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Post by sportsrancho on Aug 13, 2020 10:56:24 GMT -5
I just listened to the whole presentation again and I didn’t hear anything like that. Nevertheless do we know when in 2021 we’re getting approved? ...because the stock should run up eight months prior to the approval since that’s what has happened in the past. . So how long after submitting an NDA does it normally take for the FDA to make their decision? Google.... Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug.
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Post by sayhey24 on Aug 13, 2020 10:58:58 GMT -5
SeyHey you said: “My understanding is one of the biggest gripes VDex has with MNKD is they are not giving them enough free product, aka samples. Then again, one of the biggest issues Mike has with VDex is all they do is call and call for free samples.” That’s an interesting take on it. I would think MannKind would be eager to provide ample quantities of Afrezza to help get new patients indoctrinated into the regimen. Especially since VDEX seems to be the only outfit (or at least is the best at it) properly training patients on effective dosing protocol. We should want patients to try it, even if free the first time. A successful introduction will mean that patient being a customer for life. I gotta side with VDEX here, if MannKind was being stingy with the samples or slow to deliver them, that’s not cool. Cretin - what is ample? How long do you continue to give a new client free afrezza? Hopefully until they get a script and a method of paying for it. How long does that take; a week, a month, a year, forever? If VDex had a well oiled machine you would think within a week or two the PWD would no longer need free afrezza. I am not sure that is what is happening but if VDex could define this with Mike and guarantee a quarterly quota I don't know why Mike would not want to sign a distributor agreement with an agreed upon number of free samples. I think the issue is their well oiled machine might need some oil. How they bill and make money has always been a little fuzzy. One way may be by having the PWD continue to come back every two weeks for an office visit with a motivation of getting the free afrezza samples. I think they may still be using the Libre Pro which is a blinded CGM and can only be seen by the doctor. This is another motivation for coming back every two weeks as the sensor needs to be changed and results reviewed. In the world of connected care this IMO is not the best model. We all know the CGM should be a near real-time tool and should be guiding the PWD on follow-up dosing. However without the office visits how is VDex making money? I am hoping Galindo has a few ideas on a business model which can make money. Onduo seems to have been pretty successful in signing up a bunch of insurance partners. I don't know if they are making money. At the same time Medtronic needs to do something and I am sure IBM wants to make Watson the leaser in connected care healthcare.
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Post by sportsrancho on Aug 13, 2020 11:47:49 GMT -5
Wait one minute....Lol There is nothing fuzzy. The patients come in every week. They get a CGM and they learn how to use it within the next week or two. Then they need I believe a month or two worth of samples till Vdex can get their blood sugar down and get it approved by insurance ( if it’s not already ). The machine is pretty well oiled. They write the pre-authorization letters they get the results get the scripts and get the retention.
If this is wrong then I will correct it later:-)
When the type2’s come in most of them are already taking Metformin and other drugs. They have to wean them off those drugs.. design something to get them in range. Teach them until they can take the training wheels off. First they have to trust us. Then they trust Afrezza.
If the patient for whatever reason is not able to use Afrezza then we prescribe something else, we can prescribe any insulin. This is a lifestyle change. We want blood sugar sugar control, non-diabetic numbers, and for diabetics to lead a normal life ....which Bill calls “freedom from diabetes”.
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Post by sportsrancho on Aug 13, 2020 12:08:18 GMT -5
I feel that a big problem is the dosing, and that is constrained by the label. Once doctors get over the idea that they can dose more heavily than the label says (as with VDex) then they get good results. However, I would be willing to bet that the majority would not be comfortable with the higher dosing because this is insulin and they are concerned about hypos. At this point there are three options. Either educate a sizeable chunk of the doctors on correct dosing - good luck with that, in the words of the Princess Bride, "have fun storming the castle". Or run a trial to get the label changed which will automatically move the doctors to higher dosing. Really the trial is the only practical option. The third option, and the one management seem to be following, is to keep repeating what has been done before and hoping that this time the outcome will be different (spoiler alert: It won't). An idea from Bill.... Ok here’s the solution in my opinion: first, stop spending trying to convince doctors that Afrezza insulin should be dosed higher. Aged is right they won’t believe it. ADA protocol means prandial insulin is used last anyway. So concede that conventional marketing to broader diabetes community is not going to work. So, now the issue is can you grab attention of the community in a different way? Yes, shock the diabetes community by showing cessation of disease progression, reversal of disease, and prevention of disease. Each one of these three aspects is revolutionary in its own right and the diabetes community doesn’t believe any of them are possible except with extreme lifestyle changes. MNKD needs to stop competing on the existing playing field and instead needs to define its own field. Now of course no one will believe this is possible so MNKD needs results. They should work with us and we’ll deliver those results. Let Vdex be the “bad” guy making the outrageous claims (with data showing we’ve done it). MNKD just passively benefits bc we say (and it’s the absolute truth) that you can only get the results with Afrezza.
