|
|
Post by cretin11 on Sept 30, 2024 12:38:42 GMT -5
Thanks sayhey for remembering it was indeed mentioned by MNKD. If Kendall told us Afrezza needs to be SoC, then good for him, he was right then and it's still true now.
To make prc feel better: Kendall saying it would be the easiest job he ever had, now that could qualify as an example of hubris. While it wasn't as easy as he proclaimed, the truth then and still today is we need somebody up to the task. That's how we get the long awaited hockey stick growth in Afrezza TRx.
|
|
|
|
Post by sayhey24 on Sept 30, 2024 12:59:41 GMT -5
Thanks sayhey for remembering it was indeed mentioned by MNKD. If Kendall told us Afrezza needs to be SoC, then good for him, he was right then and it's still true now. To make prc feel better: Kendall saying it would be the easiest job he ever had, now that could qualify as an example of hubris. While it wasn't as easy as he proclaimed, the truth then and still today is we need somebody up to the task. That's how we get the long awaited hockey stick growth in Afrezza TRx. Agreed - IMO Dave would have been extremely disruptive to the industry if he had the resources he needed. As he said he saw veins of gold with all the studies Al Mann had already done with afrezza and Technosphere. This was why he thought is was going to be the easiest job he ever had. He clearly under-estimated BP and not having the resources he had at Lilly. It sure would be nice if he came back now that we have a little money. |
|
|
|
Post by MnkdWASmyRtrmntPlan on Sept 30, 2024 13:28:54 GMT -5
|
|
|
|
Post by prcgorman2 on Sept 30, 2024 13:38:09 GMT -5
UPDATE: Thank you @mnkdwasmyrtrmntplan for the link confirming Dr. Kendall's remarks from several years ago which I suggested earlier might have said MannKind was openly trying to change the Standard of Care.
I appreciate you guys wanting to make me feel better. Very kind of you, but totally unnecessary. I was just trying to introduce a little sobriety into the discussion after it swerved away from what was actually published about the INHALE-3 results into hypothesizing how real-world trial results might play into hypothetical business goals (i.e., SoC changes) and hypothetical impacts (i.e., insurance coverage).
|
|
|
|
Post by cretin11 on Sept 30, 2024 13:47:44 GMT -5
Thanks MWMRP for confirming sayhey’s and my recollection. SoC was the goal we know for a fact now. That was six and a half years ago. Either they have been working stealthily/secretly on it since then or they gave up. We should all be able to agree hopefully it's the former and not the latter.
|
|
|
|
Post by sayhey24 on Sept 30, 2024 14:55:23 GMT -5
Thanks MWMRP for confirming sayhey’s and my recollection. SoC was the goal we know for a fact now. That was six and a half years ago. Either they have been working stealthily/secretly on it since then or they gave up. We should all be able to agree hopefully it's the former and not the latter. They had no money. Things were put on the shelf. The last I heard from Mike the T2 market is still on the shelf. We do have a market study going on which may recommend re-entry so we will see what happens. The UTHR deal saved MNKD and now with Tyvaso DPI paying the bills and doing better than expected MNKD has a second chance. These trials take time and a lot of money. At the same time BP has taken their eye off the ball a little in the diabetes market as GLP1s found a new market in weight loss. |
|
|
|
Post by cedafuntennis on Sept 30, 2024 15:57:06 GMT -5
Good for him or maybe not. Kendal failed at the easiest job he ever had, in his own words. This is what Kendal left behind him, after pocketing millions of dollars, then slipping into the night.
