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Post by lakers on Jan 3, 2017 23:16:34 GMT -5
Some insights....
From: "Tran, Bao-Khanh" <BAO-KHANH.TRAN@UCDENVER.EDU> Date: January 25, 2016 at 4:13:08 PM PST
I apologize for the delay in response. Those definitely good question.
We are still currently still recruiting for our cohort I (ages 13-17). As far as starting for cohort II (ages 8-12) that is dependent on the data that we have collected for our cohort I.
As far as dosing, it depends on the child's carb to insulin ratio. Currently Afrezza's insulin dosing is equivalent to that of the rapid acting insulin drug 1:1 ratio of how you would usually dose with your rapid/short-acting insulin. As far as basal, the dosing should not change when enrolled in the study.
For the CGM, the model that is being used is the G4 however the data will be blinded therefore the child will not be able to see the data on the CGM.
As far as the partnership study will still continue its course for recruitment.
We are always happy to answer any questions you or your relative may have.
Thank you for your interest in our study!
Sincerely,
Bao-Khanh Tran, BS Professional Research Assistant for Dr. Wadwa Barbara Davis Center for Childhood Diabetes University of Colorado School of Medicine Mail Stop F527 1775 Aurora Court Aurora, CO 80045 Phone: 303-724-8095 bao-khanh.tran@ucdenver.edu
Sent: Wednesday, January 20, 2016 1:20 AM To: Tran, Bao-Khanh <BAO-KHANH.TRAN@UCDENVER.EDU> Subject: Is it too late to join Afrezza pediatric study?
Hi Bao-khanh,
Regarding the Afrezza pediatric study, have you finished recruiting and started trial for Phase one yet?
When will Phase 1 finish? When will Phase 2 start and finish?
What dosing at what time do you expect? For example do you need more Afrezza units per unit of basal drug? Do you inhale 10 mins after starting a meal? What CGM do you use?
If it's not too late, I can refer my relative to join the trial.
Now that Sanofi terminates partnership with Mannkind, who gonna manage and fund Phase 1 and 2?
Thanks,
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Post by lakers on Dec 29, 2016 3:26:29 GMT -5
Afrezza, Medicare CGM Struggles Top Stories for 2016 in Evidence-Based Diabetes Management™ - See more at: www.ajmc.com/newsroom/afrezza-medicare-cgm-struggles-top-stories-for-2016-in-evidence-based-diabetes-management#sthash.2yXHcV96.dpufThere's no shortage of reader interest in Afrezza—the inhaled, meal-time insulin from MannKind—despite reports from Wall Street that the prescription count is climbing slowly. Published Online: December 23, 2016 Mary Caffrey Afrezza, the inhaled, fast-acting mealtime insulin from MannKind Corporation, remains a curious topic in diabetes care: despite weekly reports from Wall Street about low prescription counts, reader interest is enormous. Three articles about Afrezza are among the 5 articles in Evidence-Based Diabetes Management (EBDM)™ that generated the greatest online reader interest during 2016. There was no shortage of news about Afrezza over the past year, starting with Sanofi's January announcement that it would end its agreement with MannKind to market the drug. Over the course of the year, MannKind built its own sales force, relaunched the product, and worked with payers to improve access for patients with diabetes. Michael Castagna, who joined the company as its chief commercial officer, said in an interview that there’s been significant progress on patient access. The most noteworthy milestone came October 1, 2016, when ExpressScripts added Afrezza to its national and Part D formularies, without prior authorization. However, in the quarterly earnings call in November, Castagna said that besides cost, efficacy continues to be an issue with some patients who don’t stay on the drug. He attributed this to the need “to reinforce appropriate titration early on in treatment.” The novelty of the drug’s mechanism of action and the need for an individualized dosing strategy are discussed in EBDM™’s most-read article of the year. Most-read EBDM™ articles of 2016: 5. Measuring the Quality of Diabetes Care, March 2016 Authors from the Joslin Diabetes Center, Joanna Mitri, MD, MS; and EBDM™ editor-in-chief Robert A. Gabbay, MD, PhD, FACP, who is Joslin’s chief medical officer, outlined the development of the Joslin Clinical Analytic Tool, or JCAT. This