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Post by sayhey24 on Jun 11, 2022 14:16:35 GMT -5
If I was to become a type 2 diabetic is it possible with a fist full of Afrezza and a CGM to continue to eat and drink like I always have thus life more human? Ha - "Life more Human" - got to love that and Mannkind is already using it! Maybe that can go in the ad with "Medically Correct"? Maybe that flying hamburger makes more sense now. I remember some Tudiabetes people losing their minds when told they did not have to carb starve when using afrezza. God only knows what you are eating and drinking but in theory yes. You would want to crack open the 12's and make a bunch of 2 units for your snacking. You would also need to take a bunch of puffs per day with your snacks and Aged has already told use taking a puff during meals is too difficult. I am pretty sure Al had a discussion with Bernstein about using afrezza and got rebuffed as it would totally change what Bernstein was pitching. I bet if Bernstein got afrezza when his wife got him his first meter things would have been different.
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Post by peppy on Jun 11, 2022 14:31:52 GMT -5
All you Protein eaters, otherwise known as meat products, Beef/cow/MOO, Chicken/chicken/bacock.... Pork/Pig/OinkOink, Milk products, Lamb, Deer, Moose, Bear......Monkey.. Need to eat some salad with that to push the load through 23 feet of intestine........
Also, what are the chances that animal was healthy.
That's all.
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Post by hellodolly on Jun 11, 2022 14:35:46 GMT -5
All you Protein eaters, otherwise known as meat products, Beef/cow/MOO, Chicken/chicken/bacock.... Pork/Pig/OinkOink, Milk products, Lamb, Deer, Moose, Bear......Monkey.. Need to eat some salad with that to push the load through 23 feet of intestine........ Also, what are the chances that animal was healthy. That's all. Time to forget what I read in Upton Sinclair's "The Jungle".
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Post by letitride on Jun 11, 2022 14:59:02 GMT -5
God only knows what im eating but thats where the answerer to the question becomes most important does it matter? As for hitting the inhaler multiple times being to much of an inconvenience. A strict diet is by far a greater inconvenience.
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Post by mytakeonit on Jun 11, 2022 16:59:22 GMT -5
Eat more seafood, salads, and drink wine. A LOT of WINE !!!
But, that's mytakeonit (30% disabled veteran at discharge ... and numbers hasn't changed in 50 years !!! I'm still pre diabetic !!!)
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Post by agedhippie on Jun 11, 2022 22:08:11 GMT -5
God only knows what im eating but thats where the answerer to the question becomes most important does it matter? As for hitting the inhaler multiple times being to much of an inconvenience. A strict diet is by far a greater inconvenience. I agree. It's the reason I never went that route although I know people who have and their numbers are pretty much perfect. Interestingly a couple of them still got complication despite that.
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Post by beardawg on Jun 23, 2022 17:10:00 GMT -5
Aged - you said "It would probably be better to move away from the idea that Mounjaro works by making people feel nauseated." To be honest I think the entire discussion on weight loss is a red herring in the A1C discussion but a good sales pitch from Lilly. If Mounjaro is that good at reducing weight after we dial in the afrezza dosing and get the PWD stable we can add the Mounjaro. However the tech diet companies are now starting to realize what we have been saying hear on proboards and that is the T2s are gaining the weight after they lose PPG control. Who knows maybe they will be the ones to start using afrezza before the GPs. You said "Dosing is no longer once a week, but somewhere around 40 times a week for Afrezza" I really don't see that as an issue for at least 50% of the T2s. If they can pick up a fork to eat they can pick up a dreamboat. If afrezza got 50% of the T2 market it would be $10B+. Even at 10% of the market MNKD would be a $100 stock. I agree. There's a huge difference between no injections at all, and once a week injections. Once a month? maybe. Once a year? yeah, I'd go with the shot, with all else being equal. No one likes needles. If I can avoid needles, a simple dreamboat works for me.
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Post by u1682002 on Nov 13, 2022 14:06:24 GMT -5
MannKind Catalysts 🥭 Clofazimine Phase 1 readout 3Q 2022 🥭 Clofazimine FDA IND submission 4Q 2022 🥭 Nintedanib FDA pre-IND meeting with FDA 4Q 2022 🥭 Afrezza ABC Phase 4 clinical trial complete 4Q 2022 🥭 Afrezza BluHale VIS Launch Plan ready 4Q 2022 Longer term and speculative catalysts 🥭 Second United Therapeutics collaboration pipeline candidate announcement 🥭 Receptor Life Science Technosphere Cannabidiol — it could be 3-5 more years, depending on many things. My guess is any potential partners for this will want to see FDA approved clinical trial data first. Would be nice if RLS got a partnership with Jazz Pharmaceuticals. 🥭 MannKind other pipeline candidates—apparently a new pipeline asset, indication, or approval will take place each year after 2025. That’s rather ambitious, and we have heard it before from a former CEO, but we shall see. 🥭 Partnerships for our pipeline assets 🥭 Afrezza India Phase 3 clinical trial 🥭 Afrezza Pediatrics Phase 3 clinical trial That’s all I got right now I wonder if someone can give updated catalysts list for 2023. Personally, I hope “Second United Therapeutics collaboration pipeline candidate“ announcement
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Post by sayhey24 on Nov 13, 2022 18:39:58 GMT -5
From the call this week you can add for 2023
- Medicare coverage of afrezza - Mike said this will "change the game"
- new ADA category "URAA" - IMO this too could be a game changer depending on how much Mike can influence it
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Post by cjm18 on Nov 13, 2022 19:07:28 GMT -5
MannKind Catalysts 🥭 Clofazimine Phase 1 readout 3Q 2022 🥭 Clofazimine FDA IND submission 4Q 2022 🥭 Nintedanib FDA pre-IND meeting with FDA 4Q 2022 🥭 Afrezza ABC Phase 4 clinical trial complete 4Q 2022 🥭 Afrezza BluHale VIS Launch Plan ready 4Q 2022 Longer term and speculative catalysts 🥭 Second United Therapeutics collaboration pipeline candidate announcement 🥭 Receptor Life Science Technosphere Cannabidiol — it could be 3-5 more years, depending on many things. My guess is any potential partners for this will want to see FDA approved clinical trial data first. Would be nice if RLS got a partnership with Jazz Pharmaceuticals. 🥭 MannKind other pipeline candidates—apparently a new pipeline asset, indication, or approval will take place each year after 2025. That’s rather ambitious, and we have heard it before from a former CEO, but we shall see. 🥭 Partnerships for our pipeline assets 🥭 Afrezza India Phase 3 clinical trial 🥭 Afrezza Pediatrics Phase 3 clinical trial That’s all I got right now I wonder if someone can give updated catalysts list for 2023. Personally, I hope “Second United Therapeutics collaboration pipeline candidate“ announcement Would have been nice to discuss 2023 on the call But here’s 22q4 MNKD-101 (clofazimine) FDA IND submission • MNKD-101 (clofazimine) Ph 2 protocol ready • MNKD-201 (nintedanib) FDA Pre-IND meeting • Afrezza INHALE-1 50% enrolled ✓ Afrezza ABC study complete • Afrezza BluHale VIS launch-plan ready Dpi royalties. Dpi royalties. Dpi royalties. And Bear market rally.
