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Post by Deleted on Jun 2, 2022 11:30:10 GMT -5
The next big catalyst will be getting Clozafimine through Phase 1 and signing up a partner which could take place by year end and then the 3 year track will start to get it to market. MNKD could buy more assets. I don't think a partnership will come for Afrezza until PEDS is about to be approved. I don't think PEDS will drive the afrezza partnership. The big market for afrezza is with the T2s. While PEDS will give it additional credibility it is a completely different market and sales approach. It is also a significantly smaller market. I think the next big catalyst will be a partnered Affinty-2 follow-up with CGMs and proper dosing narrowed to the GLP1s. If they can show superiority in that trial the sky is the limit. I appreciate your persistence with your Type 2 strategy but do you realize how hard it is to convince/persuade a Type 2? First of all most (like 75%) take oral meds and the other 25% take GLP-1s (one shot a week - Trulicity and others). There is no way you're going to convince a T2 to take insulin with these other options. Like Mike said if you get a young (5 - 21 year old) on Afrezza and show them how easy it will be to administer and control their BG you will have a patient for life. Just think about the parents and school nurses who can give Afrezza without worrying about needles, infections and dosing. The Type 1 market (even though it's smaller than T2) is the holy grail for MNKD at this time. As I've said before a BP Partner with clout and money will be needed to convince T2's to take INSULIN. Also you will need a huge educational campaign on insulin because diabetics have heard the stories of how dangerous it is. We will need money like DXCM. I see at least 2-3 TV ads per hour. Even Type 2's on orals or GLP-1 don't use a CGMs. Most T2's on orals don't even prick their finger. |
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Post by Deleted on Jun 2, 2022 11:34:41 GMT -5
Most companies never make it past Phase 3, let alone an FDA approval with a clean label, and even more so with a drug-device combo (even more difficult). This is MannKind’s second time and we got the clean label we all knew we would (based on the science). Our dry powder and inhaler are completely validated. We have successfully gotten FDA approval for two drug-device products using Technosphere and our dreamboat, with two completely different API. That’s quite an achievement. This approval puts us in a position of strength. So why is the stock UNDER $4.50??? |
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Post by akemp3000 on Jun 2, 2022 11:50:03 GMT -5
IMO, the biggest obstacle to Afrezza has been that all doctors are taught in med school to prescribe insulin ONLY as a last resort because it can cause hypos and death. These were my doctor's words. Afrezza offers a new and very different perspective that has not yet been sufficiently heard, understood or accepted by the mainstream. FDA approval for pediatrics should be a huge game changer because it would send a powerful message to doctors that Afrezza insulin is safe. It's hard to imagine any educated parent ever again choosing shots over inhalation for their child at mealtime. This would change everything and should become game on with the BPs.
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Post by sayhey24 on Jun 2, 2022 11:59:47 GMT -5
I don't think PEDS will drive the afrezza partnership. The big market for afrezza is with the T2s. While PEDS will give it additional credibility it is a completely different market and sales approach. It is also a significantly smaller market. I think the next big catalyst will be a partnered Affinty-2 follow-up with CGMs and proper dosing narrowed to the GLP1s. If they can show superiority in that trial the sky is the limit. I appreciate your persistence with your Type 2 strategy but do you realize how hard it is to convince/persuade a Type 2? First of all most (like 75%) take oral meds and the other 25% take GLP-1s (one shot a week - Trulicity and others). There is no way you're going to convince a T2 to take insulin with these other options. Like Mike said if you get a young (5 - 21 year old) on Afrezza and show them how easy it will be to administer and control their BG you will have a patient for life. Just think about the parents and school nurses who can give Afrezza without worrying about needles, infections and dosing. The Type 1 market (even though it's smaller than T2) is the holy grail for MNKD at this time. As I've said before a BP Partner with clout and money will be needed to convince T2's to take INSULIN. Also you will need a huge educational campaign on insulin because diabetics have heard the stories of how dangerous it is. We will need money like DXCM. I see at least 2-3 TV ads per hour. Even Type 2's on orals or GLP-1 don't use a CGMs. Most T2's on orals don't even prick their finger. Casper - what am I missing? Why do the T2s take oral meds? And then, why do they take GLP1s ($11B sales) and SGLT2s ($7B). I would argue because the SoC says so and their doctor is following the SoC. The T2 is pretty much going to do what they are told by their doctor. Its really that simple. Step 1 in changing the T2 SoC is doing the Affinity2 follow-up and I would do it only against Mounjaro. Lets get a partner to help with this study. When Mike is saying "if you get a young (5 - 21 year old)" that the T1 market and is completly different from the T2 market. How you market and how you sell is night and day. The T1 market is no where close to the holy grail. DXCM has done very well in the T1 market but they also know the big money is with the T2s. Lets see what happens here. BTW- Getting the kids day 1 on afrezza is the right approach because changing people like "Aged" is just not going to happen on a large scale. |