method of measuring quality in diabetes care was a cover story in the theme issue, “All About Measurement.” www.ajmc.com/journals/evidence-based-diabetes-management/2016/march-2016/measuring-the-quality-of-diabetes-care4. MannKind Path to Afrezza Survival Involves Lower Prices to Woo Payers, March 2016 This update about Sanofi’s decision in January 2016 to sever its marketing agreement with MannKind featured speculation from analysts who follow the company on how it might survive. MannKind has resisted calls to simply cut the price of Afrezza, saying it has not taken a price increase since the launch, and increases in other fast-acting insulins have closed the price gap with those products. www.ajmc.com/journals/evidence-based-diabetes-management/2016/march-2016/mannkind-path-to-afrezza-survival-involves-lower-prices-to-woo-payers3. A Medicare Appeal for CGM Coverage: One Patient’s Never-Ending Story, May 2016 For the issue on seniors and diabetes, distributed at the 76th Scientific Sessions of the American Diabetes Association, EBDM™ featured a first-person account from Dan Patrick who has lived with type 1 diabetes for more than 50 years. Patrick shared how he gathered data and worked through a complex, multi-level appeal to get coverage for his Dexcom G4 continuous glucose monitor (CGM). Lack of routine Medicare coverage for these devices is one of the thorniest issues on the diabetes advocacy agenda. This week, Patrick said he’s bracing for another round of problems in a new coverage year, but there’s also some hope. FDA granted just a new indication to the Dexcom G5 Mobile, which patients will be allowed to use for dosing. Some believe this will pave the way to more routine Medicare coverage for CGM. For more on the policy challenge of Medicare CGM payment, read coverage from the FDA advisory panel in July. www.ajmc.com/journals/evidence-based-diabetes-management/2016/may-2016/a-medicare-appeal-for-cgm-coverage-one-patients-never-ending-story2. Patients Report Barriers to Getting Afrezza, but A1C Results Are Worth It, September 2016 For our fall issue on therapeutics, EBDM™ invited followers of our Twitter account @ebdiabetes to share their tales of jumping through hoops with payers to get coverage for Afrezza. The surprise? Stories of having to overcome doctors’ misconceptions about the drug just to get a prescription. In this week’s interview, Castagna said that he gets calls from patients with insurance problems, “All day long. It’s the number one issue I deal with.” Said Castagna, "The weekly script counts don't reflect the underlying noise." He promised that the "noise" will translate into sales in 2017. www.ajmc.com/journals/evidence-based-diabetes-management/2016/september-2016/patients-report-barriers-to-getting-afrezza-but-a1c-results-are-worth-it1. Afrezza: Treating Diabetes in a Physiologic Manner, September 2016 The commentary from R. Keith Campbell, MBA, BPharm, CDE, professor emeritus of pharmacotherapy at Washington State University, offered readers both an overview of how the inhaled insulin does its job and a patient’s perspective on using the product correctly. Campbell’s explanation of how titrating Afrezza doses differs from that of other insulins is a must-read for physicians who treat people with diabetes, and for patients considering the drug. www.ajmc.com/journals/evidence-based-diabetes-management/2016/september-2016/afrezza-treating-diabetes-in-a-physiologic-manner
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Post by lakers on Dec 27, 2016 18:40:31 GMT -5
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Post by lakers on Dec 27, 2016 15:45:54 GMT -5
charts.stocktwits.com/production/original_70143701.png?1482453470 Filed for label change with FDA: [This should have been started in 2014] Better Kinetics Ultra Rapid Clinical Studies: Pediatric [highly needle phobic. Even the late comer Tresiba got FDA Pediatric approval on 12/20/16. This should have been started in 2014 as Novo did Tresiba right after the adult version approval.] New T1, T2 Afrezza Initiation Studies It's better late than never. Read more: mnkd.proboards.com/thread/2679/symphony-script-data?page=90#ixzz4U4ZsIOpL
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Post by lakers on Dec 27, 2016 15:09:12 GMT -5
