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Post by dreamboatcruise on Jan 7, 2018 18:02:05 GMT -5
Aged... Did Sanofi fail to sell the drug or did the incoming chief abort the effort prematurely because of his prior experience with exubera? Theres a big difference. No one can really know the thinking that went into the decision. From things that we've heard from MNKD management, and even VDEX... it appears that there were some real obstacles regarding proper education/titration, retention, insurance coverage, etc. that Sanofi (and now MNKD) would have to overcome. Could Sanofi have eventually been successful... I think so as I think MNKD will eventually be successful on their own. To me it is clear that we got screwed by having Sanofi curtail their Afrezza efforts long before MNKD was then allowed to take over. That action by SNY was contrary to the agreement... though perhaps having a minimum time before Sanofi could back out was simply a flawed desire on MNKD's part when negotiating the deal. Sometimes those sorts of clauses are beneficial, but in this case I think it did nothing but harm to MNKD. Rarely does a deal like this really compel a partner to use their best efforts.
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Post by dreamboatcruise on Jan 7, 2018 14:51:50 GMT -5
IS IT THAT THE BIG BOYS ARE WATING FOR INSURANCE COVERAGE?OR STAT STUDY? MAYBE THEY DONT BELIEVE THAT PRODUCT IS A BLOCK BUSTER? PLEASE SOME HELP ON THIS QUESTION SHAREHOLDER FOR 7 YEARS, THANK YOU your question: why haven't we found a partner in the u.s.a. yet? my reply: which one? Which of these both have experience in diabetes space and yet do not have a directly competing product to protect? Though by the time Afrezza is on solid ground that would likely interest one of these in a serious way, I think MNKD itself will be best positioned to market and sell Afrezza. At that point why look for a partner, just raise money and go it alone.
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Post by dreamboatcruise on Jan 6, 2018 21:20:06 GMT -5
Founded in 1991, Mannkind is almost 27 years in the making. 2 years ago, our U.S. sales and marketing partnership with one of the Big 3 almost bankrupted us, causing us to drop from $11 to 50 cents. I think we can take a couple extra quarters or even years doing it ourselves to avoid that kind of criminal usury again. Also, the stat study results will help us sell the insurance companies on us. Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza? The presentation at Cantor conference had a slide covering patents. It said that the FDA Orange Book patents covering Afrezza extend to 2032. Even after that point it may be more difficult than a typical generic drug to replicate Afrezza since it is a complicated device drug combo. What would a company need to do to prove that their copycat cartridges, inhaler and powder (particle size, uniformity, etc.) perform exactly the same as Afrezza? Is there possibility a copycat would need to go through its own expensive set of clinical trials to prove equivalence? (don't know the answers to these questions) Concern for others copying Afrezza is very far down on my list of what I'm concerned about.
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Post by dreamboatcruise on Jan 6, 2018 20:58:45 GMT -5
Since nobody else said that they recalled Mike mentioning a Medicare coverage increase coming up in January, 2018, I went through his recent presentations and I could not find that claim. However, I only found one radio broadcast and I thought there were two. The one I found was the Wharton Business Radio Sirius XM that Sla posted. I searched for "radio" and "broadcast", but perhaps those words are not contained in it. Anyone know of another radio interview Mike did in Qtr 4? Say, 2 to 3 months ago. Otherwise, I'll just write it off to defective memory. The only thing I did find is: Expansion of payor coverage - Mike C said they were ready to sign with a large PBM in Jan 18. That is probably what I was thinking of. You may be recalling that sometime early in 2017 there was mention (not sure who it was) by management that Medicare formularies are updated once a year and thus they didn't expect dramatic change in Medicare coverage until Jan 2018. I, and I think some others, assumed that meant they had some confidence that they would get improvement starting Jan 2018, but in reality the statement may have really only said that it would be Jan 2018 at earliest that Medicare coverage would be improved significantly, but with no real indication of probability.
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RLS
Jan 6, 2018 20:28:39 GMT -5
Post by dreamboatcruise on Jan 6, 2018 20:28:39 GMT -5
From a medical marijuana perspective, the Sessions crack-down could be a windfall for RLS which would be providing an FDA approved tar free medicine. Whats the cancer risk of pot, one joint to a pack of cigarettes? From a recreational perspective I am not sure where this goes. In a few years with the tar rates of marijuana so high you would think the law suits would follow. I suspect Trump is trying to force the issue to get Congress to decriminalize it and then leave it up to the states. But if that happens since there is no tar in the RLS product I would think RLS could have a winner. Being a schedule 1 drug puts a lot of red tape hurdles into the development process. It my be a ridiculous notion but the official stance of the US government is that cannabis has no valid medical uses. I believe that to take a cannabis based product through all the development and clinical trials would require cannabis to be reclassified. Not sure what the process for that is, but in general it seems people do not believe that is in the cards under a Trump administration. I do hope your optimism about change turns out to be correct. [caveat: I have no professional expertise in this area so take views with grain of salt] Here is the basics of what being Schedule 1 means. The following findings are required for drugs to be placed in this schedule: The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. Except as specifically authorized, it is illegal for any person: to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.
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Post by dreamboatcruise on Jan 5, 2018 20:48:47 GMT -5
Is this author independent or is she on the Novo Nordisk payroll? Those Fiasp speeds seem to be pure propaganda. Fiction. Giving benefit of the doubt, which likely isn't warranted, she may be confusing pk with pd. Perhaps that is first detection of insulin in bloodstream.
