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Post by Clement on Jun 4, 2024 7:05:20 GMT -5
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Post by mpg54 on Jun 4, 2024 16:42:53 GMT -5
Orphan drug status is assigned either during or before clinical trials. The status has a bearing on trial requirements for approval. For an official estimated timeline, best to refer to MannKind materials. Mike C. indicated in the Oppenheimer Q&A potential review of interim analysis of Clofazamine Ph3 is probably late next year. He went on to say full enrollment might be achieved well before the interim analysis review so I'm guessing the trial should complete in 2026 with approval and marketing potentially beginning late 2026 or in 2027. That doesn’t seem like fast tracking, but I really have no clue. Hate to think it’s 3 years out. |
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Post by Clement on Jun 8, 2024 10:12:30 GMT -5
At this time, Lowcountry Infectious Diseases is the only (site) location listed for this study. It could be that Charleston, SC is an epicenter for NTM. (?) Will there be more sites listed in the US? How about Japan? lowcountryid.com/research |
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Post by Thundersnow on Jun 8, 2024 16:49:30 GMT -5
At this time, Lowcountry Infectious Diseases is the only (site) location listed for this study. It could be that Charleston, SC is an epicenter for NTM. (?) Will there be more sites listed in the US? How about Japan? lowcountryid.com/researchMike said NTM is more prevalent on the coastal states and Hawaii along with Japan. Number of cases are about equal between US & Japan. |
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Post by Clement on Jul 26, 2024 9:37:08 GMT -5
At this time, Lowcountry Infectious Diseases is the only (site) location listed for this study. It could be that Charleston, SC is an epicenter for NTM. (?) Will there be more sites listed in the US? How about Japan? lowcountryid.com/researchNow there are seven locations listed for this study ---- four in Florida. |
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Post by prcgorman2 on Jul 26, 2024 9:59:11 GMT -5
I hope I'm not messing this up, but I thought Mike had said NTM Ph3 trial could be "fully enrolled" by the end of 2024. And then there is the on-again, off-again, dosing regimen which MNKD has a slide on, but I don't remember the details but want to say it's 180 days? Since dosing has already started, they should have interim results in early 2025. I was pleased sayhey24 mentioned Mike said they've figured out the dosing for Clofazimine. Mike mentioned earlier this year (in the Juicebox podcast maybe?) Clofazimine is challenging to dose because of some of the drug entering the GI tract, not just the lungs. Really learning to love this little company.
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Post by sayhey24 on Jul 26, 2024 11:19:23 GMT -5
I hope I'm not messing this up, but I thought Mike had said NTM Ph3 trial could be "fully enrolled" by the end of 2024. And then there is the on-again, off-again, dosing regimen which MNKD has a slide on, but I don't remember the details but want to say it's 180 days? Since dosing has already started, they should have interim results in early 2025. I was pleased sayhey24 mentioned Mike said they've figured out the dosing for Clofazimine. Mike mentioned earlier this year (in the Juicebox podcast maybe?) Clofazimine is challenging to dose because of some of the drug entering the GI tract, not just the lungs. Really learning to love this little company. To be clear, what I said was Mike said they had figured out TS dosing for Clofazimine DPI. This trial is not using DPI. With the other deal they just did for iSperse, I am not even sure they are moving forward with Technosphere. Mike also said for UTHR to have build their own TS factory for Tyvaso DPI it would have been around $300M. If MNKD moves forward with iSperse is Mike planning on spending that kind of money for a new facility? |
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Post by ryster505 on Jul 26, 2024 11:47:04 GMT -5
I hope I'm not messing this up, but I thought Mike had said NTM Ph3 trial could be "fully enrolled" by the end of 2024. And then there is the on-again, off-again, dosing regimen which MNKD has a slide on, but I don't remember the details but want to say it's 180 days? Since dosing has already started, they should have interim results in early 2025. I was pleased sayhey24 mentioned Mike said they've figured out the dosing for Clofazimine. Mike mentioned earlier this year (in the Juicebox podcast maybe?) Clofazimine is challenging to dose because of some of the drug entering the GI tract, not just the lungs. Really learning to love this little company. To be clear, what I said was Mike said they had figured out TS dosing for Clofazimine DPI. This trial is not using DPI. With the other deal they just did for iSperse, I am not even sure they are moving forward with Technosphere. Mike also said for UTHR to have build their own TS factory for Tyvaso DPI it would have been around $300M. If MNKD moves forward with iSperse is Mike planning on spending that kind of money for a new facility? I love knowing that Mike and Martine both know more than me. I have a fairly good intuition and both CEOs feel very comfortable where they sit, which I take as bullish. More layers of the onion will come off in due time Sayhey, I think it’s all going to be net-positive moving forward. |
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Post by patience1 on Jul 26, 2024 13:20:42 GMT -5
I personally would like to know more than Mike and Martine having that sort of knowledge I would have made more in MNKD stock than I have.
