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Post by mango on Dec 5, 2019 19:01:23 GMT -5
Doubt ADA has anything to do with it since they deal with consensus rather than science. Plus, it’s just a non-profit organization, MannKind will be the one providing the science and justification for it. Mango - the ADA makes the categories and develops the Standard of Care. The FDA only approves based on an agreed upon protocol. If the FDA agrees the protocol is going to measure speed of action as the basis of the study results then its speed of action as defined in the protocol. The problem is getting agreement on the protocol to determine non-inferiority. Speed of action would be something new for the FDA and was not possible in a large scale study prior to CGM technology. The label can say anything as long as the FDA approves. Today is says afrezza is a rapid acting insulin. I think Al tried for ultra rapid but that term was not know by the community so the FDA said no. MNKD was advised to work out the new category with the ADA. Once the ADA says we have a new "ultra acting" class then things will get interesting. If the ADA defines the new class as based on the time from dosing to sugars lowering, that would be a game changer for MC, afrezza and all MNKD longs. Interesting, did not think ADA is the gatekeeper with the category, figured it was FDA. All the better then, we have Kendall for that! 🥳
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Post by agedhippie on Dec 5, 2019 19:17:50 GMT -5
That is exactly the problem. The ADA is focused on outcomes and currently that is measured by A1c. The question the insurers would ask, even if there was a new class, is whether it produces a better outcome for the extra cost and currently the trial data says no. Therefore nothing changes. Aged - The ADA is not focused on outcomes when measured by A1c when it comes to T2s. If so insulin would be Step 2 after a long walk and diet. Whats a better outcome for insurers - lower A1c or fewer hypo's? I think hypo hospital visits are damn expensive. For insurers its fewer hypo's and the trial data clearly says the winner is afrezza. The great thing about insulin is that it always works. The bad thing about insulin is it's reputation. The perception is that if you are on insulin you have reached the end of the road. It's annoying to take insulin every time you eat (potentially twice if you use Afrezza) and if you want compliance you minimize overhead so a once a day shot or pill will always win, better still is once a week. That's just human nature. For insurers the best outcome is minimizing expenditure on the confident expectation you will soon move to another insurer. Across all insured and Medicare Advantage patients in 2015 the rate for ER visits was 2 per 1000 patient years. The worst case is end stage kidney disease where you can expect to be hospitalized once every 17 years and I am willing to bet ESRD is going to put you in hospital far more often than that. You can see that from an actuarial standpoint no insurer is going to look twice at those costs when compared to the certainty of several $1,000 per year recurrent cost. The cost/benefit is simply not there for the insurer.
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Post by ktim on Dec 5, 2019 19:55:13 GMT -5
mango ... looking at both is important when determining dosing requirements. Quickly searching for URLi it appears that has 19% less insulin action at 4hr to end of clamp. Is that similar enough to Lispro to not be clinically meaningful. It's quicker onset I think certainly would be. But your point kinda begs the question about whether there are multiple classes of modern prandial insulins or simply a continuum that might best be classified simply as prandial. Are we to have an RAA class, a class for Afrezza and another class for ones with rapid onset but not as fast clearance? I would think that best left up to doctors to decide whether it is a useful distinction. As a scientist but not a medical clinician I have always thought a distinction important, though your above point actually speaks to me in the opposite direction. You are pointing out that there are a lot of nuanced variations that might not be best captured by a binary classification of prandials. Of course there is the clear binary classification of insulin I have an investment in and those I do not. From that standpoint it is clear which I'd prefer getting unique recognition... though doubting it would have nearly the import some would wish. ktim - what Mike said during the talk was "doctors don't know" when it comes to speed. I think he is correct. While CGM usage is old hat to us its brand new to most doctors. Doctors are going to do what the standard says. If the standard says do this, thats what they do. The importance of the new class is for the Standard of Care. Once there is a new category "ultra acting" its hard to continue to ignore afrezza. Until afrezza is front and center in the SoC it will not get the 1000's of scripts per week it should be getting. The pk/pd is in the prescribing lit for insulins. It wouldn't surprise me that some doctors wouldn't read it, but I actually think most that prescribe do bother to read. If you think FDA simply putting ultra as a new adjective means the ADA SOC somehow changes I think you're engaged in wishful thinking. Until there are large trials linking faster pk/pd to beneficial clinical outcomes, the SOC is simply going to recommend advancing to use of mealtime* insulin at some point... and Afrezza, Fiasp, URLi will be options whether or not one, two or three of them are called ultra. BTW, current ADA SOC does point out uniqueness of speed in its section on inhaled insulin, though not using a flashy adjective. It's short but it's pointing docs to the pk/pd studies. The adjective Ultra may not have a ton of benefit in the market unless a company with a BIG marketing budget gets to use it and spends money doing so. * ADA should totally clean up SOC and switch to "prandial" and drop use of "RAA" when they mean fast mealtime insulin. It is still flawed in some sentences seeming to suggest RAA over other prandial (Afrezza being the only other), which would seem to be an oversight, intentional or not.
