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Post by uvula on Jul 3, 2023 20:13:38 GMT -5
Can someone please remind me what disease are we trying to treat with this drug? Google says it is for leprosy, but I doubt there are many leprosy patients.
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Post by cedafuntennis on Jul 3, 2023 20:45:58 GMT -5
It's incompetent management to be in a position like this. To respond with no plan in place. They should had responded with their plan B. Here they are again flying by the seat of their pants No, nothing wrong with what you said. One of the first things I learned in Project Management is ALWAYS go in with at least a plan B and two exit strategies. If this is not the case, they failed at the most elementary level. |
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Post by uvula on Jul 3, 2023 20:48:28 GMT -5
Can someone please remind me what disease are we trying to treat with this drug? Google says it is for leprosy, but I doubt there are many leprosy patients. Found it:Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects. |
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Post by akemp3000 on Jul 4, 2023 5:10:06 GMT -5
It's incompetent management to be in a position like this. To respond with no plan in place. They should had responded with their plan B. Here they are again flying by the seat of their pants Incompetent management is owned by the supplier in Germany who should have had a plan B. |
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Post by sayhey24 on Jul 4, 2023 6:39:11 GMT -5
Can someone please remind me what disease are we trying to treat with this drug? Google says it is for leprosy, but I doubt there are many leprosy patients. Found it:Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects. What's sad is you would think everyone here would be so excited about clofazimine that we all would know its for NTM and its use didn't need to be "found". Some common symptoms of NTM lung disease are chronic cough, fatigue, weight loss, fever and night sweats. The reason we are probably not that excited is the total market opportunity is only about 85,000 people in the U.S. Lets hope with the fire they go straight to dpi. They should be able to make enough in the lab in Danbury for the trials and once approved I would not think production volume would be high. Aged - there is that pesky word again "may" which Peter used with TS GLP1 - "Direct delivery of clofazimine to the lungs may provide" |
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Post by uvula on Jul 4, 2023 8:27:01 GMT -5
Mnkd doesn't make any drugs. They just combine drugs with technospheres. Someone else has to make the clifazimine.
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Post by sayhey24 on Jul 4, 2023 11:40:06 GMT -5
Mnkd doesn't make any drugs. They just combine drugs with technospheres. Someone else has to make the clifazimine. Good point - I guess they were getting it from Sangrose sangroselaboratories.com/our-strength/#:~:text=Sangrose%20is%20the%20sole%20Global,for%20their%20Leprosy%20Eradication%20Program You would think Sangrose would have something in the freezer which did not burn up they could ship to Danbury to put on TS. I know that was not the original plan but maybe its a better plan. |
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Post by radgray68 on Jul 4, 2023 12:54:39 GMT -5
I'm assuming the company in Germany is the same one who has produced clofazamine since the 1980's. There ARE other companies trying to get into the space, I presume. HOW MANY FIRES HAVE THEY HAD IN 40 years?
Now, IS it a coincidence that they have a devastating fire just mere weeks before needing to supply our clinical trials? Or, does this kind of ABSOLUTELY EFFED UP CRAP happen to EVERYBODY? It's hard to NOT believe in conspiracy theories, having followed this company so long. Probably not but the whole thing's hinky. IMHO
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Post by agedhippie on Jul 4, 2023 13:40:03 GMT -5
Found it:Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects. ... Aged - there is that pesky word again "may" which Peter used with TS GLP1 - "Direct delivery of clofazimine to the lungs may provide" In both cases for the same reason - no phase 2 trial data to quantify the impact and dosing. The difference is that clofazimine is currently used outside the US to treat nontuberculous mycobacterial (NTM) lung disease, whereas GLP-1 isn't used at all. The "may" in the case of inhaled clofazimine is because they are speculating that it will avoid the rather nasty side effects of the drug, whereas the "may" in the GLP-1 comment was because they have no idea if it is viable because of the fast clearance (the block to the use of GLP-1 before analogs), never mind if there are side effects. From a share price POV I don't see the delay having a material effect on the share price because it's only a phase 1 trial and generally those are seen as speculative (basically try-outs) so they don't get factored into the share price. That comes after the phase 2 results. |
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Post by hellodolly on Jul 4, 2023 14:02:57 GMT -5