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Post by sayhey24 on Aug 13, 2020 12:16:44 GMT -5
Cretin - there you go. They want about 2 months of free samples per new client. If they were sent to insulinsavings.com and the new client purchased their first 2 months of afrezza, problem solved. If VDex worked out a distributorship maybe they could sell direct like GoLo is selling Release.
The VDex billing model is based on weekly office visits which is a tough model to raise venture capital which is needed to open the type of coast to coast wellness centers we would all like. Maybe a "Wellness" approach which incorporates diet, exercise, weight loss and connected care with the right technology might get some venture money interest. Heck, Virta Health has already booked over $100M in VC and they can't do what VDex could do with the right model and afrezza.
Now - how should Mike help VDex? Maybe Bill should call Virta which is getting nearly $400 per month for the keto diet.
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Post by sportsrancho on Aug 13, 2020 12:28:16 GMT -5
You only need the samples until you get the prescription, and you can’t get the script till it’s approved by insurance.
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Post by mytakeonit on Aug 13, 2020 12:31:05 GMT -5
I think we're following the 4th option. Ship containers to foreign countries at a small profit. When they are hooked on how great Afrezza is ... then we get free ads on Facebook, Twitter, MNKD pro boards, etc.
But, that's mytakeonit
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Post by sayhey24 on Aug 13, 2020 12:44:52 GMT -5
and we get the social media in many different languages which makes afrezza a highly diverse diabetes treatment. I stand corrected on Virta. As of Series C financing they are up to $166M - you can't make this stuff up! www.virtahealth.com/careers at the bottom
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Post by agedhippie on Aug 13, 2020 13:22:01 GMT -5
Cretin - there you go. They want about 2 months of free samples per new client. If they were sent to insulinsavings.com and the new client purchased their first 2 months of afrezza, problem solved. If VDex worked out a distributorship maybe they could sell direct like GoLo is selling Release. The VDex billing model is based on weekly office visits which is a tough model to raise venture capital which is needed to open the type of coast to coast wellness centers we would all like. Maybe a "Wellness" approach which incorporates diet, exercise, weight loss and connected care with the right technology might get some venture money interest. Heck, Virta Health has already booked over $100M in VC and they can't do what VDex could do with the right model and afrezza. Now - how should Mike help VDex? Maybe Bill should call Virta which is getting nearly $400 per month for the keto diet. You have a chicken and the egg problem. You want those patients on Afrezza then you have to provide them with it for free to generate the evidence that it works for that patient so the insurer signs off. A better metric for Mannkind would be the number of patients who are started on Afrezza and get approved by insurer. Pharmas love insulin because it's a decades long revenue stream. So does two months free seem like a good price for decades of revenue? I can tell you the other manufacturers think so. Novo Nordisk gave me three months free Tresiba when I was thinking of changing from Toujeo. Sanofi will happily do the same if I want to go in the other direction. Restricting samples is amazingly stupid as it hurts your business when you are selling a lifetime product. The samples cost gets rapidly buried.
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Post by sayhey24 on Aug 13, 2020 13:32:06 GMT -5
You only need the samples until you get the prescription, and you can’t get the script till it’s approved by insurance. Sports - $99 at insulinsavings.com gets me a box today as long as VDex sends the script. Virta is getting people to pay nearly $400 per month for a keto diet. I would hope VDex can get their client to spend $100. In fact, why doesn't VDex just buy the first box from insulinsavings.com? Here are the Virta outcomes www.virtahealth.com/outcomes Bill and VDex can do much better with less effort. The problem is Virta has a better marketing team and a billing model to get the client to pay. I don't think Virta is sitting around waiting for an insurance company to approve.
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Post by sportsrancho on Aug 13, 2020 14:26:28 GMT -5
You only need the samples until you get the prescription, and you can’t get the script till it’s approved by insurance. Sports - $99 at insulinsavings.com gets me a box today as long as VDex sends the script. Virta is getting people to pay nearly $400 per month for a keto diet. I would hope VDex can get their client to spend $100. In fact, why doesn't VDex just buy the first box from insulinsavings.com? Here are the Virta outcomes www.virtahealth.com/outcomes Bill and VDex can do much better with less effort. The problem is Virta has a better marketing team and a billing model to get the client to pay. I don't think Virta is sitting around waiting for an insurance company to approve. Vdex gets paid by insurance for the clinic visits... patients only pay a co-pay. Why would we send them someplace to buy Afrezza when after we get their numbers down their Insurance gets on board and they can get a script. Or a lot of times their insurance already covers it. Vdex doesn’t want the patient to pay out of pocket for anything.