Markets #MarketMoves 12/27/2016 @ 1:42PM 918 Views Nate Pile's Top Recommendations For 2017 www.google.com/amp/www.forbes.com/sites/kenkam/2016/12/27/nate-piles-top-recommendations-for-2017/I’ve asked Marketocracy’s managers to tell me what investment strategies and stocks they are talking about with their friends and family at this year’s holiday gatherings. Here’s what Nate Pile is recommending. Nate Pile is the Founder and Editor of Nates Notes and a Marketocracy member since October 30, 2002. Over the past 14+ years his Marketocracy portfolio returned 18.12% which compares nicely to the S&P500’s 9.06% return for the same period. Over the past 10 years, Nate has outperformed the top U.S. equity mutual fund tracked by Morningstar. Before taking anyone’s investment advice, you should always check out their track record. Here is Nate’s. Ken Kam: What was your most successful investment this year? Nate Pile: My most successful investment this year was NVIDEA (NVDA) – from roughly $25 at the beginning of the year to today’s close just over $100 (for the first time ever!). I first recommended the stock in my newsletter at $4.49, and I believe it is a great testament to/validation of my approach. Kam: What stock are you recommending to your friends and family? Pile: The stock I am recommending to my friends and family over the holidays is MannKind (MNKD). Though I can’t promise MannKind will have what it takes to get it across the goal line, I am more convinced that ever that Afrezza is on its way to success for two reasons: a) the final termination and “settlement” with Sanofi greatly improved their odds of success, and b) with MannKnd currently being valued at less than when it came public (and still had a product in clinical trials rather than an FDA approved product that is proving to be superior to all existing therapies) I continue to believe that at 60 cents, this is is the sort of opportunity that only comes along once or twice in most investors’ lifetimes. Kam: MannKind has not done well this year, what do you see happening to turn things around? Pile: A label change is on the way that will not only help elevate/differentiate the status of Afrezza in the eyes of docs when they first look into it, but it will also make it significantly more difficult for competitors to bully it around on the formularies since it will no longer be in the same class as “regular” insulin. Kam: What other stocks you are recommending? Pile: For my relatives who might not be interested in “speculative” biotech, I will be steering them towards Illumina (ILMN) and Walt Disney (DIS) as two “big name, fairly conservative stocks” that they should look into, as well as advise them to buy small lots of gold on a regular basis (i.e. every 4-8 weeks) over the course of 2017. I use the SPDR Gold Trust (GLD) for this in my newsletter, but I actually own gold through the Sprott Physical Gold Trust (PHYS) in my Marketocracy account (and personal accounts as well). My Take: While Nate does not have a set formula when choosing stocks, the first screen is always done at the fundamental level. For a company to even make it onto his list for consideration, it must have a compelling long-term growth story (be it a new product or a significantly better version of an existing product or service), and its management team must have a clear and sensible business plan against which investors can measure the company’s progress over the years. When looking at a company from this standpoint, Nate asks himself a question he first saw posed several years ago in a book on Warren Buffet’s investment philosophy, namely “if the stock market closed for five years and we could not trade the stock again until the market re-opened, would we be still be happy buying the stock today?” If the answer is “yes,” then there is a chance the stock will make it into his portfolio. Generally, speaking, Nate tends to build positions in stocks with a three- to five-year time period in mind, though as long as a company is continuing to execute on its business plan, he is likely maintain at least a partial position in the stock for a much longer period of time. In fact, many of the stocks in Nate’s Marketocracy portfolio have been there since the early 2000s (albeit with some scaling-in and scaling-out along the way in response to changed market conditions). It is also worth noting that a majority of his picks tend to come from the biotech and high-tech sectors.
