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Post by peppy on Aug 10, 2022 18:56:02 GMT -5
I was mistaken, non-inferior is the label, correct? I know Kendall could not do it. As far as type two, I read what you type. I have watched insurance coverage at some level, I do not believe insurance will pay for the type two's Afrezza coverage. I know there are exceptions to the rule. Spiro and Joey are type two with insurance coverage, Glenn is a type two with insurance coverage. all using afrezza. So many names I can not recall now. There was another type two here 4 or 5 years ago that got Afrezza, the sailor, he sailed rivers. I believe some do dose a 4 unit at 120, after 45 mins to an hour. Case in point. I believe this is Afrezzaguy.  |
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Post by sayhey24 on Aug 10, 2022 19:33:12 GMT -5
Peppy - if afrezza shows superiority to the GLP1s and SGLT2s and it is listed as Step 2 in the SoC after metformin why do you think it would not get insurance coverage?
The problem is not afrezza showing superiority. It can and it will if Mike does the trials. The problem is we would then be asking the ADA to totally disrupt this $40B industry. Dave Kendall thought getting the ADA to do this would be the easiest job he ever had. HA! I think unless Mike partners with a BP and approaches it as an add-on to a GLP1 and slowly over years transforms the SoC to favor afrezza this is going to end up in a huge lawsuit. Is Mike up for that? If that happens the diabetes industrial complex will do whatever it can to blackball MNKD and blackball Mike.
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Post by peppy on Aug 10, 2022 20:15:10 GMT -5
Peppy - if afrezza shows superiority to the GLP1s and SGLT2s and it is listed as Step 2 in the SoC after metformin why do you think it would not get insurance coverage? The problem is not afrezza showing superiority. It can and it will if Mike does the trials. The problem is we would then be asking the ADA to totally disrupt this $40B industry. Dave Kendall thought getting the ADA to do this would be the easiest job he ever had. HA! I think unless Mike partners with a BP and approaches it as an add-on to a GLP1 and slowly over years transforms the SoC to favor afrezza this is going to end up in a huge lawsuit. Is Mike up for that? If that happens the diabetes industrial complex will do whatever it can to blackball MNKD and blackball Mike. quote, "The problem is we would then be asking the ADA to totally disrupt this $40B industry." reply, that is the problem case in point, this new legislation saying it is reducing medication prices. Limited to 20 medications. That is all they could get in the legislation, because legislators need Pharma donations/ money for re-election campaigns. So the large legislation is 20 medications..... perhaps now a 39.7 billion dollar industry. In the mean time, I am getting a medication and disease state education everyday watching the big Pharma commercials on the television. Pharma, Progressive, and the pillow guy are the only people left advertising on the boob tube, and the boob tube can not lose their last large funder, Big Pharma. Keep typing Sayhey, the industry will make people pee it out, 5 liters blood volume, these people lose too much water when the water is accompanying glucose, and become dehydrated to a point. Love my numbers, miss my leg. |
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Post by bones1026 on Aug 10, 2022 20:59:05 GMT -5
Aged - you are right the statement is not quantified. From some social media sites potential patients are saying their doctor said no, afrezza is not for you. They seem to be like the "Soup Nazi". In a lot of cases new afrezza users are saying they are their doctors first afrezza patient. For the T1s "the fix" is the kids trial. If the kids trial ends up good and it seems like it is afrezza with the T1s should mimic what happened with the pumps. In the kids study they have been uping doses and "dosing as needed". For the T2s a totally different trial needs to be done. Affinity2 already showed afrezza to be superior but Sanofi wasted the moment and never followed up. As Mike said in the podcast it was done so long ago the "research community" has forgotten and has gotten busy with the GLP1s/DDP4s/SGLT2s. Mike needs to develop a plan on how to attack this market and then execute it. A new trial needs to be part of this. Clearly, whatever they did with "Seeing is Believing" was a failed mission