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Post by prcgorman2 on Jun 4, 2023 14:47:42 GMT -5
Agree lenny. It’s easy to simply say “the FDA makes it too difficult” but the successful companies don’t let that stop them. Afrezza has so much going for it, a good marketing campaign is most definitely possible (and should’ve already happened). It’s easy to simply say (emphasis on “simply”) “successful companies don’t let that stop them”. That platitude is worth the money I paid to read it. Wave your hands, be dismissive. The FDA publishes their rules and anyone who wishes to educate themselves about the reality of marketing within FDA regulations can take the time to read it for themselves. If anyone can quote chapter and verse what the challenges are and then make a detailed argument why MNKD could “simply say” “we won’t let that stop us”, I might be persuaded but hand waves will get you one in response but not with all of the digits extended. I studied this topic of marketing drugs and Afrezza years ago because I also thought all we needed was a good marketing campaign. agedhippie, matt, and others tried to persuade me differently and after the sustained attempt that spent $10M+ (going from memory) without budging the needle, I became convinced, finally, that DTC was not what was missing from MannKind’s marketing strategy, at least not given the lack of clinical data needed to persuade SAFETY and superiority. We’re finally getting there with the Pediatrics Trial, and that was interrupted by COVID, so it’s been a long time coming, but the early indications we’ve read here are that the results are good and will be persuasive. Once that’s complete and assuming the results should “move the needle”, THEN it would make more sense to re-attempt a sustained DTC campaign, and I assume not before then. Others can feel differently of course, and not to be rude, but unless there’s some marketing experience and credentials to back up the assertions, it’s just more platitudes and BS.
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Post by akemp3000 on Jun 4, 2023 15:01:58 GMT -5
I agree and to add believe with pediatric approval, the company will have two strong options; go it alone with DTC advertising or partnership. Pediatric approval is a much bigger DTC message to take to market than anything to date. It eliminates the barrier that "Afrezza is going away" or prescribing insulin has to be the last resort. As for a partnership, it would not be surprising to learn that one has been in the works and is only pending pediatric approval.
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Post by lennymnkd on Jun 4, 2023 15:21:38 GMT -5
We already ran a commercial add , just not the right one often enough.. so I guess the hurdles at that time weren’t very high . it may be more difficult in what’s coming,,, but I believe will be achievable.
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Post by cretin11 on Jun 5, 2023 6:29:13 GMT -5
Agree lenny. It just may be that flying hamburgers was not the best way to sell Afrezza. (Cue prcgorman explaining that commercial was “award winning”)
Also agree that having a big piece of a huge pie is better than owning 100% of some crumbs. akemp you’re hopefully right that we have a partnership deal in the works, just awaiting peds to be announced. If not, it would be reasonable to question why not.
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Post by prcgorman2 on Jun 5, 2023 7:14:50 GMT -5
The commercial won some industry award, but no idea why. I was not a fan of the flying hamburgers. Having known and worked with professionals in Corporate Communications, PR, and marketing, I can understand how the FDA restrictions (because TV commercials require pre-approval is my memory) and the conversation around “the value proposition” and the “call to action” could result in flying hamburgers, but I found it very disappointing other than I liked seeing TV commercials for Afrezza.
I’d like to blame the commercial for the dismal results but if the arguement was the most imiiportant issue was complete lack of awarenesss, the campaign should have had measurable results. But remember, those results (i.e., improved sales of Afrezza) were dependent on persons with diabetes becoming aware of Afrezza and being persuaded to argue with their doctor to get a prescription for Afrezza. The DTC experiment proved to my dissatisfaction that DTC wasn’t the ticket to improved sales, at least not at that time. And to the credit of agedhippie, Matt, and others, they predicted as much.
The remaining headwinds are persuading the prescribers (with clinical evidence) and bribing the Pharmacy Branch Managers with discounts so that Afrezza receives better tier coverage in the insurance formularies. I agree with sayhey24 that the Inflation Reduction Act requirement for $35 max copay on insulin may have significantly lowered the insurance barrier for senior citizens on Medicare, but that’s also a wait-and-see situation. Patience grasshopper.