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Post by awesomo on Jun 2, 2022 11:59:53 GMT -5
Most companies never make it past Phase 3, let alone an FDA approval with a clean label, and even more so with a drug-device combo (even more difficult). This is MannKind’s second time and we got the clean label we all knew we would (based on the science). Our dry powder and inhaler are completely validated. We have successfully gotten FDA approval for two drug-device products using Technosphere and our dreamboat, with two completely different API. That’s quite an achievement. This approval puts us in a position of strength. So why is the stock UNDER $4.50??? Because they have yet converted any of that "strength" to actually making money. Hopefully Tyvaso changes this, but they need to show results. |
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Post by akemp3000 on Jun 2, 2022 13:40:45 GMT -5
Results seem to be as close to guaranteed as possible and should become visible in the Q2 earnings report in early August. If so, the street should take notice and this little company may finally leave the launching pad  |
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Post by cretin11 on Jun 2, 2022 13:45:22 GMT -5
So why is the stock UNDER $4.50??? Because they have yet converted any of that "strength" to actually making money. Hopefully Tyvaso changes this, but they need to show results. Yes. But be prepared for some people to attribute it instead to manipulation, naked shorting and other such shenanigans. The market has done the math on our expected revenues from Tyvaso. Martine will deliver that revenue. The good news is our share price seems to reflect lack of confidence that our leadership team can deliver more results. That’s good news because it means with just average performance we can exceed those basement expectations. For example, let’s start issuing guidance like other respected companies, that’s a layup and should occur at next quarterly call. Get the bb warning off Afrezza, also should be doable now given Tyvaso’s clean label. These are easy ones that’ll boost our price, especially as the Tyvaso royalties become reality. And then other deals, legit partnerships, etc. will be needed to get share price where we all want it to go. It’s easy to see why many here believe we are a screaming value at these sub $5 prices. Most here think MC is an excellent CEO. If he’s merely average we are underpriced, and if he is truly excellent he will deliver on the above and much more, and then those triple digits (which remember is only $20 reverse split adjusted) can become reality. |
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Post by sayhey24 on Jun 2, 2022 14:21:25 GMT -5
Because they have yet converted any of that "strength" to actually making money. Hopefully Tyvaso changes this, but they need to show results. Yes. But be prepared for some people to attribute it instead to manipulation, naked shorting and other such shenanigans. The market has done the math on our expected revenues from Tyvaso. Martine will deliver that revenue. The good news is our share price seems to reflect lack of confidence that our leadership team can deliver more results. That’s good news because it means with just average performance we can exceed those basement expectations. For example, let’s start issuing guidance like other respected companies, that’s a layup and should occur at next quarterly call. Get the bb warning off Afrezza, also should be doable now given Tyvaso’s clean label. These are easy ones that’ll boost our price, especially as the Tyvaso royalties become reality. And then other deals, legit partnerships, etc. will be needed to get share price where we all want it to go. It’s easy to see why many here believe we are a screaming value at these sub $5 prices. Most here think MC is an excellent CEO. If he’s merely average we are underpriced, and if he is truly excellent he will deliver on the above and much more, and then those triple digits (which remember is only $20 reverse split adjusted) can become reality. I can tell you why I am here. MNKD has an approved product which if properly marketed should be one of the greatest selling drugs of all time. All the worries and concerns which many first had with long term safety issues and was afrezza as good as we had first thought are no longer concerns. Afrezza is better. The first problem is the street currently views afrezza as it first predicted it would and that is it would be a niche drug with limited sales. Its really hard to argue with that and if I did not know better I would fully agree with this assessment. The thing is the street does not fully understand the diabetes market and that it is really two separate markets. The second problem is our CEO until very recently never really understood afrezza and the difference between the T1 and T2 market. He has never explained the two to the street and granted people want to conflate the two. The street understands simple and at this point needs to see results. I think Tyvaso DPI is discounted based on MNKD results to date. |