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Post by prcgorman2 on Jul 26, 2024 13:52:44 GMT -5
Here's to you getting more knowledge!! (Raises virtual glass as a salute.)
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Post by sayhey24 on Jul 26, 2024 14:00:39 GMT -5
To be clear, what I said was Mike said they had figured out TS dosing for Clofazimine DPI. This trial is not using DPI. With the other deal they just did for iSperse, I am not even sure they are moving forward with Technosphere. Mike also said for UTHR to have build their own TS factory for Tyvaso DPI it would have been around $300M. If MNKD moves forward with iSperse is Mike planning on spending that kind of money for a new facility? I love knowing that Mike and Martine both know more than me. I have a fairly good intuition and both CEOs feel very comfortable where they sit, which I take as bullish. More layers of the onion will come off in due time Sayhey, I think it’s all going to be net-positive moving forward. Lets hope. Its been a long slog. If they do as Mango said and throw out the results of those intentionally non-compliant in Inhale-3 then we got something. Add the kids and Gestational and we are moving. I know if I where Mike first thing today I would have called Kevin Sayer and said - I told you so and asked if he is now ready to do some kind of deal. I would also be calling Robert Ford and pushing him to push SoC and Medicare coverage for afrezza. He was banking on icodec too for Libre sales. A joint Abbott/MNKD study comparing afrezza to glp1 use in T2s should be something Robert would now fund since icodec is DOA. |
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Post by agedhippie on Jul 27, 2024 18:24:21 GMT -5
... I know if I where Mike first thing today I would have called Kevin Sayer and said - I told you so and asked if he is now ready to do some kind of deal. I would also be calling Robert Ford and pushing him to push SoC and Medicare coverage for afrezza. He was banking on icodec too for Libre sales. A joint Abbott/MNKD study comparing afrezza to glp1 use in T2s should be something Robert would now fund since icodec is DOA. Ken Sayer's problem is the reduced price of CGMs sold through pharmacy benefits rather than DME. A lot of Dexcom users are using them because they are integrated into their pumps so those are DME sales and very profitable. The other (and growing) sales are pharmacy and low margin. What Dexcom wants is more DME sales and Afrezza cannot help there. Abbott doesn't care if Iodec is approved or not. Iodec is a replacement for existing basal insulin and since they are already covered there is nothing Afrezza can offer. Both Abbott and Dexcom are going after the OTC market so involving prescription drugs is a drag on that. Medicare does not cover any drug, it says a drug is allowed. The insurer decides if the drug will be covered. |
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Post by celo on Aug 7, 2024 11:16:51 GMT -5
^ "This single registrational study, identified as ICoN-1, anticipates getting underway by end of 2Q 2024 in the U.S., and internationally in the second half of 2024." PMDA is Japan's pharmaceuticals and medical devices agency. Normally, PMDA does not rubber-stamp an FDA approval. PMDA has its own procedures and requirements. So, Japan will eventually require its own submission of final trial results to obtain approval. FDA and Japan have aligned for a single trial? Was that known? Or something new from the quarterly report? I mean that is great news as the process through Japan should be even swifter. |
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Post by agedhippie on Aug 7, 2024 11:50:19 GMT -5
^ "This single registrational study, identified as ICoN-1, anticipates getting underway by end of 2Q 2024 in the U.S., and internationally in the second half of 2024." PMDA is Japan's pharmaceuticals and medical devices agency. Normally, PMDA does not rubber-stamp an FDA approval. PMDA has its own procedures and requirements. So, Japan will eventually require its own submission of final trial results to obtain approval. FDA and Japan have aligned for a single trial? Was that known? Or something new from the quarterly report? I mean that is great news as the process through Japan should be even swifter. The FDA approval will not be valid in Japan hence that phrasing about "require its own submission of final trial results". It's the same trial though. From memory this is a two center trial with one of the centers being in Japan which is why they can do this (the PMDA wants to know the drugs will work on Japanese people specifically). |
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Post by letitride on Aug 23, 2024 9:02:41 GMT -5
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