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Post by dreamboatcruise on Aug 29, 2017 13:34:16 GMT -5
Whether anyone likes him or not, Trump has been pushing reform of FDA procedures and speed of evaluation. I don't think the FDA is going to fight a guy that has already begun the reform of the VA with such success. As a vet, I already see a difference and lo and behold, a deference by the people I have interacted with. They used to treat us as if we were at the DMV. Now there is a definite increase in service and respect. Yet, it looks like FDA is as yet behaving the same way and not making a decision about the label change until the latest time they are allowed by law to make the decision... i.e. Sept. |
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Post by sayhey24 on Aug 29, 2017 16:08:19 GMT -5
DBC - To compare RHI to afrezza might be one of the more naive claims by the afrezza deniers. Welcome to the club. While RHI eventually breaks down to the usable 51 amino acid monomer molecule unless its given IV you can't compare the two. They are night and day. afrezza profiles exactly like pancreatic released insulin. RHI does not and absorption rates vary from location to location and time to time depending on things like hydration.
Now, if I were Mike C. I would try and get the "Rescue afrezza" approved not requiring spiro testing. If they can do that then just like RHI it can be sold over the counter without prescription in most states. How awesome would than be and it would make the boot camp lady happy too.
Yes, the "Near Natural", I clearly coined. I have been saying it here for a long time and I should TM it today. But the reality is we do not know what Ray U. submitted for the label change. I sure hope it is not ultra. He clearly did not say "Ultra" in the last call and as I have said here and to MNKD management "ultra" compares it to the analogs and afrezza ain't no analog. Its the same near natural insulin released by the pancreas so it needs to be totally separate from the Frankenstein analogs.
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Post by dreamboatcruise on Aug 29, 2017 16:22:38 GMT -5
sayhey24... sorry, but you're wrong. RHI is what Afrezza is made from. Nothing naive about it... just a fact. And as a fact it is true no matter what one thinks about Afrezza. You don't get you're own facts just because you are a MNKD stock pumper. The route of administration from previous methods of delivering RHI (IV, subq, intramuscular... demonstrating a wide range of pd profiles from slow to basically as fast as Afrezza) is different, but the insulin molecule of Afrezza is RHI, which isn't exactly the same as pancreas produces, which you often claim.
Management has discussed what was submitted for label change. I'll focus on what they say they are doing. You can trademark your ideas.
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Post by Deleted on Aug 30, 2017 8:21:58 GMT -5
The FDA should describe analogs around Afrezza since Afrezza mimics pancreatic insulin. Unfortunately, that is too simple for the FDA to comprehend.
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Post by agedhippie on Aug 30, 2017 9:03:32 GMT -5
The FDA should describe analogs around Afrezza since Afrezza mimics pancreatic insulin. Unfortunately, that is too simple for the FDA to comprehend. What the FDA comprehend is that the insulin response is both phased and comprises far more than just insulin so the natural/mimic argument will go nowhere. Stick to the drug benefits, and not the features, if you want to win over the FDA. |
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Post by lennymnkd on Aug 30, 2017 9:49:26 GMT -5
Comprised of ? Phased Thur the human bodies natural processing, witch majority of diabetics patients can still process ..sustain
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Post by agedhippie on Aug 30, 2017 12:35:55 GMT -5
Comprised of ? Phased Thur the human bodies natural processing, witch majority of diabetics patients can still process ..sustain Sorry, but I am not sure what you are saying. |
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Post by lennymnkd on Aug 30, 2017 13:10:56 GMT -5
What part of the linear process is being either compromised or not having some sort of and advantage with AFREZZA.
