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Post by sayhey24 on Jun 5, 2022 8:44:53 GMT -5
To keep things short I'd rather say what the press release said. Raising the bar is easy too. A follow-on trial with proper dosing targeted at Mounjaro. What we know from Affinity2 is they under dosed but still got superior results. ... That trial was always going to deliver superior results for Afrezza - both group continued on their oral meds, and one group added Afrezza. If you add an extra drug it's going to outperform the do nothing arm (well, not always. Some drugs have failed spectacularly over the years!) You could equally have improved their A1c by adding GLP-1 or basal insulin. That's why Affinity 2 failed to get traction. Naturally the PR didn't raise that and was tightly scoped, but it looks like the doctors did.  I entirely agree about a trial between Afrezza and Mountjaro, and it needs to be done ASAP. Lilly will support Mountjaro with lots of follow on trials and studies to build a deep bench of trial data. The longer Mannkind waits to challenge it the bigger the task will be. For years MNKD should have been promoting the fact it was shown to be "Superior" regardless of how the trial was designed. The fact is the FDA designed the study if I remember correctly. For years all I hear is afrezza was found "non-inferior" which for the T2s is folklore. I think the great news is we agree on Mountjaro, and it needs to be done ASAP. I am hoping for a press release tomorrow morning announcing it but I am not going to hold my breath. I am 100% confident with proper dosing and proper coaching afrezza will blow away Mountjaro A1C. Of course there is room on the afrezza side to spike the punch a bit. With Mountjaro you get the weekly shot. |
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Post by mango on Jun 5, 2022 11:21:11 GMT -5
I believe before we can fund a large scale superiority clinical trial we need to have the dosing dialed in 100% and an excellent grasp on CGMs with Afrezza. The trial needs to be conducted with CGMs and have the clinical trial hypothesis supporting TIR being a superior measurement of glucose homeostasis compared to A1C. Every trial participant wears a CGM throughout the entire study.
Prove both Afrezza and TIR is superior all in one study, forever changing the SoC. Go down as a landmark study in diabetes history.
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Post by letitride on Jun 5, 2022 11:51:16 GMT -5
It seems what I agree with is that a much larger and more aggressive trial should already be in the works while I await the conclusion of PEDS. So if PEDS fails to knock it out of the park were not waiting a few more years to do so.
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Post by prcgorman2 on Jun 5, 2022 11:52:25 GMT -5
I agree except for the part about “dosing dialed in”. Aged, Sam Finta, and numerous other PWDs have all told us, more than once, that dialing in self-treatment is something that takes time. So maybe two studies; one with experienced Afrezza users and one with novices. I guess more to the point is study design is the important aspect here. Maybe impanel endos and other experts, and PWDs to discuss study and recommend design, and partner with the FDA. From my perspective, I care less about proving superiority than I do about proving SAFETY from hypos. One way or the other, I’m fully in favor of studies which demonstrate SAFETY (which should be a primary hallmark of the Peds trials) and superiority. I’d like to see studies being a significant part of the earnings reports. I don’t want Mannkind to be a one-dimensional pipeline company. They’ve been forced to market their own products and have been successful insofar as they could be for what they had as working capital. The capital restraints are not completely out of the way, but they’ve definitely eased, and we can all see (as can competitiors) that story should continue to improve. Someone wrote the question recently whether Dr. Castagna can pivot as a “rescue” CEO to a “growth” CEO. My opinion is yes, but the proof is in the doing and our posts show we’re all anxioius to see Mike take us to the next level if he can.
