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Post by avichen on May 23, 2016 8:52:02 GMT -5
All the links are not the same anymore... what happened to MNKD's booth?
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Post by kc on May 27, 2016 14:27:23 GMT -5
What day and time does the ADA release the Abstracts for viewing?
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Post by mnkdnut on May 27, 2016 20:30:08 GMT -5
Looks like abstract text will be released by the ADA on Friday, June 3. We've got 6 Abstracts accepted, however be aware that there are different levels of acceptance. The best acceptance level is for oral presentation, either in a general session or symposium (think speaker at a podium with a large room full of people). None of the 6 Abstracts were accepted for that. We've got 5 in General Poster Session, and 1 in a moderated poster session. As such, the exposure of these abstracts will be limited to those motivated to go browse the poster room during the 2 hours around lunch. The one moderated poster session will involve a walk-by by a moderator with a microphone having a brief discussion with the author of the poster.
Probably the best use of these Abstracts will be to get the label tweaked (maybe, if FDA agrees) as alluded to at the ASM. However, these studies will likely only enable a plea for better language around dosing and PK/PD. There's nothing there that will support more significant label change around superiority to RAAs in lowering A1Cs, lower incidence of hypos, or other larger clinical outcomes measures.
Mike C. has a long, hard road ahead in digging us out of the hole our non-inferior Trial data and Sanofi's failed launch put us in, but I believe his solid commercial plan is the very best shot we have (unless we win the lotto and RLS turns out to have a budding blockbuster in their portfolio). I don't believe there will be any significant cash available from an International distribution rights deal until MC's salesforce demonstrates they can get increasing traction in the US market.
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Post by nylefty on May 27, 2016 20:36:40 GMT -5
All the links are not the same anymore... what happened to MNKD's booth? What do you mean what happened to it? MNKD has booth 360, at a good location: stocktwits.com/message/55659939
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Post by avichen on May 28, 2016 8:33:13 GMT -5
If that is the case, then M&M have to prepare their own video recording team, make the best use of the event and the environment, capture that important moments and post it on youtube. It's another way to reach out to larger audiences.
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Post by mnkdfann on May 28, 2016 9:04:43 GMT -5
If that is the case, then M&M have to prepare their own video recording team, make the best use of the event and the environment, capture that important moments and post it on youtube. It's another way to reach out to larger audiences. Based on the conferences I have attended, a videotape of the important moments at a poster session would only be useful as a sleep aid.
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Post by mnholdem on Jun 2, 2016 13:07:37 GMT -5
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Post by charlespk on Jun 3, 2016 1:32:46 GMT -5
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Post by trondisc on Jun 3, 2016 2:30:03 GMT -5
Hell yeah + y0u r0x0r f0r p0st!ng = thanks charlespk. Here's to Al Mann trying to make a damn difference/dent in the universe. I'm sad but a semi-proud bagholder since 3.20 yet if Technosphere can revolutionize modern medicine with some sort of wireless digital monitoring integration...I'm willing to risk 35K in the name of making a difference for patients worldwide. For the greater common good, MannKind needs to survive.
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Post by agedhippie on Jun 3, 2016 16:05:04 GMT -5
Abstracts are up! The onset times from the clamp studies are impressive.
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Post by saxcmann on Jun 3, 2016 16:37:58 GMT -5
Abstracts are all very good. Science behind afrezza is strong. Hopefully this finally changes course of mnkd.
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Post by peppy on Jun 3, 2016 16:39:31 GMT -5
can someone take a snap shot of the results?
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Post by centralcoastinvestor on Jun 3, 2016 16:39:44 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?
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Post by saxcmann on Jun 3, 2016 16:42:17 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? Sorry can't. My endo friend just text me. In summary all good abstracts he said. I'll try to send a few things he said later.
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Post by sportsrancho on Jun 3, 2016 16:42:21 GMT -5
DIETHER RUEPPEL, RAPHAEL DAHMEN, ANDERS BOSS, MARSHALL GRANT, ROBERT BAUGHMAN, THOMAS KLABUNDE, Frankfurt, Germany, Bridgewater, NJ, Danbury, CT Disclosures D. Rueppel: Employee; Author; Sanofi. R. Dahmen: Employee; Author; Sanofi. A. Boss: Employee; Author; Sanofi. M. Grant: Employee; Author; Mannkind Corporation. R. Baughman: Employee; Author; MannKind Corporation. T. Klabunde: Employee; Author; Sanofi. A large percentage of patients with type2 diabetes are treated with multiple daily insulin injections. Technosphere® insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. The aim of this analysis is to a) quantify the dose response relationship for TI in comparison to subcutaneously (sc) administered regular human insulin (RHI) and b) compare the onset and duration of action of TI and RHI. Population PK and PK/PD models were developed using data from an euglycemic glucose clamp study in 32 healthy volunteers, each receiving one dose of sc regular human insulin (15 IU) and 4 doses of TI (10 TI U, 30 TI U, 60 TI U, 80 TI U). The glucose infusion rate (GIR) was recorded for 4 hr following each dose of TI and 10 hr following administration of RHI. The population PK/PD model (PK-GIR model) was based on an Emax model to relate insulin concentrations from an effect compartment to the glucose infusion rate (GIR). In a second step, a dose response model was developed relating insulin doses of TI and RHI with the area under the curve (AUC) of GIR, also by an Emax model (dose-GIRAUC model). GIR AUCs were calculated until 20 hr to ensure that GIR values have returned to baseline to capture the full PD effect. GIR values beyond the last observation were simulated from the PK-GIR model. GIR time curves for doses of TI or RHI not measured in the study, but necessary to capture the dose-response relationship, were also calculated from the PK-GIR model. The dose-GIRAUC model suggests that the dose-response for TI and RHI can be described by a linear relationship for therapeutically relevant doses (RHI up to 16 IU and TI up to 80 TI U). Finally, GIR time curves were simulated for a RHI dose of 8 IU and a TI dose of 40 TI U, i.e., a dose providing an equivalent PD effect (as expressed by GIR-AUC). The onset of action was found to be faster for TI as expressed by steeper cumulative GIRAUC curves and shorter times to reach the half maximal effect (RHI, 296±64 min versus TI, 124±25 min). (NCT01490762).
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