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Post by dreamboatcruise on Feb 3, 2018 15:49:35 GMT -5
For as much as some complain about MannKind and Mike Castagna not being transparent enough, I for one think they are doing a pretty good job of communicating the current targets of the company. It takes time to achieve paradigm changes in the diabetes market. I wish the share price was greater. But when you have entities that are willing to short one third of the outstanding shares, it is going to be very hard to move the price up. But it seems to me, that if I was in Mike C.s shoes, I wouldn’t share everything that was in the works. It is very apparent to me that there are a lot of people out there that want to take MannKind down. So the last thing I would want is for them to know all that I was working on. In fact, I might even send out some information that was some misdirection. It wouldn’t surprise me if one day we get news that will be completely from left field. Some shareholders will complain that we should have been told. I say hogwash. As shareholders we need to know some things, but not everything. I actually don’t want to know everything, because our enemies would know too. Respectfully... you should never be CEO of a public company if you really hold these views. Perhaps you are just spinning to praise Mike.
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Post by dreamboatcruise on Feb 3, 2018 15:45:42 GMT -5
What is still up for debate is how fast is needed. Certainly RAAs were proven better at mealtime than injected RHI because of their quicker action. Further, some of the benefits of fast action are self evident. The label, for instance, shows that Afrezza is cleared out of the system much faster than RAA. Since an insulin induced hypo can only be caused while the insulin is still active it is self evident that the period of time over which a hypo can occur is reduced with Afrezza. It would be nice if we also had data showing improvement of A1c and time in range, but there are benefits to speed beyond that. Who is debating that and what are they debating over? Afrezza is able to restore/replace the first-phase insulin response because it reaches peak serum insulin concentration in 12-15 minutes. It must be that fast in order to mimic endogenous prandial insulin secretion. The first-phase insulin response is a homeostatic response that is vital for regulating glucose homeostasis. I don't see how there can be any debate about this, Afrezza is the answer. Just because you wish to not see it, doesn't mean there aren't doctors that don't believe Afrezza has meaningful benefit. I had a discussion with a random physician I met some time ago and asked if he was aware of Afrezza. He was, and his response based on the experience of doctors in his medical group was "it works for some, but it doesn't work for many". So there are narratives that are held which must be confronted/debunked/debated.
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Post by dreamboatcruise on Feb 2, 2018 20:57:46 GMT -5
Though it seems insulins would be a bit more complicated than that. Certainly there is some general understanding that speed of action is important for a prandial... why else would Novo have spent so much money developing Fiasp. Afrezza's pk/pd profile is now clearly differentiated in the label from the three old school RAAs. The FDA hasn't yet decided to take the step of defining a new category of faster than rapid, but they clearly believe speed of action is something important as can be seen in the labels for Afrezza and Fiasp that highlight it. Non-inferior vs superior is in regard to particular metrics, such as A1c, isn't it? For a class of drug where speed of action is important, isn't a label showing quicker action something that would be deemed superior? I imagine Novo is sweating the appearance of biosimilars. Basaglar's success so far suggests Sanofi's admelog could become a potent competitor. No doubt Novo is looking for some edge. The problem is that no one has actually proven that speed of action is important. Fiasp's trial results don't look all that impressive: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004046/WC500220890.pdfWhat is still up for debate is how fast is needed. Certainly RAAs were proven better at mealtime than injected RHI because of their quicker action. Further, some of the benefits of fast action are self evident. The label, for instance, shows that Afrezza is cleared out of the system much faster than RAA. Since an insulin induced hypo can only be caused while the insulin is still active it is self evident that the period of time over which a hypo can occur is reduced with Afrezza. It would be nice if we also had data showing improvement of A1c and time in range, but there are benefits to speed beyond that.
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Post by dreamboatcruise on Feb 2, 2018 17:09:36 GMT -5
DBC, You need to do your own due diligence on Santa, but I'm happy to share my beliefs about Amgen. As a former employee and executive of Amgen, Castagna knows the company and they know him. This would enable Mike to present pipeline candidates that he could be reasonably certain would fit within Amgen's areas of focus. As a PharmD, Castagna understands the properties of the various molecules that MannKind's scientists have successfully joined to Technosphere probably better than any MannKind executive since Alfred Mann. Mike would bring experience and credibilty into discussions. This second attribute would apply with any potential partner, while the first is related specifically to Amgen and, as is true with any business, who you know can be every bit as important as what you know. The things you point out are reasonable assertions. However, especially given that we've had a firm trying to play matchmaker for the pipeline for quite some time and given Mike's recent comment about needing to get through Phase 1 trials to get a reasonable deal (comment specifically about Trep for PAH), I think the chances of a deal before the pipeline is moved forward are not great. Actually your observation on Mike knowing people at Amgen would indicate to me that they don't see a match... i.e. it probably isn't an issue of Mike being granted access to pitch that has resulted in lack of a deal to date during this period when MNKD desperately needs cash in order to ramp up marketing of Afrezza. Just my take on the state of pipeline. Obviously all of us are relegated to speculation. By the way, a large talking rabbit once assured me that Santa is real... why would he lie?