and cost $6M. Maybe they can learn a lesson or two from this $6M failure. BTW - Mike said in the podcast they have already submitted for label changes. He did not say what changes they have requested. There is no driver to get the endos to prescribe Afrezza for their Type 1s. The positive data is largely anecdotal, or pilots/small studies and that will not move endos. My experience is that if the person is persistent enough the endo will prescribe it provided there is insurance cover. That is not going to give you a big subscriber pool though. What will need to happen off the back of the kids trial will and adult trial with the better protocol. Without that the response is going to be that it works for kids, but not for adults (cue arguments about metabolism, weight, age, diet, etc.) This will take trial data to move the needle. On the plus side it can be prescribed to kids so it expands the market regardless. Affinity-2 is a red herring. Every diabetes drug company out there has the same trial data - if you add our product when the previous step fails there is a drop in HbA1c compared to simply continuing the failed protocol. Mounjaro, to name just one, has exactly the same trial and produced a 2.39 point drop. You are perfectly right though; there needs to be a new trial where the next step is either GLP-1 or Afrezza - a good result there would be a gamechanger. What I always found facinating…Cretin posts “us” and “we” in speaking about Mnkd longs..yet every negative rebuttal, from the guy whose not even invested in the stock but spends his evenings on their message boards (think how crazy that sounds)..usually gets 1 person to “like” their posts..🤔 |
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Post by cretin11 on Aug 10, 2022 22:02:22 GMT -5
There is no driver to get the endos to prescribe Afrezza for their Type 1s. The positive data is largely anecdotal, or pilots/small studies and that will not move endos. My experience is that if the person is persistent enough the endo will prescribe it provided there is insurance cover. That is not going to give you a big subscriber pool though. What will need to happen off the back of the kids trial will and adult trial with the better protocol. Without that the response is going to be that it works for kids, but not for adults (cue arguments about metabolism, weight, age, diet, etc.) This will take trial data to move the needle. On the plus side it can be prescribed to kids so it expands the market regardless. Affinity-2 is a red herring. Every diabetes drug company out there has the same trial data - if you add our product when the previous step fails there is a drop in HbA1c compared to simply continuing the failed protocol. Mounjaro, to name just one, has exactly the same trial and produced a 2.39 point drop. You are perfectly right though; there needs to be a new trial where the next step is either GLP-1 or Afrezza - a good result there would be a gamechanger. What I always found facinating…Cretin posts “us” and “we” in speaking about Mnkd longs..yet every negative rebuttal, from the guy whose not even invested in the stock but spends his evenings on their message boards (think how crazy that sounds)..usually gets 1 person to “like” their posts..🤔 Interesting (kinda) observation. I suppose you’re referring to agedhippie’s posts, which are usually informative. To me, informative posts like that are a big part of the value of this board. I “like” informative posts, yes. We MNKD longs should welcome such posts, regardless of whether the poster has 500,000 shares, or none, or anything in between. |
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Post by sayhey24 on Aug 11, 2022 5:52:57 GMT -5
Peppy - if afrezza shows superiority to the GLP1s and SGLT2s and it is listed as Step 2 in the SoC after metformin why do you think it would not get insurance coverage? The problem is not afrezza showing superiority. It can and it will if Mike does the trials. The problem is we would then be asking the ADA to totally disrupt this $40B industry. Dave Kendall thought getting the ADA to do this would be the easiest job he ever had. HA! I think unless Mike partners with a BP and approaches it as an add-on to a GLP1 and slowly over years transforms the SoC to favor afrezza this is going to end up in a huge lawsuit. Is Mike up for that? If that happens the diabetes industrial complex will do whatever it can to blackball MNKD and blackball Mike. quote, "The problem is we would then be asking the ADA to