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Post by Deleted on Mar 17, 2022 10:05:06 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. One correction HELLO....The 3,000 patients is more Afrezza than Tyvaso DPI. I don't think 3K patients have tried DPI. |
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Post by hellodolly on Mar 17, 2022 11:18:11 GMT -5
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. One correction HELLO....The 3,000 patients is more Afrezza than Tyvaso DPI. I don't think 3K patients have tried DPI. Correct. Thank you. |
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Post by sayhey24 on Mar 17, 2022 11:21:06 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. If Mike is spending less on flying hamburgers on TV I am all for that. If he is trying to get a more focused efforts with things like "Seeing is Believing" and that is going to cost less and sell more afrezza, I am all for that too. Sponsoring race cars is nice but I doubt its selling more afrezza. Sponsoring ADA activities is also probably not going to influence the ADA unless MNKD can come in with big money to buy these guys off, so spending less with the ADA is also probably a good idea because these guys are not our friends. |
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Post by radgray68 on Mar 17, 2022 11:23:36 GMT -5
With Technosphere, around 70% gets into the deep lung. Other DPI devices and inhaled drugs only get about 30%.
We stabilize previously unstable monomers.
Our platform is already approved.
We now finally have the capital to continue our programs.
We've never been "Rejected" as some would phrase it. We're just delayed.
Everyone knows the CP is BS. Even the filers and their attorney.
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Post by peppy on Mar 17, 2022 11:39:59 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. If Mike is spending less on flying hamburgers on TV I am all for that. If he is trying to get a more focused efforts with things like "Seeing is Believing" and that is going to cost less and sell more afrezza, I am all for that too. Sponsoring race cars is nice but I doubt its selling more afrezza. Sponsoring ADA activities is also probably not going to influence the ADA unless MNKD can come in with big money to buy these guys off, so spending less with the ADA is also probably a good idea because these guys are not our friends. Seeing is believing is the way to go. The people that need to see blood glucose levels ARE the public. Here is my campaign idea..... Injectable insulin. (Takes too long to work, lasts to long.)  Afrezza inhalable insulin, quick in quick out. The dosing is different.  See the difference? Time to peak effect. Time to baseline.  People on Injectable insulin do not feel good.  If only health insurance would cover it, physicians could start prescribing Afrezza. |
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Post by cretin11 on Mar 17, 2022 11:52:29 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. If Mike is spending less on flying hamburgers on TV I am all for that. If he is trying to get a more focused efforts with things like "Seeing is Believing" and that is going to cost less and sell more afrezza, I am all for that too. Sponsoring race cars is nice but I doubt its selling more afrezza. Sponsoring ADA activities is also probably not going to influence the ADA unless MNKD can come in with big money to buy these guys off, so spending less with the ADA is also probably a good idea because these guys are not our friends. Agree sayhey, the money spent on flying hamburgers and race cars has resulted in flat sales. We can probably have flat sales without spending that money. The job is to spend money and actually move the needle to achieve that hockey puck trajectory we used to predict. That job hasn’t been accomplished, and everyone has their own excuses/reasons why, but hopefully “seeing is believing” will be the ticket. |
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Post by peppy on Mar 17, 2022 11:58:34 GMT -5
I liked the flying hamburgers.
Afrezza needs health insurance is all.
Even Stevil told us part of his physicians training is don't fight insurance coverage.
If he orders something that isn't covered by insurance, the pharmacy calls him to change the order.
Cretin you seem to be a troll.
