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Post by joeypotsandpans on Jul 13, 2018 11:01:18 GMT -5
Please correct me if I am wrong, but as I understand it we now owe Deerfield $25m and The Mann Foundation $90m for a total of $115m in Debt. If I am accurate I would say this is progress for the balance sheet. Let's just say MNKD is in a lot better shape than Greece and a host of other countries..., and yes that is what Mike is systematically doing (making progress) with what he currently has to work with
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Post by joeypotsandpans on Jul 12, 2018 14:25:29 GMT -5
Count me in the volume yesterday and today, another add....was going to p/u the 2500 yesterday anyway but after seeing the circle jerk with the added SI, had to p/u another 2500 today...everytime I use it at the poker tables along with checking the BG live with the libre they all ask me for the ticker symbols...I give them that along with Sam's website and suggest they watch his testimony at the ADCOM + BOT 2,500 MNKD 1.785 USD NYSE + 2 12:17:18 12.50 BOT 2,500 MNKD 1.7084 USD IBKRATS JUL 11 12:58:33 12.50
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Post by joeypotsandpans on Jul 3, 2018 12:50:42 GMT -5
No manufacturer can compel the ADA to do anything. STAT, while helpful, did not exactly provide earth shattering results as the conclusion was pretty much predetermined. Physicians look to "levels of evidence" when making treatment recommendations and if you are not familiar with the levels, in the United States these are: Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-1: Evidence obtained from well-designed controlled trials without randomization. Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees Some countries have additional levels of evidence but the framework is similar. STAT was not a controlled trial since only the patients on the Afrezza arm were allowed to adjust their insulin dose following the meal in response to the CGM. That makes it a Level III study at best, and that is the least persuasive form of evidence. If MNKD wants to move the needle they need to sponsor a large randomized mullti-center controlled trial where all patients are given the opportunity to adjust their insulin dose after seeing the results from a glucose meter. If the results from that study demonstrate that time in range is statistically better with Afrezza than other RAI products, or if Afrezza has similar time in range but with fewer hypoglycemic events that require a visit to the ER, then they will have a compelling argument. The two big problems with STAT are these: 1. The cohort sizes were too small. In order to get the necessary statistical power, a proper study would require 300-500 patients over a longer period such as 90-180 days. 2. Allowing the Afrezza patients to adjust their dosing in response to the CGM results, not once but twice, stacked the deck against the comparator. Both arms must be allowed to adjust the dose after seeing the initial results for the trial to be credible. Some will say that patients on injectable insulin will avoid multiple needle sticks or that they will have too many severe hypo events, but that is precisely what the trial needs to show. If so many needle sticks is a major issue then patients on RAI will not be in range as long, and if the second bolus causes hypo events that should show up in the data as well. Opinions are not Level I evidence; data from a well-designed trial is evidence. Level I evidence, preferably with some parallel economic evidence showing that Afrezza is cost effective, is what it will take. Again, common sense, I will take my lead from the qualified chief medical officer who was a former head of the ADA and chief global scientist for one of the leading BP's in the space rather than someone that trolls the boards with ulterior motives and recommends via direct messaging to people to sell their shares thank you.
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Post by joeypotsandpans on Jun 27, 2018 22:50:18 GMT -5
If Castagna, Kendall, Edelman, and many others see this as game changing, and data supports it, why no partner or buyout? If it’s such a game changer, which I wholeheartedly agree, why such a struggle. Honest question. Here are my thoughts on this. 1. CGM companies do not want to align themselves with a single pharmaceutical therapy. They think the broader they keep their market audience, the greater their revenue. 2. The current valuation of MNKD is so off track that no one can make a reasonable offer without looking silly in the eyes of many (shareholders, market analysts, etc) 3. The label has not been improved enough yet to take the claims being made by management to the broader market via advertising or other regulated means, thus making it harder to increase valuation of the company so that #2 can come to fruition. 4. The competition is using their deep war chest (deep rebates to the PBM's) to maintain/protect their oligopoly stranglehold on the current inferior, slower acting, non pancreas mimicking, higher hypo risk, barbaric, now obsolete, unpredictable Raa market.
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Post by joeypotsandpans on Jun 27, 2018 11:14:50 GMT -5
There is a lot of misguided information being tossed about regarding the STAT study.
Clinicaltrials.gov does describe the STAT study as a phase 4 study, but it also says it is a pilot study and not a pivotal study, that is, it is to provide information to guide further research, likely a pivotal study that would have more subjects and be of longer duration, namely, the dynamic dosing study.
The STAT study is what it is. Let's not over hype it or dismiss it out of hand. There are issues with how the data were analyzed and presented, but the results are positive and sufficiently convincing, and together with the hypo paper, as Peppy rightly points out, sends a powerful message.