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Post by cretin11 on Jun 5, 2023 7:57:56 GMT -5
Hmm, let me guess, you also have many leather-bound books and your apartment smells of rich mahogany?
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Post by agedhippie on Jun 5, 2023 8:09:25 GMT -5
My expectation after pediatric availability is that sales in that sector will expand to a bit less than the percentage share that Afrezza has in the adult market. Things to remember though; the adult market is far bigger than the pediatric market, and that I think Afrezza for kids below ten is a hard sell (do you trust a kid that age to always have their Afrezza on them and to always use it when they snack?) The endos are already heavily pushing pumps for kids because it backstops responsibility for managing their diabetes from the kid. The weak link for Afrezza is that management and it will more than balance out Afrezza's superior performance in the endo mind.
I feel that when kids become more responsible as they get older will be Afrezza's sweet spot. They will still have the same insurance headwinds though. Initially there is going to be a sharp ramp up as people start to onboard, but if I was modelling this I would expect it to run about 30% of the adult market after a year or so when the pent up demand is met. (In case it's not obvious that 30% is a SWAG.)
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Post by akemp3000 on Jun 5, 2023 8:20:39 GMT -5
The benefits of pediatric approval will extend far beyond pediatric scripts and pediatric market share. It will greatly improve the sales story by Afrezza reps. It will open endo's eyes to the safety of Afrezza. It sends a so-called "shot heard round the world" to BPs that Mannkind, Technosphere and Afrezza are on the verge of becoming a significant player. It will offer an opportunity for DTC marketing that has not existed previously. It might even put the company in play. There's more. Just wanted to emphasize that pediatric approval isn't only about pediatric scripts.
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Post by sayhey24 on Jun 5, 2023 8:54:55 GMT -5
My expectation after pediatric availability is that sales in that sector will expand to a bit less than the percentage share that Afrezza has in the adult market. Things to remember though; the adult market is far bigger than the pediatric market, and that I think Afrezza for kids below ten is a hard sell (do you trust a kid that age to always have their Afrezza on them and to always use it when they snack?) The endos are already heavily pushing pumps for kids because it backstops responsibility for managing their diabetes from the kid. The weak link for Afrezza is that management and it will more than balance out Afrezza's superior performance in the endo mind. I feel that when kids become more responsible as they get older will be Afrezza's sweet spot. They will still have the same insurance headwinds though. Initially there is going to be a sharp ramp up as people start to onboard, but if I was modelling this I would expect it to run about 30% of the adult market after a year or so when the pent up demand is met. (In case it's not obvious that 30% is a SWAG.) IDK - IMO with the kids its more about the moms and less about the endos. Its really about how good afrezza is with the kids. If the kids are seeing great success word will spread quickly through social media support groups. Moms not the endos will make this happen. My granddaughter is 8 and I would have absolutely no concerns with her using afrezza on her own. My five year old grandson I would have no issues taking but he would require supervision. It really depends on the kid and they are all different but the moms know. BTW - no need for pumps as a backstop when you have the CGM. Sports posted about pump sales reps already spreading the word with endo's that afrezza is being discontinued. I see that as great news for afrezza as they must already be concerned about the pediatric impact. The last time we saw this type of rumor spreading was 2014/2015 when Al was telling everyone afrezza would be the greatest selling drug of all time. I have met few moms who really enjoy having their kids wear pumps. If they can get as good control with 1 shot a day plus afrezza I think we will have great demand. If they get better mealtime control and no fear of nigh time hypos word will spread on social media really fast. If icodec is any good and they can go to one shot a week plus afrezza and the CGM - that would be huge. Right now we are in a waiting period. Having 9 years of lung history will make it hard for BP to play that card again but they will. We know they will tell us the kids lungs will explode. No one is buying MNKD is going out of business. We all have our opinions on market penetration but mine is it will change T1 care if afrezza is as good as we think. For the T2s, let wait and see what India brings us and hope Mike's 1.5-2.0% A1c reduction is correct. While we are waiting lets gets the TS GLP1 Phase 2/3 trial going. This could be the greatest selling drug of all time. I saw today where Weight Watchers and some others are getting into the GLP1 business.
