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Post by hellodolly on Jun 22, 2023 14:40:55 GMT -5
Another useless small study to show share holders Mike's doing his job and justifying his pay and reinforcing job security. Would you please take a stab at your best explanation and really make us believe your statement? Here is my best reply to you, I disagree with you and certainly believe that this is all approved in-house by the MNKD Executive Leadership Team (also likely recommended/reviewed by their SAB) and if it were just "another useless small study" in order to "justify his pay and...job security", the entire Board is also a big part (complicit even) by making sure they take care of "the man" as they squander away value, institutional trust, industry credibility and integrity. As @prcgorman stated, MNKD is not a giant or behemoth BP with billions of R&D funding, 100,000+ global employee base, a marketing budget two clicks below a chromosome and you want/expect different? Your expectations don't meet your DD or, the lack thereof. I have much more respect for an honest opinion instead of something with no effort. Honestly, it makes you lack credibility because your post has no merit and unbelievable. Do better and help us with an argument as to why this is a useless effort...before the study even starts. Do you know the results? I'd have much more respect of you and your thoughts if you used your time to sound more credible. |
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Post by agedhippie on Jun 22, 2023 16:55:54 GMT -5
Another useless small study to show share holders Mike's doing his job and justifying his pay and reinforcing job security. Not in this case. |
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Post by sayhey24 on Jun 23, 2023 7:47:54 GMT -5
Another useless small study to show share holders Mike's doing his job and justifying his pay and reinforcing job security. Not in this case. And having Irl Hirsch heading it up is a big deal. Its also great he is an afrezza user. |
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Post by Chris-C on Jun 23, 2023 18:07:05 GMT -5
This can be powered to show clinical as well as statistical significance with 120 patients. At some point, the cost of adding more subjects has to be weighed against the benefit. Clinical trials are hugely expensive. The goal is to size the study properly. It's a Goldilocks problem. More is not always better unless you expect large numbers of study dropouts. To be honest, I doubt that MC had much to do with designing the study other than looking at the cost numbers.
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Post by agedhippie on Jun 24, 2023 7:52:59 GMT -5
Running trials is what Jaeb does so I am pretty certain that they will design the trial properly. They have done huge trials in the past so they have all the contacts.
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Post by prcgorman2 on Jun 24, 2023 11:10:38 GMT -5
This can be powered to show clinical as well as statistical significance with 120 patients. At some point, the cost of adding more subjects has to be weighed against the benefit. Clinical trials are hugely expensive. The goal is to size the study properly. It's a Goldilocks problem. More is not always better unless you expect large numbers of study dropouts. To be honest, I doubt that MC had much to do with designing the study other than looking at the cost numbers. Excellent points. I especially like the acknowledgement that senior executive leaders run a business and that technical details are often the domain of folks who work for the executives. It’s one of the reasons I’ve laughed at the brouhaha over documents being places they oughtn’t as though the celebrity in the spotlight had carefully reviewed and selected tons of paperwork to take home. More likely folks tasked with assembling the material asked the celebrity where they’d like the dozens of boxes stacked and the decision-making ended there. Whether it’s lawyers, paralegals, interns, assistants, researchers, or engineers, the executives have people who do stuff for them. They have to. |
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Post by Clement on Jun 26, 2023 8:06:35 GMT -5
I've been wondering how launch of Inhale-3 can be consistent with the goal of CFBE for the endocrine business unit (EBU) this year. Inhale-3 has to be expensive.
It appears that expenses for clinical trials go under R&D. Then, are R&D expenses for this trial not counted against cash flow or profitability of the EBU?
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Post by agedhippie on Jun 26, 2023 9:02:22 GMT -5
This can be powered to show clinical as well as statistical significance with 120 patients. At some point, the cost of adding more subjects has to be weighed against the benefit. Clinical trials are hugely expensive. The goal is to size the study properly. It's a Goldilocks problem. More is not always better unless you expect large numbers of study dropouts. To be honest, I doubt that MC had much to do with designing the study other than looking at the cost numbers. Excellent points. I especially like the acknowledgement that senior executive leaders run a business and that technical details are often the domain of folks who work for the executives. It’s one of the reasons I’ve laughed at the brouhaha over documents being places they oughtn’t as though the celebrity in the spotlight had carefully reviewed and selected tons of paperwork to take home. More likely folks tasked with assembling the material asked the celebrity where they’d like the dozens of boxes stacked and the decision-making ended there. Whether it’s lawyers, paralegals, interns, assistants, researchers, or engineers, the executives have people who do stuff for them. They have to. This is completely true. The Mannkind involvement will be at a very high level, primarily goal setting. Ensuring the trial is properly powered to resolve those goals is the job of Jaeb. Companies like Jaeb exist to design trials and manage logistics, and Jaeb is one of the better ones. |
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Post by agedhippie on Jun 26, 2023 9:05:35 GMT -5
I've been wondering how launch of Inhale-3 can be consistent with the goal of CFBE for the endocrine business unit (EBU) this year. Inhale-3 has to be expensive. It appears that expenses for clinical trials go under R&D. Then, are R&D expenses for this trial not counted against cash flow or profitability of the EBU? I would have thought that this would need board sign-off in which case it may have it's own budget line under R&D (although I have seen this sort of thing assigned to sales and marketing before  ) This is what I would expect, but I have always been the beneficiary of the budget rather the the person who has to raise it... |
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Post by letitride on Jul 30, 2023 23:08:13 GMT -5
In checking clinical trials .gov site I see the study size says 145 vs the 120 patients in the PR. I don't know if this was a change to the trial size as of recently, but doses not appear to be?
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Post by dh4mizzou on Jul 31, 2023 6:16:17 GMT -5
From the News Release "INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. ". So we're looking at 6 months for the study, right? How much longer before any results are publicized?
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Post by sayhey24 on Jul 31, 2023 7:38:44 GMT -5
From the News Release "INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. ". So we're looking at 6 months for the study, right? How much longer before any results are publicized? I would think ADA 2024. |
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Post by agedhippie on Jul 31, 2023 8:38:22 GMT -5
From the News Release "INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. ". So we're looking at 6 months for the study, right? How much longer before any results are publicized? Add a year to that at least. Recruiting can easily take six months on it's own. You don't get everyone and fire the starting gun, you add them as they trickle in so it's very spread out. Then there is the run in period, you don't want to just dump people onto Afrezza (or any treatment they aren't used to) as that would be a recipe for disaster - you want them to be up to speed before you start the clock. Finally there is usually a six month data QA process to validate the data and clean up the results. They will be doing well if this makes ADA 2025. |
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Post by uvula on Jul 31, 2023 8:59:18 GMT -5
" 120 patients will be randomized in the study conducted in collaboration with the Jaeb Center for Health Research and 20 sites across the country"
Is it typical to only have a few (6) patients per site? It seems very inefficient to have to train so many people on the protocol.
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Post by agedhippie on Jul 31, 2023 9:09:01 GMT -5
" 120 patients will be randomized in the study conducted in collaboration with the Jaeb Center for Health Research and 20 sites across the country" Is it typical to only have a few (6) patients per site? It seems very inefficient to have to train so many people on the protocol. Those are locations they are drawing from. Just because somewhere is listed doesn't mean anyone will come from there, rather it's the locations where the organizer (Jaeb) has relationships and can possibly find patients. The numbers per site can vary wildly. |
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) This is what I would expect, but I have always been the beneficiary of the budget rather the the person who has to raise it...