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Post by dreamboatcruise on Feb 2, 2018 14:53:55 GMT -5
A drug's placement on a formulary is not synonymous with how well it works compared to others. There are often contracts (i.e. $$$) involved along with other factors. Sometimes I wonder if being "better" is even considered by 3rd party payers. Better is considered by a medical team at each payor (but not at the PBMs who are more commercially focused). Rarely, if ever, will a payor deem a product superior to another unless the FDA has allowed the manufacturer to label the drug as superior. This is why a non-inferiority label is a distinct disadvantage in any market with more than one product available because the manufacturer cannot market on that basis. Though it seems insulins would be a bit more complicated than that. Certainly there is some general understanding that speed of action is important for a prandial... why else would Novo have spent so much money developing Fiasp. Afrezza's pk/pd profile is now clearly differentiated in the label from the three old school RAAs. The FDA hasn't yet decided to take the step of defining a new category of faster than rapid, but they clearly believe speed of action is something important as can be seen in the labels for Afrezza and Fiasp that highlight it. Non-inferior vs superior is in regard to particular metrics, such as A1c, isn't it? For a class of drug where speed of action is important, isn't a label showing quicker action something that would be deemed superior?
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Post by dreamboatcruise on Feb 2, 2018 14:32:54 GMT -5
Yes , structuring the sale has to be quite complicated... been wondering for the longest time how it will be done, if at all . Has to be slowing our progress on that front .And MNKD management is probably embarrassed by the riches being offered, so they likely are delaying out of humility
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Post by dreamboatcruise on Feb 2, 2018 14:30:39 GMT -5
mnholdem, Thank you for reporting that information. That is very good info to know. Do you believe Amgen to be interested in the technosphere science and if so at what value? Other questions quickly come to mind then if MNKD sold the science to Amgen, like would MNKD keep the Danbury facility to continue manufacturing afrezza? or would that be included in the sale and how would the manufacture of Afrezza be structured in sale? I also wonder if this is why Mike has continued to build up the MNKD mgmt possibly knowing that cash flow will not be an issue sooner than later. Your information concerning Amgen brings alot of questions when you pair it up with MNKD technosphere. Thank you for your information sharing. ) Do you believe in Santa Claus and if so what is he bringing us
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Post by dreamboatcruise on Feb 2, 2018 13:35:12 GMT -5
Yeah, well, liane didn't specify which topic we're supposed to stay on, now did she? No, just the important ones. What I heard today is that Mike is commuting with a few shareholders via email, they seem to like the back-and-forth and his communication and responses. One is that he understands about the shorts and feels the same way we do about them. But, does he imagine he sees shorts where they don't exist
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Post by dreamboatcruise on Feb 2, 2018 13:18:42 GMT -5
Newbie question here.. what does Preferred actually mean? Nationwide @ 2% for example... does this mean that 2% of Payer nationwide are saying Afrezza is a better treatment option than the rest of the junk out there? The % listed on formularylookup.com is based on number of people within the category, so 2% of Medicare would mean plans covering 2% of all the people on Medicare. Preferred basically means a lower co-pay. Almost always a generic, if one is available, would be preferred to a brand name.
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Post by dreamboatcruise on Feb 2, 2018 4:02:48 GMT -5
Spencer, Your report which I my opinion is very clear that "United Therapeutics is pretty much the only game in town" fails to take into account the other big players who may show interest in Mannkind. Specifically Novartis (Pain Medication) and GSK (PAH)..Now if we look at the MNKD Board of Directors -they include 2 members who previously held senior management at both GSK (CMO) and Novartis. Don't be surprised if MNKD utilizes these relationships to help get a deal done. May is the operative word. If only every "may" was a should or shall.
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Post by dreamboatcruise on Feb 1, 2018 21:23:31 GMT -5
I'd give him some wild mushrooms picked by amatures and salmon-ela with kale. Ha! That's a "cleanse" diet if I've ever heard of one
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Post by dreamboatcruise on Feb 1, 2018 21:10:34 GMT -5
I'm curious. I wouldn't let that guy into my home he'd contaminate it. Why would you and if you wouldn't mind elaborating what would you make him for dinner? All said tongue in cheek. Although I'd still like to hear your answers. Good Luck to all includes You too. You seem to spend much of your life looking for this company's success. Hang in there. I think something simple. Maybe a salad followed by mushroom risotto and some grilled asparagus. Thinking a Provence rose wine. Maybe a bit of gelato with some berries for dessert. Joao Gilberto and candlelight for ambiance.