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Post by lakers on Dec 24, 2016 4:04:45 GMT -5
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Post by lakers on Dec 20, 2016 3:49:00 GMT -5
The following threatens shorts the most. I expect a partnership after IND filing in 1Q17. Shorts'd better cover in earnest to above $1.50. On the 11/9 call, our CMO stated that our current lead candidate is our inhaled epinephrine. With limited resources, we are focused on the clinical development program and post-marketing requirements for Afrezza and this lead candidate in the near term. As we’ve stated before, if there are partnering opportunities, we would announce them. You must appreciate that product candidates need to reach a level of value before any potential partner would be interested. We are focused on getting inhaled epi to that stage. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=17#ixzz4TMlWuKuu
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Post by lakers on Dec 19, 2016 15:41:10 GMT -5
Shorts would naturally cover at 60 cents to book fat profit for the year. They are too smart to step in front of the EpiHale partnership train, and the RLS CBD royalty even though they think Afrezza is a bust. There is simply too much risk for them not to cover. There isn't much profit between 60 cents and zero. Most of the profit is between $10 and 60 cents. Expect more short covering to above $1.5.
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Post by lakers on Dec 19, 2016 15:16:52 GMT -5
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Post by lakers on Dec 17, 2016 15:09:23 GMT -5
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Post by lakers on Dec 17, 2016 14:47:14 GMT -5
Mnkd needs to hire Daniel Roth. Specialty Sales Executive Sanofi February 2016 – Present (9 months) Promoting Toujeo & Apidra. • 2016 Promoted to Specialty Executive • 2016 Selected Member DAC Committee • 2016 Selected Certified Field Trainer • 2016 Ambassador Primed West Conference Sanofi Senior Sales Executive Sanofi January 2015 – Present (1 year 10 months) Launched Afrezza 01/2015 Launched Toujeo 03/2015 [198 Sny reps vs 70 Mnkd reps] • Ranked 2 out of 198 (Toujeo/Afrezza). • Top Volume Afrezza Producer Nationally. • Top Volume Toujeo Producer Regionally. • Selected into the Afrezza Pilot Program. • Afrezza National Presenter at MGM Grand. Sanofi Sanofi Contract (Inventiv) Sanofi June 2013 – Present (3 years 5 months) Promoted Lantus & Apidra. • 9/14 - Nationally Recognized (teamwork) • 9/14 - Nationally Recognized (performance) • 12/14 - Nationally Recognized (performance) • 12/14 - District MVP Quarter 4 • Ranked 3 of 59 in 2013 • Ranked 1 of 59 in 2014 cafepharma.com/boards/threads/does-sanofi-rank-sales-people-selling-afrezza.584319/ #1Aug 18, 2015 at 3:02 PM anonymous anonymous Guest 2015 Sanofi Rankings: #1 DPC1 out of 198 Q1 2015 (Lantus/Afrezza) #1 DPC1 out of 198 Q2 2015 (Toujeo/Afrezza) Afrezza Launch-to-Date: • #1 Afrezza Primary Care Rep (DPC1) in the U.S. • 282% Goal Attainment Achieved in Q2 • #3 Afrezza Rep Overall in U.S. including Speciality • Q2 Selected into the Afrezza Pilot Program • Q2 Won Sanofi Launch Spirit Award Read more: mnkd.proboards.com/thread/6446/sales-team-on-job-months?page=5#ixzz4T7uyAlOv
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Post by lakers on Dec 16, 2016 19:15:04 GMT -5
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Post by lakers on Dec 13, 2016 15:03:12 GMT -5
New update follows.
Hello ......,
You’ve asked insightful questions. However, beyond the public guidance we provided on 11/9/16, we take extreme care in any updates given the potential for Reg. FD violations and heightened scrutiny around our communications.
On the 11/9 call, our CMO stated that our current lead candidate is our inhaled epinephrine. With limited resources, we are focused on the clinical development program and post-marketing requirements for Afrezza and this lead candidate in the near term. As we’ve stated before, if there are partnering opportunities, we would announce them. You must appreciate that product candidates need to reach a level of value before any potential partner would be interested. We are focused on getting inhaled epi to that stage.
