Jul 14, 2016 14:21:56 GMT -5
Mike C. also commented that the clamp study and the ADA abstracts (papers) related to the PK/PD profile of Afrezza will be critical differentiators compared to other insulins and foundation for a FDA filing for label change in his presentation on this past Tuesday (July 12). See summary of the presentation. mnkd.proboards.com/post/73176See the video of the presentation at wsw.com/webcast/cantor4/mnkd/index.aspx. The comment was made at 11'30" of the presentation. |
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Post by compound26 on Jul 13, 2016 13:59:18 GMT -5
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Post by compound26 on Jul 3, 2016 6:40:56 GMT -5
Community Member Featured in Afrezza DocumentaryJeremy_Fultz Hi, My name is Jeremy Fultz and I am an independent filmmaker making a documentary about diabetes and afrezza. I have interviewed several people who live with Type 1 and Type 2 diabetes and all have said the same thing: "It has changed my life and changed the game on living with the fight against diabetes. Attached is the first trailer released, and features one of your very own TuDiabetes community members! My hope is this encourages every person touched by diabetes to get talking to their doctors and asking about options and afrezza. You may wonder why I am doing this? It is quite simple: I just want to help. The link is below. Jeremy_Fultz3d Great question. I am still conducting interviews with experts and doctors but hope to wrap that up in the next month with a tentative release in the fall (Sept-Oct) I hope. But I will continue to release trailers as I go just to help keep getting the word out. www.youtube.com/watch?v=_8RIPt6HJG4
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Post by compound26 on Jun 23, 2016 12:50:47 GMT -5
I've owned the company that developed Colo Guard (and watched it plummet from some decent highs), so I'm biased, however, I think that ad is excellent, especially when someone really doesn't care for the idea of having a colonoscopy. If these folks can come up with ads as good for Afrezza, I think it will really help our marketing. The Outsulin character just has to explain to the insulin character why Outsulin is superior, without insulting insulin and without giving the impression to people that Outsulin is not insulin, but some bio-engineered synthetic that is a mere gimmick. These ad people seem sharp, they ought to be able to do that. Even if I really do not like the name "Outsulin." By the way, whoever made the comment about the placement of the eye-brows - you're right on the money! great points above. Personally I have no opinion as to whether Outsulin is a good or bad brand name. By using a new brand, Mannkind and their Ad agency probably want to start from a clean slate (i.e., wiping out any stains left by Sanofi in their botched launch) and create some excitement and energy for the relaunch and Mannkind 2.0. The brand name itself also seems to be an indirect way to separate Afrezza from the RAAs and create a new product category (ultra-fast insulin) for Afrezza. That seems to be a well-though-out approach. Hope they can generate some buzz and real interest. I really like the Outsulin mascot. |
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Post by compound26 on Jun 17, 2016 8:51:16 GMT -5
Unless I'm missing something this feature is only available on the full (PC or Mac) site. It doesn't seem to be available on the mobile version. I believe you are correct; I almost never user the mobile version. For your information, I often use the mobile version of the site. Once I sign in, the mobile version also hides the applicable posts just like the full (PC or Mac) site does. Actually, the mobile version is better in that, while it hides the applicable post, it still shows who is the author of the post.  |
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Post by compound26 on Jun 15, 2016 16:47:09 GMT -5
That will require each sales representative to produce 2 new scripts a day, which translates to 10 new scripts a week. Times that with 70 sales representative, you get 700 new scripts per week. Add that to 200-300 renewals, you get about 900 to 1,000 total scripts. On average, will each sales representative be able to produce 2 new scripts a day by 1Q-2017?  Your measure of 2 scripts a day is if you want to get to 1000 scripts/week in one week. Of course that is unreasonable. The real metric is total Rx (new, renewal, refill), which could grow over time to 1000 very reasonably. It is all about accumulation. There are 26(?) weeks until Jan 1 2017. Small accumulations over that time can make big impacts. Assuming: - New scripts (purely new, not renewal) grow by 10 scripts each week, starting from 0
- Refills (component of TRX) occur 4 weeks after initial new prescription
- 100 percent of prescriptions are renewed and patients retained, renewals don't factor into NRX
| Week (t) | NRXt = t*10 | TRX = NRXt + TRXt-4 | | 1 | 10 | 10 | | 2 | 20 | 20 | | 3 | 30 | 30 | | 4 | 40 | 40 | | 5 | 50 | 60 | | 6 | 60 | 80 | | 7 | 70 | 100 | | 8 | 80 | 120 | | 9 | 90 | 150 | | 10 | 100 | 180 | | 11 | 110 | 210 | | 12 | 120 | 240
| | 13 | 130 | 280 | | 14 | 140 | 320 | | 15 | 150 | 360 | | 16 | 160 | 400 | | 17 | 170 | 450 | | 18 | 180 | 500 | | 19 | 190 | 550 | | 20 | 200 | 600 | | 21 | 210 | 660 | | 22 | 220 | 720 | | 23 | 230 | 780 | | 24 | 240 | 840 | | 25 | 250 | 910 |
