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Post by dreamboatcruise on Feb 7, 2018 18:58:03 GMT -5
Great hire. I just hope he doesn't pull a McDaniels or get the DeSisto whammy (which now with Mike I'm glad that happened). Interesting comment as one would think there was a not to compete/ non-disclosure agreement that he signed with Lilly. Sound like a very friendly hire by MannKind.
There can be a lot of issues that make non competes tricky. Chief among them is which states are involved... where did he work and where will he work. If someone worked for a CA company and goes to work for another CA company a non compete is basically unenforceable. Not so for other states. Non-disclosures bring in bunch of other muddy issues... as can be seen by lawsuits such as the one now between Uber and Alphabet regarding an employee. Only once in my career did the particular set of circumstances of a non-compete make me decide to skip past my first choice candidate.
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Post by dreamboatcruise on Feb 7, 2018 18:47:29 GMT -5
Yeah I plan to sell shares when the time is right or if I desperately need some money. I get that it is a side bet, or using the money from shorting to add to a long position. It's cool I get it. Shorting is shorting and I don't really agree with it in general. I've never been asked to loan my shares (which surprises me a little), but if I were, I'd gladly do it and for the same reasons as you've been reading. But here's another thing to think about, loaning shares is not the only way shorting can occur. It is legal to "naked short" depending on who you are (e.g., a so-called market maker) in order to ensure liquidity (is the argument). What is pure evil though, is illegal naked shorting where the shorting is egregious and the folks shorting are doing it to harm a company, or worse, without regard for the harm they know they're causing. So, naked shorting can be legal or illegal. What is the litmus test used to determine the difference? I think answering this question is the wet dream of crooks indulging in illegal naked shorting. There is no clearly specific guideline. It requires evidence of the naked shorting, and proof of intention to manipulate price in order to harm or illegally gain from the price drop. The SEC and other enforcement agencies appear to be too busy or perhaps it's too hard to chase down illegal naked shorting and prosecute offenders. Try to find 3 examples in the past 20 years of crooked brokers and market-makers hauled to court on charges of illegal naked shorting. Why is it so hard? Two things stand out. First, the evidence is buried in the bowels of the Depository Trust Corporation transaction logging which apparently is either flawed, or otherwise unavailable to the enforcement agencies. (You should be asking yourself why. The most obvious answer that springs to my mind is massive systemic corruption. Don't like conspiracy theories? Me either.) The second challenge is plain old ordinary detective work required to find proof of intent to commit criminal naked shorting. Only an idiot or a person with reason to believe they're immune would more or less openly commit the crime and leave evidence strewn about. Cramer may be an example. (Search for deep capture and Overstock.com.) Not sure which camp Cramer would fall into but given his wealth, fame, and education, it isn't obvious to me he's in the first camp. A couple more things to consider here. What is the evidence of illegal naked shorting? Well, in the case of MNKD, I would argue it is a number of things. First is the very lopsided Short Interest Rate. MNKD is a little company. Their stock is not hugely volatile. And it would be hard to argue that it's simply way overpriced and has been for an extended period (not that being overpriced for an extended period is an excuse for illegal naked shorting - they're just reasons why short interest might accumulate). So the unusually high SIR is one indicator. What's another? The number of times MNKD has appeared on the SEC's Regulation SHO Failure To Deliver list which IS direct evidence that naked shorting occurred. It just isn't direct evidence it was illegal naked shorting. I would also suggest social media trolls (e.g., Frag on Yahoo! Conversations) who are so very obviously bashing MNKD in order to manipulate and depress the stock price, as an indicator of increased likelihood of predatory financial practices. Trolls like Frag are not there to help naive investors. In fact Frag regularly belittles "retail" investors as "bag holders" (in the case of MNKD specifically). So, all of this just to say, shorting I understand. It's a bet just like investing in a security and expecting it to appreciate in value is a bet. MNKD is, even after all this time, a pharma start-up. Nobody expects MNKD pay dividends at this stage of their maturity and sales revenue. So, buying and holding MNKD means you expect the stock to appreciate in price (eventually). The fact that loaning shares potentially helps crooks is unfortunate, but I assume it is