totally disrupt this $40B industry." reply, that is the problem case in point, this new legislation saying it is reducing medication prices. Limited to 20 medications. That is all they could get in the legislation, because legislators need Pharma donations/ money for re-election campaigns. So the large legislation is 20 medications..... perhaps now a 39.7 billion dollar industry. In the mean time, I am getting a medication and disease state education everyday watching the big Pharma commercials on the television. Pharma, Progressive, and the pillow guy are the only people left advertising on the boob tube, and the boob tube can not lose their last large funder, Big Pharma. Keep typing Sayhey, the industry will make people pee it out, 5 liters blood volume, these people lose too much water when the water is accompanying glucose, and become dehydrated to a point. Love my numbers, miss my leg. The reason you are seeing the Pillow Guy running commercials is no one else wanted the spot and he is picking it up last minute dirt cheap. The issue or "root cause" we are dealing with is disrupting the $40B industry. When everyone was trying to develop inhaled insulin the GLP1s, DDP4s and SGLT2s had not taken over the T2 market. Right now they are doing $30B plus. BP has a huge interest in not disrupting this gravy train. Even when not properly dosed afrezza would show superiority to these in A1c and of course TIR. So, they move the goal posts and now your are hearing weight loss. Afrezza will never beat GLP1s on weight loss because the GLP1 users don't eat much but who cares. After 6 months most stop using GLP1s. Add afrezza to a GLP1 and it will only help in stopping the spike and TIR. The T1s taking them off label seem to be having pretty good success for weight loss and of course decreased insulin use since they are not eating much. Its really up to Mike now. I think his next step will be announcing a trial against/with GLP1s probably Mounjaro but we will need to see. At this point I don't have much more I can add on the subject. We will have to wait and see and maybe do a little prodding. |
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Post by mango on Aug 11, 2022 8:14:22 GMT -5
Mike has had a lot of failures with successfully selling Afrezza. But part of being a successful and good leader is not being afraid to fail, learning from the failures and keep trying things until one leads to success. Mike admits when their marketing ideas fail, like he just did with the PCP idea.
Some of the most successful people in the world has more failures than they can count. It was just that they didn’t give up and finally did one thing right which led to their success. Some people, of course, don’t really have any failures and managed to find success on the first try. The guy that started the $1 shave club in his garage failed numerous times, until he made that 1 Youtube video of his $1 shave club mail order idea and became a billionaire from it.
Point is, we haven’t solved the Afrezza Problem yet. It appears, at least from my perspective at least, not a single entry point to success. Changing the SoC means more clinical trials since ADA is not our friend and is primarily driven by Insulin Cartel money. Just read the SoC and we are an after thought. It’s insane that ADA would not be head over heels with promoting and advocating for medical advancement such as a very safe and effective inhaled mealtime insulin.
The Afrezza Problem is a multi facet issue. We have insurance, SoC, clinical trials data and advocacy issues across the board. I think MannKind has a real shot with the Pediatric population, but we will need a successful marketing plan that drives deep into that patient population. We have to hit them with revelationary, profound ideas that drive Pediatric patient demand (which would also include the parents).
I suspect we will see better growth over time with pediatrics just organically, but if we want to really make an impact in the current adult markets we need a large scale STAT clinical trial and/or a superiority clinical trial, or something very unique. We need to exploit Afrezza’s strengths to our advantage.
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Post by peppy on Aug 11, 2022 8:24:16 GMT -5
I'll say it, Mike put in a submission for a label change?
Perhaps the black Box warning for bronco spasms since broncho spams was emitted from the Tyvasso DPI label?
Afrezza human insulin, which does not require a prescription.
Just sayin.