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Post by rfogel on Dec 5, 2019 23:23:50 GMT -5
Mango - the ADA makes the categories and develops the Standard of Care. The FDA only approves based on an agreed upon protocol. If the FDA agrees the protocol is going to measure speed of action as the basis of the study results then its speed of action as defined in the protocol. The problem is getting agreement on the protocol to determine non-inferiority. Speed of action would be something new for the FDA and was not possible in a large scale study prior to CGM technology. The label can say anything as long as the FDA approves. Today is says afrezza is a rapid acting insulin. I think Al tried for ultra rapid but that term was not know by the community so the FDA said no. MNKD was advised to work out the new category with the ADA. Once the ADA says we have a new "ultra acting" class then things will get interesting. If the ADA defines the new class as based on the time from dosing to sugars lowering, that would be a game changer for MC, afrezza and all MNKD longs. Interesting, did not think ADA is the gatekeeper with the category, figured it was FDA. All the better then, we have Kendall for that! 🥳 Speaking of Dr. Kendall, does anyone have any idea what he is working on currently? Does he ever speak anywhere?
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Post by ktim on Dec 6, 2019 20:49:48 GMT -5
Interesting, did not think ADA is the gatekeeper with the category, figured it was FDA. All the better then, we have Kendall for that! 🥳 Speaking of Dr. Kendall, does anyone have any idea what he is working on currently? Does he ever speak anywhere? My understanding of what he does would include... Overseeing Afrezza clinical trials. Working on advancing pipeline and submitting Phase I plans for the APIs they intend to move forward. Overseeing any non-manufacturing related work for UTHR. Overseeing or conducting discussions with physicians in other organizations (such as insurers, provider organizations, etc) regarding Afrezza studies and scientific data. Perhaps the patient support effort that is related to usage not reimbursement falls under his domain. Though I've never worked in pharma industry, so just an opinion based on what he's talked about when he has been on calls and assumptions about what would report in to him. It is my understanding that the sales/marketing people that don't have scientific qualifications are fairly limited in what they can talk about and I would assume it would be Kendall or someone reporting to him that would step in for discussions beyond what's in the prescribing lit.
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Post by lakers on Dec 7, 2019 11:34:23 GMT -5
kevinmik 12/6/19, 06:56 AM $MNKD Mike said during Piper Conference to expect within 3 to 5 years, Mannkind will be focused on Organ & Lungs that will include Diabetes and a Pulmonary Division including a commercial organization. He also suggested the remaining pipeline will shake out going forward ideally packaging out non-pulmonary disease drug candidates to one source (partner). It looks like United Therapeutic is going to play a major role in what Mannkind looks like within 3 to 5 years and we need to see how Mannkind will be structured. The fact Mike said within 3 to 5 years Mannkind will be focused on Organ & Lungs that will include Diabetes & a Pulmonary Division suggest a restructuring of the company is coming. David Kendal : former Lilly CMO, Cialis -inhaled Tadalafil James Shanon: former GSK CMO, Mnkd Board, Imitrex - inhaled Sumatriptans, Aloxi- inhaled Palonosetron CINV. These can be bundle-licensed to GSK. Focusing on Organ dovetails with UT’s Organ transplant roadmap. Ditto Pulmonary. This points to UT will likely take an equity stake in Mnkd after 12/27/19 to benefit from $3B NOL and avoid 1.6 Warrants dilution. Read more: mnkd.proboards.com/user/1882/recent#ixzz67RGoWqYF
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Post by mytakeonit on Dec 7, 2019 13:45:36 GMT -5
And that's why someone on this board said ... pps will be at $100 in 3 years and $200 in 5 years. dementia is kicking in so I can't remember who posted that? But, that's mytakeonit
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Post by mango on Dec 7, 2019 16:01:43 GMT -5
And that's why someone on this board said ... pps will be at $100 in 3 years and $200 in 5 years. dementia is kicking in so I can't remember who posted that? But, that's mytakeonit Realistically speaking, MannKind certainly has the potential to move the PPS to $100, and even $200. That is of course if they suck seed (succeed). 😎
