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Post by Thundersnow on May 18, 2023 9:51:28 GMT -5
Mike and Steve will have to make a decision on increasing Afrezza manufacturing capacity. Do they make the call now or wait until approval and scramble to meet the anticipated demand??
There's also INDIA.....if they approval (which is likely) will they suffer from the demand rush??
And there's Brazil....which will be coming back on line early next year??
ALL GOOD PROBLEMS!!!
As I mentioned before I believe this is the reason why they increased the AS.
Let's hope they make the right decision. Hope we don't have another DNDN.
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Post by porkini on May 18, 2023 9:59:34 GMT -5
Mike and Steve will have to make a decision on increasing Afrezza manufacturing capacity. Do they make the call now or wait until approval and scramble to meet the anticipated demand?? There's also INDIA.....if they approval (which is likely) will they suffer from the demand rush?? And there's Brazil....which will be coming back on line early next year?? ALL GOOD PROBLEMS!!! As I mentioned before I believe this is the reason why they increased the AS. Let's hope they make the right decision. Hope we don't have another DNDN. ? Help please ?  |
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rebby
Researcher
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Post by rebby on May 18, 2023 10:28:52 GMT -5
Mike and Steve will have to make a decision on increasing Afrezza manufacturing capacity. Do they make the call now or wait until approval and scramble to meet the anticipated demand?? There's also INDIA.....if they approval (which is likely) will they suffer from the demand rush?? And there's Brazil....which will be coming back on line early next year?? ALL GOOD PROBLEMS!!! As I mentioned before I believe this is the reason why they increased the AS. Let's hope they make the right decision. Hope we don't have another DNDN. ? Help please ? I’ll take a crack at AS - Authorized Shares |
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Post by uvula on May 18, 2023 10:37:10 GMT -5
www.dendreon.com/Had a good prostate cancer drug and went bankrupt. Not sure of the relevance to mnkd.
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Post by porkini on May 18, 2023 10:48:02 GMT -5
Thanks for the input rebby and uvula. Just for clarification, increasing "authorized shares" at this point is still an ask, pending shareholder vote approval. So, they have not increased the authorized shares yet. My search on DNDN came up with Dendreon as well, but I did not know there was a connection to MNKD. The other search possibility was "Dungeons & Dragons"!  |
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Post by uvula on May 18, 2023 10:54:58 GMT -5
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Post by mango on May 18, 2023 11:38:13 GMT -5
If the Peds trial shows superiority then we will have a good problem on our hands. ADA will be forced to change the SoC and Afrezza will be the preferred mealtime insulin for pediatrics. I have a feeling Afrezza is dominating in the Peds trial.
Afrezza in India likely depends on how it is viewed by their ADA equivalent (if they have one) and/or medical establishment. If Afrezza has indeed produced a 1.5-2% drop in A1C then that’s damn good.
This large scale Pump Switch trial is also very exciting. What’s going to happen when MannKind proves basal plus Afrezza produces just as good if not better results than a pump? Throw in things like better safety with Afrezza, no lipohypertrophy or localized insulin-derived amyloidosis, and significantly less needle sticks then ADA has a trilemma on their hands.
All very good problems to soon have.
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Post by awesomo on May 18, 2023 11:41:04 GMT -5
Thanks for the input rebby and uvula . Just for clarification, increasing "authorized shares" at this point is still an ask, pending shareholder vote approval. So, they have not increased the authorized shares yet. It will 100% pass. Retail voting doesn't matter. |
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Post by Thundersnow on May 18, 2023 17:48:24 GMT -5
www.dendreon.com/Had a good prostate cancer drug and went bankrupt. Not sure of the relevance to mnkd. The relevance is that DNDN borrowed over $500 Million to build a 2nd and 3rd manufacturing facility because the CEO expected HUGE DEMAND. The Demand never materialized because the drug was very expensive and the doctors did not want to front the money for treatment while waiting for reimbursement. They filed for Bankruptcy and their immunotherapy drug was sold for peanuts. |
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Post by sayhey24 on May 18, 2023 18:24:06 GMT -5
www.dendreon.com/Had a good prostate cancer drug and went bankrupt. Not sure of the relevance to mnkd. The relevance is that DNDN borrowed over $500 Million to build a 2nd and 3rd manufacturing facility because the CEO expected HUGE DEMAND. The Demand never materialized because the drug was very expensive and the doctors did not want to front the money for treatment while waiting for reimbursement. They filed for Bankruptcy and their immunotherapy drug was sold for peanuts. Are you kidding me - everyone knew DNDN was a pump and dump scheme. What did their studies say - maybe extend life by 3 months, if I remember correctly. I think a lot of people played this one all the way up to $50 and got out. No one was ever going to be able to afford the medications huge price tag and no insurance was going to cover it. DNDN is nothing like MNKD. MNKD has the greatest advance in diabetes care in over 100 years. Afrezza is real. It has significant provable instant results which can be measured with a CGM. Al Mann thought sales were going to be so huge he installed a third filling line. To date I doubt they need one full time. I know they took one for Tyvaso DPI. When did Mike say they are running out of afrezza capacity? If thats true, that would be HUGE. |
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Post by Thundersnow on May 19, 2023 14:54:52 GMT -5