Wow. That is what Osborne has said for months about the stat study. Wrong! He's stated the results were not statistically significant, tell me, where did he get his medical degree from? He is a self professed "hobby writer", you are a funny one
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Post by joeypotsandpans on Jun 26, 2018 14:13:47 GMT -5
The price target did move as I recall didn't Wainwirght lower the target to $2 very recently? I think that $2 target was indeed a typo. Note in today's report, it is once again, " reiterate". All the recent reports from Wainwright has been "reiterate". It does not look like there was a downgrade recently. If there was a downgrade recently, then in today's report, it would be noted that it is an upgrade. Analyst upgrades/downgrades are worth the same as or maybe even less than a SA writer's article in my opinion. The only upgrade that has any merit is an upgrade in scripts to people who desperately need to have better compliance/control of their BG. When that upgrade comes out, that is where you will see a huge tipping point, it will happen and with recent events hopefully that much closer to happening. After a high carb dinner yesterday and dosing with Afrezza 1hr after dinner and 1hr. after that, no basal, never would have happened previously, especially after bruschetta, caesar salad, lasagna, and black cherry ice cream with coffee. Sorry if that offends the cave man diet folks but every now and then I like to enjoy life the way I like to enjoy it.
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Post by joeypotsandpans on Jun 25, 2018 8:00:05 GMT -5
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Post by joeypotsandpans on Jun 24, 2018 17:13:59 GMT -5
Here's flyonthewall's take: 17:22 EDT MNKD theflyonthewall.com: MannKind presents positive Afrezza clinical data from STAT, AFFINITY studies MannKind announced that new data for Afrezza from the STAT study were released at the American Diabetes Association's 78th Scientific Sessions. The STAT study involved 60 patients with Type 1 diabetes and is the first randomized, controlled study to use continuous glucose monitoring with Afrezza. The dual primary endpoints were assessment of glucose time-in-range and postprandial glucose excursions in the 1-4 hour post-meal period. STAT study poster highlights include significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12%, significantly decreased daytime glucose variability by 17%, significantly reduced the time spent in hypoglycemia by 41% or approximately 23 minutes per day. The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia. MannKind also presented a late-breaking poster presenting a post-hoc analysis of a representative subset of the AFFINITY 1 study that demonstrated the use of Afrezza significantly lowers the rate of hypoglycemia in patients with Type 1 diabetes while providing non-inferior glycemic control. :theflyonthewall.com I'd like to be a fly on the wall in Sanofi's board room when this is defined as the #newSOC...how you doing Olivier?
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Post by joeypotsandpans on Jun 24, 2018 13:49:22 GMT -5
Beta was better but vhs won the video tape war. Now they are both dead. I am very impressed and encouraged by Kendall. But it is too soon to declare that the pump is dead and afrezza is the standard of care. We also have to separate afrezza the drug from mnkd the investment. Are you analogizing Beta/VHS to a significant treatment improvement to PWD lives? Uvula you're smarter than that, the excitement by Kendall's arrival and impact naturally causes everyone involved to expect relatively more instantaneous results regarding s/p and scripts. He and Mike et. al. have the task of overcoming what the former FDA regime saddled the drug and company with...he will and has already started that process. I believe you will acknowledge that the difference between prior mgmt. since the SNY debacle and now is night and day, in essence (other than Al's impact of course) you have to look at this company is only a little over a year old, that is the perception one has to have and leave their sentiment as a prior investor in the past as hard as that may be. It's time to move on from the past, regarding the "new Mannkind" one of my favorite lines applies...."experience isn't expensive, it's priceless"
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Post by joeypotsandpans on Jun 24, 2018 12:44:08 GMT -5
Take hammer's comments and agedhippie's comments, average them together, and you probably end up with something resembling reality. I will take Dr. Kendall's comments, no need to listen to any others as their backgrounds and education and experience are but a pimple on his rear end. You were there and heard him don't get lost in the noise #newSOC EOM ....and for that other post regarding LLY and the "ultra fast" most likely another one of the reasons Kendall left LLY "ultra fast" .....again kudos to Mike for bringing him on, great minds think alike...again why he deserved CEO of the year award he received.
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Post by joeypotsandpans on Jun 23, 2018 11:09:32 GMT -5
It was very interesting to me that over the last couple of days how the naysayers have been frantic to downplay the results. The shorts attacked the share price while all of this FUD has been spread about the STAT study being a dud. Thank goodness the medical world doesn’t care about what people on Stocktwits or SA post. What the medical world cares about is honest trial data. What the medical world considers to be significant is different than we might expect. That is why I am grateful that MannKind published the news release explaining that Dr. Kendall believes that the STAT study and the late breaking poster are significant results. Dr. Kendall will be preaching these results everywhere. Good news indeed. Unfortunately it is on your screen, it's tough to wipe your rear end with it, that's the only thing they're useful for. The one question I asked that was consistently passed over.... can you tell me if you know what the statistical significance is regarding the numbers? Please note the following for the carrier pigeon's and you know who you are Dr. Kendall >>> than two bit writers (that is a greater sign btw) as I have stated over and over again.... you can't fix stupid because as they understand and interpret it a statistically significant reduction in hypo risk while being allowed to increase one's (PWD) BG control with Afrezza is not going to be translated into saving lives. Let alone translate into the investment world either. sayhey24 you have been spot on, no need to waste anymore time trying to educate that which cannot be helped. Enjoy the rest of your weekends!!
