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Post by phdedieu12 on Dec 13, 2022 22:42:38 GMT -5
I have not heard this said anywhere, but my assumption was it’s hard to recruit sales people to sell a drug that isn’t selling, and it’s something else they can have in their sales box🤷🏼♀️ must be more to it though… “The real competition for V-Go is afrezza.” “If afrezza was prescribed early in the diagnosis the PWD should never progress to needing the basal.” Yep agree with sayhey. It's difficult to get talent at any level when everyone think the company is going under, it's been an uphill battle at every turn, and of course having multiple products is beneficial for the sales force. If, if, if, if... If Afrezza was prescribed by all endos, we'd be rich... |
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Post by phdedieu12 on Dec 13, 2022 22:54:04 GMT -5
Sports - IDK, but I don't think there is more to the story. He is sending out sale reps who are not properly equipped to sell afrezza for a number of reasons so of course it is not selling. If we put it on costplusdrugs,com for cheap it also would not sell because the proper marketing and sales strategy has not been developed. We are $3B+ in development costs and still don't have a plan to sell into the T2 market. Mike now has a simple gizmo the sales reps can whip out when they can't explain afrezza and the doctor says hit the bricks. Its simple, its using existing RAA and the story is simple - got an older T2 on medicare who now needs basal and prandial use this and they don't need to take MDI they just push the button at mealtime. I am still waiting to see you as head of sales and show these guys that proper marketing and sales strategy you keep talking about. Can you articulate it? How exactly are the sales reps not properly equipped? What do you think they need to be effective and successful? What is your plan to sell to T2 market, precisely? So the sales reps can't explain Afrezza? How do you know? |
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Post by Chris-C on Dec 13, 2022 23:19:25 GMT -5
Whenever I want to pump up lagging spirits I know I can come to the MNKD proboards to get a lift. Sometimes it's like a boot camp for actors auditioning to play Ebeneezer in "A Christmas Carol".
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Post by sayhey24 on Dec 14, 2022 7:26:14 GMT -5
Sports - IDK, but I don't think there is more to the story. He is sending out sale reps who are not properly equipped to sell afrezza for a number of reasons so of course it is not selling. If we put it on costplusdrugs,com for cheap it also would not sell because the proper marketing and sales strategy has not been developed. We are $3B+ in development costs and still don't have a plan to sell into the T2 market. Mike now has a simple gizmo the sales reps can whip out when they can't explain afrezza and the doctor says hit the bricks. Its simple, its using existing RAA and the story is simple - got an older T2 on medicare who now needs basal and prandial use this and they don't need to take MDI they just push the button at mealtime. You really don't have a clue do you? The salespeople are well equipped with the tools to sell Afrezza but the majority of doctors are reluctant to try it because of the poor label and lack of changing their patients to a drug that PER THE LABEL is INFERIOR. We all know it works but doctors don't lurk on message boards or forums and read patients experiences. Can you imagine having your doctor say to you as the patient....I read on the INTERNET that this drug is safe and good?? Don't think so! Most doctors who have their patients under control (albeit a 7.0 - 9.0 A1C) with their therapy is very reluctant to switch to something new. Doctors are just like engineers - they don't take to CHANGE very well. Mike & Co. is working to get Afrezza widespread but we are dealing with a Bad Label, EDUCATION and BEHAVIOR with patients and doctors. All of them are not easy to convert. It will take time but I would not say the salespeople are not equipped. I think the first misunderstanding is asking doctors to switch their patients. The step program typically is additive. The Affinity-2 trial was additive and showed superiority. What you are saying is after 8 years doctors don't want to change and add afrezza to metformin or the GLP1 when the patient no longer wants to use the GLP1. How long will it take for the doctors to add afrezza with the current sales strategy, 8 more years? BTW Mounjaro just got added as a step 1 in the 2023 ADA SoC. Can you give me an example from the label where the bad words are which are stopping doctors from prescribing and don't tell me its the acute bronchospasm? Here is the label. What needs to change for doctor to prescribe? www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf |
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Post by mango on Dec 14, 2022 8:46:08 GMT -5
Actually, Afrezza is non-inferior. And the reason why physicians are reluctant to prescribe is simply because the ADA’s SoC is unfavorable for Afrezza. Want a significant new cohort of physicians to start prescribing? Change the SoC.