unlikely shareholders loaning shares and earning interest will bring MNKD down. MNKD will succeed or fail based on many more factors. I guess I would dispute some of your assumptions. Illegal manipulation of stocks I think is a separate issue from naked shorting. Stocks can be manipulated in both directions and the same sort of factors are involved to determine if illegal manipulation occurs. Wishing to profit from having a company fail and thus have the price go down is no worse from a legal perspective than wishing a company succeeds and thus have the price go up... neither is trashing vs hyping from a legal perspective. Naked shorting is when a short occurs when the stock has not already been verified as available for borrowing before the settlement date. Market makers do have laxer rules regarding the need to locate shares to borrow. Failing to deliver a shorted share on settlement date triggers processes that resolve the situation. A failure to deliver does not necessarily mean there was an underlying naked shorting situation... i.e. shares could have been located that for some reason then disappeared. Certainly in the past it has been shown that true Naked Shorting has been done where brokers were allowing larger quantities of shorting to occur than the number of shares to borrow they actually could locate. That violates regulations but doesn't have anything to do with what the person(s) doing the shorting had as their intent. Afterall, anyone shorting is hoping the stock goes down and thus financially gain from the price drop. I don't see a valid argument as to why a high open short interest would be evidence of some particular problem with naked shorting. Open short interest could be unlimited with absolutely no naked shorting as long as you continue to have buyers that are taking the shorted shares and willing to loan them back out once again. Theoretically this could go on until open short interest is more than the actual number of issued shares... with not a single naked share short needed in the process. SHO likely is an indication of naked shorting. Though if there is a change in shares available to borrow it wouldn't even have to be from naked shorting. If I had a million shares held with fidelity that weren't loaned out on a Monday but were in the share loan program, another Fidelity client could short one million on Monday with Fidelity validly having located the million shares to borrow (my shares)... i.e. a short not a naked short. If on Tuesday, before the settlement date, I tell Fidelity I am withdrawing my shares from the loan program, the shares that were shorted by the other guy might indeed be a failed delivery on settlement date if another million could not be located in the meantime. This situation is not a naked short, yet a SHO failure occurred. I also think part of the problem is that the system for located shares to borrow is perhaps set up in a lax manner that allows lots of volume to fall into a grey area where the involved parties did what the system requires to locate the shares (technically not naked shorting) and yet the shares end up not really being there or having been double counted. That's not really illegal, though if happening it needs fixing. BTW: with the relatively small number of shares I have with Schwab I had to ask to get them in the program, not the other way around.
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Post by dreamboatcruise on Feb 6, 2018 14:30:57 GMT -5
C raig Dean@ Michael Kovacocy think any chance this article from a week ago about Lilly having 9 billion from the new tax plan to spend on acquisitions and partnerships And the new hire today from Lilly is associated? Might be nothing but interesting regardless. Michael Kovacocy
Craig Dean that is some good sleuthing and interesting. I can't comment with certainty on speculation, and if I did know anything specific on this point, I wouldn't be able to comment. So it is clear that I will just have to defer to you and say that it is certainly plausible, why not? Michael Kovacocy
I would say this. And it isn't rocket science. Mike the CEO continues to deliver what he promised, and is ticking off all the boxes on the company's to do list. This is public info, the list is on loads of presentations, etc. And there are now just a few tick boxes left on the list, and they are biggies. One relating to the subject you have mentioned above. So if I were a betting man, I would expect material news on this point sooner than later. And there is nothing to say that your speculation has any more or less merit than that of others with less optimistic views on the company. I would even be so inclined to say that your thesis makes sense - not so much just for Lilly, but a whole swath of players who might wish to cosy up to MNKD. So the general thrust of your thesis makes sense. Might not be the right company, but makes sense. One doesn't have more merit than the other, yet he's inclined to agree with one over the other. Does this guy read what he writes, or does he not realize that doesn't make logical sense.
