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Post by dreamboatcruise on Mar 31, 2018 20:32:55 GMT -5
Anyone know what forms of advertising we are currently using? We did have Afrezza on like 6,000 or so doctors’ office screens in waiting rooms (don’t recall the number)? We had sponsored the TV show Reversed last summer which I think a sequel will be playing again sometime soon? We did the advertisement in an MLB playoff flyer in the fall and more recently up in lights in the scoreboard area of a hockey game. Facebook, Twitter ? Television in select areas from around October- December I believe. Magazines? Just wondering what we still have going if anything or are we basically just selling with reps? I thought the advertising in docs’ offices was a great idea. Don’t know how much it costs and I wonder how long it lasted. Mike said Afrezza is extremely responsive to advertising, Im guessing by now they know which forms of it are the best and most cost efficient, so we should soon be ready to roll again when we will be able to afford it. Though I'm a bit confused if it is "extremely responsive" why do they not pick some limited geography and do heavy, sustained consumer marketing to really showcase this responsiveness. If they couldn't afford to continue advertising in all the trial markets from Q4, narrow it down to one or two that were the most promising. Do online, on air, educational dinners for doctors, etc. Then share the actual results with investors. I would like to believe management regarding the promotional responsiveness, but they've been saying that for a long while. I think many potential investors aren't willing to take that leap of faith based purely on the claim by management. Maybe I'm missing something, and this strategy has flaw I do not see.
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Post by dreamboatcruise on Mar 30, 2018 3:54:34 GMT -5
digger ... he seems to be quite active professionally. Yes, but as a diabetic spokesman, he lasted for all of one day and that was it. He's not really a "diabetic spokesman". He's an actor... with a family that he needs to provide for by doing what he gets paid for. Kudos that he took the time to testify that day.
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Post by dreamboatcruise on Mar 30, 2018 3:48:22 GMT -5
Q4 CC Mike C "Additionally, we have a fine term sheet for a large market upsize U.S. and when the process of finalizing a second term sheet. One of both is we hope to announce in the first of this year but as you know, these things take time. We do expect these deal structures will have a combination of upfront milestones royalties and more importantly we need to continue to serve patients around the world - well we know these markets may not generate a lot of cash, they will tremendously make a difference for society, and I believe with the 80 million to 100 million people in some of these markets, who haven't [indiscernible] just a minor share in these segments will offset a tremendous difference in people's lives." Seeking Alpha transcripts are typically horrendous and they always seem to butcher MannKind conference calls in particular. I'm not saying they do it intentionally...it might be that MannKind is such a small biotechnology company that they don't put their best people to the task. I think the transcript should have been written as follows: " We do expect these deal structures will have a combination of upfront, milestones, royalties and, more importantly, we need to continue to serve patients around the world..."Adding a few punctuation marks makes a huge difference to context. Yes, punctuation makes a lot of difference, hence very ambiguous as to whether it is "upfront, milestones, royalties" or "upfront milestones, royalties", as any payment before revenue might be considered upfront... who knows... not me. Though perhaps revealing that, "more importantly... ". Which I'm ok with as well. I will be very impressed if the deal that already has a finalized term sheet (per Mike) has a meaningful immediate upfront payment.
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Post by dreamboatcruise on Mar 29, 2018 19:10:42 GMT -5
digger... he seems to be quite active professionally.
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Post by dreamboatcruise on Mar 29, 2018 18:57:03 GMT -5
Is the runway/funding still expected to last until end of Q2? If so, then a cash infusion is very imminent and there is a great possibility that dilution will be necessary. I suspect this is being priced into SP at this time. I think that is a fair assessment. Mike has promised a number of things since arriving at MNKD, some of which he delivered on and some he has not. A hard core fundamental investor would say that he has hit on some of the softer commitments and missed on the harder to achieve financial metrics. He claims he has two term sheets in process and that he hopes to get some big upfront dollars, but the market is showing its disbelief. That is not to say that Mike is deliberately misleading, but the market wants to see executed definitive agreements and the cash in the bank before they will credit his statements. Compounding that perception is presentation at the H.C. Wainwright conference in a few weeks; nobody presents at the Wainwright conferences unless they are looking to do a raise, and the financial terms on Wainwright deals are almost never attractive. When the words and the music don't go together, the market gets nervous. I do not believe he has ever said that. Said upfront, yes. Shareholders here have speculated "big", but please show me where Mike has ever said anything about the size of such upfront payments. Apologies if I did miss some statement by Mike along those lines.
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Post by dreamboatcruise on Mar 29, 2018 18:50:37 GMT -5
Forgot to mention, my new PCP said he had heard that it's hard to figure out correct dosing and that was part of his issue. I wonder if One Drop has any info on their website or public statement about having available coaching to support new Afrezza patients. Seems if this "issue" is a real one for the doctor, a patient could allay it by saying he was going to use the One Drop coaching... would be helpful I would assume to be able to point to something showing One Drop specifically knows how to coach patients through Afrezza titration. It probably wouldn't be possible for patients on government programs (Medicare/caid), but I wonder if MNKD could pay for some number of months of the One Drop Pro for each new patient. Seems One Drop might cut a really good deal as some percentage of the patients might opt to continue even after the free period.