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Post by dreamboatcruise on Feb 1, 2018 20:49:48 GMT -5
Call me paranoid, but there are a lot of visitors to this forum, and it might be better not to post anything that suggests or alludes to casting multiple votes. I would hate to see someone use this thread to discredit the legitimacy of Mike getting this award that I think he very much deserves. Just a thought, and "Go Mike!!!" I'm surprised that he even qualifies to be in the contest. He does have a degree in pharmacy, but I would think the CEO award from this trade magazine would go to a company that is more directly in the pharmacy business rather than the drug business. Also surprised they open voting to anyone on the internet rather than the magazines subscribers or some polling of people actually in the industry. Given that it's totally open to anyone, they have to realize there is going to be a lot of game playing. Heck, if the Russians have a favorite, they'll probably set up a bot network that will swamp all the actual people voting, even if people are voting 100 times. Heck, I even can still code well enough to do that. Shall I throw a few million votes to Mike
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Post by dreamboatcruise on Feb 1, 2018 15:41:30 GMT -5
drman7... I've never invested in TSLA or Twitter so can't comment on them from investment standpoint, though I'd love to own TSLA car. Zero to sixty in less than 2 seconds. So I guess one could say the investment thesis for TSLA resembles the one for MNKD. I do own some AMZN, though my position in MNKD is larger. I have read some of SO's articles including the one just today referencing thread here. Seems amusing to me how he's taking advantage of all the attention he's getting here. All the whinging here just plays into building up awareness of him. It seems we both have the same basic assessment of what he writes... that he's presenting info that is available elsewhere such as here and in MNKD financials. Just seems you are upset about it, whereas I see no reason to be bothered by it. Tons of articles written about companies are exactly that... summarizing info readily available. I would never have as much money as I do in MNKD without doing my own due diligence digging into financials, the clinical trials, etc., otherwise I might find SO's articles useful... though as he has stated more than once, he is primarily targeting traders.
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Post by dreamboatcruise on Feb 1, 2018 14:07:48 GMT -5
I hope this interview happens with either SO or AF. An interview will be a great way for MannKind to have that transparency In my opinion, I hope no interview happens. These guys are not welcome and are not worth Mannkind's time or MC's time. Also, why now? They had their chances in the past - yearly investors meeting, quarterly earning calls, etc. No excuses. If they spend so much time writing articles, why can't they find time to call, email, etc. A reporter does whatever it takes to get the truth/story why can't these so called analyst do the same. Anyone that wants this interview is loosing focus on the goal. What transparency? I think after Monday's presentation, I got all the information that I wanted. Lets just wait to see who the CMO is on Monday and go from there. Funny how Matt P. has AF as a connection on Linkedin. Anyway, SO and AF are not really contributing in any way just giving day traders something to chew on, but when a long term places a comments on their articles they go on the defensive and never retract their wrongdoings. Also, when folks like myself start talking about the science behind afrezza, forget about, SO,risingskeptism, AF are all scientist all of a sudden. Dudes probably don't even have their Master's degree. I remember going 1:1 with SO on comparing Afrezza to the pancreas. Went back and forth for a while. This is not rocket science the science has already been done/proven/FDA approved thanks to Technosphere. Moreover, SO never called out risingskeptism on his SA message board when he attacked investors opinions on Afrezza, why because he is a hypocrite. Al, may he rest in peace, called Shkreli a punk. I call AF and SO punks as well. SO says he still believes Mannkind is speculative. What does that mean? SO - Don't tell us what we already now, tell us what do you think. Not that hard. i.e. running out cash, dilution, scripts are flat, etc..dude we all know the scripts numbers every Friday just like you do.Has SO or AF helped any PWD with their vast knowledge of diabetes? Personally, i have. For example- I recommended Tresiba to my T1D cousin. He mentioned Tresiba to his doctor, got a prescription and loves it. His life has changed dramatically with less injections and less hypo. I tried to explained Afrezza to him but, like many PWDs, only listen to their endo. Long story short Mannkind long. There are no current profits, so any valuation put on the company is speculative concerning earnings that have yet to materialize. Profitable companies can be valued on real, not speculative earnings. I don't read SO because as you point out he's primarily writing things that I know... i.e. he's not writing for you or I. Many people aren't members of this forum and don't follow MNKD as closely. They are who he is writing for. Don't get upset that he is presenting information for other people that you may already know.
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