|
Post by itellthefuture777 on Aug 21, 2017 14:48:01 GMT -5
Afrezza is Monomeric active form delivered systemically..mimics the healthy pancreas with less then a 30 second difference...nothing else is closer to the healthy pancreas kenetic profile then Afrezza....period..drop the mic..boom!
|
|
|
Post by dreamboatcruise on Aug 21, 2017 15:35:38 GMT -5
Afrezza is Monomeric active form delivered systemically..mimics the healthy pancreas with less then a 30 second difference...nothing else is closer to the healthy pancrease kenetic profile then Afrezza....period..drop the mic..boom! And IV injection, which obviously isn't practical for daily use.
|
|
|
Post by dreamboatcruise on Aug 21, 2017 15:39:02 GMT -5
Just waiting on the FDA to approve a Superior label lol... that's not gonna happen. At least not on or before Sept 30th, 2017. Some people may view an ultra-rapid designation as "superior", whereas for others superior would mean with regard to A1c and/or time in range. The latter obviously isn't what has applied for since there is yet to be trial data demonstrating it.
|
|
|
Post by itellthefuture777 on Aug 21, 2017 16:04:01 GMT -5
One Drop will demonstrate A1C Superior...and Superior Glucose Control has already been proven..A1Cs...are non-inferior proven..Hypos are significantly less when used with a basil..proven..Users are learning..and combined with these FDA approved Apps..Afrezza frontline..is the future view..
|
|
|
Post by nylefty on Aug 21, 2017 16:06:12 GMT -5
My view..layman terms...No other insulin maker could stabilize Monomeric active insulin..which is the exact same insulin the pancreas produces in the healthy individual...All the industrialized insulins zinc bond 6 monomeric molecules into a hexomeric (six pack)...then..it is stable but in an inactive form. Then you inject it...it's in the blood..near the injection site..slowly spreads out in the body..and then your blood has to eat through that zinc bonding...takes a long..long time...then it is active..Mannkind"s Afrezza is the worlds only stabilized Monomeric active insulin..you breath it into the lungs with a Ph balance of 7 the known inert Technosphere carrier melts away at the deep lungs Avila delivering through a 1 cell thick lung wall (which if you stretched out your lung it is about the size of a tennis court) into the blood stream systemically (like air..exchanges into your blood..feels good to get that air systemically) the difference between the healthy individuals pancreas and Afrezza is less then 30 seconds..and basically the same human monomeric insulin so...it mimics the healthy individual..NO other insulin can do this..and since type 2 diabetes starts at meal time (where you lose control) Afrezza is a meal time insulin..kol's say it's obvoius Afrezza halts progression..in a study where type 2 took Afrezza..but didn't eat..they had zero hypos..in all cases..when ised with a basil..there were some hypos but a 62% reduction when used with Afrezza..so..thats how I view it..you can't put a pencil mark between a healthy individuals kenetic profile and Afrezza..the goal to have a fast insulin..by Pfizer using the lungs failed..because while inhaled..they still were Hexomeric..and like the shot..still to slow to activate..Afrezza mimics the pancreas..and faster then rapid insulins..ultra rapid...and is a monopoly...and there is nothing else on the horizon..So Metformin doesn't halt progression to blindness..amputations..liver..heart..ect..Afrezza isers show many graphs in range..they love it..what other insulin users say that about their insulin? Paragraphs and complete sentences are your friends. I find the above to be unreadable.