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Post by ktim on Dec 7, 2019 16:46:09 GMT -5
kevinmik 12/6/19, 06:56 AM $MNKD Mike said during Piper Conference to expect within 3 to 5 years, Mannkind will be focused on Organ & Lungs that will include Diabetes and a Pulmonary Division including a commercial organization. He also suggested the remaining pipeline will shake out going forward ideally packaging out non-pulmonary disease drug candidates to one source (partner). It looks like United Therapeutic is going to play a major role in what Mannkind looks like within 3 to 5 years and we need to see how Mannkind will be structured. The fact Mike said within 3 to 5 years Mannkind will be focused on Organ & Lungs that will include Diabetes & a Pulmonary Division suggest a restructuring of the company is coming. David Kendal : former Lilly CMO, Cialis -inhaled Tadalafil James Shanon: former GSK CMO, Mnkd Board, Imitrex - inhaled Sumatriptans, Aloxi- inhaled Palonosetron CINV. These can be bundle-licensed to GSK. Focusing on Organ dovetails with UT’s Organ transplant roadmap. Ditto Pulmonary. This points to UT will likely take an equity stake in Mnkd after 12/27/19 to benefit from $3B NOL and avoid 1.6 Warrants dilution. Read more: mnkd.proboards.com/user/1882/recent#ixzz67RGoWqYFThat's some very creative pumping. Though taking an equity stake would not confer any benefit of MNKD's accumulated NOL. And if Mike said (I haven't listened) they were planning to develop a commercialization team for pulmonary that would point to not being partnered with UTHR on anything pulmonary beyond PAH. Quite frankly, at this point I think they might be better off partnering with UTHR for anything pulmonary rather than adding onto marketing expenses of MNKD. They need to get Afrezza marketing up to some decent level first, and they are still a LONG way off of national coverage for T1 and T2 with advertising. Think this is more of the same shiny object strategy from Mike & Co. How about getting new APIs to Phase I trials before he starts pitching building sales teams for them. I guess I should listen to the call. What in the heck does focused on "Organ" mean?
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Post by mnholdem on Dec 7, 2019 16:49:14 GMT -5
Let me guess...the Erectile Dysfunction API? (LOL)
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Post by lakers on Dec 7, 2019 17:04:32 GMT -5
If UT becomes the majority SH of a future profitable Mnkd who pays no tax for a foreseeable future due to $3B NOL, Ops margin becomes pure profit margin. Furthermore, UT could potentially give generous mfgr and R&D contracts to Mnkd to make MNKD more profitable while not paying tax, maybe dividend.
Even SO saw it too. He said UT could buy in phases to take advantage of $3B NOL.
Once UT becomes majority SH, UT and Mnkd’s interest align. UT would want to make Mnkd tax free profitable.
Mnkd would become an outsourced R&D and mfgr arm of UT plus tax free royalty - a legal non-Bermuda tax shelter for both companies.
You can ask if the future Mnkd Director, mnholdem, likes the idea such as how much % for the initial stake, valuation, 2nd stake, 2nd valuation, the trigger. Let’s start the mock interview before he becomes the official Director, then can’t say much. It’s a golden opps to pick his brain as he can freely talk now.
Mnholdem’s chance of being elected is high as I believe Thompson will certify 5%, then he will get more than enough vote. I’d treat Mnholdem as Director elected now. Pick his brain everyone for all biz matter. I still believe UT may likely take the initial stake before next May ASH meeting, before the new slate of Directors getting elected when it will be harder to get a unanimous approval and valuation will be higher.
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Post by ktim on Dec 7, 2019 17:10:42 GMT -5
Let me guess...the Erectile Dysfunction API? (LOL) HA! Maybe they could expand and focus on both the Organ and the Squeeze Box.
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Post by helmut8056 on Dec 7, 2019 17:33:58 GMT -5
Now that's funny !
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Post by mango on Dec 7, 2019 18:15:36 GMT -5
Let me guess...the Erectile Dysfunction API? (LOL) HA! Maybe they could expand and focus on both the Organ and the Squeeze Box. What is a Squeeze Box for $1000, Alex.
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Post by mytakeonit on Dec 7, 2019 20:39:52 GMT -5
Let me guess...the Erectile Dysfunction API? (LOL) No No No ... it has more to do with the limp node. Or was it limp noodle? But, that's mytakeonit
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