... Aged - there is that pesky word again "may" which Peter used with TS GLP1 - "Direct delivery of clofazimine to the lungs may provide" In both cases for the same reason - no phase 2 trial data to quantify the impact and dosing. The difference is that clofazimine is currently used outside the US to treat nontuberculous mycobacterial (NTM) lung disease, whereas GLP-1 isn't used at all. The "may" in the case of inhaled clofazimine is because they are speculating that it will avoid the rather nasty side effects of the drug, whereas the "may" in the GLP-1 comment was because they have no idea if it is viable because of the fast clearance (the block to the use of GLP-1 before analogs), never mind if there are side effects. From a share price POV I don't see the delay having a material effect on the share price because it's only a phase 1 trial and generally those are seen as speculative (basically try-outs) so they don't get factored into the share price. That comes after the phase 2 results. I think they have been authorized to go directly to a PHII/III trial and MC had mentioned at one of the recent healthcare conferences they had been waiting on the FDA to give them the final go ahead. Overall, these Phase 1 safety and pharmacokinetic data provide a basis for late-stage clinical development of inhaled clofazimine as a treatment for pulmonary NTM infections. Inhaled antibiotics have been associated with respiratory side effects [11]. As noted above, cough and bronchospasm are commonly reported in patients with pulmonary NTM disease receiving inhaled amikacin. In some cases, such adverse events lead to interruption of inhaled amikacin for up to 14 days or reduction in dosing frequency from every day to 3 days a week until resolution of symptoms. Additional warnings and precautions included in the prescribing information for inhaled amikacin include ototoxicity, nephrotoxicity, and neuromuscular blockade. The approved dose of inhaled amikacin, 590 mg, is considerably higher than the doses of inhaled clofazimine (30 to 90 mg in the Phase 1 study), reflecting the lower MIC and higher potency of clofazimine against NTM infections." "Collectively, the preliminary evidence from the Phase 1 study suggests that inhaled clofazimine may be well tolerated in the lung and systemically. The rate of respiratory and other side effects will be monitored in the planned Phase 2/3 clinical trial." |
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Post by agedhippie on Jul 4, 2023 14:19:17 GMT -5
Sorry, yes you are right. The delay is to a phase 2/3 trial, not a phase 1 trial. The share price impact stands though as I don't see that getting factored in until after the trial results (usually the phase 2, but in this case if there is a single trial then after that)
Clofazimine is used in this role outside the US so I expect it to work. The question will be efficiency and side effects when delivered via DPI.
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Post by mango on Jul 4, 2023 14:30:29 GMT -5
... Aged - there is that pesky word again "may" which Peter used with TS GLP1 - "Direct delivery of clofazimine to the lungs may provide" In both cases for the same reason - no phase 2 trial data to quantify the impact and dosing. The difference is that clofazimine is currently used outside the US to treat nontuberculous mycobacterial (NTM) lung disease, whereas GLP-1 isn't used at all. The "may" in the case of inhaled clofazimine is because they are speculating that it will avoid the rather nasty side effects of the drug, whereas the "may" in the GLP-1 comment was because they have no idea if it is viable because of the fast clearance (the block to the use of GLP-1 before analogs), never mind if there are side effects. From a share price POV I don't see the delay having a material effect on the share price because it's only a phase 1 trial and generally those are seen as speculative (basically try-outs) so they don't get factored into the share price. That comes after the phase 2 results. The Clofazimine trial is a Phase 2/3 trial. They have already completed Phase 1. And agree, the 3-6 month delay is inordinately insignificant. |
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Post by hellodolly on Jul 4, 2023 14:37:02 GMT -5
Sorry, yes you are right. The delay is to a phase 2/3 trial, not a phase 1 trial. The share price impact stands though as I don't see that getting factored in until after the trial results (usually the phase 2, but in this case if there is a single trial then after that) Clofazimine is used in this role outside the US so I expect it to work. The question will be efficiency and side effects when delivered via DPI. Efficacy at lower doses is a great target. If they can reach their endpoints with efficacy and reduce the toxicity due to the lower dose (combined with the 28 day cycle with 60 day drug holiday) it would be a nice story. |
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Post by cretin11 on Jul 4, 2023 16:49:28 GMT -5
HOW MANY FIRES HAVE THEY HAD IN 40 years? Now, IS it a coincidence that they have a devastating fire just mere weeks before needing to supply our clinical trials? Or, does this kind of ABSOLUTELY EFFED UP CRAP happen to EVERYBODY? It's hard to NOT believe in conspiracy theories, having followed this company so long. Probably not but the whole thing's hinky. IMHO Has Shkreli been in Germany recently? Or a roving gang of naked shorts perhaps… |
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Post by peppy on Jul 4, 2023 17:11:50 GMT -5
It seems like a great opportunity to refocus resources and determine if MKC253 may have therapeutic potential in obesity. If it does I think we are sitting on a blockbuster significantly larger than clofazimine . and all, please remind me what MKC253 is? Sayhey do you recall many years ago, 2016, 2017, MNKD had a weight loss drug it wanted to develop/sell? it could be seen on their pipeline list at the time, (it disappeared from pipeline candidates.) The drug was named. Do you recall the name? Mounjaro is said to be priced between $10,000 to $18,000/ year. When people stop, they regain weight. |
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