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Post by esstan2001 on Dec 16, 2015 10:35:46 GMT -5
its all about timing - dosing and onset of action and peaking ..and afrezza is the most closest to way insulin should work. So you started on a wrong base. Go back and do your DD again and come back It seems like the first part of your post agreed with me exactly. Therefore, I don't agree I started on some wrong base and need to do my DD again. What point are you making? My point was pretty clear, that in some sense Afrezza is only superior because you can use it in ways that make it more effective. You can also use it in ways that make it less effective. You can also use it in ways that make it less effective >>>>>>> this argument also applies to injectable insulin. In fact, misuse of injectable is more likely to result in death than the same dose / time to dose misuse of Afrezza. So on balance, IMO one can not claim that they are equally inferior here... safer would lead to superiority IMO... Afrezza's action in the body appears superior too ( again IMO)- it distributes over a much larger area to gain entry to the blood faster, and it dissociates immediately releasing monomeric insulin. The end result best mimics endogenous healthy insulin secretion, so here I believe it is superior to the most rapid injectable too. Today, you get a lot of my opinion. ;-)
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Post by esstan2001 on Dec 14, 2015 18:04:03 GMT -5
If they file for bankruptcy, there is going to be quite a bit of old school justice coming management's way - let's hope for them that things turn positive sooner rather than later. I wouldn't call it BK, that won't happen. We are moving into a range where plenty are interested globally..... just do a google trends search for Mannkind Corporation, look at where the interest is... Why would the Swiss have their eye on MNKD? Something very fishy in Denmark. I am curious, what is the correlation between Denmark and Switzerland? Denmark is known for fish, oil, shipbuilding, ad waterways... Switzerland for cheese, chocolate, timepieces, and banking...
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Post by esstan2001 on Dec 14, 2015 12:08:38 GMT -5
Thanks to the tens of trillions of new money globally over the past seven years, nothing makes sense. >>>> you got that right. Created many distortions that we have yet to see the effects of. Look at solar. It should be sky high right now thanks to the climate deal. But it's also down 90% over the past several years. >>>> eh, Solar still has many economic (and some environmental, if you take a holistic view) issues, and especially in light of the low prices of oil. In the long run, it could be the Federal Reserve that's to blame. .... >>>> For a lot ! ....But, whomever is manipulating this one had ready access to insider information. Oh yes, it looks like they'll win, if enough sell (but we are not seeing the volume yet). >>>> Very plausible that you are onto something here, considering all the incest between Golden Slacks, Greenhill, various hedgies, and SEC, Treasury, etc. You are likely correct in that some were privileged to illegally view key deal info that allowed them to craft a scheme to drive down the market cap and retail wealth associated with Mannkind. Live and learn, there is a crook around every corner that is after your money, and a lack of any enforcement of the myriad statutes and laws already on the books.
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Post by esstan2001 on Dec 11, 2015 15:45:43 GMT -5
Dudley, Sorry to nitpick, but there's a pretty big disparity between cure and treatment. Afrezza will never cure diabetes. Just wanted to make that point clear lest you mislead others. Afrezza will also not be the only treatment option needed for diabetes. The liver is constantly regulating glucose levels in the blood. A basal insulin will always be needed post-prandial to help with those spikes in glucose levels. All Afrezza does is help decrease the post-prandial glucose spike back to physiological levels. Actually, there may be some instances where early intensive insulin treatment does, in fact, result in what some would describe as a cure. A study by a group of Japanese researchers revealed that, caught early enough, several weeks of intensive insulin therapy healed the pancreas. After the EIIT was discontinued, approximately 40% of the patients required no further diabetes treatment whatsoever.
I've forwarded that study to Pascal Witz, along with a recommendation that Sanofi consider funding this group to run the study again using Afrezza. In terms of PR, Sanofi would become the opposite of Martin Shkreli in the public eye. They would be eliminating the need for basal insulin for approximately 40% of pre- and early-diabetes patients. The remaining 60% who went through EIIT would be de-sensitized to the idea of taking insulin, especially since they didn't need injections. It's similar to the brilliance of Steve Jobs of Apple Computer giving college kids steep discounts on their personal computers. The kids needed a college computer for cheap, but then after graduating they kept buying Apple McIntoshes (and eventually the I-series) for years after. The same would likely be the case with inhaled insulin.