This isn’t complicated.
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Post by hellodolly on Dec 14, 2022 8:56:08 GMT -5
Here is what Mike said "We also believe you'll start to see V-Go as a platform. I think that's something I don't want to talk about now, but as we get ready for next year, that's kind of where some of that capital can go, which is how do you re purpose V-Go outside of diabetes. And we think it's a platform device that can be leveraged for other products. So that's an area that we're looking at." A platform for what? You can't just jam another drug into the device without trials. Is he really going to spend resources on putting something into a mechanical pump especially when he has a GLP1 which has already done phase 1s which seemed to show huge promise? I think he just got caught up in the excitement of buying his first company and then started getting feedback afrezza and V-Go are not only competing products but are incompatible. If you believe in afrezza V-Go has no place. Mike also said they will "leverage the existing infrastructure we have. So we have 60 current Afrezza salespeople across the country, and we'll be dropping V-Go in that bag around late January." Really? This is like trying to mix oil and water. Maybe I am wrong and for the sake of the share holders I hope Mike is right and I am wrong but I will be surprised. We not only have wasted $15M+ which could be focused on afrezza and GLP1s but wasted a lot of time. That's it, thank you. I've read a couple of your responses (bold below) and maybe I wasn't clear, but Mike has made it very clear...even if you disagree with me or Castagna: You wrote, "Sports - IDK, but I don't think there is more to the story."As MC stated in an interview on a pharma podcast a few months ago, [paraphrase] "...discussions to make acquisitions are held long before a decision is made and the acquisition takes place". I believe the MNKD team has certainly looked at this as an opportunity to use the V-Go device for something more than just the insulin that is currently approved by the FDA. Discussions, as you know like these, can take more than a year because pharma research is deep, expensive and takes a long time to decide if the Net Present Value (NPV) assessment results in a positive or negative figure. This takes place, as you know, long before negotiations to buy a company so, add another 6-12 months. On the acquisition; Castagna said it himself, " I think that's something I don't want to talk about now, but as we get ready for next year, that's kind of where some of that capital can go, which is how do you re purpose V-Go outside of diabetes."
What is it? I haven't the slightest idea but, MNKD certainly does as they don't want to discuss any details until "next year". What we do know is UTHR saw the DPI formulation and delivery device as the next step in their drug development and commercialization strategy for treprostinil. MNKD is clearly looking at alternatives for V-Go and we know that based on what MC stated but, why? Maybe MNKD was approached by someone with another drug they believe could work with the V-Go technology, just like UTHR did with TI, before MNKD purchased the device and that made the decision much easier? His talk about getting into the offices and having another card to play [my words] is accurate but not what I believe their real intentions are. It does give the sales team a throw down if they get turned around at the door with Afrezza and expands their territory into practices they hadn't been able to reach because they were, in the past, a one trick pony. I think that is all a big distraction that staves off questions, especially if it can become profitable, he'll look like a genius before it's repurposed. You also said, "A platform for what? You can't just jam another drug into the device without trials." Well, we ALL know that. We also know based on the recent partnership with UTHR that devices can be versatile AFTER drug trials like UTHR and MNKD conducted for DPI. So, another player pays to have their drug tested and used with the V-GO device? It flies or it doesn't but a trial would be needed regardless...as it was for treprostinil. What about a liquid insulin form of Afrezza? Can't speak on it but just thinking outside the box as if I was in a boardroom and did understand it. But hey, remember..."re purposed outside diabetes". So, at face value Mike and his team have done their homework and the acquisition is brilliant or, as some believe not so brilliant. My bet is most are going to wisely take the 'wait and see' approach before deciding while others ignore the evidence in plain sight and have already passed judgement. |
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Post by Thundersnow on Dec 14, 2022 8:58:10 GMT -5