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Post by agedhippie on Jun 5, 2023 9:59:39 GMT -5
IDK - IMO with the kids its more about the moms and less about the endos. Its really about how good afrezza is with the kids. If the kids are seeing great success word will spread quickly through social media support groups. Moms not the endos will make this happen. My granddaughter is 8 and I would have absolutely no concerns with her using afrezza on her own. My five year old grandson I would have no issues taking but he would require supervision. It really depends on the kid and they are all different but the moms know. BTW - no need for pumps as a backstop when you have the CGM. Sports posted about pump sales reps already spreading the word with endo's that afrezza is being discontinued. I see that as great news for afrezza as they must already be concerned about the pediatric impact. The last time we saw this type of rumor spreading was 2014/2015 when Al was telling everyone afrezza would be the greatest selling drug of all time. I have met few moms who really enjoy having their kids wear pumps.... Based on my experience with the parents of T1 kids I feel you are overestimating how willing parents will be to overrule their kid's endo but time will tell. They follow everything obsessively, but they are very reluctant to go counter to the endo (I have tried on things I saw as no-brainers.) The argument is going to go like this: Parent: Look at these wonderful trial results, I want my kid on this. Endo: Ah, but they are comparing Afrezza to shots. We don't suggest using shots any more because pumps a vastly superior, look at this real world data are against shots and I wouldn't suggest using shots we have moved past that, they should be on a pump because that is far better. Parent: Do you have anything to support that? Endo: Sure, look at this real world data for the Medtronics pump ( Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users) and remember this is kids in the real world when you cannot be standing over them. This is why we believe pumps are better and they continue to improve. That's hard to argue with. Beyond that I don't believe a kid should be making life or death decisions even if they appear able, I have seen the psychological fall out from that and it is not pretty. The primary motivator used to secure the child's compliance is fear (do exactly this or you will die horribly if you deviate in any way at all) so the end result is predictable. There is a paper out there to be research on the incidence and levels of PTSD in adults who were child diabetics.
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Post by sayhey24 on Jun 5, 2023 12:29:27 GMT -5
IDK - IMO with the kids its more about the moms and less about the endos. Its really about how good afrezza is with the kids. If the kids are seeing great success word will spread quickly through social media support groups. Moms not the endos will make this happen. My granddaughter is 8 and I would have absolutely no concerns with her using afrezza on her own. My five year old grandson I would have no issues taking but he would require supervision. It really depends on the kid and they are all different but the moms know. BTW - no need for pumps as a backstop when you have the CGM. Sports posted about pump sales reps already spreading the word with endo's that afrezza is being discontinued. I see that as great news for afrezza as they must already be concerned about the pediatric impact. The last time we saw this type of rumor spreading was 2014/2015 when Al was telling everyone afrezza would be the greatest selling drug of all time. I have met few moms who really enjoy having their kids wear pumps.... Based on my experience with the parents of T1 kids I feel you are overestimating how willing parents will be to overrule their kid's endo but time will tell. They follow everything obsessively, but they are very reluctant to go counter to the endo (I have tried on things I saw as no-brainers.) The argument is going to go like this: Parent: Look at these wonderful trial results, I want my kid on this. Endo: Ah, but they are comparing Afrezza to shots. We don't suggest using shots any more because pumps a vastly superior, look at this real world data are against shots and I wouldn't suggest using shots we have moved past that, they should be on a pump because that is far better. Parent: Do you have anything to support that? Endo: Sure, look at this real world data for the Medtronics pump ( Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users) and remember this is kids in the real world when you cannot be standing over them. This is why we believe pumps are better and they continue to improve. That's hard to argue with. Beyond that I don't believe a kid should be making life or death decisions even if they appear able, I have seen the psychological fall out from that and it is not pretty. The primary motivator used to secure the child's compliance is fear (do exactly this or you will die horribly if you deviate in any way at all) so the end result is predictable. There is a paper out there to be research on the incidence and levels of PTSD in adults who were child diabetics. Wow - I did not realize that you were a pump rep for Medtronics. Time will tell. I believe in the power of moms but it all depends on just how good afrezza is with the kids. It seems pretty good, maybe better than good. We will see once the trial numbers are in. Who knows, maybe afrezza can help reduce the amount of PTSD in the parents. Here are the things which worked in the past to attack afrezza use 1. lung concerns from cancer to exploding lungs 2. It does not work 3. hypoglycemia 4. fear of trying something unproven 5. afrezza is being discontinued 6. the cough 7. cost I don't think any of these will work large scale this time around. With the moms able to track the kids CGM on their phones I don't think the fear factor will work. I am not aware of a single case of severe hypoglycemia where the afrezza user died. Has one even been hospitalized??? I am also not aware of a single case where afrezza caused a lung cancer case since approval. The funny thing on the cough is we never hear about it with Tyvaso DPI so it can't be that bad. I am sure someone can dream up another roadblock. There has to be something but I have no idea what.