At least that's what I advocated to Ms. Witz when I laid out the market profile. A few weeks of early intensive insulin treatment could eliminate the need even for metformin for a number of early diabetes patients. If EIIT (which must be done with an ultra-fast insulin like Afrezza) were to become the gold standard for first treatment, Sanofi would be admired for contributing to the reduction of diabetics, while at the same time catching early diabetics who don't have a remission and shepherding them to their basal/prandial insulin (ie Toujeo + Afrezza).
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Here's the link to the study: onlinelibrary.wiley.com/doi/10.1002/dmrr.2603/full
IMO that was a brilliant tactic that warrants serious consideration; I only hope that no one in SNY management looks upon this as something that may in the long run cannibalize treatment sales.
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Post by esstan2001 on Dec 11, 2015 14:16:00 GMT -5
"Afrezza signals the first phase insulin response: which signals the liver to stop putting glucose into the blood."
The superiority trial should continuously monitor participant's blood glucose level and the design should take into great consideration all the pancreatic 'positives' with regard to first phase signaling.
Results will then kick a$$ and mop the floor with all the other prandial insulins...
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Post by esstan2001 on Dec 11, 2015 12:03:40 GMT -5
looking forward to it, and glad I got you to smile or laugh!
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Post by esstan2001 on Dec 11, 2015 12:01:30 GMT -5
Anyone know the pharmacokinetics? As just another hexamer, I'd venture to guess subtly different (faster) than any other injected prandial; but no where near the speed of afrezza. Peppy or msccguy can probably elaborate from a more chemistry-centric point of view as to the whys of the subtlety- Novo is not talking monomer-insulin, that is our key.
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Post by esstan2001 on Dec 11, 2015 6:50:53 GMT -5
esstan, Of course you know what happens next when you find yourself in irons and your favorite female is aboard right? a) You think you are about to start something fun. As you begin to get underway, you realize you ARE underway, and about to capsize (if you are on a small catamaran). b) You become the recipient of all kinds of yelling about how you got her out there and now can't get her back (on time, safely, alive, etc.) Neither of these 2 choices is the preferred outcome.
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Post by esstan2001 on Dec 10, 2015 21:19:38 GMT -5
But... understandable. Have you read any of his humor??? gosh, esstan, I've recently lost whatever sense of humor I had - I'm rudderless out here! You are in irons. Just let go of the main sheet and keep the helm neutral (centered). you will eventually find water passing your rudder, albeit in reverse. Gently turn the rudder to bear off the wind; once the main sheet starts to fill, gently sheet in a bit, the craft should start to move forward. At the point where water starts passing the rudder in the forward fashion, again turn the helm to bear off (but it will be the opposite of what bears you off when piloting in reverse) but not to quickly or sharply, else you will stall the craft due to rudder drag. Once she starts moving along, you will have steerage; your rudder is back. As for your sense of humor, I can't help you with that- but I somehow doubt you've lost any of it, especially if you were willing to endure reading this without wanting to mame me. :-)
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Post by esstan2001 on Dec 10, 2015 11:37:53 GMT -5
baba - I just sent you a PM now; no I haven't received any from you in recent months. Wow...liane blocked baba! Harsh. But... understandable. Have you read any of his humor???
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Post by esstan2001 on Dec 10, 2015 11:29:41 GMT -5
No way do I want them to sell off Afrezza. This has the potential to be the biggest drug ever - and I'm not pumping. BTW - 2500 more shares not available for covering shorts!
Outstanding, Liane! Going through the couch cushions myself......hmmm, a venti coffee or 4 more shares of Mannkind, lol! I agree with you wholeheartedly!