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Post by dreamboatcruise on Feb 6, 2018 14:17:50 GMT -5
Amphastar is already in China. They have a plant there with Chinese workers, so they already have more than just a foot in the door...from what I understand, China typically insists that if you're going to sell in China, you must manufacture in China. Amphastar to get us going in China, and Amgen to get us going here in the USA... I would be more than okay with that! GLTA! Nothing is going to happen with Amgen here, so would you be sort of ok if Amphastar ever decides to move with Afrezza in China?
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Post by dreamboatcruise on Feb 5, 2018 17:30:12 GMT -5
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Post by dreamboatcruise on Feb 4, 2018 19:37:25 GMT -5
Allocate budget out of the next funding raise? Matt would have a better idea than me, but from old filings I would say $2M would do it. Without that trial data we can advertise all we like and not see significant movement. There is still the requirement for the large scale lung safety trial out there, maybe that could be combined with a superiority trial (design it as a superiority trial and have lung safety as a secondary objective for the Afrezza arm). Those are my thoughts. What is your answer? $2M does not sound like a whole lot of money. If it were accurate, it does beg the question why MNKD hasn't done it, as it is such a no brainer. How long does such a study has to be? How much does MNKD need to survive till then? My answer is more drastic and dramatic. I suggest we put our potential in the Chinese for bid. Part of the price is to collect data / run comparison to show superority. Remember that the Chinese gov is already requiring and permitting the safety studies on Chinese population be done on its population as one is marketing its drug. Then we turn around and use that data here in US. Amphastar having first right of refusal for the Chinese market does raise a barrier to finding other interested parties willing to do all the due diligence, knowing that whatever they agree to could be snagged out from under them.
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Post by dreamboatcruise on Feb 4, 2018 19:28:54 GMT -5
No shortage of subjects (China) as china has the largest number of obese children in the world, as well as more diabetes patients than anywhere else / Last statistics I saw the US still had around 5 times higher incidence of diabetes per capita. As I remember the only country in the world worse was Saudi Arabia, but we were darn close. Go USA
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Post by dreamboatcruise on Feb 4, 2018 19:20:43 GMT -5
On second thought will, the FDA let us use a foreign country for trials give the cultural differences ? It is very common to have some patients in FDA approved trials enrolled in foreign countries.
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Post by dreamboatcruise on Feb 4, 2018 17:50:39 GMT -5
So I guess Medicare plan coverage varies from state to state. I know Medicaid plans do but I did not realize Medicare plans do. I would have thought all Medicare plans would all be offered to all states and their coverage equal to all states. I guess I’m still learning the complexity of government health insurance. "Traditional" Medicare is the same from state to state. Medicare Advantage plans are the private ones and those fall under state by state regulatory frameworks... and differences driven by the provider networks in each state. Medicare Part D, which added drug coverage to Medicare and is the newest major component has never had a "traditional" version run directly by the government. It started off as a plan which would only be done through commercial insurance providers, either as part of Medicare Advantage or as a standalone Part D prescription plan. As such it has always been within the framework of state by state insurance.
