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Post by dreamboatcruise on May 17, 2018 17:13:39 GMT -5
sayhey24... to your #10, it seems bioexec is saying Kindall believes a label change to ultra-rapid can be achieved without additional trials.
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Post by dreamboatcruise on May 17, 2018 16:52:09 GMT -5
Perhaps that's because there have been numerous trials to that effect. I cannot speak to other OADs, but Metformin does nothing to compare itself to the Conclusion in this and other studies, particularly with regard to β-cell function. The key words in this Conclusion, for me anyway, is early insulin helps "long term". Maybe it's just a poorly written abstract. I don't see how they would have drawn that conclusion based on the methodology and the "results" they list... but perhaps, as I think you're saying, they are comparing the long term results they obtained with prior studies using the same OADs. Just think it would have more impact if that had comparison arm especially if blinded.
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Post by dreamboatcruise on May 17, 2018 16:47:11 GMT -5
Schwab dropped loan from 5% to 4.5% today. Given it was strong up day, I guess I would interpret there was short covering that happened.
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Post by dreamboatcruise on May 17, 2018 16:22:18 GMT -5
One of the 2018 AACE Abstracts deals with a favorite subject of mine, one which I've long advocated for Afrezza:
Abstract #255 EARLY INTENSIFIED INSULIN THERAPY IN NEWLY DIAGNOSED TYPE 2 DIABETES LEADS TO SUSTAINED IMPROVEMENT IN GLYCEMIC CONTROL AND IMPROVED BETA CELL FUNCTION
Jatinder Mokta, MD, FACP, FRCP1, Viswanathan Mohan, MD, FRCP, FACE, MACP2 1. IGMC Shimla, 2. dr. Mohan’s Diabetes Specialities Centre
Objective: Type 2 diabetes (T2D) is a progressive disease characterized by relentless deterioration of pancreatic β-cell function. Traditionally, insulin is used in later stages of T2DM. This study looks at use of insulin at time of diagnosis of T2D and its effect on glycemic control and beta cell function.
Methods: This is a prospective observational study conducted in symptomatic newly diagnosed type 2 diabetes adults (>18 years) who presented with glycated hemoglobin (A1C) levels > 9%. For the initial 8 weeks, patients were treated with pre-mix insulin after which they were changed over to oral agents, and followed up for next three years.
Results: Of 122 study participants, who completed the study, 50% were female and 90% were from rural areas. Average age of participants was 51.4 ± 9.6 years. Baseline mean fasting plasma glucose (FPG), post prandial plasma glucose (PPPG) and A1C were 267 ± 76 mg/dl, 408 ± 101 mg/dl and 11.5 ± 1.4% respectively. At the end of insulin therapy (8 weeks), the mean FPG, PPG and A1C reduced to 107 ± 10 mg/dl, 145 ± 24 mg/dl and 7.3 ± 0.8% respectively all of which were highly significant. The mean post-prandial C-peptide significantly increased from 1.8± 0.6 to 2.8± 0.9 ng/dl. An average of 1.7 kg weight gain and 0.97 episodes of mild to moderate hypoglycemia were observed. At the end of study (156 weeks), the mean FPG, PPG and A1C were 99 ± 14 mg/dl, 152 ± 12 mg/dl and 6.7 ± 0.4%.
Conclusion: helps to maintain long term normoglycemia and improves β-cell function. Early insulin therapy in treatment naïve patients with type 2 diabetes results in rapid improvement of glycemic control.
Source: am.aace.com/files/Abstract-Book-2018.pdf
Interesting they call that "early"... I perhaps would have called in "marginally earlier" Surprised by low incidence of hypos. Overall, I'm disappointed in the study design. It seems these patients had no prior treatment, so the results would be much more meaningful if it had an arm where half the patients were immediately put on oral agents without the short term insulin. From what's presented it doesn't seem like you can say adding the short term insulin had any benefit over just orals.
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Post by dreamboatcruise on May 17, 2018 16:07:22 GMT -5
Nice move today. Wish I'd been bolder and bought some short term June options. We may get some real strength running up to ADA.
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Post by dreamboatcruise on May 17, 2018 15:45:25 GMT -5
... * Total publications to date 13, in last 3 months, 14 more publications using the existing data. ... * Runway with little to no competition is approx 10 years based on today's technology and pipelines in diabetes care. Mike and David emphasized nothing even comes close in the mealtime space. ... * ACE/ADA who's mission is to prevent and cure diabetes and to improve the lives of PWD is in contact with Mannkind (Dr.K) to discuss afrezza and standard of care requirements. * Emphasis was put on not needing any more clinical trials to achieve this goal. Dr. Kendall considers existing data a gold mine. The now infamous veins of gold comments. ... * The Mannkind Cares program (process for questions, on-boarding patients/docs) had been flat, but last two weeks straight up spike in the number of inquires. This process is critical to sustainable on-boarding to avoid dropouts. ... I have some views on risks or critical success factors and maybe can articulate those at some point. Thanks for all these details! You've got a great memory or good at note taking. I realize this wasn't an all day event, so you've probably given most of the detail as presented, but your list sparked the following questions: - I'm uncertain what the "in last 3 months" is referring to regarding publications. - Regarding the runway vs competition did they by chance specifically mention "smart insulin" and their view on its viability/timeline? - When you say not needing more data to achieve the goal, what is the "goal" he thinks achievable without additional trials... being listed as sole ultra-rapid, being called out in ADA treatment guidelines as a preferred treatment above other prandials, placed earlier in their treatment guidelines, or ? - Did they talk about what caused the sharp increase in Mannkind Cares inquiries? Would be interested in your views on risks and success factors once it is a suitable time period from ASM so that you don't get labeled as evil for mentioning such things.