The relevance is that DNDN borrowed over $500 Million to build a 2nd and 3rd manufacturing facility because the CEO expected HUGE DEMAND. The Demand never materialized because the drug was very expensive and the doctors did not want to front the money for treatment while waiting for reimbursement. They filed for Bankruptcy and their immunotherapy drug was sold for peanuts. Are you kidding me - everyone knew DNDN was a pump and dump scheme. What did their studies say - maybe extend life by 3 months, if I remember correctly. I think a lot of people played this one all the way up to $50 and got out. No one was ever going to be able to afford the medications huge price tag and no insurance was going to cover it. DNDN is nothing like MNKD. MNKD has the greatest advance in diabetes care in over 100 years. Afrezza is real. It has significant provable instant results which can be measured with a CGM. Al Mann thought sales were going to be so huge he installed a third filling line. To date I doubt they need one full time. I know they took one for Tyvaso DPI. When did Mike say they are running out of afrezza capacity? If thats true, that would be HUGE. You really think Danbury can handle Tyvaso DPI, Afrezza US w/ Pediatric Approval, Brazil, INDIA and R&D? Wake up Sayhey. By the way DNDN was not a P&D. They made a bad decision to grow without the demand. They would have been fine with their 1 main facility and wait for the demand. Classic Wharton business case. OBTW Provenge does work. The PROCEED Registry showed median overall survival of approximately 4 years in men who were treated with PROVENGE when their prostate-specific antigen (PSA) levels were less than or equal to 5.27 ng/mL. |
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Post by mytakeonit on May 19, 2023 15:19:04 GMT -5
Yes ... I believe the plan was to see the volume in these different locations. If warranted ... then more manufacturing facilities would be built in those locations.
But, that's mytakeonit
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Post by hellodolly on May 19, 2023 15:23:27 GMT -5
www.dendreon.com/Had a good prostate cancer drug and went bankrupt. Not sure of the relevance to mnkd. The relevance is that DNDN borrowed over $500 Million to build a 2nd and 3rd manufacturing facility because the CEO expected HUGE DEMAND. The Demand never materialized because the drug was very expensive and the doctors did not want to front the money for treatment while waiting for reimbursement. They filed for Bankruptcy and their immunotherapy drug was sold for peanuts. I was going to ask for the comparison and I'm glad you answered it. If I read what you posted, DNDN took a loan of $500M to expand the capacity to manufacture their drug. Several points for readers to consider: 1. MNKD doesn't need to take out a loan to build out capacity to manufacture more Afrezza. They could, if needed, find alternative financing that could eliminate any loans. Besides, revenues from Tyvaso and Afrezza could potentially provide the CAPEX fund. 2. DNDN started from scratch without any real market analysis for the demand, rather they used the TAM and misjudged the demand. A fatal flaw by their team. 3. MNKD has years of growth and an ongoing sales trajectory that is giving them guidance. This is the sort of data a CEO should have available before making "difficult decisions." 4. Added capacity at this point, doesn't mean it has to be solely for Afrezza. Anything they build can be manufactured under their TS platform, which makes the decision to move ahead not so "difficult". |
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Post by sayhey24 on May 19, 2023 15:25:58 GMT -5
Are you kidding me - everyone knew DNDN was a pump and dump scheme. What did their studies say - maybe extend life by 3 months, if I remember correctly. I think a lot of people played this one all the way up to $50 and got out. No one was ever going to be able to afford the medications huge price tag and no insurance was going to cover it. DNDN is nothing like MNKD. MNKD has the greatest advance in diabetes care in over 100 years. Afrezza is real. It has significant provable instant results which can be measured with a CGM. Al Mann thought sales were going to be so huge he installed a third filling line. To date I doubt they need one full time. I know they took one for Tyvaso DPI. When did Mike say they are running out of afrezza capacity? If thats true, that would be HUGE. You really think Danbury can handle Tyvaso DPI, Afrezza US w/ Pediatric Approval, Brazil, INDIA and R&D? Wake up Sayhey. By the way DNDN was not a P&D. They made a bad decision to grow without the demand. They would have been fine with their 1 main facility and wait for the demand. Classic Wharton business case. OBTW Provenge does work. The PROCEED Registry showed median overall survival of approximately 4 years in men who were treated with PROVENGE when their prostate-specific antigen (PSA) levels were less than or equal to 5.27 ng/mL. Come on - if you got beyond the hype it was clearly a pump and dump and thats what hype is all about. I sold at $50. If you held - too bad so sad. Did I ever say Danbury could handle all the production? Where did you get that??? I asked did Mike say he was out of afrezza production space??? I doubt they are using one filling line full time for afrezza. I suspect they took the slower line and repurposed for Tyvaso DPI. Brewing the powder was not the issue. Its filling the pods and you can bulk ship the powder to other places. Now - if you have a $B product do you want a single brewing facility - not me. You need disaster recovery. BTW - there is no space in Danbury. I have not been to the facility in a number of years thanks to Covid and now to Mike. I can only guess the facility is kind of a mess right now or Mike would have proudly had the Annual meeting there with cold coffee and some donuts and some NY analysts. It seems next year it will be back. Maybe by that time he will have learned to promote the stock a bit and will have been on some of the TV business shows. |
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Post by lennymnkd on May 19, 2023 15:39:02 GMT -5
I thought the deal with DNDN WAS they chose to go it alone rather than partner ..
and that did them in.
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