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Post by joeypotsandpans on Jun 22, 2018 14:36:28 GMT -5
Temper expectations—but it will be a shock? Can we all just say what we want to say about the poster. Massive disappointment.....61% vs 55%. This is what we’ve been waiting for 6 mos? There’s going to be some positive take aways from the trial to share, however, I like a few others have posted, was expecting to see the Dexcom readings my colleagues with Type 1 have shown me. Just extremely disappointed. Endos will not bat an eye at that TIR data, especially from 15 patients. Unbelievable. Truly crushed by these numbers. Two questions, have you heard your CMO speak yet (in depth) since he arrived at the company and what is the minimum percentage difference that you would take as statistically significant? I understand you're coming at it from the sales side but obviously as a user and personally having a significant drop in my A1c after using other methods/treatments that couldn't deliver anywhere close to what Afrezza has I think you should temper your disappointment. Also the acceptance of the late breaker session regarding lower hypo's is very important as well. I sure hope as a salesperson that you aren't one of those that walks into the office already defeated ....I know my rep doesn't and has a great outlook especially having come from Dexcom. BOL to you going forward.
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Post by joeypotsandpans on Jun 22, 2018 9:50:48 GMT -5
The Kendall effect, notice how they are emphasizing the delivery via lungs now and the benefits as opposed to the FUD that has been used, he is taking the correct perspective via the physiological aspects and technology of Afrezza and TI.
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Post by joeypotsandpans on Jun 21, 2018 22:28:31 GMT -5
Hey MannBoarders - If I missed an earlier thread on the subject - happy to delete this one. Doing a quick sanity-Google search on "inhaled insulin" - the top of page in search results is the WebMD definition. It dates back to early 2017, and IMO, was written to fry Afrezza: www.webmd.com/diabetes/inhaled-insulin Though mentioning it, it focuses on "COMMON" side effects (rather than possible) - and they land the final sentence talking about a fear of lung cancer. With the more recent studies and possible removal of some of the FUD verbiage, perhaps it's time for an update? I hope Dr. Kendall would have some more pull with WebMD. I do recall there were troubles a few years back with the reviews, competitors and WebMD, etc. But if one of you has that direct line into the company, you could relay a flag so they can look into it? Just a thought. Every little bit counts. .02 Dr.Kendall is actually of the mindset that the lungs are the way to go, he's totally opposite opinion and stated as much at the ASM....one of the reason's he left LLY was the new leader was not of the progressive mindset....that is from a source very close to the MNKD CMO
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Post by joeypotsandpans on Jun 21, 2018 21:01:24 GMT -5
Btw, I sure wish I could have posted this response on SA, but we know how that goes lol Here is a classic one talking about akemp3000 when he SO should look in the mirror!! Here's to the pot calling the kettle black lol, Spencer Osborne, Contributor Comments (14622) |+ Follow Author’s reply » mat.... akemp is a drive by shooter. He swoops in, drops his bomb, and then leaves so as not to face the tough questions about relating this to the investment. Its okay. Some people feel better when they can live in their bubble and retreat to it before the heat turns on.21 Jun 2018, 08:21 PM Reply1Lik You know Spence after you claimed that this board wouldn't let you become a member, I inquired on your behalf because I couldn't believe that to be true knowing the past history of the fairness of the moderators which watch over this forum. They said you originally signed up and never followed through, so I asked them to send you another "invite" of which you became a member for all of about 48hrs. if that. Then a couple of posters made some posts that I guess hurt your feelings, we ALL thought you had thicker skin than that but instead you obviously using your own words above FELT BETTER LIVING IN YOUR OWN BUBBLE AND "RETREATED" TO IT because you couldn't take a little heat and trust me that was absolutely nothing compared to some of those pigeons you got hanging out at your coop. You say that you don't control the SA moderators, well no matter what I post in diplomatic fashion without breaking any "code of conduct" does not get posted on YOUR threads (my comments on other threads at SA do) so unfortunately (or fortunately actually) I get to post them (my responses) here. I lost what little respect I might have had for you when you ran like a little chicken poop and retreated back to "your bubble". so then what do you do, you respond to my posts over there where I can't because I'm selectively edited. That is the purest form of cowardice there is IMO. Enjoy the weekend!!
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