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Post by peppy on Mar 16, 2022 20:20:06 GMT -5
- 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. Just throwing it out in the atmosphere, When I listen to Martine, she has said, "FDA feedback, The FDA suggested" Could the FDA have suggested to exclude Asthmatic children? Hi Stevil. |
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Post by porkini on Mar 16, 2022 20:50:12 GMT -5
Just tossing this out, if asthmatic subjects were included against a black box warning and even the slightest adverse reaction occurred with the subject(s), then what?
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Post by sellhighdrinklow on Mar 16, 2022 21:14:53 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? Hello Hopeandwilling - I just read through 25 of your previous posts. You are a short shill and nothing more or less. I suggest others read your commentary as well. |
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Post by uvula on Mar 16, 2022 21:47:50 GMT -5
If Hope is a short, but what he says is true, then it is still worth listening to him.
Mnkd is not the only dpi company.
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Post by cedafuntennis on Mar 16, 2022 22:12:37 GMT -5
If Hope is a short, but what he says is true, then it is still worth listening to him. Mnkd is not the only dpi company. It is not about DPI only but most importantly about the powder formulation. It is mono which I believe sets them distinctively apart from the other 19 or so, most of which we never heard of. We all know who guards the FDA chicken coop. While this is the reality, they cannot deny approval forever and they will run out of excuses sometime. |
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Post by Deleted on Mar 17, 2022 0:04:52 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? Hello Hopeandwilling - I just read through 25 of your previous posts. You are a short shill and nothing more or less. I suggest others read your commentary as well. Is HOPING******......SPENCER OSBORNE??? My God it sounds just like him. |
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Post by peppy on Mar 17, 2022 1:47:30 GMT -5
If Hope is a short, but what he says is true, then it is still worth listening to him. Mnkd is not the only dpi company. It is not about DPI only but most importantly about the powder formulation. It is mono which I believe sets them distinctively apart from the other 19 or so, most of which we never heard of. We all know who guards the FDA chicken coop. While this is the reality, they cannot deny approval forever and they will run out of excuses sometime. Here is the thing about MNKD product. It allows for delivery into the alveoli, which are arterial capillary rich and allows for the medication to go right into the blood stream. for instance, why Afrezza is so good. It is regular insulin, delivered into the left atrium and out to the system. 5 liters of blood gets insulin. Technosphere is an IV. A non invasive IV. Those other DPI's as far as I can make tell, deliver to the bronchioles. That is good for brochospasms. She rearing up..... |
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Post by mango on Mar 17, 2022 6:33:25 GMT -5
🥭 Afrezza cash flow break even 2023
🥭 Afrezza Phase 3 India clinical trial ongoing
🥭 Afrezza Pediatric Phase 3 clinical trial readout late 2023
🥭 New Afrezza Phase 4 clinical trial this year
🥭 Tyvaso DPI launch Q2 this year
🥭 >$100 MILLION in annual Tyvaso DPI royalties + manufacturing royalties
🥭 Clofazimine Phase 1 ongoing
🥭 Nintedanib for IPF
🥭 Dornase Alpha for cystic fibrosis
🥭 TGF-B for IPF
🥭 Additional indications for Tyvaso DPI + years of exclusivity and zero competition PH-COPD, PH-ILD, IPF
🥭 NO serious adverse events & NO bronchospasm in Tyvaso DPI clinical trials
🥭 Launching 1 new product or indication beginning 2025
🥭 TGF-B pharmacodynamics study results 2H this year
🥭 Afrezza dosing label change incoming
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Post by hellodolly on Mar 17, 2022 6:47:27 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? We were, in part, speaking on Boehringer's portfolio regarding the dry powder formulations. Yes, many other companies have them, but specifically for the target indication with Boehringer...just to drill down on that more for you. As far as the UTHR delay, we now know from MC (after the Oppenheimer presentation) that the CP is asserting a certain issue concerning bronchspasms and the relationship to Afrezza, therefore, it must mean bronchspasms in Tyvaso DPI are also a SAE . The assumption in the petition, to make that effort, we now is more of a distraction than with any reality. According to MC, here have been over 3,000 patients involved with Tyvaso DPI and not one had any bronchospasm related AE. I think you read more into the response, IMHO. |