|
|
|
Post by itellthefuture777 on Aug 21, 2017 16:09:12 GMT -5
My view..layman terms...No other insulin maker could stabilize Monomeric active insulin..which is the exact same insulin the pancreas produces in the healthy individual...All the industrialized insulins zinc bond 6 monomeric molecules into a hexomeric (six pack)...then..it is stable but in an inactive form. Then you inject it...it's in the blood..near the injection site..slowly spreads out in the body..and then your blood has to eat through that zinc bonding...takes a long..long time...then it is active..Mannkind"s Afrezza is the worlds only stabilized Monomeric active insulin..you breath it into the lungs with a Ph balance of 7 the known inert Technosphere carrier melts away at the deep lungs Avila delivering through a 1 cell thick lung wall (which if you stretched out your lung it is about the size of a tennis court) into the blood stream systemically (like air..exchanges into your blood..feels good to get that air systemically) the difference between the healthy individuals pancreas and Afrezza is less then 30 seconds..and basically the same human monomeric insulin so...it mimics the healthy individual..NO other insulin can do this..and since type 2 diabetes starts at meal time (where you lose control) Afrezza is a meal time insulin..kol's say it's obvoius Afrezza halts progression..in a study where type 2 took Afrezza..but didn't eat..they had zero hypos..in all cases..when ised with a basil..there were some hypos but a 62% reduction when used with Afrezza..so..thats how I view it..you can't put a pencil mark between a healthy individuals kenetic profile and Afrezza..the goal to have a fast insulin..by Pfizer using the lungs failed..because while inhaled..they still were Hexomeric..and like the shot..still to slow to activate..Afrezza mimics the pancreas..and faster then rapid insulins..ultra rapid...and is a monopoly...and there is nothing else on the horizon..So Metformin doesn't halt progression to blindness..amputations..liver..heart..ect..Afrezza isers show many graphs in range..they love it..what other insulin users say that about their insulin? Paragraphs and complete sentences are your friends. I find the above to be unreadable. I cnduo't bvleiee taht I culod aulaclty uesdtannrd waht I was rdnaieg. Unisg the icndeblire pweor of the hmuan mnid, aocdcrnig to rseecrah at Cmabrigde Uinervtisy, it dseno't mttaer in waht oderr the lterets in a wrod are, the olny irpoamtnt tihng is taht the frsit and lsat ltteer be in the rhgit pclae. The rset can be a taotl mses and you can sitll raed it whoutit a pboerlm. Tihs is bucseae the huamn mnid deos not raed ervey ltteer by istlef, but the wrod as a wlohe. Aaznmig, huh? Yaeh and I awlyas tghhuot slelinpg was ipmorantt!
|
|
|
Post by peppy on Aug 21, 2017 16:38:05 GMT -5
I couldn't believe it either. wow. itellthefuture, nylefty is a very respected member here. I always listen to Nylefty.
|
|
|
Post by zuegirdor on Aug 21, 2017 17:06:21 GMT -5
Paragraphs and complete sentences are your friends. I find the above to be unreadable. I cnduo't bvleiee taht I culod aulaclty uesdtannrd waht I was rdnaieg. Unisg the icndeblire pweor of the hmuan mnid, aocdcrnig to rseecrah at Cmabrigde Uinervtisy, it dseno't mttaer in waht oderr the lterets in a wrod are, the olny irpoamtnt tihng is taht the frsit and lsat ltteer be in the rhgit pclae. The rset can be a taotl mses and you can sitll raed it whoutit a pboerlm. Tihs is bucseae the huamn mnid deos not raed ervey ltteer by istlef, but the wrod as a wlohe. Aaznmig, huh? Yaeh and I awlyas tghhuot slelinpg was ipmorantt! ww, yu ln sg nw ey dy!
