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Post by dreamboatcruise on May 22, 2018 14:18:04 GMT -5
STAT is another step in the right direction linking Afrezza's unique pk/pd to outcomes that matter. There are beginning to be studies looking at TIR and PPG spikes showing preliminary evidence better control of post meal glucose is needed... but that is certainly not "consensus" yet. It will take time.
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Post by akemp3000 on May 22, 2018 14:26:50 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously. As diabetes industry leaders become aware of and start discussing the results that Mike says, "doctors can't believe", then the ADA, insurance coverage, marketing expansions, scripts and another label improvement will all begin falling into place.
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Post by mnholdem on May 22, 2018 14:38:06 GMT -5
I wouldn't rule out a new class of insulin either.
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Post by joeypotsandpans on May 22, 2018 14:44:18 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously. As diabetes industry leaders become aware of and start discussing the results that Mike says, "doctors can't believe", then the ADA, insurance coverage, marketing expansions, scripts and another label improvement will all begin falling into place. I'll let MN edit the countries and or studies, but to your point the first 2 country domino's got flicked (Brazil & India) by MNKD's version of Curry, the study domino is about to get flicked by their version of LeBron, unfortunately the inaugural team was akin to the Raptors (especially after they lost their illustrious owner)...looks good until they get to the playoffs, time to take it to the next level. Kastanes stop worrying about the runway they (the doubters and hecklers) have been preaching the worrying about it for years....thoughts of selling the golden goose off before it starts laying the eggs is why bus drivers will always drive the bus and not own the bus company   |
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Post by dreamboatcruise on May 22, 2018 15:06:17 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously. As diabetes industry leaders become aware of and start discussing the results that Mike says, "doctors can't believe", then the ADA, insurance coverage, marketing expansions, scripts and another label improvement will all begin falling into place. I'll let MN edit the countries and or studies, but to your point the first 2 country domino's got flicked (Brazil & India) by MNKD's version of Curry, the study domino is about to get flicked by their version of LeBron, unfortunately the inaugural team was akin to the Raptors (especially after they lost their illustrious owner)...looks good until they get to the playoffs, time to take it to the next level. Kastanes stop worrying about the runway they (the doubters and hecklers) have been preaching the worrying about it for years....thoughts of selling the golden goose off before it starts laying the eggs is why bus drivers will always drive the bus and not own the bus company To be fair to anyone preaching that concern in the past about finances, it now seems we've had confirmation it was warranted... we've just had our CEO come out and make a remark about what dire straights the company had been in. And we've had one heck of a lot of dilution over those years. To you it may not matter whether the stock price collapses while still in a period of needing funding... but having run start up companies myself I guarantee you the owner of the bus company had better not be taking the view you seem to be espousing people should have about the finances. Granted, the leader of an organization needs to be selling a positive vision but that doesn't mean ignoring financial realities. Successful leaders are very rarely Pollyannas. I saw a whole slew of companies in my field go bankrupt in the dotcom bust because of CEOs not paying attention to runway. I did not go under. Perhaps your view is simply, investors don't worry about it that's managements job... fine if that's your thing, but I think very few successful investors (e.g. Buffet) would espouse that. |
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Post by joeypotsandpans on May 22, 2018 15:25:51 GMT -5
DBC,look at it this way if one is worried about the length of the runway then they shouldn't be on the aircraft, correct? It's all about choices and those making the choice to invest in entry level biotechs should know or be aware of the dilution cycles that come with them, it's generally speaking their only source of fuel to get off the runway . So either most of those on board are confident in the current personnel in the cockpit and the aircraft their on or they're nervous stowaways that are on board for other reasons |
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Post by agedhippie on May 22, 2018 15:51:06 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously.The obvious question is why not? Actually Afrezza has been mentioned in over 500 articles since 2014, and over 50 this year, according to Google Scholar. The short answer as to why not in my opinion is that it was never seen as a priority. Al expected a partner would snap up Afrezza, Matt was focused on living hand to mouth through the transition, Mike thought the answer was direct sales to the doctors, and Dr Kendall understands that what matters is the environment rather than the sales force. Dr Kendall is aiming to make Afrezza a comfortable choice for doctors which means not frightening the horses, and publishing data that shows Afrezza working to achieve that. |
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Post by mnholdem on May 22, 2018 15:56:37 GMT -5
Joey, we may as well add Israel to that list. MannKind just received the patent a few weeks ago on their 2016 application for the inhaler device (aka Dreamboat).
