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Post by sayhey24 on Mar 16, 2022 11:41:54 GMT -5
I always wondered why MNKD never reviewed as Mike called it a "poorly designed" study in the last 7 years. At the time I know Al just wanted to get approval and figured they could fix this later. Maybe it is as simple as they had no cash but after the SNY deal they did. After watching what MNKD has gone through for the last 10 years and after watching Dopesick I wonder if there is more to the story than just a poorly designed trial. If Tyvaso gets a clean label and Mike can present a convincing case for the afrezza label change this would be huge. It sounded that he has the modeling data to get approval to change the dosing which should solved the issue of PWDs saying it does not work. All great things and still trading below $5. I thought I had enough MNKD but may not. I agree, I think Al just wanted to get to the finish line and never thought it would become such an issue. I wonder if vdexdiabetes has any patients on Afrezza who also have COPD, asthma or another chronic lung condition. Would be interesting to see where it would lead if Vdex compiled that patient data, and sent it over to MannKind to support removal of the Black Box Warning, if they did. Thats a fine idea on Vdex maybe Sports can help out here. The overall afrezza population with COPD is probably pretty low as the label says "AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD." |
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Post by stevil on Mar 16, 2022 11:54:52 GMT -5
If I remember correctly, MNKD isn't doing themselves any favors by having asthma be part of the exclusion criteria for the peds trial.
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Post by sportsrancho on Mar 16, 2022 13:08:48 GMT -5
I always wondered why MNKD never reviewed as Mike called it a "poorly designed" study in the last 7 years. At the time I know Al just wanted to get approval and figured they could fix this later. Maybe it is as simple as they had no cash but after the SNY deal they did. After watching what MNKD has gone through for the last 10 years and after watching Dopesick I wonder if there is more to the story than just a poorly designed trial. If Tyvaso gets a clean label and Mike can present a convincing case for the afrezza label change this would be huge. It sounded that he has the modeling data to get approval to change the dosing which should solved the issue of PWDs saying it does not work. All great things and still trading below $5. I thought I had enough MNKD but may not. I agree, I think Al just wanted to get to the finish line and never thought it would become such an issue. I wonder if vdexdiabetes has any patients on Afrezza who also have COPD, asthma or another chronic lung condition. Would be interesting to see where it would lead if Vdex compiled that patient data, and sent it over to MannKind to support removal of the Black Box Warning, if they did. We do ..we also have patients that smoke. I’ll get right on that😎 |
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Post by sportsrancho on Mar 16, 2022 13:10:40 GMT -5
If I remember correctly, MNKD isn't doing themselves any favors by having asthma be part of the exclusion criteria for the peds trial. I just saw that… and I thought what the heck? |
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Post by sayhey24 on Mar 16, 2022 13:13:59 GMT -5
If I remember correctly, MNKD isn't doing themselves any favors by having asthma be part of the exclusion criteria for the peds trial. Why? I would think you would do this in three steps; get the non-asthma kids approved; get the black box removed; do a follow-up small study for kids with asthma |
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Post by sportsrancho on Mar 16, 2022 13:20:40 GMT -5
If I remember right Tom‘s daughter had asthma and sometimes that’s psychosomatic. Let’s not exclude anyone we’re having a hard enough time getting them signed up as it is.
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Post by stevil on Mar 16, 2022 14:39:26 GMT -5
Why? I would think you would do this in three steps; get the non-asthma kids approved; get the black box removed; do a follow-up small study for kids with asthma - Because it implies the manufacturer is concerned enough about its validity to make it seem as though it is probably a real risk. - Doctors look at this stuff when they look at trials. They're going to assume that the risk is real. - Why do extra work if you don't have to? Time and money are not free. - The more times you force doctors to review data, the less likely you are that they'll get the message. Meaning, if they look at the trial once and see the exclusion criteria, they'd then have to be informed again later on that the risk was proven illegitimate. What usually happens is they review data, make conclusions, and move on. We've seen this issue play out with Exubera already. |
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Post by oldfishtowner on Mar 16, 2022 15:47:09 GMT -5
Very good call. Listen to it when you have time. Cash flow positive in 2023! Good cash position. Will keep their eyes open to acquire other assets on the cheap. Working on formulations with other potential partners. Really excited about Peds trial and the big medical schools are involved (Harvard, Stanford, etc.). India trial progressing. Good progress on pipeline products. Said 2 or 3 times that the CP was probably filed by a competitor but there was no bronchospasm in any of the T-DPI studies. He indicated that there was only one poorly designed trial on Afrezza where bronchospasm occurred. Sounds like they may eventually request that the black box be removed but Mike did not say that just to be clear. Added: Nice after hours price action! While it was not clear whether Castagna was speaking relative to just Afrezza or MNKD, the question asked was relative to a statement Castagna made in a previous presentation regarding cash flow breakeven for Afrezza not MNKD. It could be that a slightly better script growth together with significant margin improvements due to Tyvaso DPI absorbing some of the manufacturing overhead is what he believes will achieve this. Spending on R&D may prevent the company as a whole from reaching cash flow breakeven. Nevertheless, this would be an important milestone for the Afrezza franchise as well as the company.
On the other hand, additional partnerships, significant Afrezza script growth, and /or rapid Tyvaso DPI uptake could result in MNKD achieving positive cash flow from operations, but I do not think that this is what Castagna was addressing in his response. |
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Post by oldfishtowner on Mar 16, 2022 15:53:06 GMT -5
MNKD has started Phase 1 testing for Nintedanib which is made by Boehringer Ingelheim. I'm assuming once MNKD successfully completes Phase 1 they will announce a deal with them. Castagna clearly said that MNKD will begin animal studies for Nintedanib in the 2nd quarter. There was no mention of when phase 1 studies would begin, but certainly it will not be until sometime after the animal studies are completed. |
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Post by hopingandwilling on Mar 16, 2022 16:17:33 GMT -5
Why would Boehringer seek to partner with MannKind?