After thinking about this a lot yesterday, I too went back to the well for some more this AM
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Post by esstan2001 on Dec 9, 2015 13:17:59 GMT -5
Scotta, excellent post.
Regarding Dexcom and SNY-Google partnership, my best guess.. early '16 they have some decent prototypes they are demonstrating... mid '16 they can start delivering product- early '17 there is a viable / sale-able database that ins Co's can procure and make decisions on. Hopefully the timeline can be pulled in a quarter, but this may be why SNY has dragged their arse on the superiority trials, thinking they will become less important with the data available, and probably why MAtt / Hakan never got too alarmist regarding their partner's efforts.
Meantime, how do we make it to that point in time.... Al... whoever? Gotta get another TS deal or 2 in place.
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Post by esstan2001 on Nov 29, 2015 7:57:32 GMT -5
Many of us believe Brandicourt was referring to MNKD when he made that comment. That comment and the omission of Afrezza in SNY's major launch list was what got many of us talking about SNY sand-bagging Afrezza so that MNKD's financial situation would deteriorate to the point where they would agree to a SNY buy-out. Based on how SNY's actions lately, it could be that they're playing hardball to be able to buy-out Afrezza at the lowest possible price. If so, it's pretty underhanded IMO, and I think opens them up to a lawsuit later. I think it's more possible that their actions are suggesting that Brandicourt has already decided to give up Afrezza in the new year. Having worked directly with medical device sales forces for over 2 decades, I find it almost impossible to believe that the stagnant script numbers are due only to the various sales barriers (insurance coverage, spirometry, education, etc.) already well discussed. IMO, a motivated US SNY salesforce with a comp plan incentivizing them properly would produce higher script numbers and higher growth just feeding off the low hanging fruit out there right now. Targeting needle-phobic patients, poorly controlled patients with good insurance, progressive/aggressive physicians, etc. should result in much more than 600/week if they are really trying! In other words, Brandicourt has taken his foot off the Afrezza gas pedal and has decided to do the minimum under the Partnership Agreement until he can exit. That would also explain why no large, long term outcomes studies have been announced, no international expansion plans announced, and why Brandicourt gave Afrezza the cold shoulder atu , quickly, to ensure life beyond SNY, and Hakan is not the guy to do that. Prospective partners would be able to close a deal much more quickly with Al because he's the final decision maker anyway. Same for TS negotiations. Hakan stays on just to make sure nothing internally falls through the cracks while Al focuses on the deal making. Hakan takes the fall for letting things get to this sorry point. MNKD desperately needs a partner that will do more than just the minimum short-term activities. I hope there's more under the surface going on in our favor, and a 90-y.o. Al can ride in and save the day. Continuing to use that word "hope" is making me feel more and more foolish every day. The only worse situation would be to sell out at a big loss and then see the PPS recover on some unexpected, positive announcement. The more you use that word 'hope', the more you are sounding like Hakan :-) I really hate your post, because it succinctly lays out the case for the less optimistic alternative; we all tend to fit wonderful theories to the lousy circumstances, and the circumstances also match very well to the case you make. I 'hope' there is a better explanation.
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Post by esstan2001 on Nov 20, 2015 18:06:02 GMT -5
No one posted this today, [Edit: Falcon beat me to it while I was composing away] so I thought it should be put out here- it is not new, but it is another story that makes one question whether Sanofi can really do the right job. www.cnbc.com/2015/11/20/sanofi-whistleblower-lawsuit-kicks-into-higher-gear.html?__source=yahoo|finance|headline|headline|story&par=yahoo&doc=103179002Does this effectively tie their hands from aggressively marketing Afrezza, which we so sorely need? That leads me to my next thought, when we find whether the clamp study generated anything that can be used to enhance the label (as has been speculated on this board). Given this environment, I think SNY management may keep efforts close to the legal limits, but who knows. They apparently have played dirty in the past.
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Post by esstan2001 on Nov 20, 2015 9:23:28 GMT -5
Except they will now have to pay $2m+ for a new guy with huge options none of that matters if he executes
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