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Post by prcgorman2 on Mar 17, 2022 7:06:05 GMT -5
What an interesting thread this has turned out to be. It is interesting that the short story posts we used to see bashing Afrezza have largely dried up and gone away, only to be replaced by new posts fearing and doubting Tyvaso DPI safety and approval. SSDD
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Post by mango on Mar 17, 2022 7:47:29 GMT -5
The Citizen Petition is merely an anti-competitive scheme deployed by a competitor. The scientific data on Tyvaso DPI reveals no study drug serious adverse events in any clinical trial and no bronchospasm in any Tyvaso DPI clinical trial. FDKP has been used in stable asthmatics and COPDers with no bronchospasm. The handful number of participants in the clinical trial that had bronchospasm were in unstable asthmatics. That is a key point. The participants were taken off their controlled medicine(s) which was a serious study design flaw. Any inhaled foreign matter would pose the same risk in that situation and is not unique to FDKP/Afrezza. The Black Box Warning is over rated, and it was nice to see michaelcastagna discuss the details of the bronchospasm and safety of FDKP and Afrezza during this recent Oppenheimer call. BTW, Mike delivered a phenomenal presentation. Audio was much improved from previous calls, the flow was very smooth, Mike was very articulate, enthusiastic and had a good sense of preparation. MannKind has a serious pipeline in development with some serious drugs for some serious indications. With enough working capital on hand and $60M available tranche upon Tyvaso DPI approval, we have enough to fund the company for years and fund our own pipeline and pick up additional low cost assets (companies/pipeline candidates). |
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Post by cretin11 on Mar 17, 2022 8:09:07 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? Hello Hopeandwilling - I just read through 25 of your previous posts. You are a short shill and nothing more or less. I suggest others read your commentary as well. I went back and read a couple of pages worth of hopingandwilling’s post. Does not appear to be a “short shill” at all. In fact, some of his posts get thumbs up from none other than mango and some other regulars. And as uvula said, even if a poster did happen to be short, it’s no reason to discount their info. Arguably we’d learn more from a short, as they obviously have made more money trading MNKD down from $55 to present, than us perpetually optimistic (hopefully not quixotic) longs. Some here would prefer to censor any negative opinion as if it might somehow influence share price movement. Others of us prefer legit info whether positive or negative. To each their own, and GLTAL as we could use some. |
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Post by sayhey24 on Mar 17, 2022 8:54:09 GMT -5
Lets hope the days of trading down from $55 are over and behind us. I doubt those shorts ever thought MNKD would still be in business but here we are with a pile of cash and a very exciting portfolio.
hopeandwilling said "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?" Did I miss that memo from Mike? I thought what he said is they currently have the "Seeing is Believing" campaign in pilot and the indication is they are seeing some good results and if this pans out they are rolling it out on a bigger scale in June.
Mike has also said he expects afrezza break even in June with no significant changes in their current approach. What am I missing? Whats the cut back?
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Post by cretin11 on Mar 17, 2022 9:41:56 GMT -5
I doubt the shorts cared whether MNKD would still be in business. They cared about the share price going down and they profited handsomely from that for years. The days of trading down from $55 are indeed over, we’d have to get back there again to even have that conversation. I’d settle for trading halfway back there…
I seem to recall MC referencing a scale back on Afrezza marketing spend, can’t remember exact details but I’m sure several folks here can.
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Post by peppy on Mar 17, 2022 9:46:51 GMT -5
I doubt the shorts cared whether MNKD would still be in business. They cared about the share price going down and they profited handsomely from that for years. The days of trading down from $55 are indeed over, we’d have to get back there again to even have that conversation. I’d settle for trading halfway back there… I seem to recall MC referencing a scale back on Afrezza marketing spend, can’t remember exact details but I’m sure several folks here can. That picture of you combing the lice off your shirt is distracting. |
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