1) Boehringer is in the top #20 largest drug companies in the world.
2) They are a multi-billion revenue company.
3) They have the right to nintedanib which brings in more than a billion in revenue for them.
4) They have more than 50,000 employees worldwide.
5) They already do manufacturing for other drug companies---so they can manufacture their own drugs.
6) Currently they have some of the world's largest selling drugs that are inhaled drugs.
I'm just puzzled--what can MannKind do for Boehringer that they can't already do? Why would they want to share revenue with any other company for a drug they already have in the blockbuster category for drugs?
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Post by Deleted on Mar 16, 2022 16:25:40 GMT -5
Why would Boehringer seek to partner with MannKind? 1) Boehringer is in the top #20 largest drug companies in the world. 2) They are a multi-billion revenue company. 3) They have the right to nintedanib which brings in more than a billion in revenue for them. 4) They have more than 50,000 employees worldwide. 5) They already do manufacturing for other drug companies---so they can manufacture their own drugs. 6) Currently they have some of the world's largest selling drugs that are inhaled drugs. I'm just puzzled--what can MannKind do for Boehringer that they can't already do? Why would they want to share revenue with any other company for a drug they already have in the blockbuster category for drugs? Very good questions. Mike has made all the right moves to date so we will have to wait and see if a deal is pending. |
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Post by hellodolly on Mar 16, 2022 18:02:55 GMT -5
Why would Boehringer seek to partner with MannKind? 1) Boehringer is in the top #20 largest drug companies in the world. 2) They are a multi-billion revenue company. 3) They have the right to nintedanib which brings in more than a billion in revenue for them. 4) They have more than 50,000 employees worldwide. 5) They already do manufacturing for other drug companies---so they can manufacture their own drugs. 6) Currently they have some of the world's largest selling drugs that are inhaled drugs. I'm just puzzled--what can MannKind do for Boehringer that they can't already do? Why would they want to share revenue with any other company for a drug they already have in the blockbuster category for drugs? Do they manufacture dry powders and have a delivery device like MNKDs? I ask, I have no clue. |
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Post by cedafuntennis on Mar 16, 2022 18:31:44 GMT -5
More to the point. Do they have patents covering the device and power formulas that Mannkind has? Let me save you the effort and answer it. No they do not. With all the employees in the world, and all the resources at their disposal, sometimes it is much more efficient not to reinvent the proverbial wheel to extend the life and functionality of a product on it's back-legs.
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Post by sayhey24 on Mar 16, 2022 19:26:42 GMT -5
Why? I would think you would do this in three steps; get the non-asthma kids approved; get the black box removed; do a follow-up small study for kids with asthma - Because it implies the manufacturer is concerned enough about its validity to make it seem as though it is probably a real risk. - Doctors look at this stuff when they look at trials. They're going to assume that the risk is real. - Why do extra work if you don't have to? Time and money are not free. - The more times you force doctors to review data, the less likely you are that they'll get the message. Meaning, if they look at the trial once and see the exclusion criteria, they'd then have to be informed again later on that the risk was proven illegitimate. What usually happens is they review data, make conclusions, and move on. We've seen this issue play out with Exubera already. Its currently contradicted on the label. Doctors are and have been looking at the label. The kids trial is not going to change the black box on the label but once the kids get approved and then the label gets changed to removed the black box all kids will probably benefit from that label change. If not its no more than a small trial but it may not even be required or worth it. I have no idea how big the asthma population is in T1 kids. But a rough guess is there are 73 million kids in the U.S. and about 1 in 400 has t1 diabetes. Based on some studies 0.04% have asthma and diabetes or 182,500 * .004 = 730 which seems like a pretty small number. In my mind the goal of getting the kids approved and using afrezza in addition to helping these kids is to try and change how the industry views afrezza. The hope is the kids, as they did with pumps, will blaze the afrezza trail. 182,500 is a good size number but its not the 30M T2 market. If however they can influence afrezza acceptance then thats a huge win in the perception war. |
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Post by hopingandwilling on Mar 16, 2022 20:19:05 GMT -5
Ceda,
Since you asked me the question --"Do they have patents covering the device and power formulas that Mannkind has? Let me save you the effort and answer it. No they do not. With all the employees in the world, and all the resources at their disposal, sometimes it is much more efficient not to reinvent the proverbial wheel to extend the life and functionality of a product on it's back-legs."
MannKind has existed for 30 years and with their device and powder formulations, they got two FDA rejections for Afrezza before they got it approved on the third NDA filing and after spending more than $3 billion dollars. Jump now to the UTHR filing for the PAH market they have received another CRL "rejection" from the FDA and now the latest delay due to issues.
Simply do a google search for dry powder drugs approved and on the market and you will find there are more than 20 companies that have dry powder inhalation(DPI) products. And let me remind you--Liquidia who is now competing for the PAH market against MNKD--LQDA has already gotten FDA approval for their DPI product and MNKD hasn't. All the patents that MNKD has it hasn't stopped one company from developing a DPI and getting their FDA approval.
I have no desire to debate this issue with you--but making up stuff and denying the reality of the facts -- trying selling your version of the facts to your banker or the FDA and see if they believe your version of the facts. Doesn't the fact that MNKD has told you they are cutting back their market efforts with Afrezza--is that because they are selling more than they manufacture or COULD it be another fact of the reality?
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