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Post by esstan2001 on Jan 27, 2017 8:21:18 GMT -5
I just visited my brother in Australia. His son is 10 years old and was diagnosed as a Type 1 diabetic two years ago. Both parents are scientists and my nephew is a brilliant young naturalist himself. He uses a MiniMed pump, and his parents try to keep his life as normal as possible; letting him eat what everyone else is eating, bolusing at mealtime and not before, trying to be relaxed about his routine (which was more difficult when I saw him on vacation). He has access to the finest money can buy in Australian medicine, but not quite everything available here, including a slightly inferior CGM. His blood sugar control is OK but not great. (I just observed and did not ask intrusive questions.) His parents are always worried and routinely check his blood a near midnight and again at 3 am. He has minor issues with skin irritations around his pump site. Bottom line is that this kid could certainly use a safer, easier, less intrusive and less costly therapy. Right now his parents are looking forward to a new CGM that will be available to them in two years. As Phd. scientists they feel they have a rigorous understanding of the disease and are not interested in considering anything that hasn't been well proven. My take away is that this boy could certainly benefit from Afrezza when he is older, but it will take many years before its efficacy and safety is proven in the eyes of scientists whose training is to be skeptical of any new idea. Also, of course, a typical mealtime bolus was about 1.5 units equivalent and we are still waiting for pediatric studies and 2 unit cartridges. So Afrezza should be a success, just maybe not in our lifetimes. ezra, the info on the PK/PD profile; the mimicry of first phase insulin release like a human pancreas, the fact that it is human insulin, and all the social media 'anecdotal' results... even some of the more recent scientific journal publications... if you make the case for them surely they would at least consider... sportsrancho has family friends with kids on Afrezza. Put your brother in touch with them through this board... For your nephew it is worth the effort and at least worth trying for him, with the reduced chances of hypos. Good luck. (of course, there is still the issue of getting him a script in a country where it has yet to be approved...)
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Post by esstan2001 on Jan 17, 2017 8:03:14 GMT -5
Hmm.....admin closed my last thread which is still VALID but I dont hold a Grudge ... Jason Appel is now at MNKD That makes 3 AMGEN guys that moved over to MNKD ..... Hmmmmm what could that mean? That these guys knew (of) each other, worked well together, and consider this an opportunity worth pursuing...
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Post by esstan2001 on Jan 10, 2017 19:26:16 GMT -5
Vials and syringes? Seriously? And rolling the insulin vial-these people are not using analogs! The problem is this looks like the stone age to diabetics and undermines the idea of inhaled insulin by association. If you are going to do this (and please do) then be realistic and use pens or pumps as the opposition. I'm no diabetic, but could there be some medical reason he is not on one of the analogs- allergic to a variant?
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Post by esstan2001 on Jan 5, 2017 17:48:37 GMT -5
This is great news. A proven track record and loads of experience can only help this product get out to the field. In my opinion however, the approach has been flawed since inception. The product needs to be marketed to the END USER...not the physicians. The end user who injects several times daily needs to be made aware of this excellent convenient alternative to their diabetes related medical needs. Who would prefer injections over an inhaler? Physicians generally are very busy and the last thing they are motivated to do is to suggest an alternative solution for the patient which may require pulmonary testing, dose determinations and closer monitoring of the patient during the transition period. Of course, this recommendation on their part also includes a bit of risk. This is not to say physicians do not have their patients best interest in mind, but more so, they take the path of least resistance and effort...steady as she goes with the current treatment...unless the PATIENT inquires about Afrezza. Once the PATIENT hears about a diabetes treatment as simple as using an inhaler, then the physician will respond, and the trials will begin, and the prescriptions will start flying off the shelves. Lets see some prime time television advertising and satellite radio ads promoting this excellent product. Market to the END USER...they are the ones who really matter.
