|
Post by mnholdem on Feb 10, 2016 9:52:05 GMT -5
Makes sense and is usually the way to roll out trial data. But, will it matter? Will the clamp data results make endos/pcps change their mind about Afrezza and embrace it as a viable weapon to fight diabetes? I'm not so sure it will. I hear scientific data is very important and how it is released. Positive clamp results would influence endos/pcps strongly. Currently data is insufficient. Doctor education and DTC marketing will also be very important for success,imo. The primary objective of one trial was:
"To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting."
The primary objectives of another trial was:
"To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting.
"To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting."
---
It's quite possible that these study results may lead to MannKind being able to distribute FDA-approved Afrezza dosing literature that will benefit physicians and endocrinologists in working with their patients.
|
|
|
Post by peppy on Feb 10, 2016 10:35:56 GMT -5
I hear scientific data is very important and how it is released. Positive clamp results would influence endos/pcps strongly. Currently data is insufficient. Doctor education and DTC marketing will also be very important for success,imo. The primary objective of one trial was:
"To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting."
The primary objectives of another trial was:
"To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting.
"To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting."
---
It's quite possible that these study results may lead to MannKind being able to distribute FDA-approved Afrezza dosing literature that will benefit physicians and endocrinologists in working with their patients.
The best thing that clamp study could do for afrezza is somehow point out, or allow afrezza to say that, "afrezza initiates the phase 1 insulin response." ? IF Afrezza could make that claim it would be an advantage as fast acting analogues do not initiate the first phase. ?
screencast.com/t/ZaphFSR2qYT5
|
|
|
Post by brooklyndoc on Feb 10, 2016 11:28:15 GMT -5
The primary objective of one trial was:
"To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting."
The primary objectives of another trial was:
"To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting.
"To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting."
---
It's quite possible that these study results may lead to MannKind being able to distribute FDA-approved Afrezza dosing literature that will benefit physicians and endocrinologists in working with their patients.
The best thing that clamp study could do for afrezza is somehow point out, or allow afrezza to say that, "afrezza initiates the phase 1 insulin response." ? IF Afrezza could make that claim it would be an advantage as fast acting analogues do not initiate the first phase. ?
screencast.com/t/ZaphFSR2qYT5
Nope - won't be possible. That would be an implied claim for superior efficacy, and wouldn't be allowed by FDA.
|
|
|
Post by benh on Feb 10, 2016 11:33:24 GMT -5
Last ADA there were big hopes of an Rx bump. It never came.
If the results offer anything and is at the very least "quite positive"*, why wait.? Will the 'big reveal' be of value greater than the potential cost of delay.?
|
|
|
Post by cjc04 on Feb 10, 2016 13:59:18 GMT -5
Last ADA there were big hopes of an Rx bump. It never came. If the results offer anything and is at the very least "quite positive"*, why wait.? Will the 'big reveal' be of value greater than the potential cost of delay.? That is exactly my point in starting this thread.... Is Matt going to be standing there himself (cuz at this rate, he may be the only one left) with a card table (about all they'll be able to afford) with the results in his hand and a box of Afrezza? ? How do plan for June to be a new start at the ADA with test results, if you'll be broke shortly thereafter,,, unless you have a reason to know otherwise. Again, not trying to create some wild conspiracy, but something doesn't add up (namely the bank account) with Matt talking about Clamp results at a June ADA, here and now desperate in February. Not to mention, he just took over a few weeks prior, in total chaos, yet he has a clear vision to June.
|
|
|
Post by symbil on Feb 10, 2016 14:00:59 GMT -5
Last ADA there were big hopes of an Rx bump. It never came. If the results offer anything and is at the very least "quite positive"*, why wait.? Will the 'big reveal' be of value greater than the potential cost of delay.? That is exactly my point in starting this thread.... Is Matt going to be standing there himself (cuz at this rate, he may be the only one left) with a card table (about all they'll be able to afford) with the results in his hand and a box of Afrezza? ? How do plan for June to be a new start at the ADA with test results, if you'll be broke shortly thereafter,,, unless you have a reason to know otherwise. Again, not trying to create some wild conspiracy, but something doesn't add up (namely the bank account) with Matt talking about Clamp results at a June ADA, here and now desperate in February. Not to mention, he just took over a few weeks prior, in total chaos, yet he has a clear vision to June. Didnt he say he'd speak in more detail during the earnings call about the cash runway? Seems many people missed that.
