|
|
Post by mango on Jan 21, 2022 11:20:23 GMT -5
The famous pilot Phase 4 clinical trial called, STAT demonstrated phenomenal results. It is regarded as one of MannKind investor’s favorites and one of the best-to-date clinical studies MannKind has achieved. Despite this, the trial did not make large ripples in the ADA’s Standards of Care because of the small size of the study. MannKind itself refers to the study as a pilot study—usually pilots are meant as a foundation to investigate a hypothesis and see if further investigation is warranted. In the case of STAT, it clearly is. Let’s review the STAT results: “Compared to standard of care for mealtime therapy, the per-protocol use of Afrezza (i.e. supplemental doses 1 and/or 2 hours post-meal), on average demonstrated: • Significantly increased glucose TIR by approximately 2 hours per day • Significantly reduced time in hyperglycemia > 180 mg/dL • Significantly lower PPGE 1 to 4 hours post-meal • Significant reductions in glucose as early as 60 minutes following Afrezza dose • Less hypoglycemia (as measured by time spent less than 60 mg/dL); notably, the average Afrezza-treated individual spent approximately 3 minutes per day with blood glucose values less than 50 mg/dL compared to approximately 12 minutes per day for aspart-treated individuals This is the first of a number of planned randomized trials, intended to evaluate the potential benefits of Afrezza (Technosphere Insulin) compared to the standard of care for mealtime plus basal insulin.” investors.mannkindcorp.com/node/15846/pdfAs we can see, the results were significant and warrant further, large scale investigation. MannKind has the opportunity to change the ADA Standards of Care with a large scale STAT study, demonstrating superiority and establishing Afrezza as the Standard in Mealtime Control. I urge michaelcastagna to consider partnering with Dexcom or similar BP company to launch this trial. The pilot results are too powerful to ignore—the holy grail of diabetes is in MannKind’s possession. |
|
|
|
Post by sportsrancho on Jan 21, 2022 11:28:02 GMT -5
👍🏻❣️💪🏻
|
|
|
|
Post by cretin11 on Jan 21, 2022 18:19:04 GMT -5
I urge michaelcastagna to consider partnering with Dexcom or similar BP company to launch this trial. The pilot results are too powerful to ignore—the holy grail of diabetes is in MannKind’s possession. Your suggestion here seems reasonable (is it overstatement to say it’s obviously wise?). What is your opinion on why it hasn’t already happened? |
|
|
|
Post by olderteampt on Jan 22, 2022 2:14:43 GMT -5
Dexicom could surely benefit from buying MNKD but I think UTHR would benefit more from buying MNKD and Receptor Life Sciences. In buying both(MNKD and RLS) UTHR could become the leader in the dry powder inhaler industry for treatments for Diabetes with Afrezza becoming the standard of care for adults and pediatrics. Next, they could become the leader in the field for Cannabis with the MNKD inhaler and receptor life sciences products. UTHR would be able to transition all their current and future products to MNKD's technosphere platform. Just think of all the Billions of dollars of revenue UTHR could achieve buy buying MNKD and Receptor Life Sciences to become known as the leader in the Big Pharma Industry for dry powder inhaled pharmaceuticals.
|
|
|
|
Post by prcgorman2 on Jan 24, 2022 19:54:05 GMT -5
I urge michaelcastagna to consider partnering with Dexcom or similar BP company to launch this trial. The pilot results are too powerful to ignore—the holy grail of diabetes is in MannKind’s possession. Your suggestion here seems reasonable (is it overstatement to say it’s obviously wise?). What is your opinion on why it hasn’t already happened? Two reasons; money and COVID. If we can get some relief from COVID, and revenue from Tyvaso combined with the much improved cash position from the last refi, a large scale trial which demonstrated superiority and which emphasized SAFETY above all else should be possible. A potential marketing partner could obviously play an important role. |
|
|
|
Post by letitride on Jan 24, 2022 22:18:18 GMT -5
Since before approval more large scale trials have been required above and beyond needed. The Peds trial is just the beginning. The label needs to be changed and to that end is what needs to be addressed next. Partner? The money is just about to arrive to get it done on our own in my opinion. I have been waiting years. This baby has grown. Not sure why I need to wash it now with a partnership unless it is truly mutually beneficial. Just maybe rest and grow was an appropriate plan. I want more and every day I buy more.