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Post by sayhey24 on Aug 13, 2020 15:17:10 GMT -5
Sports - because we want to sell more afrezza and not give it away for months and months. Additionally to sell more afrezza we need to expand the VDex client base. To do this probably requires a change to the business model of getting paid per visit. This works for a proof of concept but it has not worked for a large up-scaling. We know the proof of concept works because nothing works better than afrezza especially for T2s. Combine afrezza with a wellness program and nothing can touch it. The struggle for VDex seems to be the right business model. Virta uses a club fee. GoLo sells a product - Release. What can VDex do to scale up to sell more afrezza? Back in the days of Matt Pfiefer the VDex plan was to have 100 clinics in a year. That was at least 4 years ago. I have got to believe there is a way to partner with black churches and get big$$$ grants to pay for the CGMs and afrezza. There are things like Project Power which if properly leveraged could transform the Project Power success rate and put VDex growth on steriods which would really help afrezza sales. chronicdiseaselocal.org/resource/american-diabetes-association-project-power
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Post by agedhippie on Aug 13, 2020 16:49:54 GMT -5
Sports - because we want to sell more afrezza and not give it away for months and months. ... In terms of cost to Mannkind we are talking about $250 of Afrezza which will generate $7,000 of revenue (based on my usage, as Type 2 they are probably higher) over the next year, and every following year. That is why Novo Nordisk, Lilly, and Sanofi shower clinics with free samples, they understand business and that ROI is golden. For a one time $250 payment Mannkind can buy a revenue stream worth $7,000 per year for decades. (Numbers based off Mannkind's 10Q, get greater production efficiency and make more money)
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Post by sayhey24 on Aug 13, 2020 18:40:13 GMT -5
Sports - because we want to sell more afrezza and not give it away for months and months. ... In terms of cost to Mannkind we are talking about $250 of Afrezza which will generate $7,000 of revenue (based on my usage, as Type 2 they are probably higher) over the next year, and every following year. That is why Novo Nordisk, Lilly, and Sanofi shower clinics with free samples, they understand business and that ROI is golden. For a one time $250 payment Mannkind can buy a revenue stream worth $7,000 per year for decades. (Numbers based off Mannkind's 10Q, get greater production efficiency and make more money) Great, only $250. Again why can't the PWD buy it themselves for $99 a box or if VDex wants to give it away then they should buy it. People are forking over nearly $400 to Virta for a keto diet. VDex should have a business model which is going to make money. If it is only $250 on a $7000 sale then it should be the cost of business to VDex. The VDex business model should not be based on making money by relying on free samples from Mannkind. The reason why you can not compare afrezza to other RAAs is because it is uniquely different. Bill knows he can not just substitute Novalog for afrezza. Aged, while you still may not fully understand this, Bill does. Bill's treatment model just does not work without afrezza. Bill has one choice of insulin and its afrezza. His business is built on afrezza and Bill knows nothing else will work. In this world afrezza has no competition. VDex is still years ahead of the diabetes community. IMO VDex needs to work out a distributorship where they get the product at wholesale prices and as part of the deal Bill can negotiation some amount of samples. That way Bill has a defined model to make money, Mike has a committed sales quota and Bill does not need to keep calling Mike with his hat in his hand. Back to my original question - what is it people want Mike to do for VDex, aside from free samples? I know we all would like to see VDex open their 100 clinics and sell more afrezza. How about a diabetesmobile which Bill sets up outside the busiest endos offices and a guy walks around the parking lot with a sandwich board which say "got 8+ A1c, would you like 6?" Bill could hire the clients who don't have the $99 who need the free samples to man the sandwich board and at the same time get a little exercise walking around.
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Post by cretin11 on Aug 13, 2020 20:40:13 GMT -5
SeyHey you may be overcomplicating things. Aged and Sports have laid it out well. It’s simple, get the Afrezza to as many people as possible, let VDEX do the rest. Providing ample supply to VDEX is simply good business for MNKD. It almost seems that Mike C has acted out of spite towards VDEX because it wasn’t his idea? That would seem ridiculous, but I wonder... Anyway, hopefully he’s learning that it would be a win win to collaborate. Aged summed it up, a small expense now to reel in a patient will result in thousands of dollars in Afrezza revenue.
Don’t miss the forest for the trees! Don’t cut off your nose to spite your face! Don’t win the battle and lose the war! Ok sorry for the lame cliches, you get the picture!
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