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Post by kc on Dec 20, 2016 13:27:21 GMT -5
This is the link we need. Thanks National Drug Code (NDC): 47918-0880-18 Generic Name: INSULIN,HUMAN 4 UNIT X 90/8 UNIT X 90 INHL,ORAL,CARTRIDGE,KIT
Trade Name: AFREZZA INSULIN HUMAN INHL PWD 90X4MG/90X8MG VA Class: INSULIN FSS Price: $413.33 Prime Vendor (PV): YES
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Post by johnhindepost on Dec 20, 2016 13:49:40 GMT -5
and The Validity 2016 Medal goes to iam2 for prompt corroborative evidence on: MannKind gets Interim VA agreement
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Post by littledoc1 on Dec 20, 2016 13:57:12 GMT -5
Per VA... ABout 25% of its veterans are diabetic!
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Post by mnkdfann on Dec 20, 2016 19:22:24 GMT -5
It also seems that this was part of a normal bid process for the VA to accept drugs. Notice there were 999 offers in full and open competition. ... Extent Competed Full and Open Competition, 999 offer(s) Normal bid process for sure, not so sure the 999 really means that there were 999 competing bids (if that is what you are suggesting). Because: Seems strange if 998 others were competing with Mannkind to supply Afrezza made by Mannkind; and Seems like an excessively large number of competing bids.
I've noticed a few other contracts also have 999 bids, but there are no contracts featuring other 3 digit numbers of bids that I saw (doing a quick search). So, that is also peculiar. I am thinking that 999 is just a default placeholder value to be edited / updated at a later date.
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Post by kc on Dec 20, 2016 22:56:56 GMT -5
It also seems that this was part of a normal bid process for the VA to accept drugs. Notice there were 999 offers in full and open competition. ... Extent Competed Full and Open Competition, 999 offer(s) Normal bid process for sure, not so sure the 999 really means that there were 999 competing bids (if that is what you are suggesting). Because: Seems strange if 998 others were competing with Mannkind to supply Afrezza made by Mannkind; and Seems like an excessively large number of competing bids.
I've noticed a few other contracts also have 999 bids, but there are no contracts featuring other 3 digit numbers of bids that I saw (doing a quick search). So, that is also peculiar. I am thinking that 999 is just a default placeholder value to be edited / updated at a later date. Multiple drugs being offered not just insulin
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Post by mnkdfann on Dec 20, 2016 23:37:16 GMT -5
Could be, but there are the other issues I raised (e.g. 999 being a fairly common placeholder, etc.). And according to the www.va.gov link near the top of this page, it appears to cover 4 drugs / products (not 999). But, really, it doesn't even matter (as far as I can see). I was just making an observation. The main thing is they have a VA contract.
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Post by akemp3000 on Dec 21, 2016 0:05:15 GMT -5
Could be, but there are the other issues I raised. Really, it doesn't even matter (as far as I can see). The main thing is they have a VA contract. Yes. Regardless of how significant the VA contract turns out to be, it's nice to see Matt, Mike and company continuing to make progress while the nattering nabobs of negativism continue to complain. Frankly, the future's so bright we gotta wear shades. Hmmm...Safire to Timbuk 3
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Post by lennymnkd on Dec 21, 2016 10:11:23 GMT -5
Could be, but there are the other issues I raised. Really, it doesn't even matter (as far as I can see). The main thing is they have a VA contract. Yes. Regardless of how significant the VA contract turns out to be, it's nice to see Matt, Mike and company continuing to make progress while the nattering nabobs of negativism continue to complain. Frankly, the future's so bright we gotta wear shades. Hmmm...Safire to Timbuk 3 Not worthy of a press release ??