You really don't have a clue do you? The salespeople are well equipped with the tools to sell Afrezza but the majority of doctors are reluctant to try it because of the poor label and lack of changing their patients to a drug that PER THE LABEL is INFERIOR. We all know it works but doctors don't lurk on message boards or forums and read patients experiences. Can you imagine having your doctor say to you as the patient....I read on the INTERNET that this drug is safe and good?? Don't think so! Most doctors who have their patients under control (albeit a 7.0 - 9.0 A1C) with their therapy is very reluctant to switch to something new. Doctors are just like engineers - they don't take to CHANGE very well. Mike & Co. is working to get Afrezza widespread but we are dealing with a Bad Label, EDUCATION and BEHAVIOR with patients and doctors. All of them are not easy to convert. It will take time but I would not say the salespeople are not equipped. I think the first misunderstanding is asking doctors to switch their patients. The step program typically is additive. The Affinity-2 trial was additive and showed superiority. What you are saying is after 8 years doctors don't want to change and add afrezza to metformin or the GLP1 when the patient no longer wants to use the GLP1. How long will it take for the doctors to add afrezza with the current sales strategy, 8 more years? BTW Mounjaro just got added as a step 1 in the 2023 ADA SoC. Can you give me an example from the label where the bad words are which are stopping doctors from prescribing and don't tell me its the acute bronchospasm? Here is the label. What needs to change for doctor to prescribe? www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdfYou're blaming MNKD and the Salesforce. Why don't you blame the ADA. Doctors have protocols and guidelines and most (like 85%) do not deviate. If the ADA do not recommend Afrezza then the doctors will not prescribe it. So maybe your energy needs to be towards the ADA. |
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Post by peppy on Dec 14, 2022 9:04:33 GMT -5
Actually, Afrezza is non-inferior. And the reason why physicians are reluctant to prescribe is simply because the ADA’s SoC is unfavorable for Afrezza. Want a significant new cohort of physicians to start prescribing? Change the SoC. This isn’t complicated. I think Kendall tired/would have tried that. Easier said than done. The way the SOC are set up, unless you are type 1, insulin is the last medication. What I think needs to be changed, is the way a non-inferior label works, I think the physician should be able to choose the medication rather than the Pharmacy purchasing manager. Tricky business set up. I think people should learn, have it made known there is a manufacture rebate to the pharmacy purchasing managers. Like my neighbor with ALS who had to quit his job and go on medicare, when given a expensive script for coagulation that medicare didn't cover. We can't afford this, then the script was changed to Warfarin. If they get a script, the bill will be what determines the accessibility. |
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Post by sayhey24 on Dec 14, 2022 18:11:55 GMT -5
Here is what Mike said "We also believe you'll start to see V-Go as a platform. I think that's something I don't want to talk about now, but as we get ready for next year, that's kind of where some of that capital can go, which is how do you re purpose V-Go outside of diabetes. And we think it's a platform device that can be leveraged for other products. So that's an area that we're looking at." A platform for what? You can't just jam another drug into the device without trials. Is he really going to spend resources on putting something into a mechanical pump especially when he has a GLP1 which has already done phase 1s which seemed to show huge promise? I think he just got caught up in the excitement of buying his first company and then started getting feedback afrezza and V-Go are not only competing products but are incompatible. If you believe in afrezza V-Go has no place. Mike also said they will "leverage the existing infrastructure we have. So we have 60 current Afrezza salespeople across the country, and we'll be dropping V-Go in that bag around late January." Really? This is like trying to mix oil and water. Maybe I am wrong and for the sake of the share holders I hope Mike is right and I am wrong but I will be surprised. We not only have wasted $15M+ which could be focused on afrezza and GLP1s but wasted a lot of time. That's it, thank you. I've read a couple of your responses (bold below) and maybe I wasn't clear, but Mike has made it very clear...even if you disagree with me or Castagna: You wrote, "Sports - IDK, but I don't think there is more to the story."As MC stated in an interview on a pharma podcast a few months ago, [paraphrase] "...discussions to make acquisitions are held long before a decision is made and the acquisition takes place". I believe the MNKD team has certainly looked at this as an opportunity to use the V-Go device for something more than just the insulin that is currently approved by the FDA. Discussions, as you know like these, can take more than a year because pharma research is deep, expensive and takes a long time to decide if the Net Present Value (NPV) assessment results in a positive or negative figure. This takes place, as you know, long before negotiations to buy a company so, add another 6-12 months. On the acquisition; Castagna said it himself, " I think that's something I don't want to talk about now, but as we get ready for next year, that's kind of where some of that capital can go, which is how do you re purpose V-Go outside of diabetes."