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Post by dreamboatcruise on May 17, 2018 15:11:13 GMT -5
Thanks! So it looks like the amended version in redacted form is exactly the same as the original version in redacted form... i.e. the only change is to the list of countries, which we've never seen? Presumably that is removing country(ies) rather than adding, and from the meaning of those excluded countries (which tied into a term clause through definition of "territories"), it would seem that a removal of a country would happen when some agreement between Amphastar and a 3rd party holding exclusivity within a country ended. I guess that could be indicative of something MNKD is currently working on... or not. I'm a little surprised SEC allowed this to be redacted. Actually that seems like a pretty big deal with shareholders having a strong interest in knowing which countries are excluded. Having to find an alternate insulin supply, and whatever additional tests/trials might be necessary, for some countries seems important. But I really don't know what additional hoops a foreign country might make MNKD jump through if they were looking at US trials/approval but MNKD substituting a different insulin supplier.
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Post by dreamboatcruise on May 17, 2018 13:02:49 GMT -5
According to SO a change has occurred. "MannKind entered into a third Amendment to its supply agreement with Amphastar in April. Details of the changes are not available, but the changes were in the section of the agreement titled "Excluded Countries". The entire paragraph was replaced with new language." Unfortunately, it is confidential. What is his evidence of this change? When it was first posted here no one could provide any source other than pointing me to a stocktwit thread, which I reluctantly looked into, and still couldn't find anyone actually discussing the source of this assertion. I didn't even know of these excluded countries. I'm not doubting there was a change, but I'd be curious if there are any additional clues regarding the nature of this clause. This excluded list could be a reason for the slow progress in international deals... or not... hard to tell with details shrouded.
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Post by dreamboatcruise on May 17, 2018 12:50:51 GMT -5
FDA has no jurisdiction over publication of studies. Those studies occurred pre FDA approval and could have been published back then... and they still can be. Even now if MNKD wanted to do a study with the Medtone inhaler they'd be free to do so and publish. The results of those studies can't be used for marketing to consumers as that is under FDA jurisdiction. Thanks DBC for additional clarification and distinction between the two; marketing and pre-approval studies.
Another good example would off label uses. A pharma can do clinical trials for an off label use of a drug and have those results published. They can't have their sales reps marketing off label uses to doctors or do consumer marketing for that indication until after the FDA approves the new indication.
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Post by dreamboatcruise on May 17, 2018 12:38:26 GMT -5
So they can use the data from these studies even though the FDA issued a CRL denying the same? How many of these studies were done with the medtone inhaler? I personally think the FDA is all wet, but I’m curious if something has changed there to allow this data into the mix? FDA has no jurisdiction over publication of studies. Those studies occurred pre FDA approval and could have been published back then... and they still can be. Even now if MNKD wanted to do a study with the Medtone inhaler they'd be free to do so and publish. The results of those studies can't be used for marketing to consumers as that is under FDA jurisdiction.
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Post by dreamboatcruise on May 17, 2018 0:56:46 GMT -5
Of course, when they start switching to hemp, that will drive down the cost of the CBD oil, and that $100,000 an acre will rapidly shrink. Welcome to the life of a farmer. A large % of CBD oil sold on the market has always been processed using industrial hemp and then deliberate false claims about the oil are made and people are ripped off. This has been going on for a long time. Industrial hemp contains such a small amount of CBD to start with that an enormous and ungodly amount of material is required to extract a small amount of CBD. Some of these so-called CBD oils contain no CBD at all. That would make it a homeopathic cure?
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Post by dreamboatcruise on May 16, 2018 23:07:18 GMT -5
Did everything on the agenda pass? I gotta admit, I almost fell off my chair when I read that question! It's beyond anything I could possibly comprehend. Glad you enjoy my sense of humor.
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Post by dreamboatcruise on May 16, 2018 22:36:14 GMT -5
SO doesn't forecast. Like a backseat driver, he simply charts current data and then throws his literary darts at it. At least at one point he had a model for script growth and was comparing real numbers against it. Though, I don't really think he intended it to be a "forecast" if that's what you mean. I think his intent was just to have a model of very modest growth trajectory as something to benchmark the actual numbers against... and use to look at finance requirement scenarios. I suspect if the actual numbers started exceeding that he'd be the first to adjust the parameters accordingly.
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Post by dreamboatcruise on May 16, 2018 16:54:19 GMT -5
It seems to me that it will be Biomm who provides guidance for Afrezza sales in Brazil. That said, this is an interesting little factoid:
The diabetes epidemic affects most countries across the world and is increasing at alarming rates in Latin America. Nearly 12 million individuals have diabetes in Brazil, and the current prevalence ranges from 6.3% to 13.5%, depending on the region and the diagnostic criteria adopted in each study.
Source: www.sciencedirect.com/science/article/pii/S2214999615013077Certainly a lot of potential if they get payers on board there.
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Post by dreamboatcruise on May 16, 2018 16:30:08 GMT -5
How much revenue, money, cash, dinero, Brazilian Real It's not even approved yet. No idea what restrictions or label it might get. No idea whether government programs would cover it... or private insurance. If they were throwing out revenue predictions at this point it would be BS... hopefully they wouldn't try that on shareholders.
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