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Post by compound26 on Apr 20, 2018 17:39:29 GMT -5
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Post by compound26 on Apr 20, 2018 16:57:02 GMT -5
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Post by compound26 on Apr 20, 2018 16:50:16 GMT -5
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Post by compound26 on Apr 20, 2018 12:02:19 GMT -5
Here is how the current ADA standard of care (2018) describes/deals with inhaled insulin: prnt.sc/j7x3c9Cost comparison (of different insulin treatment): prnt.sc/j7x6kuComplete version of the standard of care (2018) care.diabetesjournals.org/content/diacare/suppl/2017/12/08/41.Supplement_1.DC1/DC_41_S1_Combined.pdfMy impression of reading the standard of care (2018): If I am a doctor who is not already well informed about inhaled insulin, based on the information presented in the ADA standard of care, I will have little or no incentives to prescribe inhaled insulin. The standard of care is giving out the [IMHO: somewhat misleading and incomplete ] impression that: (a) inhaled insulin is non-inferior to RAA, but less effective in reducing A1C; (b) inhaled insulin has more limited dosage range; (c) inhaled insulin is contradicted with chronic lung disease and not recommended for someone who smokes; (d) inhaled insulin requires spirometry testing; and (e) is more expensive than RAA. Will ADA update the living standards of care after the ADA and in particular in relation to inhaled insulin with respect to the STAT study? Let's see how this living standards of care work out!
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Post by compound26 on Apr 20, 2018 10:43:50 GMT -5
Interestingly, there is one presentation in ADA that has something to do with inhaled treatment, though it appears not Mannkind related.
Exploring the Next Frontier in
Diabetes Pharmacology
Peptides Gone “Oral” or Other
Delivery Routes (Transnasal,
Transdermal, Inhaled, etc.) for
Glucose-Lowering Agents
Hugh Smyth, PhD
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Post by compound26 on Apr 19, 2018 15:20:55 GMT -5
That's great. Texas can have a lot of them!
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Post by compound26 on Apr 16, 2018 18:24:17 GMT -5
Only took 16 years... What year are we in? And am not talking about dog years although each of ours feels like that long... From the time Dexcom's first generation of CGM was approved by FDA (2006), Mannkind is 8 years behind (2014). "In 2006, the Dexcom (San Diego, CA, USA) SEVEN, the first real-time continuous glucose monitoring system, was approved by the FDA." www.ncbi.nlm.nih.gov/pmc/articles/PMC5298755/
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Post by compound26 on Apr 13, 2018 21:25:05 GMT -5
Mike tweeted that Mannkind launched its Affrezza Youtube channel. Afrezza Commercial (60 seconds) youtu.be/eJzRxzdBjwI via @youtube we just launched our YouTube channel.
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Post by compound26 on Apr 13, 2018 16:52:48 GMT -5
Dr. Pettus also gave one of the best presentations about Afrezza in this Medscape Education video. This is an excellent video. And I think this video will be much more persuasive once we have the STAT results released.
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Post by compound26 on Apr 12, 2018 19:25:29 GMT -5
| Q1 | Q2 | Q3 | Q4 | 1 | Hired new national sales director | New commercial stretety | Deal 2 announcement (China?) | Brazil approval | 2 | Reshuffled sales force | New market campaign | Publish existing trial data | A-One trial results | 3 | Revamped incentives policies | Add Afrezza earlier to treatments | One drop (app support + cash program)? | Levin trial results | 4 | Announced CVS contract | Publish existing trial data | Improve insurance coverage | File in Mexico? | 5 | Weekly TRX reached 519 | STAT data announcement at ADA | Negotiate other international deals | Improve insurance coverage | 6 | HIRED RENOWNED CMO | Deal 1 announcement (India?) | treprostinil phase 1 trial results | Publish existing trial data | 7 |
| Improve insurance coverage |
| Negotiate other international deals | 8 |
| Raised cash ($28 million) |
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| 9 |
| Phase out legacy Sanofi packaging |
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| 10 |
| Revamped Affreza.com website |
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Compound, you left out the single most important catalyst in 2018 IMO I put number 6 down and actually it should be numero uno, reading this interview will hands down illustrate the most important addition to the company and Afrezza in 2018. One cannot underestimate the value and credibility that Dr. Kendall adds/brings to the battles those being the war on Diabetes and the war on the dark side IMO. For those that haven't seen it or just need a reminder www.healthline.com/diabetesmine/david-kendall-from-lilly-to-Afrezza-inhaled-insulin#1 joeypotsandpans Agree! I have added this one to the chart.
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Post by compound26 on Apr 12, 2018 18:23:45 GMT -5
There is too much uncertainty about the co-promotion partner, especially regarding when it will happen. So I did not put it on the chart.