What is it? I haven't the slightest idea but, MNKD certainly does as they don't want to discuss any details until "next year". What we do know is UTHR saw the DPI formulation and delivery device as the next step in their drug development and commercialization strategy for treprostinil. MNKD is clearly looking at alternatives for V-Go and we know that based on what MC stated but, why? Maybe MNKD was approached by someone with another drug they believe could work with the V-Go technology, just like UTHR did with TI, before MNKD purchased the device and that made the decision much easier? His talk about getting into the offices and having another card to play [my words] is accurate but not what I believe their real intentions are. It does give the sales team a throw down if they get turned around at the door with Afrezza and expands their territory into practices they hadn't been able to reach because they were, in the past, a one trick pony. I think that is all a big distraction that staves off questions, especially if it can become profitable, he'll look like a genius before it's repurposed. You also said, "A platform for what? You can't just jam another drug into the device without trials." Well, we ALL know that. We also know based on the recent partnership with UTHR that devices can be versatile AFTER drug trials like UTHR and MNKD conducted for DPI. So, another player pays to have their drug tested and used with the V-GO device? It flies or it doesn't but a trial would be needed regardless...as it was for treprostinil. What about a liquid insulin form of Afrezza? Can't speak on it but just thinking outside the box as if I was in a boardroom and did understand it. But hey, remember..."re purposed outside diabetes". So, at face value Mike and his team have done their homework and the acquisition is brilliant or, as some believe not so brilliant. My bet is most are going to wisely take the 'wait and see' approach before deciding while others ignore the evidence in plain sight and have already passed judgement. Just so we are on the same page we are talking about V-Go. This is the user manual www.go-vgo.com/instructions-for-patient-use/How Mike expects to use this for something else might take some imagination, more imagination than I have. It comes in three fixed sizes 20/30/40. The selling point of this device is it allows the PWD to push the button at mealtime and bolus. This device is only T2 only approved. Which means this is for T2s who have already been put on basal insulin and are still failing the ADA step program and have reached the final step - mealtime insulin. IMO, to repurpose this device you need an application which needs a predetermined steady state release but also requires bolusing from time to time which is going to be done manually by pushing the button. I guess there could be another application but aside from diabetes I am not sure what. This device would also require re-engineering if it needed to deliver something other than the pre-configured 20/30/40 units. Does UTHR have a drug which fits the V-Go better than an electric pump, IDK. What I do know is the relationship Martine had with Al Mann started when he made a Minimed pump for her kid. Its possible UTHR might have something to fit the V-Go but I would be surprised. In my day I have bought and sold a few companies. I have also gotten up at the closing of several companies and walked away from the table. These acquisitions would take months and months. It can get pretty exciting during the process - like buying your first house. I think thats what we have with V-Go but I know you and others have a different opinion which is good. What I do know is that we will be in about $20M by year end. I also know that right now its like the old "I Love Lucy" show where she was bottling beer and Rickie asked her how much she was losing per bottle and she told him 10cents but she was going to make up the loss in volume. I also know the selling point of this device is to avoid MDI for the T2. Its to allow the T2 to push the button at mealtime and avoid the injections. Do you see a problem here with afrezza? The point of afrezza is to avoid the injection, avoid the hypo from the RAA and provide the PWD with significantly better mealtime control. Now we are going to put this in the "sales reps bag" in January and when they can't explain why afrezza is better we are gong to say forget it - just use this device with your favorite RAA. |
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Post by sayhey24 on Dec 14, 2022 18:32:41 GMT -5
