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Post by casualinvestor on Jan 29, 2018 14:41:29 GMT -5
Lots of good info in that presentation. I was especially impressed by the time-in-range comparison to the pump. Wow! Although maybe I just overestimated how well a pump works
Will the long term safety study (or any currently planned/ study) do anything to remove the black box warning?
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Post by peppy on Jan 29, 2018 14:46:12 GMT -5
Lots of good info in that presentation. I was especially impressed by the time-in-range comparison to the pump. Wow! Although maybe I just overestimated how well a pump works Will the long term safety study (or any currently planned/ study) do anything to remove the black box warning? I think I recognized those graphs off the vdex paper. www.screencast.com/t/HrjrYsACwww.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdfjust didn't want any one to think it was the time in range study.
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Post by xanet on Jan 29, 2018 15:18:21 GMT -5
Lots of good info in that presentation. I was especially impressed by the time-in-range comparison to the pump. Wow! Although maybe I just overestimated how well a pump works Will the long term safety study (or any currently planned/ study) do anything to remove the black box warning? I think I recognized those graphs off the vdex paper.www.screencast.com/t/HrjrYsACwww.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdfjust didn't want any one to think it was the time in range study.That is a good point about not assuming that is from the time in range study. That said, the data is different on the two graphs, but the take away is the same: Afrezza works.
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Post by peppy on Jan 29, 2018 15:29:27 GMT -5
That is a good point about not assuming that is from the time in range study. That said, the data is different on the two graphs, but the take away is the same: Afrezza works. thank you for pointing this out to me xanet. I thought it was vdex. The comparison has been used in other conferences, perhaps ray put it together before he left. (?)
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Post by tingtongtung on Jan 29, 2018 15:43:19 GMT -5
Have to go thru the presentation once its available..
So far: * Filing IND for tret. ==> Good, but nothing for now. * Good data about Afrezza, which we already know. * Nothing about raising money/partners/etc?
Is that right? Would there be any catalyst for the price in the very short term (like the bump earlier today)? Or, will it go back to 2.50 range?
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Post by mannmade on Jan 29, 2018 15:43:42 GMT -5
I beleive those graphs are a couple of years old as I have seen them before. However, they are a great tool for a rep to show a doctor. I would (am sure htye have done this but if not...) create a 6 page slide presentation with the time in range, the PK/PD profile graph, the other two illustrativr pages and one top page with bullet points speaking about peak on set and dissolution (eg: much less stacking) and other items such as less sever hypos which prior to the label change I am not sure they could have said.
Using David Letterman's marketing model I would create the TOP 10 reasons Afrezza should be the first prandial choice followed by the four pages of graphs. That way it would be simple and easy to read and the docs would not have to spend 30 mins to an hour jsut to be introuced by the rep to Afrezza, time which none of them seem to have.
In five minutes a rep could set the stage, leave the presentation and lastly ask a doctor to find one out of range pateint that in ther opinion could use a new form of treatment and let mannkind work with them(doctor and patient) to show them the possibilities.
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Post by peppy on Jan 29, 2018 15:59:39 GMT -5
I beleive those graphs are a couple of years old as I have seen them before. However, they are a great tool for a rep to show a doctor. I would (am sure htye have done this but if not...) create a 6 page slide presentation with the time in range, the PK/PD profile graph, the other two illustrativr pages and one top page with bullet points speaking about peak on set and dissolution (eg: much less stacking) and other items such as less sever hypos which prior to the label change I am not sure they could have said. Using David Letterman's marketing model I would create the TOP 10 reasons Afrezza should be the first prandial choice followed by the four pages of graphs. That way it would be simple and easy to read and the docs would not have to spend 30 mins to an hour jsut to be introuced by the rep to Afrezza, time which none of them seem to have. In five monutes a rep could set the stage, leave the presentation and lastly ask a doctor to find one out of range pateint that in ther opinion could use a new form of treatment and let mannkind work with them(doctor and patient) to show them the possibilities. the TOP 10 reasons Afrezza should be the first prandial choice followed by the four pages of graphs. 1. Afrezza keeps blood glucose from going up/high in the first place.
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Post by madog365 on Jan 29, 2018 16:22:35 GMT -5
Well i read the presentation, and personally i didn't see much new discussed within it.
We got confirmation about RLS and the product they are working on. Marinol has approx $500m market size and growing 5% each year. I'd really like to have more information about who is behind RLS, what their timing to FDA submission is, and when we can expect to have a product in market. If we are talking about years, then this really has limited upside in the near term, huge upside long term if Mannkind can make Afrezza successful.
On the Afrezza front it's good to see sales growing but i struggle to understand how the company plans to accelerate this growth in 2018. Are we hiring more sales reps? Increasing marketing spend? What is the plan?
Notably missing updates are the big four. International Expansion (great map but where's the beef?), Co-Promotions and partnerships, Cash (recapitalization), and One Drop (direct to consumer plans?)