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Post by akemp3000 on May 22, 2018 16:08:59 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously.The obvious question is why not? Actually Afrezza has been mentioned in over 500 articles since 2014, and over 50 this year, according to Google Scholar. The short answer as to why not in my opinion is that it was never seen as a priority. Al expected a partner would snap up Afrezza, Matt was focused on living hand to mouth through the transition, Mike thought the answer was direct sales to the doctors, and Dr Kendall understands that what matters is the environment rather than the sales force. Dr Kendall is aiming to make Afrezza a comfortable choice for doctors which means not frightening the horses, and publishing data that shows Afrezza working to achieve that. That's a fair question. IMO it's because the previous management team did not have the necessary diabetes expertise to make it through the gauntlet of challenges it faced such as simplifying titration. Some team members had more expertise in oncology than diabetes. Additionally, past results only showed "non-inferiority" because of the poor, antiquated testing protocols required by the FDA at the time. What has been learned since then and now having Dr. Kendall on board along with the STAT study results proving superiority has the potential to change everything relatively quickly. |
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Post by od on May 22, 2018 16:10:04 GMT -5
IMO, nothing will have a more significant impact than Dr. Kendall's new Scientific Advisory Board combined with fresh new articles written by him and published in major medical journals, explaining the simplicity and superior results of Afrezza (STAT). The company has not been able to do this previously. As diabetes industry leaders become aware of and start discussing the results that Mike says, "doctors can't believe", then the ADA, insurance coverage, marketing expansions, scripts and another label improvement will all begin falling into place. Major medical journals publishing articles written by Dr. Kendall? Perhaps opinion or commentary pieces. |
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Post by dreamboatcruise on May 22, 2018 16:24:36 GMT -5
DBC,look at it this way if one is worried about the length of the runway then they shouldn't be on the aircraft, correct? It's all about choices and those making the choice to invest in entry level biotechs should know or be aware of the dilution cycles that come with them, it's generally speaking their only source of fuel to get off the runway . So either most of those on board are confident in the current personnel in the cockpit and the aircraft their on or they're nervous stowaways that are on board for other reasons Setting aside analogies, that are quite possibly one of the worst things to have ever been invented when it comes to business (i.e. you can always come up with some analogy to justify a bad decision). I would not agree with that first statement AT ALL. Whether in management with a company or as an investor, one always needs to be worried about the cash burn and runway... even when profitable in many cases, and ALWAYS when pre profit. I have had too long of a career in and around start up companies to set aside looking at risk and be blinded by potential reward. It is looking at both risk and reward that gives me the confidence to hold my MNKD investment... and also to do things such as utilizing straddle option position about a year ago taking advantage of all time low price even when I thought the risk level significantly higher than it is today. Though, your second sentence implies being aware of financing requirements and dilution is important. If investors should know about dilution cycles as you say... why do you seem to belittle those that raise the issue on a discussion forum, one of whose purposes would seem to be educating people about biotechs, and MNKD in particular, as an investment? I'm invested in MNKD, I'm well aware of dilution cycles (including that MNKD has been way beyond the norm)... and I think the dilution is as much of a valid topic for discussion as how great Dr. Kendall is or dreaming about who is going to acquire MNKD. It was worrying about dilution that I knew was coming that convinced me to earlier in the year sell some May calls I had. Not worrying about that dilution could have resulted in holding onto those calls and they would have expired basically worthless. Pilots worry about the runway... and the amount of weight they have on board... passengers do not. Most investors successful at investing in technology do not view themselves as passengers along for the ride. Index funds are for that. (Caveat: One of my pet peeves in business is watching people get into analogy arguments... as if the original premise of having the analogy was valid) |
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Post by mango on May 27, 2018 9:00:38 GMT -5
What we also know is that lispro and aspart have been compared in a study using CGMs in people with T2D (while on Metformin) and the results show that lispro and aspart both cause a lot of hypos and both produce results insignificant of one another and demonstrate very similar outcomes, confirmed by the CGMs.
The data we see with Aspart in the STAT study will mean the same for Lispro. They are insignificantly different, confirmed by the CGMs.
The cool thing about Afrezza is it has consistently produced reproducible and verifiable results: demonstrating significantly less hypoglycemia, significant decreases in fasting blood glucose, and a significant weight advantage (decrease w/ Afrezza, increase w/ Aspart).
STAT is a Phase 4 clinical trial, just like real-life after Phase 3. I have a feeling it will result in some hard truths. Phase 4 studies commonly show what Phase 1-3 RCTs could never reveal because of their design flaws to begin with (controlled experiment vs real-life natural settings). Phase 4 is an official real-life study comparing Aspart and Afrezza, and luckily for us they used CGMs.
Also, thanks to CGMs, there is now plenty of data illustrating what the various levels of the so-called Standards of Care translates to in real-life (Triple therapy w/ CGM & SC prandial insulins w/ CGM), and really, I really think, that these CGMs store data that can show a significant trend, backed by historical data and wouldn't justify resting easy if it were also associated with having long been regarded as barbaric. Endos will lose their licenses and lawsuits will be commonplace when they knowingly precribe barbaric treatments that result in barbaric outcomes (at least they can be captured by the CGM).
Prescribing barbaric treatments will soon truly mean flirting with prison. No amount of clinical trials can make up for stupid. But, hopefully they will see the CGMs before that happens and dial it in by hearing Dr. Kendall describing the whole thing as being nothing less than barbaric.
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Post by liane on May 27, 2018 10:01:02 GMT -5
mango - As much as I believe Afrezza is the best prandial insulin and will eventually become the standard of care, it's way too extreme to suggest the current treatments are barbaric and that there will be lawsuits and jail time for docs that continue to prescribe injectable insulin.
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Post by boca1girl on May 27, 2018 16:55:53 GMT -5
mango - As much as I believe Afrezza is the best prandial insulin and will eventually become the standard of care, it's way too extreme to suggest the current treatments are barbaric and that there will be lawsuits and jail time for docs that continue to prescribe injectable insulin. I believe it was reported on Pro Boards that Dr. K used the term “barbaric” when describing injected pranadial insulins at the ASM. |
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Post by mannmade on May 27, 2018 16:58:06 GMT -5
Boca, yes he did, I was at the ASM and heard him say it. I believe Liane is talking about Mango being judge, jury and executioner... LOL!  . Guess we are all a bit battle fatigued at this point.... |
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. Guess we are all a bit battle fatigued at this point....