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Post by dreamboatcruise on Jan 5, 2018 20:13:46 GMT -5
IS IT THAT THE BIG BOYS ARE WATING FOR INSURANCE COVERAGE?OR STAT STUDY? MAYBE THEY DONT BELIEVE THAT PRODUCT IS A BLOCK BUSTER? PLEASE SOME HELP ON THIS QUESTION SHAREHOLDER FOR 7 YEARS, THANK YOU It seems management has indicated they aren't looking for the same type of deal as with Sanofi, turning over all responsibility for marketing and sales... even with option for Sanofi to take over manufacturing at some point. Management has indicated they might look to partner in order to share sales force(s)... with MNKD sales repping something else or some other company with underutilized sales staff repping Afrezza. That is unlikely to be "the big boys"... IMO ( matt , please correct me if this is bad assumption). How long have they been looking? How common is that type of arrangement, and thus how long might it be expected to take? Is this something mentioned more as window dressing for investors, perhaps being explored but without high probability of finding a good match? I would not put too much weight on management's comment about pharma contacting right after SNY dump. It could be true but it may have been offers assuming MNKD was desperate and would accept anything. Of course from an investor perspective with all the eventual dilution and opportunity cost perhaps a hypothetical low ball offer back then will not seem that bad. Now we must look to the future. I just wouldn't be holding breath for a deal with the "big boys" that doesn't seem to be within the parameters that management has indicated they are pursuing. It's unlikely that any would step forward with a great offer until MNKD can prove a solid turnaround and profitability... and once MNKD proves that, I really don't see why as shareholders we'd want to split the profits with big pharma. At that point the share price would be much higher and MNKD could fund the expansion of their own sales team... a sales team that at that point would have the institutional knowledge of how to sell Afrezza.
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Post by dreamboatcruise on Jan 5, 2018 14:06:02 GMT -5
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Post by dreamboatcruise on Jan 5, 2018 14:01:57 GMT -5
If MNKD received any type of payment from RLS prior to the end of the 4th Q how big of a window before we would see a PR on it? The $1M Payment from RLS made on 12/30/16 was reported on 1/2/17. Could there have been another Dec '17? Not impossible, but I'd assume they would announce it pretty quickly... don't see any reason to delay such an announcement. Also, there would be no reason to suspect that a development progress milestone would occur exactly a year after the prior one. In the absence of other info I'd say it is as likely that it happens in Feb, or April, or any other month as it having happened in Dec. And always two caveats in general... some very small chance that there is a science/technology reason why technosphere simply doesn't work and milestones are unachievable, and somewhat more likely chance that RLS halts development of inhaled cannabis product for business reasons and agreement is drafted such that they can opt out of it without paying outstanding milestones. Though I would think that the latter two undesirable outcomes would trigger an announcement... so I'm assuming it is still on track even if the train's velocity is unknown.
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Post by dreamboatcruise on Jan 5, 2018 13:29:34 GMT -5
Leading up to earnings there could be additional downward pressure on expectation of guidance miss. I might consider adding to my position as these two potential negatives play out. Not to say that I will buy more after 1/15, but I think they will warn of missing guidance well before earnings, if in fact they will miss. Is there a chance they did meet guidance? It appears that gross to MNKD would need to be basically be 100% of reported Symphony retail for Q4 to meet guidance? Even if we assume that recent pricing change increased MNKD gross to retail ratio (skeptical that is valid assumption), we know that there has to be a significant gap as there is with all pharma products. I'd be curious if anyone has some reasoned hypothesis about meeting guidance. If we were to somehow do that I think stock would react very positively, especially if then coupled with strong future guidance.
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Post by dreamboatcruise on Jan 5, 2018 12:23:13 GMT -5
Certainly would have been nice if new label pharmacodynamics info had been reflected.
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Post by dreamboatcruise on Jan 5, 2018 12:10:41 GMT -5
I will not buy more before we see what happens on 1/15 with the Deerfield debt. Leading up to earnings there could be additional downward pressure on expectation of guidance miss. I might consider adding to my position as these two potential negatives play out.
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Post by dreamboatcruise on Jan 5, 2018 12:06:03 GMT -5
Mann, I hope Nate knows what he's doing. Seems like he does. It has been stressed to be diversified. If you've held all the stocks he recommends you've done pretty well despite the loses on MNKD.
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Post by dreamboatcruise on Jan 5, 2018 1:31:52 GMT -5
The one big misstep was not raising capital when they could have at multiple billion valuation. The slow pace of progress is mainly due to lack of financial resources... in addition to some nasty realities about insurance coverage in the modern era of restrictive formularies. True. But Management has promised to be transparent... they haven’t done a great job of it. Also, the clinical trials also took forever to get started. Specifically the Pediatric. It’s a 2 month study that can be extended for a year. It started on September 28th 2017 and has an end date of January 2021. I want data! Or, a least the ‘when’ that data will be available. They may be more transparent than people assume... i.e. no big secret deals being withheld. Yes, trials should have started earlier, but again... lack of money. What is the data you want? Something you think they have? One thing I can think of... I'd like more insight into the script data, such as how things are doing in the markets that are targets of advertising... but I suspect that might not be allowed with their contract with Symphony.
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Post by dreamboatcruise on Jan 5, 2018 0:01:44 GMT -5
This must be one of those “you had to be there” threads... FYI to everyone else: Mr. Brandicourt is Sanofi’s CEO. Personally I think he might have done us a favor (long term) for ending the Partnership. For any financial losses, I blame MannKind’s management not Sanofi’s. They took to long to get use where we are now. Hopefully they have the team together (now) to get MannKind to profitability. This year please! The one big misstep was not raising capital when they could have at multiple billion valuation. The slow pace of progress is mainly due to lack of financial resources... in addition to some nasty realities about insurance coverage in the modern era of restrictive formularies.
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