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Post by mango on Aug 11, 2022 9:16:48 GMT -5
I'll say it, Mike put in a submission for a label change? Perhaps the black Box warning for bronco spasms since broncho spams was emitted from the Tyvasso DPI label? Afrezza human insulin, which does not require a prescription. Just sayin. I think it’s a dosing label change if I recall. Black Box Warning label change would be nice though Afrezza doesn’t require a prescription? It says on the Afrezza website available by prescription only. |
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Post by peppy on Aug 11, 2022 10:53:48 GMT -5
I'll say it, Mike put in a submission for a label change? Perhaps the black Box warning for bronco spasms since broncho spams was emitted from the Tyvasso DPI label? Afrezza human insulin, which does not require a prescription. Just sayin. I think it’s a dosing label change if I recall. Black Box Warning label change would be nice though Afrezza doesn’t require a prescription? It says on the Afrezza website available by prescription only. I miss spoke. Human Insulin does not require a prescription is my understanding. My understanding is I can go to a Walmart pharmacy and get human insulin from the pharmacy with out a prescription. Do I have it wrong? |
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Post by markado on Aug 11, 2022 11:28:31 GMT -5
I still want our upgrade. Noone would be sticking out their neck putting a solid $10-12 pt based on the current and positively evolving scenarios. Mike should be informing analysts, accordingly, with the full expectation of an upgrade vs. begging for it/one. Once we get one, we'll get another (or two). This is the job of the CEO and chief communicator, in addition to running the show.
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Post by sayhey24 on Aug 11, 2022 11:45:48 GMT -5
I think it’s a dosing label change if I recall. Black Box Warning label change would be nice though Afrezza doesn’t require a prescription? It says on the Afrezza website available by prescription only. I miss spoke. Human Insulin does not require a prescription is my understanding. My understanding is I can go to a Walmart pharmacy and get human insulin from the pharmacy with out a prescription. Do I have it wrong? Peppy - you have it correct human insulin does not need a prescription. However afrezza is a device/drug combo and does. Should it - IMO no but Mike needs to make that fight and he has not even figured out how to sell to T2s yet. Should you just be able to buy the powder and use a refillable inhaler, I think so but these are battles for another day. On the label - If I were to guess they put in for black box removal and dosing changes. What they get we will see but IMO the black box is not stopping prescriptions being written. Removing it will have little effect Mango - I think between the kids trial and the ABC trial they will have enough to begin knocking on endos doors. There are only about 2000 in the US who prescribe if I remember correctly. They should also have enough new "data" to get some additional words in the T1 SoC. Over time affreza should grow in the T1 market. It already is starting to pick up some steam within the last 6 months. The T2 market is another animal and has its own SoC. Getting the right words in that is the keystone to insurance, prescriptions, etc. Getting afrezza its proper place in that SoC will be the "Mother of All Battles" and will require new trials. Its not the "insulin companies" who the battle is with. Its the GLP1/SGLT2 and DDP4 interests. When Mike made mention that afrezza + V-Go has 2% is of the RAA market my head nearly exploded. Afrezza should not be associated or thought of as a rapid insulin in the T2 market. Thats is the last step in the SoC. We want to be before the GLP1s. Worst is our CEO is referring to afrezza as an RAA - its not an analog. Its monomer human insulin. No one has this. Its unique. |
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Post by mytakeonit on Aug 11, 2022 13:45:28 GMT -5
markado you need to calm down. When you post and stick your neck out like that ... your head could fall off. 3 analysts already put a BUY rating on MNKD right after the conference call.
MannKind Consensus Rating and Price Target (2022) How MarketBeat Calculates Price Target and Consensus Rating
Consensus Analyst Rating - Buy
Based on 3 Analyst Ratings
Consensus Analyst Price Target $6.00
44.93% Upside
High Prediction $6.00
Average Prediction $6.00
Low Prediction $6.00
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Post by markado on Aug 11, 2022 15:13:08 GMT -5
Mtoi,
I'll take the buy ratings, but the $6 price targets are an insult at this time. I have all expectation that this will change, but the analysts aren't demonstrating superior acumen (that is better than the average retail investor) with PT's of $6. I'm losing respect for those that bothered to be on the call, this week. JMO.
Mkdo
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Post by mytakeonit on Aug 11, 2022 17:40:17 GMT -5
Analysts will always pick a number that is reachable in the near term. But, going up $2 is almost a 50% gain and not something to ignore.
But, that's mytakeonit
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