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Post by prcgorman2 on Jun 5, 2023 13:51:56 GMT -5
<abbr> agedhippie said stuff that got edited out by prcgorman2 for purposes of brevity (you're welcome radgray and cretin) but is available 2 posts above...</abbr> With the moms able to track the kids CGM on their phones I don't think the fear factor will work. I am not aware of a single case of severe hypoglycemia where the afrezza user died. Has one even been hospitalized??? I am also not aware of a single case where afrezza caused a lung cancer case since approval. The funny thing on the cough is we never hear about it with Tyvaso DPI so it can't be that bad. I am sure someone can dream up another roadblock. There has to be something but I have no idea what. SAFETY, SAFETY, SAFETY. "It's the SAFETY, stupid."
Can't wait to see how these predictions turn out.
On a separate topic (i.e., the topic of this thread), a family member started Ozempic over the weekend and only threw up 3 times (so far). The doctor told her that the nausea and vomiting typically goes away after a few days and at most a few weeks.
agedhippie (and/or others) is there any reason to believe an inhalable version of GLP-1 would reduce the nausea and other side-effects?
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Post by prcgorman2 on Jun 5, 2023 13:55:29 GMT -5
Hmm, let me guess, you also have many leather-bound books and your apartment smells of rich mahogany? I do have leather-bound books! One is a Christian Bible. The other is a Tanach. And, the table I began using as a desk when COVID hit is stained to look like mahogany. Does that count?
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Post by cretin11 on Jun 5, 2023 16:28:28 GMT -5
Hmm, let me guess, you also have many leather-bound books and your apartment smells of rich mahogany? I do have leather-bound books! One is a Christian Bible. The other is a Tanach. And, the table I began using as a desk when COVID hit is stained to look like mahogany. Does that count? It would be a stretch to classify two books as many, and a mahogany-colored stained table likely does not actually smell of rich mahogany. But let's be charitable and call it close enough, so we can say: Stay classy San Diego!
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Post by agedhippie on Jun 5, 2023 16:36:31 GMT -5
Wow - I did not realize that you were a pump rep for Medtronics. Time will tell. I believe in the power of moms but it all depends on just how good afrezza is with the kids. It seems pretty good, maybe better than good. We will see once the trial numbers are in. Who knows, maybe afrezza can help reduce the amount of PTSD in the parents. ... A Medtronics pump rep because I cited a paper using their data? I guess if you can't disprove the data you try calling the poster names and see if that distracts people. Remember - the trial is not against AID pumps, it was against pens. The response will go exactly as I described it; Afrezza is good, but that was not against AID pumps and those are better since they manage your levels all the time and not just when you dose. Endos in my hospital group don't mess around, they put you on a pump at diagnosis even in the pre-AID days (even dumb pumps give better results than pens.) My PTSD concern if for the kids rather than the parents. Since you seemed to have missed that here it is again; " The primary motivator used to secure the child's compliance is fear (do exactly this or you will die horribly if you deviate in any way at all) so the end result is predictable. There is a paper out there to be research on the incidence and levels of PTSD in adults who were child diabetics."
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