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Post by sayhey24 on Aug 30, 2017 16:07:59 GMT -5
sayhey24... sorry, but you're wrong. RHI is what Afrezza is made from. Nothing naive about it... just a fact. And as a fact it is true no matter what one thinks about Afrezza. You don't get you're own facts just because you are a MNKD stock pumper. The route of administration from previous methods of delivering RHI (IV, subq, intramuscular... demonstrating a wide range of pd profiles from slow to basically as fast as Afrezza) is different, but the insulin molecule of Afrezza is RHI, which isn't exactly the same as pancreas produces, which you often claim. Management has discussed what was submitted for label change. I'll focus on what they say they are doing. You can trademark your ideas. Wrong, too funny! Look the pancreas stores insulin in six packs. I store my beer in six packs but I drink it one bottle at a time just like the human body uses insulin in its monomer form. Once the insulin passes through the pancreatic canal its immediately absorbed as a monomer. Once afrezza goes into the deep lung the ph melts away the fdkp and the monomer goes into the blood. When you "same as, what afrezza is made from" when your hexamer six pack goes SQ, it waits and waits as the six pack is broken into dimmers and then monomers. Eventually its the same but because of the process of breaking down the six pack which varies it ain't the same. Clearly from the PK graphs you can understand that, right??? Its like a six pack of beer and I can't drink all six bottles at the same time. You can say it till the cows come home but you will still be singing the same off key tune. If you don't understand it from my beer analogy, I just have to give up and get some old number 7. Good news is I am in a state with old number 8, so I think I will go and get some now. |
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Post by agedhippie on Aug 30, 2017 20:58:29 GMT -5
What part of the linear process is being either compromised or not having some sort of and advantage with AFREZZA. When insulin is released you also get amylin and glucagon released, as well as c-peptide formed by the creation of insulin from proinsulin. When you take insulin all those components are missing. When you take insulin, and this applies to all artificial insulin (RHI and analogs), you are missing c-peptides because the the conversion from proinsulin to insulin never happened - this was one of the objections people had in moving to RHI when it first came out. |
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Post by peppy on Aug 30, 2017 21:18:54 GMT -5
What part of the linear process is being either compromised or not having some sort of and advantage with AFREZZA. When insulin is released you also get amylin and glucagon released, as well as c-peptide formed by the creation of insulin from proinsulin. When you take insulin all those components are missing. When you take insulin, and this applies to all artificial insulin (RHI and analogs), you are missing c-peptides because the the conversion from proinsulin to insulin never happened - this was one of the objections people had in moving to RHI when it first came out.
RHI = regular human insulin. What other choices were there?
Bovine?
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Post by sayhey24 on Aug 31, 2017 6:29:41 GMT -5
What part of the linear process is being either compromised or not having some sort of and advantage with AFREZZA. When insulin is released you also get amylin and glucagon released, as well as c-peptide formed by the creation of insulin from proinsulin. When you take insulin all those components are missing. When you take insulin, and this applies to all artificial insulin (RHI and analogs), you are missing c-peptides because the the conversion from proinsulin to insulin never happened - this was one of the objections people had in moving to RHI when it first came out. The last I checked the pancreas releases glucagon when the concentration of glucose in the bloodstream falls too low. Maybe my understanding is incorrect as I always thought glucagon causes the liver to convert stored glycogen into glucose, which is released into the bloodstream. Can you point me to some info so I can get a better understanding of what you are trying to say? Having some amylin may be nice but its main role is to inhibit glucagon secretion. Since afrezza works as fast as it does not having it seems minor. Additionally for the T2 they are producing some amylin and c-peptide. As they use afrezza more and more and allow the beta cells to heal they should get back to near normal levels. It might be nice to have a second cartridge for the c-peptide but probably not worth it at this point. Lets get the BG back to near normal levels first. |
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Post by Deleted on Aug 31, 2017 6:33:08 GMT -5
"The last I checked the pancreas releases glucagon when the concentration of glucose in the bloodstream falls too low. Maybe my understanding is incorrect as I always thought glucagon causes the liver to convert stored glycogen into glucose, which is released into the bloodstream."
That is correct.
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Post by agedhippie on Aug 31, 2017 8:43:40 GMT -5
When insulin is released you also get amylin and glucagon released, as well as c-peptide formed by the creation of insulin from proinsulin. When you take insulin all those components are missing. When you take insulin, and this applies to all artificial insulin (RHI and analogs), you are missing c-peptides because the the conversion from proinsulin to insulin never happened - this was one of the objections people had in moving to RHI when it first came out.
RHI = regular human insulin. What other choices were there?
Bovine?
It was porcine or bovine. |
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Post by peppy on Aug 31, 2017 8:46:43 GMT -5
RHI = regular human insulin. What other choices were there?
Bovine?
It was porcine or bovine. so aged, which is better? The analogs or RHI porcine or bovine?
Quote: When insulin is released you also get amylin and glucagon released, as well as c-peptide formed by the creation of insulin from proinsulin. When you take insulin all those components are missing. When you take insulin, and this applies to all artificial insulin (RHI and analogs), you are missing c-peptides because the the conversion from proinsulin to insulin never happened - this was one of the objections people had in moving to RHI when it first came out.
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