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Post by mango on Jun 2, 2022 16:58:27 GMT -5
So why is the stock UNDER $4.50??? Because they have yet converted any of that "strength" to actually making money. Hopefully Tyvaso changes this, but they need to show results. Why do they require more results from MannKind, and not for other companies with far less, far less capital, no FDA approved products, dismal revenue, etc…? |
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Post by awesomo on Jun 2, 2022 17:23:22 GMT -5
Because they have yet converted any of that "strength" to actually making money. Hopefully Tyvaso changes this, but they need to show results. Why do they require more results from MannKind, and not for other companies with far less, far less capital, no FDA approved products, dismal revenue, etc…? Because MannKind's shine has long wore off since Afrezza has been in the market for 8 years, has never made money in a quarter, and has yet to crack 1,000 scripts/week. Wall Street doesn't care one bit for it's "potential", it is not a speculative stock anymore. |
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Post by Deleted on Jun 2, 2022 18:50:02 GMT -5
Why do they require more results from MannKind, and not for other companies with far less, far less capital, no FDA approved products, dismal revenue, etc…? Because MannKind's shine has long wore off since Afrezza has been in the market for 8 years, has never made money in a quarter, and has yet to crack 1,000 scripts/week. Wall Street doesn't care one bit for it's "potential", it is not a speculative stock anymore. Exactly - Over the last 8 years MNKD has lost the confidence of Wall Street. It will take time (at least 2 Qtrs w/ GUIDANCE) to get it back. Mike needs to get into the faces of Top Tier Wall Street Houses and tell the MNKD story. It's time to take MNKD to the next level. Is Mike up to the job??? His whole career has been as a TURNAROUND Specialist....now he has to be a MARKETER of the company. |
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Post by agedhippie on Jun 2, 2022 19:01:31 GMT -5
Casper - what am I missing? Why do the T2s take oral meds? And then, why do they take GLP1s ($11B sales) and SGLT2s ($7B). I would argue because the SoC says so and their doctor is following the SoC. The T2 is pretty much going to do what they are told by their doctor. Its really that simple. ... They take oral meds because it's easy and until TIR becomes the standard it appears effective. Given the choice between one injection a week and one of two inhales every time they eat it's never even going to be a contest. From a compliance standpoint the fewer doses the better - once a day is good, once a week is better, three to six times a day is not good. Compliance in chronic diseases with little obvious penalty for non-compliance has historically been awful. |
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Post by agedhippie on Jun 2, 2022 19:10:12 GMT -5
IMO, the biggest obstacle to Afrezza has been that all doctors are taught in med school to prescribe insulin ONLY as a last resort because it can cause hypos and death. These were my doctor's words. Afrezza offers a new and very different perspective that has not yet been sufficiently heard, understood or accepted by the mainstream. FDA approval for pediatrics should be a huge game changer because it would send a powerful message to doctors that Afrezza insulin is safe. It's hard to imagine any educated parent ever again choosing shots over inhalation for their child at mealtime. This would change everything and should become game on with the BPs. To be clear here. The competition in pediatrics is not shots, it's automated insulin delivery via a pump. The default action for new Type 1 diabetics is to immediately get them on a pump if their insurance covers it. These days the focus for kids is the automated delivery pumps. |
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Post by sweedee79 on Jun 2, 2022 19:50:50 GMT -5
I don't care one bit for these shots once a week or the side effects.... My dad can't even go anyplace because he has to be near a bathroom at all times... It's been so bad that they had to cut the dose in half... I am awaiting his A1C... How much you wanna make a bet it is going to be horrible... Ozempic is bad stuff... Anything that causes chronic diarrhea can't be good!!!!
Not ALL kids think pumps are the way to go... Just ask Afrezza Jake!!!!
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Post by prcgorman2 on Jun 2, 2022 19:59:26 GMT -5
I don't care one bit for these shots once a week or the side effects.... My dad can't even go anyplace because he has to be near a bathroom at all times... It's been so bad that they had to cut the dose in half... I am awaiting his A1C... How much you wanna make a bet it is going to be horrible... Ozempic is bad stuff... Anything that causes chronic diarrhea can't be good!!!! Not ALL kids think pumps are the way to go... Just ask Afrezza Jake!!!! The kids don’t prescribe their treatment. And I agree with Aged that being successful with kids and T1 kids especially would be huge. I’ve begun to say, “Afrezza is the SAFE choice”. I’m hoping it catches on. Early on in my career I remember hearing the phrase, “Nobody ever got fired for buying Big Blue”. It was a truism that IBM computers, typewriters, and other business equipment were the safe choice. SAFETY matters. Afrezza is the SAFE choice. |
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