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Post by sayhey24 on Mar 17, 2022 12:44:18 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage. If he orders something that isn't covered by insurance, the pharmacy calls him to change the order. Cretin you seem to be a troll. Mike keeps working the insurance. He said the other day about getting the copay to $35 so its now covered under Medicare. I hated that flying hamburger commercial. I just watched Dopesick. It was all about targeting the prescribing physicians. While OC and afrezza are clearly different some of the sales/marketing tactics could be reused by MNKD. If MNKD had the money, I would be all for creating shadow industry groups to go against the ADA and put out lots a lots of positive info. How about our own Step program for T2's which includes a 'Prescribing Card" like the OC card which all the physicians get which shows prescribing afrezza after taking a walk and shows Sglt2 way after using afrezza. In the mean time I sure hope Mike has some live demo's of "Seeing is Believing" at the 82nd Scientific Sessions. What has everyone been saying for the last 2 years about follow the science? Maybe its time the ADA follows the science but I am not holding my breath. |
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Post by peppy on Mar 17, 2022 13:17:32 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage. If he orders something that isn't covered by insurance, the pharmacy calls him to change the order. Cretin you seem to be a troll. Mike keeps working the insurance. He said the other day about getting the copay to $35 so its now covered under Medicare. I hated that flying hamburger commercial. I just watched Dopesick. It was all about targeting the prescribing physicians. While OC and afrezza are clearly different some of the sales/marketing tactics could be reused by MNKD. If MNKD had the money, I would be all for creating shadow industry groups to go against the ADA and put out lots a lots of positive info. How about our own Step program for T2's which includes a 'Prescribing Card" like the OC card which all the physicians get which shows prescribing afrezza after taking a walk and shows Sglt2 way after using afrezza. In the mean time I sure hope Mike has some live demo's of "Seeing is Believing" at the 82nd Scientific Sessions. What has everyone been saying for the last 2 years about follow the science? Maybe its time the ADA follows the science but I am not holding my breath. I don't think targeting the prescribing physicians help until Afrezza is insured. According to Stevil, they are educated to fall in. They are in the army now. It is health insurance. Until health insurance is explained to the American people, how it actually works, as long as we all live in Lala land, Big Pharma has their operations. Sayhey, Medicare Part D. Are they really covering Afrezza? Any chance Mike is selling Afrezza to Medicare part D at 99 dollars a month, like the program they ran for a year. You know Medicare isn't covering retail. They are covering? at 35 dollars? sweedee79 did you find anything out regarding? |
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Post by stevil on Mar 17, 2022 13:26:35 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage.If he orders something that isn't covered by insurance, the pharmacy calls him to change the order. Cretin you seem to be a troll. Not exactly. I do fill out PAs from time to time if I think the patient really needs the medication and I'm sure I can convince the insurance company that they do. Sometimes insurance companies just put a PA barrier on medications because they know it will be enough to deter us from prescribing. Other times, they make the barrier a mountain and require a ton of extra documentation and sometimes testing to justify our decisions as well as "step-therapy" where you have to try and fail x, y, and z before they'll cover A. It's just a game they play and we're subject to it. It doesn't improve healthcare at all. I'd actually contend the opposite. There are some docs that need leashes because they'll prescribe the latest and greatest to keep the drug reps bringing them great lunches and dinners but most of the time it just increases workload and burden which leads to burnout- all for the sake of saving a few dollars. These PAs can sometimes take 15 min each to complete and we do not get reimbursed for them. This is on top of all of the other work we're already doing. As you can see, the time adds up quickly and it is completely unrealistic to do this for even 2 patients a day as this would cause an extra half hour of unpaid work every day. And that's only for the chance insurance will approve. I believe Mike said only 70% of the PAs get approved, so for every 3 PAs you submit for Afrezza, you're wasting your time on 1 of them. That's going to put you off from trying unless it's really a "must have" situation. Fewer true videos than these. Tragic, really. Hopefully doctors will be the ones making decisions for their patients in the future once this system collapses. One can only hope. www.youtube.com/shorts/ayyafnuQ5m4www.youtube.com/shorts/FVAFfd3oCgA |
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Post by peppy on Mar 17, 2022 13:36:01 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage.If he orders something that isn't covered by insurance, the pharmacy calls him to change the order. Cretin you seem to be a troll. Not exactly. I do fill out PAs from time to time if I think the patient really needs the medication and I'm sure I can convince the insurance company that they do. Sometimes insurance companies just put a PA barrier on medications because they know it will be enough to deter us from prescribing. Other times, they make the barrier a mountain and require a ton of extra documentation and sometimes testing to justify our decisions as well as "step-therapy" where you have to try and fail x, y, and z before they'll cover A. It's just a game they play and we're subject to it. Fewer true videos than this. Tragic, really. Hopefully doctors will be the ones making decisions for their patients in the future once this system collapses. One can only hope.