|
|
|
Post by helmut8056 on Aug 21, 2017 18:23:01 GMT -5
I love Shakespeareian soliloquy
|
|
|
Post by mango on Aug 21, 2017 21:23:09 GMT -5
lol... that's not gonna happen. At least not on or before Sept 30th, 2017. Some people may view an ultra-rapid designation as "superior", whereas for others superior would mean with regard to A1c and/or time in range. The latter obviously isn't what has applied for since there is yet to be trial data demonstrating it. The FDA does not require a trial for everything, when will people stop assuming they do? They just approved new indications for Metformin this year based off of epidemiological data, most of it many many years old. Afrezza can be approved for new indications based off of real life data via a CGM. 1 year with hundreds of CGM data compiled by clinical experts in the field and submitted along with whateverelse would be just fine. It definitely would be multitudes higher in clinical evidence grades than that of freaking epidemiological data. This is a good example of why it is important to know what you're talking about before misleading people from the truth. 🙄
|
|
|
Post by dreamboatcruise on Aug 21, 2017 21:36:29 GMT -5
Some people may view an ultra-rapid designation as "superior", whereas for others superior would mean with regard to A1c and/or time in range. The latter obviously isn't what has applied for since there is yet to be trial data demonstrating it. The FDA does not require a trial for everything, when will people stop assuming they do? They just approved new indications for Metformin this year based off of epidemiological data, most of it many many years old. Afrezza can be approved for new indications based off of real life data via a CGM. 1 year with hundreds of CGM data compiled by clinical experts in the field and submitted along with whateverelse would be just fine. It definitely is a multiple grades higher in clinical evidence that freaking epidemiological data. 🙄 FDA isn't going to take evidence from self selected people posting CGM data to social media. MNKD has basically discussed what they submitted for a label change and it isn't A1c or time in range. FDA certainly isn't considering anything that MNKD hasn't requested them to consider. Management is being pretty good about telling us what they are doing. If you think you have some insight into what the FDA will accept as evidence tweet Ray or Mike and see if you can convince them. I would assume they are planning a time in range study because in their expertise they feel it is necessary to do it that way. Perhaps you can sway them to take existing CGM data to FDA and forgo the expense of the upcoming FDA approved study, though I expect not.
|
|
|
Post by mango on Aug 21, 2017 21:52:43 GMT -5
The FDA does not require a trial for everything, when will people stop assuming they do? They just approved new indications for Metformin this year based off of epidemiological data, most of it many many years old. Afrezza can be approved for new indications based off of real life data via a CGM. 1 year with hundreds of CGM data compiled by clinical experts in the field and submitted along with whateverelse would be just fine. It definitely is a multiple grades higher in clinical evidence that freaking epidemiological data. 🙄 FDA isn't going to take evidence from self selected people posting CGM data to social media. MNKD has basically discussed what they submitted for a label change and it isn't A1c or time in range. FDA certainly isn't considering anything that MNKD hasn't requested them to consider. Management is being pretty good about telling us what they are doing. If you think you have some insight into what the FDA will accept as evidence tweet Ray or Mike and see if you can convince them. I would assume they are planning a time in range study because in their expertise they feel it is necessary to do it that way. Perhaps you can sway them to take existing CGM data to FDA and forgo the expense of the upcoming FDA approved study, though I expect not. Who said From social media? You assume too much. Physicians can collect these data from their patients. Remember that word? Epidemiological data? Yeah, the FDA approves indications based off of it. Anyways...
|
|
|
Post by bones1026 on Aug 21, 2017 22:48:29 GMT -5
Afrezza is Monomeric active form delivered systemically..mimics the healthy pancreas with less then a 30 second difference...nothing else is closer to the healthy pancrease kenetic profile then Afrezza....period..drop the mic..boom! And IV injection, which obviously isn't practical for daily use. You agree that our product is the equivalent of walking around with an IV all day...yet doom and gloom at every opportunity..confusing
|
|
|
Post by uvula on Aug 21, 2017 23:00:32 GMT -5
Is this another One Drop competitor? Diathrive.com
|
|
|
Post by sayhey24 on Aug 22, 2017 5:24:03 GMT -5
Everyone is jumping into the monitoring and supply game. Lots of radio/TV commercials in my area. But who can address the problem of real time meal time sugar spikes? I am only aware of One solution which mimics a healthy pancreas. I think the advantage OneDrop has is their monitoring system. IMO it has a very good UI. It reminds me of what set aside the IPod. Here is a nice user review. www.seapeptide.com/single-post/2016/11/10/Analyzing-Data-With-One-Drop
|
|