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Post by MnkdWASmyRtrmntPlan on Jul 4, 2022 8:27:04 GMT -5
The article is dated July 3. It says, "For the first time this week, MannKind Corp. began shipping its “Dreamboat” inhalers to treat pulmonary arterial hypertension". If that's true, it appears that sales to which royalties apply will be reported beginning with Q3 earnings call. I would guess that "launch" happened in June, that is, promotion and samples, but maybe not any sales. Comment anyone? Yes, when the FDA approved Tyvaso-DPI, it was said that sales will be ready end of May, so June should be a complete month of sales.
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Post by MnkdWASmyRtrmntPlan on Jul 4, 2022 8:36:05 GMT -5
What we do know now from CGMs is the first thing the "prediabetic" loses is post prandial glucose control. We also know if you give them the afrezza early and often you will have a fighting chance of stopping progression. Thats what I thought too. But it doesn’t square with this quote from Mike: “I was pre-diabetic, and I knew it wasn’t a matter of if I would get diabetes — it was a matter of when.” Yeah, Exactly, he hasn't even learned what he is selling yet, let alone how to sell it. Hey, Sayhey, would you please add that to your list of things you are going to talk with that boy about.
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Post by MnkdWASmyRtrmntPlan on Jul 4, 2022 9:13:54 GMT -5
FTA: Westlake Village remains MannKind’s diabetes treatment development center, with the company preparing a Pediatric version of Afrezza for Food & Drug Administration review.
SAY WHAT? A Pediatric version of Afrezza? - Maybe they can put Clown faces, or Animals, or Marvel characters on the Dream Boats, but Afrezza is Afrezza is Afrezza!!!
- Come on, man! We're already having to wait until 2023 (or is it 24?) for peds revenue, and for sales to finally get its footing. Having to also wait to get another version FDA-approved would push it until freakin 2025!
That must be just a mistaken statement by an unseasoned writer.
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Post by sportsrancho on Jul 4, 2022 9:17:53 GMT -5
Size 2 units perhaps?
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Post by MnkdWASmyRtrmntPlan on Jul 4, 2022 9:43:39 GMT -5
Maybe. Yeah, they probably would have to get FDA approval for a 2 unit size since it is for Pediatrics. Good Grief, Lucy pulled the football again!
So, how long will it be now until kids can get Afrezza? 2024? 2025?
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Post by prcgorman2 on Jul 4, 2022 9:54:34 GMT -5
Breathe. Oxygen good. Extra small (e.g., 2 unit) cartridges are not a prerequisite for treating pediatric patients unless the patients are so small that anything larger prohibits them taking it. As you said, Afrezza is Afrezza. As for the timeline, the pediatric studies are not yet completed, analyzed, and published, and won’t be for some time (I forget the timeline). Was anyone expecting anything before 2023 at the earliest? I gave up on hoping for that some time back, around March 2020 to be exact.
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Post by peppy on Jul 4, 2022 15:32:01 GMT -5
The article is dated July 3. It says, "For the first time this week, MannKind Corp. began shipping its “Dreamboat” inhalers to treat pulmonary arterial hypertension". If that's true, it appears that sales to which royalties apply will be reported beginning with Q3 earnings call. I would guess that "launch" happened in June, that is, promotion and samples, but maybe not any sales. Comment anyone? The sample orders are shipping. Nuggets of gold. Matt P said, the sample order of afrezza was gold nuggets. sweet a PR was put out.
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Post by sayhey24 on Jul 5, 2022 6:10:14 GMT -5
A lot of people gained weight during Covid because the gyms were closed, everybody sat around in their sweatpants and didn’t do anything, there was no reason to buy new clothes yada yada yada. Myself included.. I had to start jogging, but I lost muscle because I don’t have a home gym. Took me eight months to get my strength back. Yep true - but the research is pointing to the SARS virus. A lot of people got fat but didn't get T2. Here is an example www.sciencedaily.com/releases/2022/03/220321115835.htmJoslin identified 4 viruses years ago. Here is the thing - through autopsy we know obese non-diabetics will grow more beta cells. The body is amazing and will adapt to weight gain. We also know diabetics lose beta cell mass regardless of being them fat or not. I know some very fit T2s. They are just not making enough insulin.