|
|
|
|
Post by cretin11 on Jan 25, 2022 5:47:27 GMT -5
Since before approval more large scale trials have been required above and beyond needed. The Peds trial is just the beginning. The label needs to be changed and to that end is what needs to be addressed next. Partner? The money is just about to arrive to get it done on our own in my opinion. I have been waiting years. This baby has grown. Not sure why I need to wash it now with a partnership unless it is truly mutually beneficial. Just maybe rest and grow was an appropriate plan. I want more and every day I buy more. I agree with mango here. A partner would’ve helped, that seems clear in hindsight. And going forward it would still help. “Rest and grow” has stunted the baby’s growth. It has rested, that much is true. |
|
|
|
Post by prcgorman2 on Jan 25, 2022 7:41:25 GMT -5
Since before approval more large scale trials have been required above and beyond needed. The Peds trial is just the beginning. The label needs to be changed and to that end is what needs to be addressed next. Partner? The money is just about to arrive to get it done on our own in my opinion. I have been waiting years. This baby has grown. Not sure why I need to wash it now with a partnership unless it is truly mutually beneficial. Just maybe rest and grow was an appropriate plan. I want more and every day I buy more. I agree with mango here. A partner would’ve helped, that seems clear in hindsight. And going forward it would still help. “Rest and grow” has stunted the baby’s growth. It has rested, that much is true. Arrested growth would be a more accurate statement. COVID-19 has had a material impact on being able to conduct studies and market Afrezza and somehow that is very often overlooked. It’s not an excuse, it’s simply obvious. And maybe that’s why it doesn’t get mentioned but at the same time I don’t see how people can continue to claim impatience as though COVID-19 didn’t happen and is not a factor. |
|
|
|
Post by radgray68 on Jan 25, 2022 11:45:11 GMT -5
Man, I can't wait for 2020 to be over.
|
|
|
|
Post by cretin11 on Jan 25, 2022 12:30:16 GMT -5
Yes, Covid happened. Doesn’t alter my agreement with mango that a partner would’ve been the way to go, and it doesn’t alter my disagreement with the strategy of rest and grow. Afrezza is a uniquely miraculous creation, superior to others in the space, we all know that. MannKind created it but the company wasn’t set up for sales.
We brought in a CCO in 2016, he was tasked with leading commercialization efforts for Afrezza. That was years before Covid, the commercialization efforts fell flat due to mistakes made (but the CCO became CEO so I guess it worked out for him).