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Post by compound26 on Apr 12, 2018 17:20:37 GMT -5
| Q1 | Q2 | Q3 | Q4 | 1 | Hired new national sales director | New commercial stretety | Deal 2 announcement (China?) | Brazil approval | 2 | Reshuffled sales force | New market campaign | Publish existing trial data | A-One trial results | 3 | Revamped incentives policies | Add Afrezza earlier to treatments | One drop (app support + cash program)? | Levin trial results | 4 | Announced CVS contract | Publish existing trial data | Improve insurance coverage | File in Mexico? | 5 | Weekly TRX reached 519 | STAT data announcement at ADA | Negotiate other international deals | Improve insurance coverage | 6 | Hired Renowned CMO (Dr. Kendall) | Hypo Rates poster for ADA | European Diabetes Meetings (4 Posters) | Publish existing trial data | 7 | TreT Phase 1 started | Improve insurance coverage |
| Negotiate other international deals | 8 |
| Raised cash ($28 million) |
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| 9 |
| Phase out legacy Sanofi packaging |
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| 10 |
| Revamped Affreza.com website |
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| 11 |
| Formed Scientific Advisory Board |
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| 12 |
| Deal 1 announced (India) |
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| 13 |
| TreT phase 1 completed |
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| Weekly TRX reached 561 |
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Post by compound26 on Apr 12, 2018 11:59:26 GMT -5
oldfishtowner great post, fish. On the international deal with upfront money, I think Mike has already expressly lowered the expectation on upfront money. Assuming the signed term sheet is for India, my expectation of the upfront money is $10 million. So anything above that will be a bonus from my perspective. Also, I do not think announcement of a deal with upfront money less than $20 million will be a huge disappointment, especially given that Mike has indicated that we won't be getting that much upfront cash anyway. I think most likely is that in such a situation, the announcement of such a deal won't have much impact on the PPS, which will be similar to what the announcement of the Brazil deal did to the PPS. But that is okay to me. A deal is a deal and will always help to improve the chance of Mannkind's success in the long term. On the sales front, do not forgot that Mike mentioned in his last two presentations that Mannkind has once against revamped its marketing message and strategy in March/April timeframe, reshuffled its sales force and updated its incentives policies recently. I do expect these actions will have a positive impact on the sales front in the coming weeks/months. Additionally, there are many other catalysts that may kick in over time. The one-drop partnership with cash subscription model, filings in countries like Mexico and Canada, and partnerships for countries like Japan and EU (for which we may get some serious upfront money $25-50 million each), studies other than STAT (ADD 1, Levin, Pediatric, etc.). The thing I like Mike and the current management team is that they are constantly tinkering and keep fighting. This is the number one factor to me that will contribute to Mannkind’s success over time. If you think about it, Mike and his team has tweaked the sales strategies a couple of times already, first they used someone else’s sales force for about half a year, then they started their own sales force, and now they are revamping again with new marketing message. It is obvious that the management does not just sit idle watching the sales team doing the work. They are keeping measuring and analyzing and adjusting the strategy. Additionally, Mike has also done a lot in other areas. Hired Steve, Pat and Dr. Kendall. Made progress in pipeline (treprostinil). Filed in Brazil. Partnered with One Drop. Completed STAT and advanced in other trials. Partnered with Charles and Damon. Restructured the packaging and pricing. Restructured the debt and cleared the debt overhang. Made the commercial ad and test ran the TV commercial. And I understand they are also updating the Afrezza website. In short, Mike indeed has a plan and is executing (and adjusting as necessary) diligently. I really appreciate what he and his team are doing for us. I also appreciate what Matt has done for us (saved the company when Sanofi returned Afrezza to us, raised cash, partnered with Receptor, hired Mike and settled with Sanofi). And as for Hakan, I really can’t think of anything that he has done for us shareholders over his entire tenor. If you compare Mike with Hakan, you will see how much an upgrade we have had in the position of CEO. I hope we will be equally or more positively surprised soon over how much an upgrade we have had in the position of CMO pretty soon.
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Post by compound26 on Apr 10, 2018 11:54:44 GMT -5
Where are the "Several Territories Already Exceed 1% Market Share on Mealtime Insulin Market"? To gain credibility, he really needs to identify exactly how many there are and where they are. Based on the numbers "otherottawaguy" is reporting in his "competing scripts" thread, I don't see how it's possible. Overall, 1% of $300,000,000 a week is $3,000,000. At the current around $600,000 a week, afrezza barely has 0.2%. What Mike said is pretty in line with these numbers. So there is no spinning there. In his presentation, Mike says that they are targeting about about 60% of the overall insulin market. And within the targeted market, they are now at about 0.25% market share. And within the overall market, they are now probably at about half that (based on the slide provided by Mannkind, probably at 0.15%). So there you have it. And pursuant to Mike, they have about 100 territories. In a few territories, if they have a few relatively heavy writers of Afrezza, that will certainly skew the market share of Afrezza. And it will be very easy to skew that market share to above 1% as the 1% hurdle isn't that high.
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Post by compound26 on Apr 9, 2018 19:29:31 GMT -5
I thought Castagna used that 35% reduction in his comments about the STAT results, during his 4Q17 earnings call, although it won't surprise me if Dr. Kendall finds similar results and more from MannKind's archive of pre-market trial data. I recall Mike mentioned on the presentation that these data was derived from "pivotal phase III trials". That indicates these are existing data (not new data from STAT trial). However, I definitely agree with Mike and Dr. Kendall that we should publish as many existing data as possible. The more the merrier.
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