As for RLS, we stated in our 11/9 call that we would achieve certain predetermined technical objectives in November, which we did accomplish. There is a process with RLS wherein their approval and acceptance will trigger a milestone payment. Until we have gone through this process with RLS, we are not assured of timing/receipt of milestone payments which we would most likely announce via press release given the market’s interest in our corporate developments and any extension of our financial runway.
Thank you for your support.
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Post by lakers on Dec 10, 2016 15:33:09 GMT -5
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Post by lakers on Dec 9, 2016 15:19:19 GMT -5
m.4-traders.com/SANOFI-4698/news/Sanofi-New-Findings-on-Type-1-Diabetes-Mellitus-Described-by-Investigators-at-Sanofi-Aventis-Deuts-23522757/Here is the bombshell. Sanofi : New Findings on Type 1 Diabetes Mellitus Described by Investigators at Sanofi-Aventis Deutschland GmbH [Improving Efficacy of Inhaled Technosphere... 12/08/2016 | 06:14 pm New Findings on Type 1 Diabetes Mellitus Described by Investigators at Sanofi-Aventis Deutschland GmbH [Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing: In-silico Clinical Trial with the University of ...] By a News Reporter-Staff News Editor at Clinical Trials Week -- Current study results on Nutritional and Metabolic Diseases and Conditions - Type 1 Diabetes Mellitus have been published. According to news reporting originating in Frankfurt, Germany, by NewsRx journalists, research stated, "Technosphere ® insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose. We used the University of Virginia (UVA)/Padova simulator to explore in-silico the potential benefit of different dosing regimens on postprandial glucose (PPG) control to support the design of further clinical trials." The news reporters obtained a quote from the research from Sanofi-Aventis Deutschland GmbH, "Tested dosing regimens included at-meal or postmeal dosing, or dosing before and after a meal (split dosing). Various dosing regimens of TI were compared among one another and to insulin lispro in 100 virtual type-1 patients. Individual doses were identified for each regimen following different titration rules. The resulting postprandial glucose profiles were analyzed to quantify efficacy and the risk for hypoglycemic events. This approach allowed us to assess the benefit/risk for each TI dosing regimen and to compare results with simulations of insulin lispro. We identified a new titration rule for TI that could significantly improve the efficacy of treatment with TI." According to the news reporters, the research concluded: "In-silico clinical trials comparing the treatment effect of different dosing regimens with TI and of insulin lispro suggest that postmeal dosing or split dosing of TI, in combination with an appropriate titration rule, can achieve a superior postprandial glucose control while providing a lower risk for hypoglycemic events than conventional treatment with subcutaneously administered rapid-acting insulin products." For more information on this research see: Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing: In-silico Clinical Trial with the University of Virginia/Padova Type 1 Diabetes Simulator. Diabetes Technology & Therapeutics, 2016;18(9):574-585. Diabetes Technology & Therapeutics can be contacted at: Mary Ann Liebert, Inc, 140 Huguenot Street, 3RD Fl, New Rochelle, NY 10801, USA. (Mary Ann Liebert, Inc. - http://www.liebertpub.com; Diabetes Technology & Therapeutics - www.liebertpub.com/overview/diabetes-technology-and-therapeutics/11/)Our news correspondents report that additional information may be obtained by contacting T. Klabunde, Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt, Germany. Additional authors for this research include C. Giegerich, R. Jager, R. Dahmen, A. Boss, M. Grant, C. Dalla Man, C. Cobelli and T. Klabunde (see also Nutritional and Metabolic Diseases and Conditions - Type 1 Diabetes Mellitus). Keywords for this news article include: Frankfurt, Germany, Europe, Nutritional and Metabolic Diseases and Conditions, Insulin Dependent Diabetes Mellitus, Clinical Trials and Studies, Type 1 Diabetes Mellitus, Clinical Research, Peptide Proteins, Peptide Hormones, Proinsulin, Sanofi-Aventis Deutschland GmbH.
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