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Post by dreamboatcruise on Apr 23, 2018 16:06:16 GMT -5
When Mike has alluded to the two signed term sheets, did he specifically state that those related to international expansion? I know that was what I thought he was referring to when I heard, but I can't remember if he actually said that. I am wondering if one of those term sheets could have been the Treprostinil Technosphere. He was referring to two international deals. One with signed term sheet and the other not yet signed (as of last mention that I know of).
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Post by dreamboatcruise on Apr 23, 2018 15:08:50 GMT -5
Just now Schwab returned all the rest of my shares.
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Post by dreamboatcruise on Apr 21, 2018 20:18:39 GMT -5
As our overall script is left dangling in the wind like grandpa's underpants I start to imagine markets that are less constrained than our good ole US of A's. While script's weekly sales are somewhat reliable in that the dollar amount hovers right around $500k, we have seen no traction in terms of script growth. Although outside of the US, per script dollar amount will drop significantly we can make up for this with large numbers. The real problem is how much longer can we survive doing these piecemeal offerings. On a seperate note. Why the heck is Dr. Kendall so damn silent? Why does Mike keep leading us with tidbits of partnership and up front money? Still a believer. Still a bag holder. Still looking down the barrel of a gun. Here's to MNKD's ability to get the gun out of my face and start practicing on live targets, namely shorts and the like. Hibernation mode activated. George 1) Indefinitely as long as 20% of market cap is greater than half of the yearly cash burn rate (restriction on offering discounted shares). Until loans come due. 2) What do you expect a Chief Medical Officer to be doing? His job is basically running the clinical trials and pipeline development, not being spokesperson (contrary to what some might think). 3) Restating your question... why do CEOs try to convince investors their companies are good bets? Answer... it's part of their job.
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Post by dreamboatcruise on Apr 20, 2018 18:22:54 GMT -5
It takes a long time to get stuff published. It was 60 or so I believe rather than hundreds... and likely only a limited set really worthy of being published. Personally I think STAT will be more impressive than the older stuff which were all pre-CGM. Since there only 47 or so registered with the Clinical Trials site which is a prerequisite for publication I think the 60 or so is a work of fiction. It is hard to present anything pre-dreamboat since the delivery device changed which renders the result suspect. Then there is the whole feeling that the world has moved on. At this point they should concentrate on STAT and the upcoming trials. People are going to want to know when the STAT-2 trials are starting where they show that the results scale. Right now there is a pilot only. They may be including things such as in vitro cell studies looking at things like carcinogenicity. I don't believe those are registered as clinical trials since they don't involve human subjects. I believe that number did come from Mannkind management, so I'll give benefit of the doubt it is some difference in meaning rather than a "fiction". Just because it was pre-dreamboat it wouldn't preclude publishing/presenting it. If it's good/interesting science it could get attention. No requirement that it has to be about an FDA approved product. But I wouldn't expect anything earth shattering in the old studies and agree that the future is the future, not the past.
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Post by dreamboatcruise on Apr 20, 2018 17:35:22 GMT -5
‘SMART’ Insulins – Stuart Weinzimer, MD When I googled smart insulin......Afrezza.com was the second listing. Afrezza isn't what is meant by "smart insulin". That term means insulins that respond dynamically to glucose levels. You may be getting Afrezza related things showing up on your searches because of previous searching/browsing habits. When I google the same I don't get anything related to Afrezza. Hopefully Afrezza will be included in the presentation on ultra-rapid insulin. Neither Afrezza nor Fiasp actually has that designation from FDA, but they have to be talking about something and seems logical the fastest of the fast would be part of it.
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Post by dreamboatcruise on Apr 20, 2018 16:38:27 GMT -5
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Post by dreamboatcruise on Apr 20, 2018 15:03:08 GMT -5
Sales reps are almost useless these days. The only way to reach new doctors is to present stuff at medical conferences. I trust Dr. K's judgement on this one. I recall that a lot of people here were enthusiastic about the first, second and third wave of sales guys. If they are almost useless, why did MNKD spent money on them? If ADA is the big thing then they should have focussed to get all the hundreds of studies published that Al did (according to this board). Something does not fit here. Maybe fourth time is the charm I think many here imagine the sales force in a way that doesn't match their real role more as marketing reps. It's not as if they carry boxes of Afrezza around in their cars trying to sell them to meet a weekly quota. With access to doctors by reps being increasingly constrained, one of the key roles I would imagine the reps are playing is helping doctors who by other means have decided to start prescribing Afrezza... i.e. a support tool more than a direct driver of growth. It takes a long time to get stuff published. It was 60 or so I believe rather than hundreds... and likely only a limited set really worthy of being published. Personally I think STAT will be more impressive than the older stuff which were all pre-CGM.