I think the first misunderstanding is asking doctors to switch their patients. The step program typically is additive. The Affinity-2 trial was additive and showed superiority. What you are saying is after 8 years doctors don't want to change and add afrezza to metformin or the GLP1 when the patient no longer wants to use the GLP1. How long will it take for the doctors to add afrezza with the current sales strategy, 8 more years? BTW Mounjaro just got added as a step 1 in the 2023 ADA SoC. Can you give me an example from the label where the bad words are which are stopping doctors from prescribing and don't tell me its the acute bronchospasm? Here is the label. What needs to change for doctor to prescribe? www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdfYou're blaming MNKD and the Salesforce. Why don't you blame the ADA. Doctors have protocols and guidelines and most (like 85%) do not deviate. If the ADA do not recommend Afrezza then the doctors will not prescribe it. So maybe your energy needs to be towards the ADA. Brilliant - I am taking from your answer is you can not point to something in the label which is so bad. Mango mentioned that the label says non-inferior which is true for the T1s but for the T2s it says "statistically significantly greater" aka "superior" to the orals the PWD was taking. Its been 8 years and you ask am I blaming MNKD and the Salesforce. I am not blaming the sales reps. I think we are in our third or fourth wave of sales reps since Mike started. We keep sending these guys out into no-mans land and its like watching them get mowed down with a MG 08. How long have I been asking what is our sales and marketing plan is for the T2s??? Maybe years??? Do we have one??? The last I heard afrezza for T2s was put on hold. The last I heard prior to seeing the patent was the TS GLP1 was still in the freezer. Do I blame MNKD for not having a T2 plan??? Your'e damn right I do. We are sitting on the greatest advance in diabetes care in 100 years and our plan to sell it is "its on hold". BTW - Mounjaro got approved in the May and guess what - the ADA's 2023 SoC is out and guess what is step 1b - GIP. Did I predict that??? I think so. Better yet - the FDA is giving it accelerated approval for weight loss diatribe.org/fda-accelerates-review-type-2-weight-loss-drugMaybe the FDA could give TS GLP1 accelerated approval for weight loss if we took it out of the freezer. |
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Post by Thundersnow on Dec 14, 2022 21:42:24 GMT -5
You're blaming MNKD and the Salesforce. Why don't you blame the ADA. Doctors have protocols and guidelines and most (like 85%) do not deviate. If the ADA do not recommend Afrezza then the doctors will not prescribe it. So maybe your energy needs to be towards the ADA. Brilliant - I am taking from your answer is you can not point to something in the label which is so bad. Mango mentioned that the label says non-inferior which is true for the T1s but for the T2s it says "statistically significantly greater" aka "superior" to the orals the PWD was taking. Its been 8 years and you ask am I blaming MNKD and the Salesforce. I am not blaming the sales reps. I think we are in our third or fourth wave of sales reps since Mike started. We keep sending these guys out into no-mans land and its like watching them get mowed down with a MG 08. How long have I been asking what is our sales and marketing plan is for the T2s??? Maybe years??? Do we have one??? The last I heard afrezza for T2s was put on hold. The last I heard prior to seeing the patent was the TS GLP1 was still in the freezer. Do I blame MNKD for not having a T2 plan??? Your'e damn right I do. We are sitting on the greatest advance in diabetes care in 100 years and our plan to sell it is "its on hold". BTW - Mounjaro got approved in the May and guess what - the ADA's 2023 SoC is out and guess what is step 1b - GIP. Did I predict that??? I think so. Better yet - the FDA is giving it accelerated approval for weight loss diatribe.org/fda-accelerates-review-type-2-weight-loss-drugMaybe the FDA could give TS GLP1 accelerated approval for weight loss if we took it out of the freezer. I love your persistence but you're talking like MNKD has deep pockets like an AMGEN or Pfizer. Mike knows what has to be done to get Afrezza on the SOC but they don't have the money to run the Studies. You seem to forget MNKD has been running on a SHOESTRING budget for YEARS. We saw what happened