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Post by liane on Sept 20, 2017 7:21:29 GMT -5
sportsrancho, If it comes to that point, and if it's appropriate, go for the anterolateral procedure. And obviously pick a surgeon who's done lots of them. In this procedure, they don't really cut the muscles, they go between. Much less soft tissue damage, and faster recovery. I was amazed, right after the procedure, my muscles still worked!
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Post by peppy on Sept 20, 2017 9:36:13 GMT -5
sportsrancho , If it comes to that point, and if it's appropriate, go for the anterolateral procedure. And obviously pick a surgeon who's done lots of them. In this procedure, they don't really cut the muscles, they go between. Much less soft tissue damage, and faster recovery. I was amazed, right after the procedure, my muscles still worked! off topic, for fun and games I have watched the surgery on youtube. It is amazing how far the surgical procedures have come.
I am crazy.
Sorry sports and all, I should have kept the fingers in the air. I think I was medicine disturbed yesterday.
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Post by mango on Sept 20, 2017 9:54:41 GMT -5
sportsrancho , If it comes to that point, and if it's appropriate, go for the anterolateral procedure. And obviously pick a surgeon who's done lots of them. In this procedure, they don't really cut the muscles, they go between. Much less soft tissue damage, and faster recovery. I was amazed, right after the procedure, my muscles still worked! off topic, for fun and games I have watched the surgery on youtube. It is amazing how far the surgical procedures have come.
I am crazy.
Sorry sports and all, I should have kept the fingers in the air. I think I was medicine disturbed yesterday.
por favor, publique el enlace
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Post by peppy on Sept 20, 2017 9:59:18 GMT -5
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Post by dreamboatcruise on Sept 20, 2017 10:56:42 GMT -5
sportsrancho , If it comes to that point, and if it's appropriate, go for the anterolateral procedure. And obviously pick a surgeon who's done lots of them. In this procedure, they don't really cut the muscles, they go between. Much less soft tissue damage, and faster recovery. I was amazed, right after the procedure, my muscles still worked! off topic, for fun and games I have watched the surgery on youtube. It is amazing how far the surgical procedures have come.
I am crazy.
Sorry sports and all, I should have kept the fingers in the air. I think I was medicine disturbed yesterday.
Saw one probably 12 - 15 years ago on cable medical show. It looked horribly brutal. I didn't know much about the surgery but was surprised a body could recover from such abuse. Now people are walking within a few days. Amazing how much improvement. The flip side of all the money we spend is that real advances in medicine are occurring... like hip replacement, and Afrezza.
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Post by orlon on Sept 21, 2017 14:08:34 GMT -5
Away from hip replacements and back to Mannkind. Do we go down to a nickel if no label change?
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Post by ghochr on Sept 21, 2017 14:17:46 GMT -5
Away from hip replacements and back to Mannkind. Do we go down to a nickel if no label change? It's definitely a binary event as that would impact insurance coverage based on Mike comments on the label change.
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Post by lennymnkd on Sept 21, 2017 14:43:53 GMT -5
Cantor Fitzgerald: Monday morning, ? Hmmmm
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Post by lakers on Sept 21, 2017 18:18:12 GMT -5
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT) clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&cond=diabetes&spons=mannkind&rcv_s=01%2F01%2F2015&rank=4clinicaltrials.gov/archive/NCT03143816/2017_09_11Changes to NCT03143816 on 2017_09_11 clinicaltrials.gov/archive/NCT03143816/2017_09_11/changesLast updated: September 11, 2017 Estimated Enrollment: 60 Anticipated Study Start Date: September 30, 2017Estimated Study Completion Date: October 15, 2017 Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure) Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: Publishing the data after the study, presenting at national scientific meetings Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2 Changes to NCT02527265 on 2017_08_23 clinicaltrials.gov/archive/NCT02527265/2017_08_23/changesPrimary Outcome Measures: Number of patients with adverse events [ Time Frame: Baseline to week 6 ] Number and percentage of patients with any TEAE, any serious TEAE, any severe TEAE, any TEAE leading to treatment discontinuation, or any TEAE leading to death (only if any occurred) will be summarized by age cohort Number of patients with hypoglycemic events [ Time Frame: Baseline to week 6 ] Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates. Secondary Outcome Measures: insulin maximum observed concentration (Cmax) [ Time Frame: 1 day ] PK measures for Afrezza Inhalation Powder as measured by Cmax - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing insulin time to reach Cmax (tmax) [ Time Frame: 1 day ] PK measures for Afrezza Inhalation Powder as measured by tmax - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing insulin area under concentration time curve (AUC) [ Time Frame: 1 day ] PK measures for Afrezza Inhalation Powder as measured by AUC - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing Assessment of fumaryl diketopiperazine (FDKP) elimination half-life (t1/2) [ Time Frame: 1 day ] PK measures for FDKP as measured by t1/2 - timepoints: -30, -25, -15, 0, 5, 10, 15, 18, 20, 30, 45, 55, 60, 90, 120, 125, 180, 240, 245, 250 minutes post dosing Number of patients adhered to dose titration rules [ Time Frame: 30 days ] Doses for each of 3 days' meals will be titrated based on the median SMBG (120 to 150 minutes post-dose) Measurement of anti-insulin antibodies [ Time Frame: Up to 13 months ] Comparison of baseline to week 6 and week 52Estimated Enrollment: 46 Anticipated Study Start Date: September 2017
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Post by dreamboatcruise on Sept 21, 2017 18:30:19 GMT -5
Away from hip replacements and back to Mannkind. Do we go down to a nickel if no label change? We still have time in range studies that could result in another submission for a label change. I'd also suspect that it won't be a strike out on all three of the requested changes this time around. I think if we get a solution to financing for a six month period or more without significant dilution, the share price will react positively even if the "ultra" adjective isn't given to us. According to management we should be getting additional Medicare coverage with 2018 formularies. Would be helpful if other plans showed some improvements in 2018 formularies even without "ultra"... e.g. as hinted at by management, they simply make the concessions necessary (such as price breaks) to get more insurers on board. According to Matt here on proboards MNKD management would be having ongoing dialog with FDA on the label... and thus presumably have some idea of the likelihood of "ultra". Hopefully management talking about all three options means they are reasonably confident of getting "ultra". But only time will tell.