|
|
|
Post by dictatorsaurus on Feb 10, 2016 14:04:41 GMT -5
Everything with MNKD is about next week, next month, next June, next year...
Looking forward to the day we start talking about and dealing with the here and now...
|
|
|
Post by dreamboatcruise on Feb 10, 2016 14:15:32 GMT -5
Last ADA there were big hopes of an Rx bump. It never came. If the results offer anything and is at the very least "quite positive"*, why wait.? Will the 'big reveal' be of value greater than the potential cost of delay.? We already have results from prior clamp studies. Given Matt's comments on quite positive we can probably assume that these additional clamp studies verify the nice pk/pd profiles we all know so well. I guess I wouldn't consider that a "big reveal" though. For these tests the "big reveal" would have been if they didn't show the same profile consistently. These may have been needed for EU approval. I doubt that would need to wait for ADA presentation. Likewise they may allow MNKD to ask FDA to remove warning about ketoacidosis
|
|
|
Post by bradleysbest on Feb 10, 2016 14:36:30 GMT -5
We need scripts to rise in the second half of April & into May. Hopefully some BP will see that Afrezza was sandbagged by SNY & realize the potential for it. MNKD needs to be ready on April 4.....
|
|
|
Post by dictatorsaurus on Feb 10, 2016 14:55:42 GMT -5
We need scripts to rise in the second half of April & into May. Hopefully some BP will see that Afrezza was sandbagged by SNY & realize the potential for it. MNKD needs to be ready on April 4..... I don't see that happening. With SNY trashing Afrezza in public and no real solid plan to promote the product the only chance we have is a buyout or some sort of aggressive partnership.
|
|
|
Post by bradleysbest on Feb 10, 2016 15:16:23 GMT -5
Yes but an increase in scripts after April 4 will only benefit us regarding a partnership or buyout.
|
|
|
Post by derek2 on Feb 10, 2016 17:43:44 GMT -5
The primary objective of one trial was:
"To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting."
The primary objectives of another trial was:
"To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting.
"To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting."
---
It's quite possible that these study results may lead to MannKind being able to distribute FDA-approved Afrezza dosing literature that will benefit physicians and endocrinologists in working with their patients.
The best thing that clamp study could do for afrezza is somehow point out, or allow afrezza to say that, "afrezza initiates the phase 1 insulin response." ? IF Afrezza could make that claim it would be an advantage as fast acting analogues do not initiate the first phase. ?
screencast.com/t/ZaphFSR2qYT5
The claim would actually be " Imitates the Phase 1 insulin response" Proving that would require changing the claim to something closer to "Imitates the Phase 1 insulin response to a glucose challenge" which most people would see as a positive. Because Afrezza in no way imitates the body's insulin response to a meal, which is much more gradual. Unless you eat candy for your meals. Although, I guess you could just say it imitates the Phase 1 insulin response, since the response is biphasic only for high-carb / fast carb ingestion, and there's no phase 1 for a balanced meal. So, you could just assume that everybody would know that Afrezza imitates the less common reaction within the body, and in Afrezza's case would do it whether or not it was appropriate. Candy? Phase 1! Chicken dinner? Phase 1! This is why Afrezza worked so well for the "Coca Cola challenge" - it's perfect for dealing with a sugar rush. See: ajpendo.physiology.org/content/287/3/E371IMO, the clamp studies will be important if they demonstrate dosing linearity and dosing consistency. Afrezza may benefit, but more importantly, the new drugs being developed could have a lower clinical trial burden, thus helping to get them approved more quickly.