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Post by Thundersnow on Nov 16, 2022 11:22:26 GMT -5
I am waiting on an announcement for Clofazimine. Will MNKD go it alone or take on a partner??? Mike is at a crossroads...should and could MNKD develop Clofazimine?? Mike sees the value in owning your own drug and this will make MNKD more attractive to the investment community. I believe Novartis owns the underlying drug?? Could a deal get done with them?? Are they even interested??
Many questions Mike has to answer. I believe he said they are meeting with the FDA in December so we should know something in January. If there is no announcement in 1Q23 then MNKD will develop the drug. We should know by the year end EPS Call in February.
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Post by prcgorman2 on Nov 16, 2022 11:50:55 GMT -5
It's worth reviewing the wiki on Clofazimine. en.wikipedia.org/wiki/ClofazimineMy guess is there needs to be a partner for development if the intended use of this orphan drug is for anything other than treating leprosy (in combination with other adjuncts).
I would love for more medically savvy investors (e.g., stevil) to offer some insight on how a drug approved for leprosy gets approved for anything else. e.g., treatment of SARS-COV-2.
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Post by radgray68 on Nov 16, 2022 20:01:06 GMT -5
I'd take it as a positive indication of going it alone that WE are the ones discussing the trial protocols with the FDA and NOT a partner. I'm in for getting it to at least P3 before partnering.
So watch the announcement comes out tomorrow. LOL
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Post by peppy on Nov 16, 2022 20:15:06 GMT -5
It's worth reviewing the wiki on Clofazimine. en.wikipedia.org/wiki/ClofazimineMy guess is there needs to be a partner for development if the intended use of this orphan drug is for anything other than treating leprosy (in combination with other adjuncts).
I would love for more medically savvy investors (e.g., stevil) to offer some insight on how a drug approved for leprosy gets approved for anything else. e.g., treatment of SARS-COV-2. stevil wrote, "Right now I'm holding because I have faith in UTHR and Tyvaso DPI and MNKD has some potentially lucrative prospects waiting in the wings that I want to see if anything materializes... Namely the clofazamine treatment. If it ends up being what they think it will, I think that has the potential to be a multi hundred million dollar molecule that MNKD hopefully gets to keep the vast majority."mnkd.proboards.com/thread/13476/afrezza-lack-awareness-learning-curve"The primary use of clofazimine is for the treatment of leprosy.[1] Other uses have not been proven to be safe or effective.[1] It has been studied in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in people with HIV/AIDS and Mycobacterium avium paratuberculosis. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum" en.wikipedia.org/wiki/Clofazimine
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Post by prcgorman2 on Nov 16, 2022 20:57:22 GMT -5
It's worth reviewing the wiki on Clofazimine. en.wikipedia.org/wiki/ClofazimineMy guess is there needs to be a partner for development if the intended use of this orphan drug is for anything other than treating leprosy (in combination with other adjuncts).
I would love for more medically savvy investors (e.g., stevil) to offer some insight on how a drug approved for leprosy gets approved for anything else. e.g., treatment of SARS-COV-2. stevil wrote, "Right now I'm holding because I have faith in UTHR and Tyvaso DPI and MNKD has some potentially lucrative prospects waiting in the wings that I want to see if anything materializes... Namely the clofazamine treatment. If it ends up being what they think it will, I think that has the potential to be a multi hundred million dollar molecule that MNKD hopefully gets to keep the vast majority."mnkd.proboards.com/thread/13476/afrezza-lack-awareness-learning-curve"The primary use of clofazimine is for the treatment of leprosy.[1] Other uses have not been proven to be safe or effective.[1] It has been studied in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in people with HIV/AIDS and Mycobacterium avium paratuberculosis. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum" en.wikipedia.org/wiki/ClofazimineNice find on stevil’s comments. Thank you peppy! I don’t doubt the possible utility. The question I have is how do you go from “it successfully stuck to TS and can be inhaled” to “the FDA approved inhalable clofazamine for <insert ailment here>”? First blush I’m thinking 3 phases of trials, hold your breath while the FDA fiddles around making a decision, and then Lord knows how many studies and salespeople and marketing after that? But, I don’t know the path for “orphan” drugs. Is there a get out of jail free card for that class of drugs?
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