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Post by mango on Jun 5, 2022 14:09:48 GMT -5
I agree except for the part about “dosing dialed in”. Aged, Sam Finta, and numerous other PWDs have all told us, more than once, that dialing in self-treatment is something that takes time. So maybe two studies; one with experienced Afrezza users and one with novices. I guess more to the point is study design is the important aspect here. Maybe impanel endos and other experts, and PWDs to discuss study and recommend design, and partner with the FDA. From my perspective, I care less about proving superiority than I do about proving SAFETY from hypos. One way or the other, I’m fully in favor of studies which demonstrate SAFETY (which should be a primary hallmark of the Peds trials) and superiority. I’d like to see studies being a significant part of the earnings reports. I don’t want Mannkind to be a one-dimensional pipeline company. They’ve been forced to market their own products and have been successful insofar as they could be for what they had as working capital. The capital restraints are not completely out of the way, but they’ve definitely eased, and we can all see (as can competitiors) that story should continue to improve. Someone wrote the question recently whether Dr. Castagna can pivot as a “rescue” CEO to a “growth” CEO. My opinion is yes, but the proof is in the doing and our posts show we’re all anxioius to see Mike take us to the next level if he can. You know, I definitely agree with you. Safety studies are for sure high yield studies. I would love to see a large scale STAT study to expand on the significantly less hypoglycemia compared to SubQ. |
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Post by radgray68 on Jun 5, 2022 14:29:28 GMT -5
I'd like to see a very large trial on newly diagnosed T2's with Afrezza as an initial therapy used only at mealtime. TIR, A1c, safety and tolerability, 24/7 CGM, the whole shebang, all the bells and whistles. 500-1000 participants or whatever number leaves no doubt about superiority.
Also, talk about a way to differentiate yourselves, could we design a second study investigating a change in dosing from units to small, medium and large? Perhaps before the big T2 trial or have it be one of the arms?
It'd all depend of course on how we do in the pediatric trial results next year. That's my next big catalyst hope, I guess. I wouldn't spend any more on trials until we see and learn from both the India and Peds trials. Unles, of course sales ramp up enough to warrant it, but I think India and peds will suffice.
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Post by sayhey24 on Jun 5, 2022 18:44:36 GMT -5
I agree except for the part about “dosing dialed in”. Aged, Sam Finta, and numerous other PWDs have all told us, more than once, that dialing in self-treatment is something that takes time. So maybe two studies; one with experienced Afrezza users and one with novices. I guess more to the point is study design is the important aspect here. Maybe impanel endos and other experts, and PWDs to discuss study and recommend design, and partner with the FDA. From my perspective, I care less about proving superiority than I do about proving SAFETY from hypos. One way or the other, I’m fully in favor of studies which demonstrate SAFETY (which should be a primary hallmark of the Peds trials) and superiority. I’d like to see studies being a significant part of the earnings reports. I don’t want Mannkind to be a one-dimensional pipeline company. They’ve been forced to market their own products and have been successful insofar as they could be for what they had as working capital. The capital restraints are not completely out of the way, but they’ve definitely eased, and we can all see (as can competitiors) that story should continue to improve. Someone wrote the question recently whether Dr. Castagna can pivot as a “rescue” CEO to a “growth” CEO. My opinion is yes, but the proof is in the doing and our posts show we’re all anxioius to see Mike take us to the next level if he can. You know, I definitely agree with you. Safety studies are for sure high yield studies. I would love to see a large scale STAT study to expand on the significantly less hypoglycemia compared to SubQ. Mango - you said "I believe before we can fund a large scale superiority clinical trial we need to have the dosing dialed in 100% and an excellent grasp on CGMs with Afrezza". That train left the station awhile ago. With the tracking systems connected to the CGM the dosing of afrezza becomes individualized. The thing with afrezza is you want to go big with dosing but you never want to see a severe low. The severe low is the safety issue and should be mostly aviodable. Here is the thing Mounjaro is a once weekly injectable. For the trial the Mounjaro PWDs do not need a CGM and they just use the current dose they are on. With afrezza the PWDs would get the CGM and you would tune and adjust dosing for each PWD. If with such as trial we can not kick butt on Mounjaro's A1C I will sell every share of MNKD I have. The thing is I expect to buy more. |