www.youtube.com/shorts/ayyafnuQ5m4It turns out that is the story. Prior to becoming a MNKD owner I had no clue. Took me years to learn. You helped teach me, how it works. As An aside, In my youth, the physician so highly thought of, Marcus Wilbe MD. During the pandemic, reports physicians are feeling like a number. A cog. Oh another thing. You should see how the vultures descend on people with really good health insurance when they are dying. OR and all. I'll watch the video now. I think you are going to tell me. |
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Post by cretin11 on Mar 17, 2022 13:36:32 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage. Cretin you seem to be a troll. peppy why am I not surprised you liked the flying hamburgers. That commercial was painfully cringeworthy. And I’ve been trying so hard to be on my best behavior lately only for you to call me a troll. I’m gonna have to try even harder! Let me start by offering to share these nachos with you 😄 Yum! |
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Post by peppy on Mar 17, 2022 13:40:28 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage. Cretin you seem to be a troll. peppy why am I not surprised you liked the flying hamburgers. That commercial was painfully cringeworthy. And I’ve been trying so hard to be on my best behavior lately only for you to call me a troll. I’m gonna have to try even harder! Let me start by offering to share these nachos with you 😄 Yum! I had determined you eat the lice you seem to be beating off the clothing. Yum |
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Post by sportsrancho on Mar 17, 2022 17:59:49 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage. Cretin you seem to be a troll. peppy why am I not surprised you liked the flying hamburgers. That commercial was painfully cringeworthy. And I’ve been trying so hard to be on my best behavior lately only for you to call me a troll. I’m gonna have to try even harder! Let me start by offering to share these nachos with you 😄 Yum! On freaking believable…. but I’m not surprised. You are not a troll. And it is not all about Insurance/ not by a long shot. And how many times has NYlefty told us exactly what was going on with Medicare🤷🏼♀️ |
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Post by sweedee79 on Mar 17, 2022 18:53:03 GMT -5
Mike keeps working the insurance. He said the other day about getting the copay to $35 so its now covered under Medicare. I hated that flying hamburger commercial. I just watched Dopesick. It was all about targeting the prescribing physicians. While OC and afrezza are clearly different some of the sales/marketing tactics could be reused by MNKD. If MNKD had the money, I would be all for creating shadow industry groups to go against the ADA and put out lots a lots of positive info. How about our own Step program for T2's which includes a 'Prescribing Card" like the OC card which all the physicians get which shows prescribing afrezza after taking a walk and shows Sglt2 way after using afrezza. In the mean time I sure hope Mike has some live demo's of "Seeing is Believing" at the 82nd Scientific Sessions. What has everyone been saying for the last 2 years about follow the science? Maybe its time the ADA follows the science but I am not holding my breath. I don't think targeting the prescribing physicians help until Afrezza is insured. According to Stevil, they are educated to fall in. They are in the army now. It is health insurance. Until health insurance is explained to the American people, how it actually works, as long as we all live in Lala land, Big Pharma has their operations. Sayhey, Medicare Part D. Are they really covering Afrezza? Any chance Mike is selling Afrezza to Medicare part D at 99 dollars a month, like the program they ran for a year. You know Medicare isn't covering retail. They are covering? at 35 dollars? sweedee79 did you find anything out regarding? No I didn't... My dad is in not in a sound mental state enough to be managing his own diabetes anymore and my sister and I can't be there all of the time... He can manage his basic needs and that is about all... Doctor believed it was safest to put him on Ozempic and so far that seems to be working for him.. He had a stroke about 3 years ago.. and since then kidney failure and also congestive heart failure... We don't think he has a lot of time left.. his memory is going too now.. has mild dementia... He doesn't want to go to a nursing home so we are taking care of him the best we can at home... he also has paranoia along with the dementia so it's really really hard... Aging can be torturous for some... Insurance has been an issue with Afrezza for us and many others, but doctors don't seem to understand Afrezza either.. so I think there have been multiple problems with patients being able getting on it.. For us it took months of determination to convince the doctors and then finally the insurance removed it from their formulary.. So there you have it.. there were too many obstacles... The entire system seemed to be pushing against it because it was different... And possibly too expensive.. |
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