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Post by kc on Dec 21, 2016 22:52:35 GMT -5
14 page document published by the VA on Afrezza. Technosphere Insulin Inhalation Powder (Afrezza) VHA Pharmacy Benefits Management Strategic Healthcare Group Medical Advisory Panel and VISN Pharmacist Executives The purpose of VACO PBM-SHG drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. Executive Summary Technosphere insulin (TI) is an orally inhaled rapid-acting insulin. There are two 24-week clinical trials that evaluated TI using the marketed device. Change in A1C was the primary outcome. The addition of TI to basal insulin in patients with T1DM was found to be non-inferior to addition of aspart; however, the magnitude of change was less with TI (-0.21% vs. -0.4%) TI was found to be superior to placebo when added to oral hypoglycemic agents in patients with T2DM (-0.82% vs. -0.42%) Cough was the most commonly reported adverse event occurring in 25-30% of patients in the TI groups. TI causes a decline in FEV1 over time (treatment difference vs. comparators -40mL [95%CI -80, -1]). The decline was noted within the first 3 months of treatment and persisted over the duration of therapy. The annual rate of decline did not appear to worsen with continued use (up to 2 years of observation). Lung cancer was reported with Exubera, another inhaled insulin. There were 4 cases of lung cancer reported with TI; 2 on therapy and 2 after completion of the trial. There were no cases reported in the comparator arms. TI has a shorter duration of action than insulin aspart or regular insulin TI is contraindicated in patients with chronic lung disease such as COPD or asthma TI is not recommended in patients who smoke or who have recently stopped smoking TI should not be used in patients with active lung cancer. Consider the risk versus benefits of using TI in patients with a prior history of lung cancer or in patients at risk for lung cancer. Monitor pulmonary function at baseline and after 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. There is less flexibility in dosing TI than injectable insulin. TI is dosed in 4U increments Afrezza is orally inhaled rapid-acting insulin that was approved in June 2014. It is a dry-powder formulation of insulin using Technosphere technology. Exubera, another dry-powder formulation was approved in 2006; however, it was removed from the market in 2007 because of poor acceptance by patients and providers. The device used to deliver Afrezza fits in the palm of the hand and is substantially smaller than the device used to deliver Exubera. The preparation of Afrezza involves adsorption of regular human insulin onto Technosphere particles. The main component of the Technosphere is fumaryl diketopiperazine (FDKP), a proprietary excipient, which self-assembles into microparticles under acidic conditions. The insulin-containing particles are then freeze dried to form a dry powder. Once inhaled, the insulin-containing microparticles dissolve immediately at physiologic pH allowing insulin to be rapidly absorbed from the lung into the systemic circulation. It has been previously determined that the optimal size for particle delivery to the alveoli is 1- 3μm in diameter. The median diameter of the Technosphere particles is approximately 2-2.5μm. For the remainder of this review, Afrezza Technospehere insulin will be referred to as TI. Updated version may be found at www.pbm.va.gov or PBM INTRAnet www.pbm.va.gov/clinicalguidance/drugmonographs/Inhaled_Insulin_Afrezza_Monograph.pdf
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Post by sophie on Dec 22, 2016 3:01:50 GMT -5
Why do they have to mention Exubera so many times in this article?
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Post by mnkdfann on Dec 22, 2016 9:25:08 GMT -5
The document appears to be from June 2015. Sadly, the Conclusions section is not particularly exciting. I'm not a (medical) doctor, but the way I read it (the conclusions section) is that VA document merely lists TI as option for those "truly averse to needles" , "with insulin - related adverse skin reactions", or "working in environments that do not allow needles." But it really doesn't describe it as the go to drug of choice for anyone else. Hopefully they update it with a more optimistic tone sometime soon.
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Post by oldfishtowner on Dec 22, 2016 9:50:04 GMT -5
The document appears to be from June 2015. Sadly, the Conclusions section is not particularly exciting. I'm not a (medical) doctor, but the way I read it (the conclusions section) is that VA document merely lists TI as option for those "truly averse to needles" , "with insulin - related adverse skin reactions", or "working in environments that do not allow needles." But it really doesn't describe it as the go to drug of choice for anyone else. Hopefully they update it with a more optimistic tone sometime soon. Isn't the statement on dosing, "There is less flexibility in dosing TI than injectable insulin" also wrong? My perception is that dosing with Afrezza is more flexible than with injectable insulin. You do not have to be so precise. And that is precisely why Afrezza is only available in 4-unit increments.
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Post by art606a on Dec 22, 2016 11:16:00 GMT -5
The document appears to be from June 2015. Sadly, the Conclusions section is not particularly exciting. I'm not a (medical) doctor, but the way I read it (the conclusions section) is that VA document merely lists TI as option for those "truly averse to needles" , "with insulin - related adverse skin reactions", or "working in environments that do not allow needles." But it really doesn't describe it as the go to drug of choice for anyone else. Hopefully they update it with a more optimistic tone sometime soon. Isn't the statement on dosing, "There is less flexibility in dosing TI than injectable insulin" also wrong? My perception is that dosing with Afrezza is more flexible than with injectable insulin. You do not have to be so precise. And that is precisely why Afrezza is only available in 4-unit increments. I suspect that "less flexibilty" in fact refers to afrezza being available only in 4/8/12 unit doses while shots can be given in any increment.
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Post by mango on Dec 31, 2016 12:04:58 GMT -5
What was Al Mann's plan to creating an industrial development organization? What does Al Mann think about the FDA? What are the ingredients for a successful Al Mann company? Watch and find out. m.youtube.com/watch?v=muBuxTqxmQo
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Post by peppy on Apr 1, 2017 11:59:58 GMT -5
I wanted to file this information. The plan. Math by OOG.
Current Burn Rate: 10M / month Annual Burn Rate: 120M
30 Day Patient Cost: 600 Profit to Mannkind: 150
30d Prescriptions Required for breakeven: 120M/150 = 800K 90d Prescriptions Required: 267k (annually) Weekly TRX Required: 267 / 52 = 5128
Roughly speaking MNKD needs 5200 total prescription per week to break even at current price structure.
This corresponds to approximately 67700 patients using Afrezza. Note: Danbury plant with 3 lines has current max capacity of 500k annual patients.
OOG
Read more: mnkd.proboards.com/thread/7477/2017-sales-marketing-developments?page=2#ixzz4d1BDulS0
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