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Post by mnholdem on Sept 21, 2017 18:51:29 GMT -5
The "back and forth" nature of discussions with the FDA will also include discussions of what claims MannKind will be allowed to use in marketing of Afrezza. This discussion is critical as it expedites the process of preparing new direct to consumer advertising, enabling the company to hit the ground running after the label change gets approved.
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Post by agedhippie on Sept 21, 2017 18:54:00 GMT -5
Away from hip replacements and back to Mannkind. Do we go down to a nickel if no label change? We still have time in range studies that could result in another submission for a label change. I'd also suspect that it won't be a strike out on all three of the requested changes this time around. I think if we get a solution to financing for a six month period or more without significant dilution, the share price will react positively even if the "ultra" adjective isn't given to us. According to management we should be getting additional Medicare coverage with 2018 formularies. Would be helpful if other plans showed some improvements in 2018 formularies even without "ultra"... e.g. as hinted at by management, they simply make the concessions necessary (such as price breaks) to get more insurers on board. According to Matt here on proboards MNKD management would be having ongoing dialog with FDA on the label... and thus presumably have some idea of the likelihood of "ultra". Hopefully management talking about all three options means they are reasonably confident of getting "ultra". But only time will tell. I don't see ultra making much difference without new trials. The evidence that is out there says Afrezza performs equal to or slightly worse than the existing options and that is the excuse insurers will stick to - Afrezza does not produce better outcomes and they can keep their juicy deals with Novo Nordisk, Sanofi, and Eli Lilly. Now the reduced hypos line has potential, that's a tangible benefit...
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Post by joeypotsandpans on Sept 21, 2017 18:59:11 GMT -5
Away from hip replacements and back to Mannkind. Do we go down to a nickel if no label change? Do we go to the sky if there is one? Just making a point about your post, however looking at the open interest for expiry 9/29 neither one looks like it's the likely scenario at this point for the day some are expecting....however, the open interest for 1/19/18 is showing a lot of open interest on the call side so looks like some are either hedged vs. their counter positions or very optimistic...or both
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Post by dreamboatcruise on Sept 21, 2017 19:02:14 GMT -5
We still have time in range studies that could result in another submission for a label change. I'd also suspect that it won't be a strike out on all three of the requested changes this time around. I think if we get a solution to financing for a six month period or more without significant dilution, the share price will react positively even if the "ultra" adjective isn't given to us. According to management we should be getting additional Medicare coverage with 2018 formularies. Would be helpful if other plans showed some improvements in 2018 formularies even without "ultra"... e.g. as hinted at by management, they simply make the concessions necessary (such as price breaks) to get more insurers on board. According to Matt here on proboards MNKD management would be having ongoing dialog with FDA on the label... and thus presumably have some idea of the likelihood of "ultra". Hopefully management talking about all three options means they are reasonably confident of getting "ultra". But only time will tell. I don't see ultra making much difference without new trials. The evidence that is out there says Afrezza performs equal to or slightly worse than the existing options and that is the excuse insurers will stick to - Afrezza does not produce better outcomes and they can keep their juicy deals with Novo Nordisk, Sanofi, and Eli Lilly. Now the reduced hypos line has potential, that's a tangible benefit... Though for what it is worth, management has indicated that it would make a difference because PBMs/insurers apparently have deals with subq prandial manufacturers which would become less of a problem if Afrezza is classified as "ultra-rapid". I do wonder if this is simply managements presumption or whether they have clearly been told this by PBMs/insurers. I tend to give some benefit of the doubt to Mike... but at end of the day "show me the money". One way or the other we need better placement on 2018 formularies. I would agree that an adjective on the label isn't going to mean a lot to doctors who can already see the pk/pd profile.
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Post by agedhippie on Sept 21, 2017 19:16:08 GMT -5
I don't see ultra making much difference without new trials. The evidence that is out there says Afrezza performs equal to or slightly worse than the existing options and that is the excuse insurers will stick to - Afrezza does not produce better outcomes and they can keep their juicy deals with Novo Nordisk, Sanofi, and Eli Lilly. Now the reduced hypos line has potential, that's a tangible benefit... Though for what it is worth, management has indicated that it would make a difference because PBMs/insurers apparently have deals with subq prandial manufacturers which would become less of a problem if Afrezza is classified as "ultra-rapid". I do wonder if this is simply managements presumption or whether they have clearly been told this by PBMs/insurers. I tend to give some benefit of the doubt to Mike... but at end of the day "show me the money". One way or the other we need better placement on 2018 formularies. I would agree that an adjective on the label isn't going to mean a lot to doctors who can already see the pk/pd profile. I hope Mike has a firm grip on this. The PBM gets a retrospective rebate based on sales so Afrezza either needs to grow the market, or set a price that compensates the PBM for their lost rebate. This is as I understand it. In the dim recesses of my mind I seem to remember Mannkind hiring someone who specialized in these deals.
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