As we know, MannKind's strategy is first to create endo and PCP fluency with Afrezza. Then when patient demand is generated by advertising, it is met with a knowledgable response by doctors, thus making much more likely a successful adoption of the product -- also largely avoiding the negative result of creating a curiosity about Afrezza that is simply not reciprocated by an uninformed medical community. But for my money (literally!), it now seems well past time when a national advertising campaign should be launched, to expand dramatically the conversation among diabetics, their families, and doctors about Afrezza's unique efficacy, a conversation that should rapidly translate into wide and successful demand for product. And here's a suggested headline for new copy: "AFREZZA, THE INSPIRED INSULIN!" So, now that we've had some local news stories, a good preamble to targeted / national market DTC advertising would be seeing our key advocate users hitting the major health / medical talk show circuits... Dr Oz, Dr. Keith Ablow, Dr. Who[mever], Phil Donahue, Ricki Lake, Sally Jesse, Larry King, Arsenio Hall, Tyra, Morton Downey Jr, Dick Cavett, David Susskind, Oprah (ehh, she isn't even on anymore- what the hell do I know) Guess that's why I'm still invested here :-)
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Post by esstan2001 on Jan 4, 2017 9:27:17 GMT -5
When I first saw the announcement, I thought maybe DeSisto. I was a little disappointed until I hit all the text about global expansion and another Amgen guy they had to woo...
I close out with a REALLY BAD joke:
How many CPO's does it take to make a Star Wars character?
3
(So I re-read it 3x; 1x. I cap'd bad 2x. I added cap'd really 3x. I bolded really)
PS- has anyone ever really heard of a Chief People Officer before? Sounds like some corporate double speak- just call'em an HR person (although he seems to have a pretty good pedigree)
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Post by esstan2001 on Jan 4, 2017 9:09:52 GMT -5
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Post by esstan2001 on Dec 23, 2016 19:33:51 GMT -5
finance.yahoo.com/news/something-strange-going-oral-insulin-174117941.htmlSomething Strange Is Going On With Oral Insulin GuruFocus.com December 23, 2016 - By Matt Winkler Something is rotten in the state of Denmark. Shakespearean quotes are often limited in their dramatic effect, but in this case the line from "Hamlet" can be taken a bit more literally. Nearly two months month ago on the day before Halloween, Danish diabetes giant Novo Nordisk A/S (NVO) (OCSE:NOVO B) unexpectedly called it quits on what was becoming a more and more promising oral insulin formulation. ... you read this (I mean the whole story in the link) and realize what a threat early insulin use is to the revenues of the big drug co's... and their apparent willingness to bury advances that threaten the status quo.
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Post by esstan2001 on Dec 19, 2016 12:01:58 GMT -5
As much as I love the cheerleading like the next guy / gal, these reports are so vacuous- they say expect gains due to increased earnings estimates revisions.. These must be robo-derived reports. I'd be much more impressed if an analyst wrote something up, after meeting with the company that inferred something about financing and plans being in place that will take sales to a better level.
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Post by esstan2001 on Dec 13, 2016 16:58:25 GMT -5
Thanks, Art. SP doesn't seem to be affected - holding still at .61. But, this is a surprise to me. Matt indicated in the cc that this should not be a problem. This is regarding the Nasdaq Biotech Index. Matt P. was referring to likely having sources of income or results drive the share price back above $1 in time thus avoiding the 6 month Nasdaq Market de-listing requirement.
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Post by esstan2001 on Dec 6, 2016 15:19:23 GMT -5
Driven by need for speed and limited resources. This is why EpiHale is not at the front of the queue. Sorry. Meant to say "this is why EpiHale is at the front of the queue. Is there a way to edit one's own posts on this board? you can edit for the first hour? (I think) after you post. There will be an edit post button in the upper right corner only for you.
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Post by esstan2001 on Dec 1, 2016 8:52:40 GMT -5
More than 2 yrs have passed w/o achieving any FDA label improvement, Ped approval. Sny sandbagged big time. Afrezza would have much better fighting chance w/ proper label, peds FDA approval. That said, ironically I believe TS, RLS may save Afrezza, not the other way around. I also agree that Afrezza needs a deep-pocket, patient partner like Tresiba owner. D+A+T is a potent combo.Why would any other of the Big 3 want to go down the same road as Sanofi? It would be the same exact disaster. They have way too many competing products in which Afrezza would cannibalize. A few months ago you touted smaller Regional Partners is the path and now it's back to Novo? We first heard of the small Regional Partner strategy from Matt back in February, it's now December. In answer as to why... if / when it becomes evident that Afrezza is as far superior to the RAA's as many here and Al Mann believed, it is ALWAYS a better strategy to own the next revolutionary product no matter how much cannibalization it exacts upon your competing products. The alternative? Being a looser in the space.