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Post by dreamboatcruise on Mar 29, 2018 18:39:25 GMT -5
Shorts may well assume we're heading to again using all the authorized shares, which would be 90% dilution. If you double the share count, it is 50% dilution. 90% dilution is if the company issues like 10x the current outstanding shares. Example: you own 10% of a company with 100 outstanding shares (10 shares). They issue 100 additional shares, you now own 5% (10/200). You were diluted 50%, not 90%. Sorry, that may be the more standard way of referring to percent dilution. I think both ways of looking at it have been used by others here, and I don't know what was meant by the range of 20 - 30% in the post I was referring to. I meant 90% more shares from where we are today... as well as anticipating that we may well end up with around 200+ million outstanding to get us to profitability (around 30% more when counting all the shares necessary to meet debt conversion obligations as already baked in).
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Post by dreamboatcruise on Mar 29, 2018 12:04:24 GMT -5
It is my opinion that the shorts are harvesting what little stop losses are available. I don’t think there are many stop loss positions left as most investors have made the decision either not to sell or to go short. The action today does very little too drop the more that 35,000,000 shares that have been shorted. In fact, the shorts may just be piling in more. The lines have been drawn and have been for some time. The shorts are betting bankruptcy and the longs are betting long term successs. The day traders are playing the price fluctuations as we all wait for the ultimate outcome. An interesting risk for the shorts this week is the script number for this Friday. We had a nice pop last Friday that brought us back into the mid 400s. If we have another pop into the mid 500s, things could get interesting. I am in no way predicting north of 500 this week as I have been wrong so many times. But it is a possibility. No. The Shorts are betting significant dilution. 20%,25% 30% dilution and the Shorts are very likely to be correct. Somehow they always know. Having 30% dilution before profitability would seem quite likely. It doesn't take having any special insight to see that. Just listen to what the company says about the cash burn and calculate how many shares would be required to raise the money. Longs know that too, but many just choose to assume a stroke of luck will occur delivering large amounts of non dilutive money. I'm actually guessing we see around 30% dilution, but I think this would not be a good long term short at this price if 30% is all we see. Hence, why I hold my shares despite thinking we'll have 30% dilution. Shorts may well assume we're heading to again using all the authorized shares, which would be 90% dilution.
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Post by dreamboatcruise on Mar 28, 2018 21:59:45 GMT -5
Maybe they are exiting to go find a better target to make some money. They wish they could ... but, not enough shares are available and they feel TRAPPED !!! That must be horrible being trapped in a trade that yielded a 6.4% profit for them in one day.
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TrpT
Mar 28, 2018 21:53:11 GMT -5
Post by dreamboatcruise on Mar 28, 2018 21:53:11 GMT -5
Material from Mannkind definitely talks about using the amorphous form for drug delivery. The process for manufacturing it involves creating a solution from a salt of FDKP and the API and then spray drying to form the amorphous particles. I do not recall reading any of the details of what would determine which form is the better (or only viable) solution for a particular API. If I were guessing, I might think it would have something to do with the size and electrostatic properties of the API. @kastanes previously stated that amorphous is cheaper to produce compared to crystalline form. Apparently stability of the two forms might vary from API to API. "Development of formulations for dry-powder inhalation combination products requires some key considerations including stability and particle architecture. Drug stability should be evaluated in both crystalline and amorphous particles"(from www.ondrugdelivery.com/publications/OINDP%20April%202011/Mannkind.pdf)But I think when it says "drug stability should be evaluated, " it just means that you have to make sure that the drug doesn't chemically react with the FDKP or undergo any other change that might alter its effect. The description of how FDKP works as a carrier implies that it must be put in an acid solution with the drug so when the FDKP crystallizes, it forms a lattice in which the drug is captured without any chemical changes, and then when exposed to the human neutral pH it dissolves and releases the drug unchanged. Using amorphous wouldn't make much sense. How would amorphous transport the drug? Just FDKP and drug wouldn't react if mixed; you'd just have a mix of FDKP and drug. I can't personally vouch for the feasibility from my own expertise, but more than one Mannkind document talks about the process to create the amorphous form of a carrier particle... i.e. using a salt of FDKP mixed with the API into a solution and then sprayed dried, resulting in uniform sized particles containing both FDKP and the API. It is a different manufacturing process from the one used for the crystalline form which you cite.