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Post by Deleted on Jan 29, 2018 16:32:44 GMT -5
Well i read the presentation, and personally i didn't see much new discussed within it. We got confirmation about RLS and the product they are working on. Marinol has approx $500m market size and growing 5% each year. I'd really like to have more information about who is behind RLS, what their timing to FDA submission is, and when we can expect to have a product in market. If we are talking about years, then this really has limited upside in the near term, huge upside long term if Mannkind can make Afrezza successful. On the Afrezza front it's good to see sales growing but i struggle to understand how the company plans to accelerate this growth in 2018. Are we hiring more sales reps? Increasing marketing spend? What is the plan? Notably missing updates are the big four. International Expansion (great map but where's the beef?), Co-Promotions and partnerships, Cash (recapitalization), and One Drop (direct to consumer plans?) I just learned of the RLS today. Still not sure I quite grasp what they are going after. Need to research it more. This said, from what I'm seeing, it's an alternative to Marinol; which does not offer euphoria. What people may not understand is, probably 70% of Marinol sales are to people who want Marinol, for it's euphoric value. They want a synthetic THC, to get them stoned, while they work. If RLS wants to cut into their market and steal some of their sales, it will be MINIMAL long term, at best. They will be cutting into Marinol's 30% of patients who aren't glorifying the product, specifically because it gets them high. The other 70% won't even bother to look at RLS. Scoff at it even. So, long term, RLS might pump the value of MNKD; but it won't be doing what Marinol does for it's corp.
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Post by harryx1 on Jan 29, 2018 16:33:20 GMT -5
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Post by mnholdem on Jan 29, 2018 17:00:56 GMT -5
Well i read the presentation, and personally i didn't see much new discussed within it. We got confirmation about RLS and the product they are working on. Marinol has approx $500m market size and growing 5% each year. I'd really like to have more information about who is behind RLS, what their timing to FDA submission is, and when we can expect to have a product in market. If we are talking about years, then this really has limited upside in the near term, huge upside long term if Mannkind can make Afrezza successful. On the Afrezza front it's good to see sales growing but i struggle to understand how the company plans to accelerate this growth in 2018. Are we hiring more sales reps? Increasing marketing spend? What is the plan? Notably missing updates are the big four. International Expansion (great map but where's the beef?), Co-Promotions and partnerships, Cash (recapitalization), and One Drop (direct to consumer plans?) I just learned of the RLS today. Still not sure I quite grasp what they are going after. Need to research it more. This said, from what I'm seeing, it's an alternative to Marinol; which does not offer euphoria. What people may not understand is, probably 70% of Marinol sales are to people who want Marinol, for it's euphoric value. They want a synthetic THC, to get them stoned, while they work. If RLS wants to cut into their market and steal some of their sales, it will be MINIMAL long term, at best. They will be cutting into Marinol's 30% of patients who aren't glorifying the product, specifically because it gets them high. The other 70% won't even bother to look at RLS. Scoff at it even. So, long term, RLS might pump the value of MNKD; but it won't be doing what Marinol does for it's corp. Do you have any evidence to support your statement or are you just throwing that out there? Please provide a link to at least one article that supports your statement.
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Post by buyitonsale on Jan 29, 2018 17:58:32 GMT -5
About 12 months to Brazil approval hopefully means we will start shipping the product shortly after and finally will be getting some substantial new revenue. What would be a yearly estimated wholesale revenue for 5% of Brazil's diabetic population of 12 million? Even at fraction of the US prices... (let's say $200 for a year supply) we could be looking at $120M a year... I will continue to add on the dips! Go MNKD!
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Post by pantaloons on Jan 29, 2018 18:04:25 GMT -5
Have to go thru the presentation once its available.. So far: * Filing IND for tret. ==> Good, but nothing for now. * Good data about Afrezza, which we already know. * Nothing about raising money/partners/etc? Is that right? Would there be any catalyst for the price in the very short term (like the bump earlier today)? Or, will it go back to 2.50 range? In regard to treprostinil: I think in the short term there's a possibility that BP may partner with MNKD for this effort. Was there much discussion on how these clinical trials will be funded? From what I understand, there's a 30 day turnaround once the IND is filed with the FDA. It's possible that PPS could increase during that time. Please correct me if I'm wrong about the 30 day FDA turnaround.
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Post by mnholdem on Jan 29, 2018 18:29:18 GMT -5
I think that you are correct that there could be a partner interested in collaborating with MannKind on the development of TreT. As Castagna pointed out, Trepostinil(TS) comes with a relatively low-cost pathway to NDA in 2020. It could be sooner if some partner with deeper pockets than MannKind hooks up.
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Post by Deleted on Jan 29, 2018 18:48:06 GMT -5
It's speaking from personal knowledge via experience. I myself have wanted a marinol script for nearly a decade, since I found out about it. As does every single person who chooses to seek out THC, for any purpose. It's synthetic; but so are the oils in a vape pen.
You don't understand the world around you, if you don't get why that specific product ever took off, in the first place. It was legal cannabis, years before we had a single recreational state. All you needed was to live in the right state, and tell your doc that you had anxiety; and they would flip that script in a heartbeat.
Of course you won't find a single statement by the creators concerning this. Why would they put that out there? At minimum, a great percentage, if not the bulk of entire patient load (secretly) sought out marinol for their various ailment, for that specific purpose. I myself curb co-morbid OCD, with THC.
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