when Mike buckled under investor pressure and spent $9 million on Afrezza TV Commercials....That was a BUST and I'm sure Mike said to himself this is the last time I cave their pressure. The biggest issue which I mentioned before is when a person mentions INSULIN.....PEOPLE FREAK OUT. Type 2's FREAK OUT. Hell...They freak out when you ask them what is their A1C or if they prick themselves 3x a day. I have (4) surplus Abbott Libre3 Sensors (from my dog's vet) and I asked my siblings who are T2 would they like to wear one to see how their BG reacts to the foods they eat and they all said NO. So you're going to try and convince a nation of Type 2's to take INSULIN??? NO WAY. Mike had to make strategic decisions and it looks like its paying off. You might forget MNKD was a SHITHOLE Company with less than 1 month of funding. So as I said earlier there is no way they could fund any head to head studies to show Superiority. I find it funny how you bash Mike at every move yet you still own stock in MNKD? That is hilarious. |
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Post by peppy on Dec 14, 2022 22:04:15 GMT -5
Brilliant - I am taking from your answer is you can not point to something in the label which is so bad. Mango mentioned that the label says non-inferior which is true for the T1s but for the T2s it says "statistically significantly greater" aka "superior" to the orals the PWD was taking. Its been 8 years and you ask am I blaming MNKD and the Salesforce. I am not blaming the sales reps. I think we are in our third or fourth wave of sales reps since Mike started. We keep sending these guys out into no-mans land and its like watching them get mowed down with a MG 08. How long have I been asking what is our sales and marketing plan is for the T2s??? Maybe years??? Do we have one??? The last I heard afrezza for T2s was put on hold. The last I heard prior to seeing the patent was the TS GLP1 was still in the freezer. Do I blame MNKD for not having a T2 plan??? Your'e damn right I do. We are sitting on the greatest advance in diabetes care in 100 years and our plan to sell it is "its on hold". BTW - Mounjaro got approved in the May and guess what - the ADA's 2023 SoC is out and guess what is step 1b - GIP. Did I predict that??? I think so. Better yet - the FDA is giving it accelerated approval for weight loss diatribe.org/fda-accelerates-review-type-2-weight-loss-drugMaybe the FDA could give TS GLP1 accelerated approval for weight loss if we took it out of the freezer. I love your persistence but you're talking like MNKD has deep pockets like an AMGEN or Pfizer. Mike knows what has to be done to get Afrezza on the SOC but they don't have the money to run the Studies. You seem to forget MNKD has been running on a SHOESTRING budget for YEARS. We saw what happened when Mike buckled under investor pressure and spent $9 million on Afrezza TV Commercials....That was a BUST and I'm sure Mike said to himself this is the last time I cave their pressure. The biggest issue which I mentioned before is when a person mentions INSULIN.....PEOPLE FREAK OUT. Type 2's FREAK OUT. Hell...They freak out when you ask them what is their A1C or if they prick themselves 3x a day. I have (4) surplus Abbott Libre3 Sensors (from my dog's vet) and I asked my siblings who are T2 would they like to wear one to see how their BG reacts to the foods they eat and they all said NO. So you're going to try and convince a nation of Type 2's to take INSULIN??? NO WAY. Mike had to make strategic decisions and it looks like its paying off. You might forget MNKD was a SHITHOLE Company with less than 1 month of funding. So as I said earlier there is no way they could fund any head to head studies to show Superiority. I find it funny how you bash Mike at every move yet you still own stock in MNKD? That is hilarious. There are a few type two's on Afrezza. spiro is one. However, he is in Siberia. joeypotsandpans is another type two on this board taking Afrezza. So is alethea. I agree with you mostly for these reasons. 1 the weight loss with the GLP-1 thing. 2. Insurance will not pay for Afrezza for type two's. It cost too much. Medicine can give these people chemicals that stimulate insulin secretion (i.e., to act as an incretin hormone) and to inhibit glucagon secretion, thereby contributing to limit postprandial glucose excursions. It also inhibits gastrointestinal motility and secretion and thus acts as an enterogastrone and part of the "ileal brake" mechanism. GLP-1 also appears to be a physiological regulator of appetite and food intake. .. blah, blah, blah and tell these people this is a good thing. while handing them packages with this warning. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C- cell tumors has not been determined (5.1, 13.1). OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1). |