|
|
|
Post by jerrys on Feb 10, 2016 22:44:00 GMT -5
The best thing that clamp study could do for afrezza is somehow point out, or allow afrezza to say that, "afrezza initiates the phase 1 insulin response." ? IF Afrezza could make that claim it would be an advantage as fast acting analogues do not initiate the first phase. ?
screencast.com/t/ZaphFSR2qYT5
The claim would actually be " Imitates the Phase 1 insulin response" Proving that would require changing the claim to something closer to "Imitates the Phase 1 insulin response to a glucose challenge" which most people would see as a positive. Because Afrezza in no way imitates the body's insulin response to a meal, which is much more gradual. Unless you eat candy for your meals. Although, I guess you could just say it imitates the Phase 1 insulin response, since the response is biphasic only for high-carb / fast carb ingestion, and there's no phase 1 for a balanced meal. So, you could just assume that everybody would know that Afrezza imitates the less common reaction within the body, and in Afrezza's case would do it whether or not it was appropriate. Candy? Phase 1! Chicken dinner? Phase 1! This is why Afrezza worked so well for the "Coca Cola challenge" - it's perfect for dealing with a sugar rush. See: ajpendo.physiology.org/content/287/3/E371IMO, the clamp studies will be important if they demonstrate dosing linearity and dosing consistency. Afrezza may benefit, but more importantly, the new drugs being developed could have a lower clinical trial burden, thus helping to get them approved more quickly. Note about the first graph: "Of crucial importance to the present review is to make a clear distinction between the insulin response following an intravenous glucose challenge and that following glucose or food ingestion. The intravenous administration of glucose triggers a biphasic insulin response...only when glucose concentration increases rapidly, as after a glucose bolus or a glucose infusion determining a square wave of hyperglycemia." That does not occur in real life. In real life, even consuming pure glucose on an empty stomach would produce a graph more similar to the second image. It might have a somewhat steeper slope, but absorption would still be spread out in the same fashion. As far as coke or candy, those are typically flavored by sucrose and/or fructose. Sucrose has to be broken down into glucose and fructose by sucrase in the intestine. Frutose has to be converted to glucose by the liver. Both of these require a relatively long time to accomplish -- at least relative to an IV infusion of glucose. One could argue that taking a dose of afrezza before drinking a coke could pose a risk of hypoglycemia since the afrezza could possilby act before the sugar was adequately digested.
|
|
|
Post by babaoriley on Feb 10, 2016 22:52:06 GMT -5
Everything with MNKD is about next week, next month, next June, next year... Looking forward to the day we start talking about and dealing with the here and now... Almost all speculative stocks are that way. "Next quarter we'll know" "the next 3-6 months will tell the tale" etc. I have many just like that - plenty of fun!
|
|
|
Post by tayl5 on Feb 11, 2016 9:37:31 GMT -5
Last ADA there were big hopes of an Rx bump. It never came. If the results offer anything and is at the very least "quite positive"*, why wait.? Will the 'big reveal' be of value greater than the potential cost of delay.? That is exactly my point in starting this thread.... Is Matt going to be standing there himself (cuz at this rate, he may be the only one left) with a card table (about all they'll be able to afford) with the results in his hand and a box of Afrezza? ? How do plan for June to be a new start at the ADA with test results, if you'll be broke shortly thereafter,,, unless you have a reason to know otherwise. Again, not trying to create some wild conspiracy, but something doesn't add up (namely the bank account) with Matt talking about Clamp results at a June ADA, here and now desperate in February. Not to mention, he just took over a few weeks prior, in total chaos, yet he has a clear vision to June. It's important to distinguish the scientific presentations at a conference like ADA from the commercial exhibits. If MannKind receives an invitation to present at the meeting (and it sounds like they have given the disclosure restrictions) then their (our) financial constraints will not be a factor. The exhibit hall is a different story. If it was just about the exhibit there would be no downside to releasing the results early, but the extra credibility that comes with a scientific presentation is worthwhile. Assuming, of course, that there is a future after June.
|
|