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TrpT
Mar 28, 2018 17:53:55 GMT -5
Post by dreamboatcruise on Mar 28, 2018 17:53:55 GMT -5
digger This is a guess: That is unlikely since Liquidia's technology doesn't form crystals. Right, I see on Liquidia's website it says "LIQ861 particles are a precise, uniform size (1µm) and trefoil pollen-like shape" and they're made from a mold of some sort. But in the case FDKP, my impression was that as FDKP crystallized, the drug would get caught within the lattice of the crystal. In other words, you need to form the lattice to produce the inhalable final product, and that requires the crystalline form. So the amorphous form wouldn't be useful for enhancing drug delivery. Material from Mannkind definitely talks about using the amorphous form for drug delivery. The process for manufacturing it involves creating a solution from a salt of FDKP and the API and then spray drying to form the amorphous particles. I do not recall reading any of the details of what would determine which form is the better (or only viable) solution for a particular API. If I were guessing, I might think it would have something to do with the size and electrostatic properties of the API. @kastanes previously stated that amorphous is cheaper to produce compared to crystalline form. Apparently stability of the two forms might vary from API to API. "Development of formulations for dry-powder inhalation combination products requires some key considerations including stability and particle architecture. Drug stability should be evaluated in both crystalline and amorphous particles"(from www.ondrugdelivery.com/publications/OINDP%20April%202011/Mannkind.pdf)
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Post by dreamboatcruise on Mar 27, 2018 10:19:09 GMT -5
I’ve done some searching also, on the clinical trials website. Perhaps they hid it well or perhaps they are doing it in another country, or perhaps a combination of the aforementioned and by another company such as GW Pharma, or something. Or something. If they want to use it for FDA approval they need to register it even if it is carried out in a foreign country. Often large trials involve international sites. It seems you are not at all a believer in Occam's razor, so I shall postulate it involves a secret society of ninjas operating from black sites in South America. This is why Mike only teases us with mention of RLS but few details, lest he be taken out by a ninja star mid presentation.
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Post by dreamboatcruise on Mar 26, 2018 16:02:20 GMT -5
My above: “Pennsylvania’s available medical marijuana forms. Note the majority are THC and little CBD. Thus I hope RLS will also be working in the THC market” Upon further reading I found dronabinol/marinol is a cannabinoid - and not a simply a CBD,, cannabidiol - if any but does have THC as I was hoping. Thus it appears RLS will be in the THC market as I was hoping (albeit it is synthetic form of the natural THC found in the plant). Sorry for any confusion. I’m stressed out. Perhaps I myself should go light one up (cannabis, cannabidiol, cannabinol, tetrahydrocannibinol....I think whomever came up with these names for these different chemicals might have been ingesting them at the same time). And since dronabinol was already approved by the FDA in 1985 (at least for the treatment of cancer treatment side effects, and then for anorexia associated with weight loss in patients with AIDS.) RLS might be closer than we might think to a viable and salable measured- dronabinol-inhalation product? PS where’s our expert Mango? It appears they haven't yet started any clinical trials.
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Post by dreamboatcruise on Mar 26, 2018 15:50:07 GMT -5
Prescribing insulin for non-insulin dependent T2’s is going to be a tougher sell than prescribing Afrezza to adults with T1. I’ve been T2 for 15 years or so. As great as Afrezza is and as much as it may help, the medical community is not going to embrace this regardless of what the trials indicate. We can’t even get endos to prescribe Afrezza to T1’s. Bingo. You nailed it. Especially when it is so ridiculously high priced. The Brain Trust at MNKD can't seem to figure out that they could triple or quadruple sales or more by significantly UNDER-pricing Novalog and Humalog. If they did that, it would amount to medical malpractice for a doctor to NOT put Type 1s on Afrezza. Sales would skyrocket.If that were what doctors believe they would now be prescribing Afrezza to all their patients that are with insurers that cover it, which the script numbers clearly indicate is not the case. Whether price is or isn't a major issue, few doctors currently believe that Afrezza is a superior prandial insulin.
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Post by dreamboatcruise on Mar 21, 2018 16:36:19 GMT -5
I assume this company does not cover Afrezza? Will certainly be good news if you can convince them to. Actually they do cover afrezza if its prescribed. The problem is most PCPs know little about diabetes except for prescribing metformin. Their problem is they are incurring huge costs because metformin just hides for a few years bigger issues which turn into huge costs. The suggestion that these 45ish who are working for big companies are leaving in 5 years is completely wrong. By that age many have been institutionalized and they are figuring out strategies to make it to retirement and keep their health benefits. At 55 they are hoping not to get kicked out the door and they are hoping to make it to 60 and then 66. The root cause is the PCP. Their knowledge of diabetes is very limited and what they have been doing is wrong. The VDex model is the right model but it needs to be done with serious funding in some type of partnership with the Onduo's. Existing insurance companies have some exploratory projects with CGMs. The next step will be adding afrezza if they really want to achieve TIR. I did find out the other day a 500 PWD study is being done outside Philly with the IWatch CGM, so interesting things are happening. It is just taking so long. Can you provide a link to the study using the Apple Watch CGM technology. I'm very curious to see how it's structured and what endpoints they have.
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