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Post by sayhey24 on Mar 22, 2023 18:16:36 GMT -5
On that slide presentation page 4, I wonder why Mike said this We ended 2022 with:
– 2 marketed products on our platform (Afrezza & Tyvaso DPI)+ V-Go®
I think he should have said, 3 marketed products. I know I can count to three, but you never know.... The key word "platform" - Technosphere Who knows maybe he will announce TS GLP1 trials. Hope springs eternal. |
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Post by MnkdWASmyRtrmntPlan on Mar 22, 2023 20:07:20 GMT -5
lenny what are the details of that, or what should we expect the details to be (and when)? I listened to the part about Dexcom over and over ... rewind, listen, and on and on. Here is what I got about Dexcom integration Very exciting: It’s going into testing I think next quarter (mike’s words). It’s gonna go on with 50 or 100 patients. Integrated bluehale (sounds like “business call” - I know, come on, Mike) on the back of the inhaler and now it exports to the Dexcom api, so you’ll be able to receive the Dexcom cgm lines along with all the cgm dosing in one spot that can be shared with your patients, and the patients can share with their doctors and their caregivers.
And so we’re super excited about that and we’re looking to use that in our next trials. We can actually look at dosing and dose correlations of cgm and time-in-range.
And so once that user testing is done and it looks good, then we'll be able to scale that for the launch so that will be the subject for the second NDA once we get to the first base. It looks like its finally here almost. |
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Post by cretin11 on Mar 22, 2023 21:35:29 GMT -5
Thanks MIMRP for the multiple listens to that excerpt and deciphering it! It does sound promising, looking forward to that playing out.
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Post by lennymnkd on Mar 22, 2023 23:13:38 GMT -5
From the horses mouth ! No guessing.
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Post by cedafuntennis on Mar 23, 2023 11:50:55 GMT -5
MMRP, thank you for the effort in translating this... Could you please share the counter (time) where is excerpt came from? I listened to the presentation but could not locate this section.
Never mind. Found it at 26:44 min in the presentation in the Q&A section. Thank you!!!
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Post by sayhey24 on Mar 23, 2023 15:45:43 GMT -5
I wonder what "we’re looking to use that in our next trials" are?
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Post by MnkdWASmyRtrmntPlan on Mar 23, 2023 18:29:17 GMT -5
From the horses mouth ! No guessing. Ha! Mr. Ed. Well, he gets paid like a kentucky derby winner. |
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Post by MnkdWASmyRtrmntPlan on Mar 23, 2023 18:29:54 GMT -5
MMRP, thank you for the effort in translating this... Could you please share the counter (time) where is excerpt came from? I listened to the presentation but could not locate this section. Never mind. Found it at 26:44 min in the presentation in the Q&A section. Thank you!!! Yeah, I thought of that afterward that I should have included that. Were you able to figure out that "business call" thing? |
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Post by MnkdWASmyRtrmntPlan on Mar 23, 2023 18:31:56 GMT -5
I wonder what "we’re looking to use that in our next trials" are? Hopefully, they will put together the app that he referred to integrating bluetooth with dexcom and providing the info to give to medical providers, etc. Or, will that take another year or so? |
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Post by radgray68 on Mar 23, 2023 19:02:27 GMT -5
Looking at the slides again, I see MNKD 101, 201, 301, and 501. What was 401? Anybody? Secret? Discontinued? I truly forget if there was a 401 at one time.
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Post by cretin11 on Mar 23, 2023 21:37:10 GMT -5
I wonder what "we’re looking to use that in our next trials" are? Hopefully, they will put together the app that he referred to integrating bluetooth with dexcom and providing the info to give to medical providers, etc. Or, will that take another year or so? Good question, pollworthy even (since we need something to entertain us during these doldrums), how long will it take? How long should it take? |
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Post by agedhippie on Mar 23, 2023 22:21:56 GMT -5
Hopefully, they will put together the app that he referred to integrating bluetooth with dexcom and providing the info to give to medical providers, etc. Or, will that take another year or so? Good question, pollworthy even (since we need something to entertain us during these doldrums), how long will it take? How long should it take? I think, but am not certain, that if they do that integration the app needs FDA approval because it would be a medical device. Sharing the data would require patient consent - I know a lot of diabetics (me amongst them) who refuse to let their data be shared. I will share very specifically, but not an open ended agreement like any doctor they chose. |
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Post by lennymnkd on Mar 24, 2023 1:16:43 GMT -5
What percentage of patients actually know or care what they’re signing. And just sign away …thinking it’s for their benefit.
I think your reading to much into it. Which it is for their benefit’
not to mention two approved devices/ integrated/ FDA… will probably move much faster.
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Post by hellodolly on Mar 24, 2023 5:28:16 GMT -5
Good question, pollworthy even (since we need something to entertain us during these doldrums), how long will it take? How long should it take? I think, but am not certain, that if they do that integration the app needs FDA approval because it would be a medical device. Sharing the data would require patient consent - I know a lot of diabetics (me amongst them) who refuse to let their data be shared. I will share very specifically, but not an open ended agreement like any doctor they chose.
Well, lets look again what Mike said, "...and the patients can share with their doctors and their caregivers..."
Don't try to read into this too much agedhippie. Mike shares your concerns, too. Nobody will lose any control over their data and this is a non-issue once PWDs are provided with the details and how it is designed to fully integrate with the CGM to their advantage. "I think, but am not certain, that if they do that integration the app needs FDA approval because it would be a medical device."Does FDA approval pose some sort of problem? MNKD lives in a regulatory environment and I'm pretty sure they don't see it as any sort of issue. Besides, it's likely they received some sort of feedback or guidance from the FDA very early on, even though nobody really knows if it's a "thing" or just a formed imaginary guess that we so often see posted. |
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Post by agedhippie on Mar 24, 2023 15:26:30 GMT -5
"Sharing the data would require patient consent - I know a lot of diabetics (me amongst them) who refuse to let their data be shared. I will share very specifically, but not an open ended agreement like any doctor they chose."
Well, lets look again what Mike said, "...and the patients can share with their doctors and their caregivers..."
Don't try to read into this too much agedhippie . Mike shares your concerns, too. Nobody will lose any control over their data and this is a non-issue once PWDs are provided with the details and how it is designed to fully integrate with the CGM to their advantage. "I think, but am not certain, that if they do that integration the app needs FDA approval because it would be a medical device."Does FDA approval pose some sort of problem? MNKD lives in a regulatory environment and I'm pretty sure they don't see it as any sort of issue. Besides, it's likely they received some sort of feedback or guidance from the FDA very early on, even though nobody really knows if it's a "thing" or just a formed imaginary guess that we so often see posted. I like the idea of the integration as it makes dosing a lot simpler if it's properly integrated. It's more complex than it seems because simply recording when you took a dose is not terribly useful IMHO because you want to know what the future looks like as the CGM tells you what's happening right now. This means you need to generate a predictive curve and that's the bit that gets the FDA worked up. For some reason (I have no idea why) the FDA really doesn't like bolus assistants and has blocked them from meters in the US - it's deeply annoying. Generally though I think this is a good idea. In an ideal world I would say integrate it into xDrip+ because that will get a lot of visibility amongst early adopters. |
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