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Post by mango on Jul 5, 2022 7:36:04 GMT -5
Well, contrary to what many on this board has claimed over the years, CEO Mike Castagna did in fact play a key role in the UT deal and Treprostinil partnership.
Costagna said Rothblatt approached him in 2018 about the possibilities to use MannKind inhalers as a treatment delivery option for United Therapeutics.
“What can I do to help MannKind?” Castagna recalls Rothblatt asking him in 2018, after the topic of a collaboration was broached. “(Rothblatt) is a visionary.”
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Post by sportsrancho on Jul 5, 2022 7:57:36 GMT -5
No
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Post by prcgorman2 on Jul 5, 2022 8:23:06 GMT -5
Is there anyone who believes MC did not manage the partnership from early days before there was ink on paper regardless of whether he initially got it started or not?
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Post by sayhey24 on Jul 5, 2022 13:34:03 GMT -5
Is there anyone who believes MC did not manage the partnership from early days before there was ink on paper regardless of whether he initially got it started or not? I give Mike a lot of credit for keeping the lights on and the open for business sign on the door. In my mind there is no doubt Martine threw Mike a life line but Mike gets credit for closing the deal even if it was a layup. Even Steve Jobbs needed a life line from Bill Gates to keep the lights on at Apple back in the day. I am sure there where nights Mike could not sleep worrying about how he was going to pay the bills. The thing is Tyvaso DPI is not getting MNKD to $10 let alone $100 but it should keep the lights on. For 6 years Mike has been sitting on what Al Mann said should be the greatest selling drug of all time. It took Mike 5 years to figure out the dosing was wrong. Then he buys V-Go while telling us he is a T2 on afrezza. Why should he get afrezza and every other T2 gets metformin and the GLP1, then the SGLT2 and then subq or Mike's RAA in a spring-loaded pump? My concern is he seems to really be struggling to figure out how to sell to the T2s. I think with the kids trial they will follow the same pattern that happened when pumps were first introduced. I think over time more and more T1s will be afrezza users but the T1 market is tiny compared to the T2s. For MNKD to get to the $100+ he needs to crack the T2 market. The last he told us the T2 market was "On Ice" and then we hear the India trial is basically a redo of the Affinity2 trial. We need Mike to deliver on the T2 market.
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Post by sportsrancho on Jul 5, 2022 14:11:57 GMT -5
Doesn’t matter who started what, what matters is what sayhey is saying.
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Post by prcgorman2 on Jul 5, 2022 14:32:12 GMT -5
OK, good, we've agreed the Chief Executive Officer executed when it was critical.
I do not believe in magic. I believe what Bill McCullough said about doctors being highly educated providers of a service with very few innovators or risk takers. I agree that an at-scale study designed to illustrate the benefit of Afrezza for treating T2s (i.e., Afrezza superior to RAA) is needed, as well as buy-in (buying?) PBMs to get Tier 1 insurance coverage without Prior Auth and STEP requirements.
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Post by agedhippie on Jul 5, 2022 14:45:51 GMT -5
OK, good, we've agreed the Chief Executive Officer executed when it was critical. I do not believe in magic. I believe what Bill McCullough said about doctors being highly educated providers of a service with very few innovators or risk takers. I agree that an at-scale study designed to illustrate the benefit of Afrezza for treating T2s (i.e., Afrezza superior to RAA) is needed, as well as buy-in (buying?) PBMs to get Tier 1 insurance coverage without Prior Auth and STEP requirements. That study has to come sooner rather than later. After SURPASS-1 and SURPASS-2 (475 and 1,879 participants respectively) Mounjaro is aiming to be the first line choice for T2. These are studies that are large enough to get written up in the journals that matter like the Lancet, NEJM, and Diabetes Care. This is the sort of thing that moves the SoC. They are making the case that Mounjaro out-performs GLP-1 (SURPASS-2), and addresses the heart and kidney complications from Type 2 as well. They are building a (convincing) narrative that GIP/GLP-1 is simply the only option and once that is done changes gets harder.
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