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Post by dreamboatcruise on Apr 20, 2018 14:53:45 GMT -5
Actually my optimism about Hugh Smyth highlighting Afrezza in a positive way has decreased somewhat. I did some googling on his research and it seems that "excipient free dry powder inhalation" is something he works on. So he's basically developing technology competing with technosphere. Would still be interesting whether this presentation is meant as overview or mainly to highlight his own work. Some academics will give overviews of topics with fair treatment even to technologies competing with what they may work on. Seems from the title it may be an overview. Hopefully it doesn't have an anti-excipient bias. In any case, it is merely one of over 1000 presentations/posters.
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Post by dreamboatcruise on Apr 20, 2018 14:09:10 GMT -5
cjc04 ... he's an academic at Univ of Texas, Austin trying to come up with a clever title to attract attention. Yes there are some bad things that have happened and still are going on in the medical/pharmaceutical business... but I highly doubt this profs choice of title for his presentation has anything to do with a grand conspiracy of "the system" to hold back Afrezza. He's presenting an overview and routes for peptide delivery that are relatively new compared to injections. I'm actually glad to see this presentation because I assume he will talk about Afrezza, and anyone going to it that didn't know about Afrezza may well then be motivated to look into it as it may well be the only manifestation of these alternate routes that is actually currently on the market. If he's picking a title to refer to inhaled diabetes products I'm happy about it being "the Next Frontier". Would you have preferred it be "inhaled insulin that's been around a long time, failed once in the market, and second attempt not catching on". I'll take it being called Next Frontier, gladly. BTW, I criticize the profit making medical establishment all the time on this board. Sorry, I’m still a bit cynical, although had I listened to my inner cynicism over the years I’d be better off, so I call it being realistic, or at least not naive. Are we not talking about the same ADA that requires a right arm, first born, or act of Congress for anything?? Where even you have said that our world renown & respected CMO isn’t allowed to speak about the stat study for his own drug.... Yet some “academic who’s looking for attention” gets rubber stamped to present “the new frontier” Unless the ADA has never heard of Afrezza, this is BS if this presentation includes inhaled insulin and it doesn’t include Mannkind.... Why? Because Afrezza is the ONLY inhaled insulin available and it should be spoken about accurately, which should require MannKind’s approval, not just some academics opinion about what he thinks he knows about inhaled insulin in general. Mike wouldn't be disallowed by the ADA from speaking about STAT. But MNKD didn't conduct the study. It was the Univ of CO. If Univ of CO wanted to have Mike present it, I'm sure that would be allowed, but 2 things... 1) most people that secure funding for and are PI on studies want to gain the exposure for themselves and have the right to do so and 2) from drug makers perspective there is a modicum of added credibility given to having a respected, supposedly unbiased academic presenting results that look good about your product. And sorry for the way the world works, but academics absolutely do not need the permission of drug companies to speak about their drugs. That would be a terrible idea as that would mean a researcher that discovered some risk or problem with an existing therapy would be prevented from bringing that information to light. That horrible idea would certainly facilitate bad things from industry not prevent it. ADA didn't pick the title of this as they didn't with the more than 1000 presentations and posters that will be presented. All of your reaction is based on you imagining it is going to be a bad presentation and not talk about Afrezza in a professional manner. I too would think something wrong if Afrezza isn't even mentioned... but right now we have NO REASON to believe that will be the case. I'm optimistic it will be good exposure.
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Post by dreamboatcruise on Apr 20, 2018 13:35:43 GMT -5
Just checked the humalog.com website. There are no shots or videos of people using the product and no actual users, just "models." The first page of the site says this: Models used for illustrative purposes only. Not actual patients or healthcare providers.None of the "models" is saying anything or doing anything that's Humalog related. I assume this is because of FDA regulations. There is one drug that has real users, including Cyndi Lauper, in their TV ad... but they say pretty generic things presumably from FDA approved claims on label. If Afrezza were to have real users I would assume about the only thing they could say would be "It frees me from multiple daily shots. I inhale it at mealtime. It lowers my A1c." It's possible FDA could change their stance on this, but I'm not holding my breath on that by any means.