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Post by dreamboatcruise on Feb 4, 2018 17:43:06 GMT -5
Done deal, everyone needs to ask their followers and friends to vote for Mike. Spiro here, getting ready for the big one. Go Brady I've asked my followers, but given they are imaginary, I'm not counting on them being able to vote
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Post by dreamboatcruise on Feb 4, 2018 17:40:55 GMT -5
STAT is one such trial, which has already concluded. Whether it will be considered compelling enough for FDA to grant another label change is a question none of us would know an answer to. STAT is only a 40 person study and only for 4 weeks so I doubt you could get a superiority label from that. The best you will get is an improved time in range label which, while it is worth having, is not going to move the needle much.There is an HbA1c measure as a secondary objective and the HbA1c is what they will want for a superiority trial. However the test is only 4 weeks long and you need much longer to get a meaningful HbA1c result since it raises the question as to whether a result is due to a really bad month (low or high) rolling off the HbA1c or is it the treatment. That to me would be a superior label. I don't believe the FDA would ever allow a label claiming some sort of generalized superiority. It would always be with regard to some specific metric(s)... whether A1c, time-in-range, occurrence of hypos or cardiovascular risk. STAT theoretically could address the first 3 of those. In general whether STAT has a large enough cohort and lasted long enough, would be something I have no clue. Obviously those two or also linked. With large enough cohort whether particularly good or bad months happened before the start of the trial should come out in the statistical wash. Also would be the question whether a calculated A1c reduction based on average BG from CGM, as STAT will look at as secondary metric, would be something considered a valid measure of A1c by FDA. I'd suspect not, simply from over cautious nature of medicine, though the relationship between average BG and A1c is certainly well understood.
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Post by dreamboatcruise on Feb 4, 2018 13:35:44 GMT -5
Allocate budget out of the next funding raise? Matt would have a better idea than me, but from old filings I would say $2M would do it. Without that trial data we can advertise all we like and not see significant movement. There is still the requirement for the large scale lung safety trial out there, maybe that could be combined with a superiority trial (design it as a superiority trial and have lung safety as a secondary objective for the Afrezza arm). Those are my thoughts. What is your answer? Only 2m? So why hasn’t mannkind at least talked about a superiority trial? Is it length of the study? Belief that the upcomong studies are good enough? Reliance on cgm? STAT is one such trial, which has already concluded. Whether it will be considered compelling enough for FDA to grant another label change is a question none of us would know an answer to.
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Hypos
Feb 3, 2018 16:19:26 GMT -5
Post by dreamboatcruise on Feb 3, 2018 16:19:26 GMT -5
I wonder how that compares to humalog. Humalog would have TONS more hypos... but they also have TONS more patients on it. Obviously, one would need to look at per capita incidence, but there isn't a ready source of data on how many patients use different drugs. One could also look at the relative rate of occurrence of hypos vs other adverse events to determine if one insulin is better in that regard. The data for Afrezza are still fairly limited in quantity due to much smaller user base.
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Post by dreamboatcruise on Feb 3, 2018 16:08:46 GMT -5
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. You're going on about something irrelevant. Where did I say I believe physicians don't think Afrezza has meaningful benefit? You said, "What is still up for debate is how fast is needed." I specifically asked you, "Who is debating that and what are they debating over?" Not sure what you're going on about but ok. If you want something more specific... the FDA is apparently still debating over whether to create a new designation for faster than RAA insulins, and highly likely the issue of a threshold for how fast would be part of that debate. Is a new designation necessary? Would Fiasp qualify or only Afrezza? I'm sure you have an answer to these, but that doesn't mean everyone would agree with your answer. One would hope that at some point the ADA has that debate with regard to their treatment guidelines. Whether that debate has even started at the ADA I couldn't say.
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Hypos
Feb 3, 2018 15:57:35 GMT -5
Post by dreamboatcruise on Feb 3, 2018 15:57:35 GMT -5
I keep hearing that Afrezza lowers instances of hypoglycemia. Have we heard of ANY instances of hypoglycemia while using Afrezza? Just wondering. Mike's presentation this past week had a slide (#9) with a CGM plot clearly showing hypos that occurred while using Afrezza. You can also read the clinical trials which mention hypos... and thankfully with evidence that the incidence is reduced using Afrezza. The adverse events database maintained by FDA also has hypos as one of the most common reported. So... it would seem odd if you haven't heard of any. Bottom line is that any insulin can cause hypos if taken in too large of a dose. Perfect dosing simply isn't possible 100% of the time. Sadly, insulin is something that is used by some to commit suicide. Afrezza, as with any insulin, would easily cause rapid death in doses only moderately above the therapeutic range.
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