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Post by hellodolly on Dec 15, 2022 6:25:26 GMT -5
sayhey24 That's it, thank you. I've read a couple of your responses (bold below) and maybe I wasn't clear, but Mike has made it very clear...even if you disagree with me or Castagna: You wrote, "Sports - IDK, but I don't think there is more to the story."As MC stated in an interview on a pharma podcast a few months ago, [paraphrase] "...discussions to make acquisitions are held long before a decision is made and the acquisition takes place". I believe the MNKD team has certainly looked at this as an opportunity to use the V-Go device for something more than just the insulin that is currently approved by the FDA. Discussions, as you know like these, can take more than a year because pharma research is deep, expensive and takes a long time to decide if the Net Present Value (NPV) assessment results in a positive or negative figure. This takes place, as you know, long before negotiations to buy a company so, add another 6-12 months. On the acquisition; Castagna said it himself, " I think that's something I don't want to talk about now, but as we get ready for next year, that's kind of where some of that capital can go, which is how do you re purpose V-Go outside of diabetes."
What is it? I haven't the slightest idea but, MNKD certainly does as they don't want to discuss any details until "next year". What we do know is UTHR saw the DPI formulation and delivery device as the next step in their drug development and commercialization strategy for treprostinil. MNKD is clearly looking at alternatives for V-Go and we know that based on what MC stated but, why? Maybe MNKD was approached by someone with another drug they believe could work with the V-Go technology, just like UTHR did with TI, before MNKD purchased the device and that made the decision much easier? His talk about getting into the offices and having another card to play [my words] is accurate but not what I believe their real intentions are. It does give the sales team a throw down if they get turned around at the door with Afrezza and expands their territory into practices they hadn't been able to reach because they were, in the past, a one trick pony. I think that is all a big distraction that staves off questions, especially if it can become profitable, he'll look like a genius before it's repurposed. You also said, "A platform for what? You can't just jam another drug into the device without trials." Well, we ALL know that. We also know based on the recent partnership with UTHR that devices can be versatile AFTER drug trials like UTHR and MNKD conducted for DPI. So, another player pays to have their drug tested and used with the V-GO device? It flies or it doesn't but a trial would be needed regardless...as it was for treprostinil. What about a liquid insulin form of Afrezza? Can't speak on it but just thinking outside the box as if I was in a boardroom and did understand it. But hey, remember..."re purposed outside diabetes". So, at face value Mike and his team have done their homework and the acquisition is brilliant or, as some believe not so brilliant. My bet is most are going to wisely take the 'wait and see' approach before deciding while others ignore the evidence in plain sight and have already passed judgement. Just so we are on the same page we are talking about V-Go. This is the user manual www.go-vgo.com/instructions-for-patient-use/How Mike expects to use this for something else might take some imagination, more imagination than I have. It comes in three fixed sizes 20/30/40. The selling point of this device is it allows the PWD to push the button at mealtime and bolus. This device is only T2 only approved. Which means this is for T2s who have already been put on basal insulin and are still failing the ADA step program and have reached the final step - mealtime insulin. IMO, to repurpose this device you need an application which needs a predetermined steady state release but also requires bolusing from time to time which is going to be done manually by pushing the button. I guess there could be another application but aside from diabetes I am not sure