|
|
Post by mango on Sept 22, 2017 16:55:50 GMT -5
Yeah, yeah. We'll come back to this in the future. [0010] Increasingly, evidence indicates that an early relatively rapid insulin response following glucose ingestion plays a critical role in the maintenance of postprandial glucose homeostasis. An early surge in insulin concentration can limit initial glucose excursions, mainly through the inhibition of endogenous glucose production. Therefore the induction of a rapid insulin response in a diabetic individual is expected to produce improved blood glucose homeostasis. [0011] In a normal individual, a meal induces the secretion of a burst of insulin, generating a relatively rapid spike in serum insulin concentration that then decays relatively quickly (see Figure 1). This early-phase insulin response is responsible for the shut-off, or reduction, of glucose release from the liver. Homeostatic mechanisms then match insulin secretion (and serum insulin levels) to the glucose load. This is observed as a slow decay of modestly elevated serum insulin levels back to baseline and is second-phase kinetics. USE OF ULTRARAPID ACTING INSULIN |
|
|
|
Post by dg1111 on Sept 27, 2017 12:56:19 GMT -5
|
|
|
|
Post by mnholdem on Sept 27, 2017 13:40:41 GMT -5
|
|
|
|
Post by dreamboatcruise on Sept 27, 2017 13:55:44 GMT -5
Looking at the "printed labeling" documents it appears they don't yet reflect availability of the 12u cartridge, so it seems getting new data on this site in a timely manner is not guaranteed. As for MNKD's actions, might depend upon whether it's good, bad or between news and whether that news would be considered to be "material". If they get their "ultra" designation I would suspect they'll rush out a PR. |
|
|
|
Post by matt on Sept 27, 2017 17:05:18 GMT -5
Looking at the "printed labeling" documents it appears they don't yet reflect availability of the 12u cartridge, so it seems getting new data on this site in a timely manner is not guaranteed. As for MNKD's actions, might depend upon whether it's good, bad or between news and whether that news would be considered to be "material". If they get their "ultra" designation I would suspect they'll rush out a PR. There are two discussions to be had with FDA. The first is allowance of claims, and the second is approval of the label copy. The first is the tough part; the label text and printed materials can follow within a few days once there is agreement on what the company can say. It might be a few weeks before you see revised package inserts. |
|
|
|
Post by drman7 on Oct 3, 2017 12:26:57 GMT -5
If they were giving out vouchers, personally I might fill the prescription and hope I could get authorization from insurance... and then drop it if I couldn't and faced thousands of dollars a year in cost. Well, not really knowing what I know about Afrezza, but I make good money and really understand benefit of Afrezza. Seems like we've got anecdotal evidence that both insurance (cost) and poor efficacy (likely from lack of optimal dosing) have caused people to start and then stop Afrezza. Doesn't seem like there is anyway of solving the question of relative contribution to what seems unarguably to have been poor overall retention over the commercial lifespan of Afrezza. Management probably has a much better idea than any of us and even their visibility may not be full. Could it also be lack of attention and education? There's a recent video a woman did on Afrezza. Someone's wrote her a prrscription. She had no idea how it worked or even how to use it. Simply tossed the instructions and had no problems figuring it out. Was cool seeing how surprised she was. Bottom line, people are not cared for properly and the attention and time they need for isn't being provide to them. Endos are too busy to learn about this themselves. Inhaling scares them? My guess they're all too busy listening to a pill or injection rep to just simply obeying orders given out by the ADA. Puppets? Obviously good care exists. Why isn't it given across the board? They're afraid to admit their guidelines are a failure for one. They've never known what glucose homeostasis is. They can actually see an insulin restoring it. Shatters their world I'm sure. They actually gotta put in some care now. Who is gonna be the rogue Endo to lead the way? They're too small a group for small time people to go against the grain, they'll be burned. This group flocks together. The random good ones are a different species. mango - you talking about tis video - Kara Stiles www.youtube.com/watch?v=QA2_uA0qJls |
|