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Post by dreamboatcruise on Apr 20, 2018 13:14:21 GMT -5
This likely is one of the barriers facing Afrezza adoption by payers. Even if Afrezza were priced similar to the original branded RAAs for insurers (and we really can't know what deals have been cut by MNKD), insurers would still likely be (and have been) hesitant to get lots of patients using Afrezza when these cheaper biosimilars were coming to market. Even if MNKD matched the biosimilar prices, they would be in a position to raise the prices later once Afrezza caught on. I've always thought this would make negotiating with insurance difficult. It's a tough position as long as it is in the context of being merely non-inferior.
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Post by dreamboatcruise on Apr 20, 2018 12:12:26 GMT -5
cjc04... he's an academic at Univ of Texas, Austin trying to come up with a clever title to attract attention. Yes there are some bad things that have happened and still are going on in the medical/pharmaceutical business... but I highly doubt this profs choice of title for his presentation has anything to do with a grand conspiracy of "the system" to hold back Afrezza. He's presenting an overview and routes for peptide delivery that are relatively new compared to injections. I'm actually glad to see this presentation because I assume he will talk about Afrezza, and anyone going to it that didn't know about Afrezza may well then be motivated to look into it as it may well be the only manifestation of these alternate routes that is actually currently on the market. If he's picking a title to refer to inhaled diabetes products I'm happy about it being "the Next Frontier". Would you have preferred it be "inhaled insulin that's been around a long time, failed once in the market, and second attempt not catching on". I'll take it being called Next Frontier, gladly. BTW, I criticize the profit making medical establishment all the time on this board.
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Post by dreamboatcruise on Apr 20, 2018 11:34:38 GMT -5
Interestingly, there is one presentation in ADA that has something to do with inhaled treatment, though it appears not Mannkind related. Exploring the Next Frontier in Diabetes Pharmacology Peptides Gone “Oral” or Other Delivery Routes (Transnasal, Transdermal, Inhaled, etc.) for Glucose-Lowering Agents Hugh Smyth, PhD LMFAO!!!! WTF!!! I don’t know what is more hilarious, Mannkind not being involved, or “Exploring the Next Frontier” It’s as if Mannkind & Afrezza do not exist and these guys just came up with this idea for the first time. There is no reason they would necessarily have MNKD involved. In fact, given that it is academic presentation on different delivery routes, it would add an air of bias if they brought in company representatives for some but not all things being discussed. I would certainly presume they would mention Afrezza when talking about inhaled option, as to not do so would seem like they aren't very knowledgeable about their topic. Something would be very weird if they didn't mention Afrezza, but no reason from what we know currently to assume they won't.
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Post by dreamboatcruise on Apr 19, 2018 18:24:20 GMT -5
A big number of my shares returned again this afternoon, now down to only 35% of my total shares on loan. Rate still at 14.875% at close. I’ve never had this much return activity on my loaned shares. I only hope that the share price rises to offset the lost interest. Do you recall when the SP shot up to around $6 were your loan out shares activity different from usual? I had all my shares lent out in the months leading up to $6. Then after it peaked and lost around 40% of gains they returned a portion of my shares on Oct 20th. They were lent out again Jan 26th, but that was after they raised rates and I called the lending department to see if they could get them back into the program.
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Post by dreamboatcruise on Apr 19, 2018 16:35:03 GMT -5
If there is no news, like today, I wouldn't rule out that it is simply traders pushing the price around of this highly volatile stock in order to generate short term trading profits. I have been watching blocks for years. I have never seen a day of so many big HUGE green blocks being traded. Look at the 16K and up blocks.....HUGE...... for that matter blocks over 10,000 shares too...... retail buyers might be buyers of 5K to 10K shares but not much over that number.
I don't tend to watch those details much, but wouldn't one expect to see larger blocks when the share price is low... i.e. if someone or some entity wanted to invest, or divest, $X it would take more shares to do so now than it would have back last fall when price was much higher. Still interesting if the trades are a lot larger today than the past couple of days.
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