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Post by esstan2001 on Nov 22, 2016 13:10:55 GMT -5
No, that's ok. Still a very interesting article. Sounds like serious additional competition to me, but then I don't understand GLP-1 and all the technical aspects of insulin types and how they are used and combined. I would like to hear from all those on this board how much competition you all think these drug combinations will be to Afrezza's future. And, I wonder if it would benefit MNKD to acquire a BP with an established long-term insulin to market as a pair with Afrezza. Or, then again, maybe there is more advantage to Afrezza being marketed individually as flexible to work with ANY long-term insulin. Thoughts? I use a GLP-1 and it works great at controlling my over-all blood glucose level. On oral meds I had an A1c of 7.8 and morning readings (fasting) always in the 190-210 range. With the GLP-1 I am at 5.8 and my morning readings are usually 90 - 120. GLP-1's also have a side effect of curbing appetite and I've lost 40 pounds in 3 years, which also helps me maintain tight control over my blood sugar levels. What it doesn't do is help with spikes. It is slow acting and will bring my bs down, but using Afrezza to bring it down after meal highs would be ideal. Unfortunately, my doctor is not going to prescribe Afrezza for that reason, even though it is what Afrezza is for. I don't see a huge market for Afrezz withing the T2 population. As long as A1c's are controlled through other meds they are hesitant to prescribe insulin. Isn't that being ignorant (on the Doc's part) of the fact that the BG spikes are doing all the long term cellular damage to your body? Why not lobby for a script considering the science is coming around to this... and also recognizing that the market will change due both to the increasing prevalence of CGM's and the debunking of the A1C metric as primary importance?
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Post by esstan2001 on Nov 11, 2016 12:05:28 GMT -5
"frank1ss this is misinformation/fud "I can't be so sure. 5+ more months - great - but the problem here is Afrezza sales." because it was clearly stated during the call that currently they have a financial runway till 3Q2017. Also RLS will be finalising its technical arrangements in december 2016." Estann2001... I simply replied back because Tecalaa had noted what I said was "misinformation/FUD". Approx. $55 million at a $10 million a month burn rate equates to approx. 5 1/2 months. It's not FUD or misinformation - it is math and very factual. Added to what they HAD it gets us to 3Q or maybe 4Q 17...(Hopefully sale of building is quick as well) It is indeed nice to have it...great that Sanofi paid us something and waived the debt for the disasterous contract we had with them. I agree - that was all upside as it could have been $0.00. Any venting - my take/opinion - was just to say this is not FUD or misinformation and that MNKD's problems aren't solved yet. RLS technical hurdle/milestone may only be a few million as well. I'd hope for better and some partnership etc. but it could be rather small. Hope I'm proven wrong there. Al Mann's backing/support/money is gone so that backstop is not there anymore. MNKD was accustomed to going it alone, being pretty cocky and self-assured with their plans and could do and be so with money behind them. It's not there anymore so, hence why the share price is where it is until we see some substantial pick up in Afrezza sales or some partnerships etc. I don't think there is anything in what you said here that anyone materially disagrees with, but regarding your comments on management's efforts- From around the start of 2.0 moving forward... I'm curious what management activity in that time period would you critique or assail, since at this point, it is primarily that plan and execution that determine the Company's future and share price moving forward. And if you have some good / better ideas here, Mike is pretty accessible. IMO, they have planned and are executing as well as can be expected given the cards they have been dealt.
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Post by esstan2001 on Nov 11, 2016 10:44:39 GMT -5
Tchalaa... . . I'm long...I'm impressed and devoted to Afrezza and the technology...but mgmt has not played this well and Al Mann is gone along and Al Mann's money is gone too just like ours. Sanofi settlement and some good efforts MAY not be the end all to our troubles. With the exception of missing the opportunity for a capital raise at much higher share prices after inking the Sanofi deal, Matt & Mike have navigated each event as well as anyone can expect. Given their circumstance with insurance, doctors, and constrained funds, as Monday morning quarterback what plays do you suggest management should have taken to get us to score more scripts or deals sooner? If you are frustrated and venting, yeah we all get it. But the outcome of this cc was well beyond anyone's expectations. We are in a way better place, still in the game, with the time and opportunity to gain yardage.
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Post by esstan2001 on Nov 11, 2016 9:29:16 GMT -5
Krispy Kreme Donuts and Godiva Chocolate come to mind. The perfect choice for AFREZZA reps... . Actually perhaps the new sample packs for AFREZZA should also include Godiva Chocolates... 😊 I believe Spiro would be quite upset if the co-promote was not with Mallomars (...did they sever his internet connection in Siberia?)
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