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Post by cedafuntennis on Jul 4, 2023 21:31:34 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. Both. MNKD contracted them so MNKD should also have had a plan B with no mitigation plan of your own in place. You don't spend millions on a vendor and then let them do what they want just to then point fingers and say not my fault, it's theirs but you still lose millions.. |
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Post by cppoly on Jul 5, 2023 5:56:03 GMT -5
Just thinking, is clofazimine even priced into mnkd stock price? Sitting at $4, I would say Afrezza, V-Go, and Tyvaso DPI are driving the price. Clofazimine is just icing on the cake when it gets approved, no?
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Post by akemp3000 on Jul 5, 2023 6:42:01 GMT -5
Just thinking, is clofazimine even priced into mnkd stock price? Sitting at $4, I would say Afrezza, V-Go, and Tyvaso DPI are driving the price. Clofazimine is just icing on the cake when it gets approved, no? Was thinking the same. If it had been priced into the stock, the reported fire would likely have caused a sudden and reactive drop the day of the announcement. |
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Post by mango on Jul 5, 2023 9:18:38 GMT -5
Pharmaceutical related fires and explosions are said to be rare, but just type in a search for them and you will see that they happen every year, and even the BP companies are not immune. Sanofi had a major one in 2018 for example and Eli Lilly has had 2 that I know of—one in 2006 and another in 2016.
A delay of 3-6 months is so inordinately insignificant. A delay of a year or two (or possibly indefinitely) like we have seen with Liquidia’s Yutrepia is an example of a significant delay.
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Post by MnkdWASmyRtrmntPlan on Jul 5, 2023 9:31:24 GMT -5
Just thinking, is clofazimine even priced into mnkd stock price? Sitting at $4, I would say Afrezza, V-Go, and Tyvaso DPI are driving the price. Clofazimine is just icing on the cake when it gets approved, no? Well, the only thing I will counter is about Afrezza and V-Go driving the price. The only thing they may be doing is driving the price "sideways". But that's a minor point. I agree with you, cppoly, that I don't think clofazimine is priced in yet. I don't know WHY mnkd is sitting at $4 now. Additional good buying opportunity, but I certainly don't need that now. I'm way over my head in mnkd. By 12/31/2024, it should be at least at $10 and on its way to $20. I have been patient with mnkd for, what?, 6 years now. Another 1-1/2 years is 25% more time. I have been putting all my spare change into tsla, which has been doing me very well lately, and I expect that to continue. |
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Post by MnkdWASmyRtrmntPlan on Jul 5, 2023 9:37:12 GMT -5
Pharmaceutical related fires and explosions are said to be rare, but just type in a search for them and you will see that they happen every year, and even the BP companies are not immune. Sanofi had a major one in 2018 for example and Eli Lilly has had 2 that I know of—one in 2006 and another in 2016. A delay of 3-6 months is so inordinately insignificant. A delay of a year or two (or possibly indefinitely) like we have seen with Liquidia’s Yutrepia is an example of a significant delay. Good research, Mango. As some said, I am hoping that either mnkd or the Germain company have enough clofazimine stockpile laying around to enable the trials/studies to continue with no delay, so the fire will be a nothing-burger. |
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Post by phdedieu12 on Jul 5, 2023 11:08:37 GMT -5
Sounds like bad news, good news. Now we can bring the production to Danbury and control the process, and cut out the supplier....
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Post by akemp3000 on Jul 5, 2023 13:40:08 GMT -5
Pharmaceutical related fires and explosions are said to be rare, but just type in a search for them and you will see that they happen every year, and even the BP companies are not immune. Sanofi had a major one in 2018 for example and Eli Lilly has had 2 that I know of—one in 2006 and another in 2016. A delay of 3-6 months is so inordinately insignificant. A delay of a year or two (or possibly indefinitely) like we have seen with Liquidia’s Yutrepia is an example of a significant delay. I agree with all though it does bring to mind that fires and explosions in food production facilities were also considered rare...until this past year. I'm not implying there's a relationship. Just sharing an observation. |
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Post by uvula on Jul 5, 2023 14:14:26 GMT -5
Sounds like bad news, good news. Now we can bring the production to Danbury and control the process, and cut out the supplier.... Mnkd does not manufacture drugs of any kind. They buy drugs and mix them with TS. There is no way a fire is good news. If mnkd didn't need the supplier they never would have used them in the first place. |
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Post by carefulinvestor on Jul 5, 2023 19:35:50 GMT -5
ovala,
No-one said anything about "manufacture", the word was "production". Is there a difference? The product is produced (or in your terms "mixed"). Big deal. Please save your complaints for something worthwhile.
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Post by uvula on Jul 5, 2023 20:52:35 GMT -5
Mnkd cannot manufacture clofazimine. Mnkd cannot produce clofazimine. Doesn't matter what word(s) you want to use. Not a complaint. Just a fact that some people here were aparently not aware of.
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Post by agedhippie on Jul 6, 2023 5:50:35 GMT -5
Sounds like bad news, good news. Now we can bring the production to Danbury and control the process, and cut out the supplier.... Conversion into clofazimine DPI is already done at Danbury. I don't think the API supplier can be swapped, but not cut out. Clofazimine is a very cheap API, and MNKD isn't looking for large volumes so there is no way this gets bought in-house (timelines, costs, licensing, ROI, staffing all block this.) The far simpler solution is to second source the API from another manufacturer as well. |
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Post by anderson on Jul 6, 2023 7:51:50 GMT -5
Mnkd cannot manufacture clofazimine. Mnkd cannot produce clofazimine. Doesn't matter what word(s) you want to use. Not a complaint. Just a fact that some people here were aparently not aware of. Not now but hopefully in the future when they are flush with cash they can vertically integrate where it makes sense. |
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Post by hellodolly on Jul 6, 2023 8:10:48 GMT -5
Sounds like bad news, good news. Now we can bring the production to Danbury and control the process, and cut out the supplier.... Conversion into clofazimine DPI is already done at Danbury. I don't think the API supplier can be swapped, but not cut out. Clofazimine is a very cheap API, and MNKD isn't looking for large volumes so there is no way this gets bought in-house (timelines, costs, licensing, ROI, staffing all block this.) The far simpler solution is to second source the API from another manufacturer as well. Always wondered about this being converted to DPI when this will be used with a nebulizer in PHII/III not their inhaler. |
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Post by agedhippie on Jul 6, 2023 16:01:29 GMT -5
Conversion into clofazimine DPI is already done at Danbury. I don't think the API supplier can be swapped, but not cut out. Clofazimine is a very cheap API, and MNKD isn't looking for large volumes so there is no way this gets bought in-house (timelines, costs, licensing, ROI, staffing all block this.) The far simpler solution is to second source the API from another manufacturer as well. Always wondered about this being converted to DPI when this will be used with a nebulizer in PHII/III not their inhaler. It's not diabetes so I don't pay as much attention as I should. This will be delivered via a nebulizer? What happened to TS? |
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