Looking at the Symphony data, it took 22 weeks to get to >500 TRX/week for the original launch. , agree with your point. My post was half-joking. I was just looking from the perspective of how few scripts each sales representative needs to generate to reach a total weekly scripts of 1,000. I think one of the keys of success is how well Mike will be able to improve the renewal rate. In your above post, one of the assumption is "100 percent of prescriptions are renewed and patients retained". We know it is impossible to get such a renewal rate. Had we had this kind of renewal rate, I would guess we would be looking at 2,000+ weekly TRx (and a run rate of $50 million annual sale ) right now. SNY stated of a drop out rate of 65% (don't recall exactly, but something to that effect). And in Mike's presentation in the ASM, he said that it won't work when you loose 60% to 70% of the new users every month (don't recall exactly, but something to that effect). Mike also said that, had we had good renewal rate, Afrezza's first year sales would have been in the range of $20-40 million. |
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Post by compound26 on Jun 15, 2016 9:56:35 GMT -5
How soon will the script count rise to the 1000 mark? If we can hit that mark by 1Q-2017 we are off & running! Hopeful that the new MNKD sales team is full of "go getters". That will require each sales representative to produce 2 new scripts a day, which translates to 10 new scripts a week. Times that with 70 sales representative, you get 700 new scripts per week. Add that to 200-300 renewals, you get about 900 to 1,000 total scripts. On average, will each sales representative be able to produce 2 new scripts a day by 1Q-2017? |
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Post by compound26 on Jun 3, 2016 16:45:16 GMT -5
Abstracts are all very good. Science behind afrezza is strong. Hopefully this finally changes course of mnkd. Can you post any abstract summaries? Just click on the link to each abstract and you will see a brief summary of each abstract. mnkd.proboards.com/post/69370 |
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Post by compound26 on May 12, 2016 17:24:52 GMT -5
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Post by compound26 on May 10, 2016 15:10:05 GMT -5
Good points, and 2018 is fine with me. Also, IMO once sales start, and script counts begin to rebound, that in and of itself will do wonders for the SP, regardless of how the profit is divvied up in the costs. Yes, it's a long road, obstacles remain, and things might not work out, but I believe it's achievable and was encouraged by yesterday's CC. This is why I added today. Aloha. I also added to my position today with both shares and calls. I believe once Matt and Mike are able to run scripts to 1,500 - 2,000/week level, they will be able to demonstrate that: (a) Sanofi did a really lousy job; (b) Afrezza will be a viable product in the market; and (c) given them enough time, Mannkind will be able to break even with Afrezza sales. As a result of the above, (a) SP will increase to a level whereby Mannkind will be able to do additional ATM/second offering with minimal dilution; (b) partners/strategic investors (domestic and foreign) will emerge; and (c) Sanofi will be motivated to settle if they have not done that by such time. I think scripts of 1,500 - 2,000/week level is very doable if Matt and Mike are able to assemble a motivated team and reduce the price of Afrezza substantially. Not sure how long that will take. If they achieve that goal by the end of 2017, that will be fine to me. |
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Post by compound26 on May 10, 2016 14:48:32 GMT -5
Here is the $25 million requirement: "to avoid defaulting under the covenant in our facility agreement with Deerfield Private Design Fund II, L.P. (“Deerfield Private Design Fund”) and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) dated July 1, 2013 (as amended, the “Facility Agreement”) that requires us to maintain at least $25.0 million in cash and cash equivalents or available borrowings under the loan arrangement, dated as of October 2, 2007, between us and The Mann Group LLC (as amended, restated, or otherwise modified as of the date hereof, “The Mann Group Loan Arrangement”), as of the last day of each fiscal quarter." Seems like Mannkind can use all the available cash as long as they have at least $25 million available to borrow under the Mann Group facility. Since Mannkind had $27.7 million as of 3/31, as of today, 5/10, that $27.7 million probably still have $13.7 million (assuming they spent $10 million in April and then $4 million in May up to today). $13.7 + $47.5 = $61.2 million Plus, they can draw another $5 million under the Mann Group facility without violating covenants. $61.2 + $5 = $66.2 million. It appears Mannkind now has about $66.2 million available to spend. Since Matt has said he expected the burn rate to be $10-12 million per month, let's assuming the rate to be $11 million, $66.2 million will extend the runway for another six months, up to 11/10. Hope some additional funding will be secured within the next six months to further extend the runway. investors.mannkindcorp.com/secfiling.cfm?filingID=1193125-16-505366&CIK=899460 |
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