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Post by sayhey24 on Jun 5, 2022 18:59:48 GMT -5
I'd like to see a very large trial on newly diagnosed T2's with Afrezza as an initial therapy used only at mealtime. TIR, A1c, safety and tolerability, 24/7 CGM, the whole shebang, all the bells and whistles. 500-1000 participants or whatever number leaves no doubt about superiority. Also, talk about a way to differentiate yourselves, could we design a second study investigating a change in dosing from units to small, medium and large? Perhaps before the big T2 trial or have it be one of the arms? It'd all depend of course on how we do in the pediatric trial results next year. That's my next big catalyst hope, I guess. I wouldn't spend any more on trials until we see and learn from both the India and Peds trials. Unles, of course sales ramp up enough to warrant it, but I think India and peds will suffice. I think we are saying the same thing when I ask for the trial against Mounjaro. The hype is they did exactly what what you are asking for and Lilly says they are the Champion. Since we already know the "T2 Champion" I would just focus 100% on Mounjaro. If you beat Mounjaro then afrezza is the new champ and nothing is blurred. Since they already did the very large trial ours only needs to be 50-100 PWDs. If Lilly wants to fund a follow on 1000 PWD trial to try and take back the belt, let them try and pick up the tab. Mounjaro can never beat properly dosed monomer insulin. However we are the Champion in the T2 world which has nothing to do with the kids and the T1 Peds trial. The T1 and T2 markets are very much different and are not dependent on each other. Remember, few back in the day even thought afrezza would be approved for T1s. |
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Post by uvula on Jun 5, 2022 19:16:49 GMT -5
I fear we are getting off topic, but here goes.
I was researching mounjaro and found this. Maybe mnkd can exploit this:
The labeling for Mounjaro contains a Boxed Warning regarding thyroid C-cell tumors. Mounjaro is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.
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Post by peppy on Jun 6, 2022 0:33:55 GMT -5
I fear we are getting off topic, but here goes. I was researching mounjaro and found this. Maybe mnkd can exploit this: The labeling for Mounjaro contains a Boxed Warning regarding thyroid C-cell tumors. Mounjaro is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. MOUNJAROTM is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) All GLP-1 have this warning. Does it stop the endocrinologist? Is there insurance coverage? WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. TirzepatidecausesthyroidC-celltumorsinrats.Itis unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined (5.1, 13.1). MOUNJAROiscontraindicatedinpatientswithapersonal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1). 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It is a 39-amino-acid modified peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. Tirzepatide enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose- dependent manner. ========================================================================================= Gastric inhibitory polypeptide (GIP) and glucagon‐like peptide‐1 (GLP‐1) are the two primary incretin hormones secreted from the intestine on ingestion of glucose or nutrients to stimulate insulin secretion from pancreatic β cells. GIP and GLP‐1 exert their effects by binding to their specific receptors, the GIP receptor (GIPR) and the GLP‐1 receptor (GLP‐1R), which belong to the G‐protein coupled receptor family. Receptor binding activates and increases the level of intracellular cyclic adenosine monophosphate in pancreatic β cells, thereby stimulating insulin secretion glucose‐dependently. www.ncbi.nlm.nih.gov/pmc/articles/PMC4020673/ |
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Post by winner on Jun 6, 2022 3:11:44 GMT -5
Excerpt from another forum. Very impressive... I hope the link works for you
The ABC 10 News link
abc10.com/article/news/heal...
'It's changed my life' | Inhaled form of insulin a 'game-changer' f
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Post by winner on Jun 6, 2022 3:15:25 GMT -5
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Post by winner on Jun 6, 2022 3:21:53 GMT -5
Another excerpt. Our time is now.
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Post by prcgorman2 on Jun 6, 2022 6:38:52 GMT -5
God bless Becca Habegger. That was well researched and well written. Great story. Thank you winner! |
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Post by Deleted on Jun 6, 2022 8:31:13 GMT -5
God bless Becca Habegger. That was well researched and well written. Great story. Thank you winner! That was a great LONG segment except for the end. IMO - Mike needs to work on his appearance. He is a little too casual when he shouldn't be as the CEO. I wish the anchor didn't say it's very expensive. Overall VG. |
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