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Post by markado on Nov 29, 2024 14:23:50 GMT -5
I saw two separate references to this on ST, today. Can anyone here confirm the same? I went to the CDSCO site, but it was a hot mess.
If this is true and Mike has not announced it for 8-10 days, I would find that irresponsible. If it's public info in India, then it's public info here. That public "event" would disqualify any NDA provisions between MNKD and CIPLA, if any existed, and, certainly, MNKD shareholders and the market would have the right to know.
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Post by bthomas55ep on Nov 29, 2024 14:30:11 GMT -5
I saw two separate references to this on ST, today. Can anyone here confirm the same? I went to the CDSCO site, but it was a hot mess. If this is true and Mike has not announced it for 8-10 days, I would find that irresponsible. If it's public info in India, then it's public info here. That public "event" would disqualify any NDA provisions between MNKD and CIPLA, if any existed, and, certainly, MNKD shareholders and the market would have the right to know. I think this is the link you are referring to. I thought the approval date was in March. Maybe that was when the review started... About the 20th or so entry down in the list. When you expand the link, definitely says November 19th: cdscoonline.gov.in/CDSCO/cdscoDrugs*** From one of the links *** Approval Date : 19-NOV-2024 Type : Finished Formulation Composition : Insulin Human 0.3500 Milligram (Mg),Fumaryl Diketopiperazine 2.9600 Milligram (Mg) Dosage : Dry Powder for Inhalation Indication : A Rapid Acting Inhaled Insulin Indicated To Improve Glycemic Control In Adult Patients With Diabetes Mellitus. Manufacturer Name : Cipla Limited Manufacturing Site Address : Amphastar France Pharmaceuticals Sas, Usine Saint-Charles , Eragny Sur Epte France France-60590 Mankind Corporation, One Casper Street , Danbury Connecticut United States-06810 |
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Post by markado on Nov 29, 2024 14:59:40 GMT -5
I saw two separate references to this on ST, today. Can anyone here confirm the same? I went to the CDSCO site, but it was a hot mess. If this is true and Mike has not announced it for 8-10 days, I would find that irresponsible. If it's public info in India, then it's public info here. That public "event" would disqualify any NDA provisions between MNKD and CIPLA, if any existed, and, certainly, MNKD shareholders and the market would have the right to know. I think this is the link you are referring to. I thought the approval date was in March. Maybe that was when the review started... About the 20th or so entry down in the list. When you expand the link, definitely says November 19th: cdscoonline.gov.in/CDSCO/cdscoDrugs*** From one of the links *** Approval Date : 19-NOV-2024 Type : Finished Formulation Composition : Insulin Human 0.3500 Milligram (Mg),Fumaryl Diketopiperazine 2.9600 Milligram (Mg) Dosage : Dry Powder for Inhalation Indication : A Rapid Acting Inhaled Insulin Indicated To Improve Glycemic Control In Adult Patients With Diabetes Mellitus. Manufacturer Name : Cipla Limited Manufacturing Site Address : Amphastar France Pharmaceuticals Sas, Usine Saint-Charles , Eragny Sur Epte France France-60590 Mankind Corporation, One Casper Street , Danbury Connecticut United States-06810 Thanks,BT, that's the menu listing I couldn't locate and it matches the info presented on ST. That looks rather definitive to me. One more irresponsibly-managed, missed opportunity for Mike C on behalf of MNKD shareholders. This time, there's nothing to hide behind. |
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Post by ryster505 on Nov 29, 2024 15:05:06 GMT -5
I think this is the link you are referring to. I thought the approval date was in March. Maybe that was when the review started... About the 20th or so entry down in the list. When you expand the link, definitely says November 19th: cdscoonline.gov.in/CDSCO/cdscoDrugs*** From one of the links *** Approval Date : 19-NOV-2024 Type : Finished Formulation Composition : Insulin Human 0.3500 Milligram (Mg),Fumaryl Diketopiperazine 2.9600 Milligram (Mg) Dosage : Dry Powder for Inhalation Indication : A Rapid Acting Inhaled Insulin Indicated To Improve Glycemic Control In Adult Patients With Diabetes Mellitus. Manufacturer Name : Cipla Limited Manufacturing Site Address : Amphastar France Pharmaceuticals Sas, Usine Saint-Charles , Eragny Sur Epte France France-60590 Mankind Corporation, One Casper Street , Danbury Connecticut United States-06810 Thanks,BT, that's the menu listing I couldn't locate and it matches the info presented on ST. That looks rather definitive to me. One more irresponsibly-managed, missed opportunity for Mike C on behalf of MNKD shareholders. This time, there's nothing to hide behind. It’s a Cipla approval, not Mannkind. Not mikes decision to put out a PR |
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Post by prcgorman2 on Nov 29, 2024 15:38:59 GMT -5
If they’re like the FDA, sometimes the dates listed for completion of a government action are more or less aspirational. The FDA gets demerits for missing dates too often or too much. Might be the same in India. I’d love for it to be a miss by MannKind PR, but I won’t assume that yet.
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Post by markado on Nov 29, 2024 17:26:55 GMT -5
Thanks,BT, that's the menu listing I couldn't locate and it matches the info presented on ST. That looks rather definitive to me. One more irresponsibly-managed, missed opportunity for Mike C on behalf of MNKD shareholders. This time, there's nothing to hide behind. It’s a Cipla approval, not Mannkind. Not mikes decision to put out a PR Sorry, that's simply BS. It's Mannkind's drug, Cipla's license. Still Mannkind's IP and obligation to keep it's stakeholders informed. |
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Post by markado on Nov 29, 2024 17:31:32 GMT -5
I put an inquiry in with MNKD IR to understand as of Monday how 12 days could pass without a PR in such a newsworthy item. We'll see what comes back.
Will share what I hear/learn.
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Post by peppy on Nov 29, 2024 19:50:38 GMT -5
Thanks,BT, that's the menu listing I couldn't locate and it matches the info presented on ST. That looks rather definitive to me. One more irresponsibly-managed, missed opportunity for Mike C on behalf of MNKD shareholders. This time, there's nothing to hide behind. , thank you for pointing this out. Manufacturer Name : Cipla Limited Manufacturing Site Address : Amphastar France Pharmaceuticals Sas, Usine Saint-Charles , Eragny Sur Epte France France-60590 Mankind Corporation, One Casper Street , Danbury Connecticut United States-06810 (chug chug) |
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