what. This device would also require re-engineering if it needed to deliver something other than the pre-configured 20/30/40 units. Does UTHR have a drug which fits the V-Go better than an electric pump, IDK. What I do know is the relationship Martine had with Al Mann started when he made a Minimed pump for her kid. Its possible UTHR might have something to fit the V-Go but I would be surprised. In my day I have bought and sold a few companies. I have also gotten up at the closing of several companies and walked away from the table. These acquisitions would take months and months. It can get pretty exciting during the process - like buying your first house. I think thats what we have with V-Go but I know you and others have a different opinion which is good. What I do know is that we will be in about $20M by year end. I also know that right now its like the old "I Love Lucy" show where she was bottling beer and Rickie asked her how much she was losing per bottle and she told him 10cents but she was going to make up the loss in volume. I also know the selling point of this device is to avoid MDI for the T2. Its to allow the T2 to push the button at mealtime and avoid the injections. Do you see a problem here with afrezza? The point of afrezza is to avoid the injection, avoid the hypo from the RAA and provide the PWD with significantly better mealtime control. Now we are going to put this in the "sales reps bag" in January and when they can't explain why afrezza is better we are gong to say forget it - just use this device with your favorite RAA. Thank you sayhey24 I always enjoy reading your viewpoints and thoughts. You and I are equally and genuinely invested into this story. While you make great points, I can't help but be intrigued by what MC means when he says "...re purpose outside diabetes." Just exactly what he has in mind is unknown but like I said, I'll wait before making judgement calls. Talking about imagination, 50 years ago who would've thought you could fit that big heavy box on the living room floor broadcasting only three networks with those telescopic antennas into that tiny little phone hanging over on that wall in the kitchen? Not me. It could've been because I was watching too much Happy Days keeping me stuck in the 50's. |
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Post by sayhey24 on Dec 15, 2022 8:11:24 GMT -5
Dolly - IDK what Mike is thinking. Maybe he has a use for it, I hope so but I sure hope he has a partner who is going to fund its redevelopment. You do see what I am talking about - its hard wired for T2s to avoid MDI. Thats the sales pitch. It competes head to head with afrezza. The crazy thing is every day you have to stick a new one on so there is a lot of maintenance with it too. A shot of Tresiba in the morning and some puffs of afrezza during the day seems easier to me let alone getting better control. Afrezza at $35 on medicare as Mike said "changes the game". We will see in a couple of months what his thoughts are.
Some one mentioned it being a distraction to show increased revenue. I am in that camp but I could have thought of better ways to spend $20M. I know he didn't see a future for the TS GLP1 but I would be on the phone until I found a partner. Mounjaro is now getting jammed through the FDA on hyperspeed to get it approved for weight loss. Not a year after approval and the ADA has it front and center in the SoC and the FDA will soon approve for diet. Now that is marketing.
Not 50 but nearly 40 years ago I was working for one of those 3 letter agencies helping them to select their new "analyst" workstation. I went to nearly every major R&D facility in the U.S. that had a soldering iron looking for what they were dreaming about. Those flat screens were around 30+ years ago and it took nearly 30+ to become mainstream. Maybe afrezza still has a chance - ha! BTW - I bought one of those big QLEDs last year and thought I paid too much and then the price went up for Christmas and stayed up until a few months ago and now its finally back to what I paid. I have never seen that happened before as usually the prices drop right after you buy them.
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Post by Clement on Dec 15, 2022 8:24:13 GMT -5
re-purpose V-GO outside diabetes?
Do you mean like subQ Remodulin (treprostinil)?
Or,
Subcutaneous Immunoglobulin (SCIg)?
I don't know anything you don't know (about MNKD plans). I'm just throwing out a couple of examples.
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