|
|
|
|
Post by prcgorman2 on Jan 25, 2022 22:23:21 GMT -5
Yes, Covid happened. Doesn’t alter my agreement with mango that a partner would’ve been the way to go, and it doesn’t alter my disagreement with the strategy of rest and grow. Afrezza is a uniquely miraculous creation, superior to others in the space, we all know that. MannKind created it but the company wasn’t set up for sales. We brought in a CCO in 2016, he was tasked with leading commercialization efforts for Afrezza. That was years before Covid, the commercialization efforts fell flat due to mistakes made (but the CCO became CEO so I guess it worked out for him). In 2016, Afrezza marketing had to be completely revamped and restarted from scratch, which the CCO turned CEO managed while the company teetered deeply in debt and on the brink of bankruptcy. I would argue that Earl Grey’s charts of Afrezza revenues disprove your remark that Dr. Castagna’s efforts “fell flat”. Anything but. They’ve stalled during COVID which even that gets mischaracterized. “Covid happened”? Take a look at Peppy’s latest posts on COVID. It didn’t happen. It is HAPPENING. It’s the worst it’s ever been in terms of new cases and hospitalizations. What isn’t the worst is lockdowns and deaths, but that does not mean that there aren’t disruptions, particularly for health care. |
|
|
|
Post by cretin11 on Jan 25, 2022 23:29:45 GMT -5
Yes, Covid happened. Doesn’t alter my agreement with mango that a partner would’ve been the way to go, and it doesn’t alter my disagreement with the strategy of rest and grow. Afrezza is a uniquely miraculous creation, superior to others in the space, we all know that. MannKind created it but the company wasn’t set up for sales. We brought in a CCO in 2016, he was tasked with leading commercialization efforts for Afrezza. That was years before Covid, the commercialization efforts fell flat due to mistakes made (but the CCO became CEO so I guess it worked out for him). In 2016, Afrezza marketing had to be completely revamped and restarted from scratch, which the CCO turned CEO managed while the company teetered deeply in debt and on the brink of bankruptcy. I would argue that Earl Grey’s charts of Afrezza revenues disprove your remark that Dr. Castagna’s efforts “fell flat”. Anything but. They’ve stalled during COVID which even that gets mischaracterized. “Covid happened”? Take a look at Peppy’s latest posts on COVID. It didn’t happen. It is HAPPENING. It’s the worst it’s ever been in terms of new cases and hospitalizations. What isn’t the worst is lockdowns and deaths, but that does not mean that there aren’t disruptions, particularly for health care. Again, nothing you wrote there changes mango’s point which I agree with. Commercialization from 2016 until Covid (four years) fell short of expectations, given the superiority of Afrezza, and we would’ve been better off with a partner. Hindsight is 20/20, unfortunately we don’t get a do-over for those years, but a partner going forward would be beneficial. We aren’t a sales company. |
|
|
|
Post by letitride on Jan 26, 2022 1:28:05 GMT -5
Hindsight 20/20 we were not better off with a partner "Sanofi". Show me a partner putting their money where there mouth is to run trials get label changes and prove superiority. Then lets talk marketing. Seems were now in a position to do that ourselves if need be without giving away 50% of our profit.
|
|
|
|
Post by cretin11 on Jan 26, 2022 3:04:53 GMT -5
Hindsight 20/20 we were not better off with a partner "Sanofi". Show me a partner putting their money where there mouth is to run trials get label changes and prove superiority. Then lets talk marketing. Seems were now in a position to do that ourselves if need be without giving away 50% of our profit. Sanofi made the leadership change which ruined the Afrezza partnership. We then needed to either find an appropriate different partner or commercialize ourselves. We tried the latter option and failed. Maybe there were no other partners interested. Seems unlikely, with how outstanding our product is. Unclear how hard we tried to find a partner, or if we tried at all. (We sure gave VDEX the stiff arm, and they weren’t even asking for a partnership, just a collaboration.) So here we are, scripts not in the tens of thousands, or at five thousand, or even one thousand. After how many years now? With the best “mousetrap” that exists. It’s not going out on a limb, or being unfair, to suggest we didn’t play our hand optimally when it comes to commercializing Afrezza. Can’t go back and change the past, but I’m not giving up on the notion we could have leadership (maybe even the current leadership) that learns from the past. |
|
|
|
Post by sportsrancho on Jan 26, 2022 7:16:11 GMT -5
In my mind we definitely needed a partner to pick us up after Sanofi dropped us but nobody was gonna do it at that point. They killed the option for that.
There’s no need to argue about Afrezza sales ..Mannkind is well aware they have dramatically failed at it. But that is the important point, they know it. Now they can take steps to rectify it. I believe they will. You can partner with different companies for different things and make sure they are ones you trust and are aligned with in your thinking and have the same goals.
Covid was a problem but no longer is. And we’ve got telehealth for people who need it now. That wasn’t the case two years ago.
|
|