|
|
|
|
Post by sayhey24 on Sept 30, 2024 17:21:18 GMT -5
Good for him or maybe not. Kendal failed at the easiest job he ever had, in his own words. This is what Kendal left behind him, after pocketing millions of dollars, then slipping into the night. I am not sure Dave failed. I think it was more that Mike could not provide the resources Dave needed to get the job done. Not long before Dave showed up was when Mike was making flying hamburger commercials and Dave had to explain that was not going to sell afrezza. I know I would be elated if he came back to help out with afrezza and SoC changes. |
|
|
|
Post by agedhippie on Sept 30, 2024 17:29:02 GMT -5
The study proves that a Type-1 can have a better A1C without being tethered to a pump. The study assumes/implies a better Time In Range. ... The trial data shared doesn't show that you can get a better A1c without being tethered to a pump, it shows that Afrezza is better than an aggregate of MDI, dumb pumps, and AID pumps. It may be the case that Afrezza does out-perform AID pumps, but right now we have no way of knowing since they didn't share that data. TIR is implied by A1c, but again there is no breakdown between the treatments so we don't know. I suspect this is all we get until 2025 based on, "We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025." |
|
|
|
Post by JEvans on Sept 30, 2024 17:50:01 GMT -5
The study proves that a Type-1 can have a better A1C without being tethered to a pump. The study assumes/implies a better Time In Range. ... The trial data shared doesn't show that you can get a better A1c without being tethered to a pump, it shows that Afrezza is better than an aggregate of MDI, dumb pumps, and AID pumps. It may be the case that Afrezza does out-perform AID pumps, but right now we have no way of knowing since they didn't share that data. TIR is implied by A1c, but again there is no breakdown between the treatments so we don't know. I suspect this is all we get until 2025 based on, "We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025." Aged.....You have always had a love affair with pumps and not so much with Afrezza, can you at least admit that ? |
|
|
|
Post by cretin11 on Sept 30, 2024 17:55:00 GMT -5
Good for him or maybe not. Kendal failed at the easiest job he ever had, in his own words. This is what Kendal left behind him, after pocketing millions of dollars, then slipping into the night. I am not sure Dave failed. I think it was more that Mike could not provide the resources Dave needed to get the job done. Not long before Dave showed up was when Mike was making flying hamburger commercials and Dave had to explain that was not going to sell afrezza. I know I would be elated if he came back to help out with afrezza and SoC changes. That makes two of us. Well said. |
|
|
|
Post by letitride on Sept 30, 2024 18:33:15 GMT -5
The future is now leave the past in the closet. Mike has been doing what others only talked about. Lets Go Mannkind!
|
|
|
|
Post by peppy on Sept 30, 2024 19:34:02 GMT -5
The study proves that a Type-1 can have a better A1C without being tethered to a pump. The study assumes/implies a better Time In Range. ... The trial data shared doesn't show that you can get a better A1c without being tethered to a pump, it shows that Afrezza is better than an aggregate of MDI, dumb pumps, and AID pumps. It may be the case that Afrezza does out-perform AID pumps, but right now we have no way of knowing since they didn't share that data. TIR is implied by A1c, but again there is no breakdown between the treatments so we don't know. I suspect this is all we get until 2025 based on, "We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025." Quote time in range is implied by A1c. Lost in the A1c are the lows that average out the highs. A1c's are lazy for the physician, and dangerous for the Subq user, in my opinion. |
|
|
|
Post by uvula on Sept 30, 2024 20:46:57 GMT -5
Slightly off topic.
If we are trying to go from a1c to tir as the best way to measure goodness, we should invent a new term that gives the best picture of goodness. If I am correct that high is better than low, we need a tir measure that penalizes lows more than highs. Does this make sense?
|
|
|
|
Post by Clement on Oct 1, 2024 5:48:57 GMT -5
Re: Inhale 3 and "time in range" There are several TIR measures under Secondary Outcome Measures in the Study Plan. One of them is "CGM-measured (24-hours) percent time in range with glucose 70-180 mg/dL from baseline to 17 weeks, for superiority assessment". 17 weeks not 30. This information for 30 weeks was not in the Study Plan. MNKD has the numbers but they are not yet public info unless they were announced with the 17 week results. clinicaltrials.gov/study/NCT05904743?term=afrezza,%20phase%204&cond=t1d&rank=7 |
|
