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Post by radgray68 on May 10, 2024 12:48:18 GMT -5
So, none of you have any hope for the possibilities of the V-go device. An FDA approved drug delivery device that doses at a controlled rate mechanically without all the electronics.
All of you can ONLY see insulin being delivered? Even though Al Mann himself was intrigued and following this product closely before he passed? Then you have no imagination.
I’ve immediately pictured fertility drugs for the device because of my personal experience and watching my wife become a human pincushion for the better part of a decade. Then I go to anti nausea drugs for cancer patients who get awakened by alarms beeping from current electrical devices due to crimped hoses or low batteries or dislodged IVs.
There are probably countless drugs to be loaded onto V-go but we only just started making enough to thoroughly consider the possibilities.
Pleas restore my faith in the intellectual abilities of this board and come up with something……somebody? I’ve given my favorite two here.
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Post by sayhey24 on May 10, 2024 12:51:02 GMT -5
One thing we have learned about Mike is there are a lot of head fakes starting with the shareholder meeting which ended up being something else with Damon Dash. Mike did say they were looking into other uses for the device. IMO, a head fake. Was it an intentional head fake or just a miscalculation? My guess is the latter. Perhaps Zealand sold him on the concept and he bought it. Who knows about that, but we do know Zealand stock tripled immediately after unloading VGo on us, so they made out quite well in the deal. It was actually both. For some reason he did not seem to understand V-Go and afrezza are like oil and water. I am not sure why but the key accounts seemed to understand it day 1. Either you believe in afrezza and what it can do or you don't. If you believe then its as Bill from VDex says 'afrezza frist, afrezza always". The other issue is Mike has not been able to sell afrezza and GLP1s have made a big impact in the T2 space and they have insurance coverage for diabetes. Instead of addressing the three issues as to why afrezza was not selling we would hire a wave of about 100 sales reps and then they would fail and then they we would have a RIF. This has been done I think 3 times and now we are on the 4th wave but this time focused on key accounts. Why the underlying issues were not addressed and just hiring another wave to just have them fail too is a mystery. One thing Mike knew was afrezza was not selling in the T2 space and BP was in control so focusing afrezza on the much smaller T1 low hanging fruit became the strategy. However, he had no answer for the T2 market so he could tell the V-Go story and buy some time by putting V-Go "in the rep's bags". I don't think he anticipated the blow back from the key accounts. To initially hide the numbers as afrezza started to make some sales in the Medicare space through the $35 pre auth he combined afrezza and V-Go as the Endocrine Division. |
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Post by agedhippie on May 10, 2024 12:54:33 GMT -5
So we are agreed that there never been a trial between metformin only and Afrezza, and that the 175 trial had people on multiple oral meds? Do you not understand the 175 trial? The bottom line is afrezza is superior to metformin and metformin plus a bunch of other meds. The trial for people where the treatment has failed, yes I understand that was the point of the 175 trial. Do you understand that contrary to your claims there has never been a trial between metformin only and Afrezza, and that the 175 trial had people on multiple oral meds? |
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Post by prcgorman2 on May 10, 2024 13:39:21 GMT -5
So, none of you have any hope for the possibilities of the V-go device. An FDA approved drug delivery device that doses at a controlled rate mechanically without all the electronics. All of you can ONLY see insulin being delivered? Even though Al Mann himself was intrigued and following this product closely before he passed? Then you have no imagination. I’ve immediately pictured fertility drugs for the device because of my personal experience and watching my wife become a human pincushion for the better part of a decade. Then I go to anti nausea drugs for cancer patients who get awakened by alarms beeping from current electrical devices due to crimped hoses or low batteries or dislodged IVs. There are probably countless drugs to be loaded onto V-go but we only just started making enough to thoroughly consider the possibilities. Pleas restore my faith in the intellectual abilities of this board and come up with something……somebody? I’ve given my favorite two here. Great post radgray68. Sorry for being dismissive about V-Go. Your points are very good.
I have a bit of a skewed frame of reference. I've worked on many projects where the costs were anywhere between $10s of millions and in one case more than $1B. I've become dismissive of costs at the low end of that spectrum. That's not appropriate. Thank you for the correction.
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Post by agedhippie on May 10, 2024 14:32:03 GMT -5
So, none of you have any hope for the possibilities of the V-go device. An FDA approved drug delivery device that doses at a controlled rate mechanically without all the electronics. All of you can ONLY see insulin being delivered? Even though Al Mann himself was intrigued and following this product closely before he passed? Then you have no imagination. I’ve immediately pictured fertility drugs for the device because of my personal experience and watching my wife become a human pincushion for the better part of a decade. Then I go to anti nausea drugs for cancer patients who get awakened by alarms beeping from current electrical devices due to crimped hoses or low batteries or dislodged IVs. There are probably countless drugs to be loaded onto V-go but we only just started making enough to thoroughly consider the possibilities. Pleas restore my faith in the intellectual abilities of this board and come up with something……somebody? I’ve given my favorite two here. There a ton of drugs that are delivered via syringe drivers where V-Go could be substituted, a hospital pharmacist could give you a full list. You would need drugs that have a fixed delivery rate as the V-Go is controlled by the spring strength so it can only be set at manufacturing time so it cannot be varied. |
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Post by cretin11 on May 10, 2024 17:24:36 GMT -5
prcgorman you were correct to be dismissive of VGo.
radgray the creative thinking is respectable (and I like your suggestions in theory), but the VGo device will not become a platform for anything of significance.
As I’ve said many many times on here, sure hope to be wrong! (Not holding my breath.)
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Post by anderson on May 10, 2024 21:18:22 GMT -5
So, none of you have any hope for the possibilities of the V-go device. An FDA approved drug delivery device that doses at a controlled rate mechanically without all the electronics. All of you can ONLY see insulin being delivered? Even though Al Mann himself was intrigued and following this product closely before he passed? Then you have no imagination. I’ve immediately pictured fertility drugs for the device because of my personal experience and watching my wife become a human pincushion for the better part of a decade. Then I go to anti nausea drugs for cancer patients who get awakened by alarms beeping from current electrical devices due to crimped hoses or low batteries or dislodged IVs. There are probably countless drugs to be loaded onto V-go but we only just started making enough to thoroughly consider the possibilities. Pleas restore my faith in the intellectual abilities of this board and come up with something……somebody? I’ve given my favorite two here. There a ton of drugs that are delivered via syringe drivers where V-Go could be substituted, a hospital pharmacist could give you a full list. You would need drugs that have a fixed delivery rate as the V-Go is controlled by the spring strength so it can only be set at manufacturing time so it cannot be varied. Dont forget V-Go has a bolus delivery button as well: Bolus Ready Button: A grey button that lies flat on one of the long edges of V-Go. When pressed, it activates the Bolus Delivery Button. This is the first step to allow for bolus dosing of insulin. • Bolus Delivery Button: A grey button next to the insulin port on one of the short edges of the V-Go. Pressing this button (after activated by the Bolus Ready Button) delivers a bolus dose of 2 Units of insulin (1 click = 2 Units). |
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Post by sayhey24 on May 11, 2024 5:25:40 GMT -5
So, none of you have any hope for the possibilities of the V-go device. An FDA approved drug delivery device that doses at a controlled rate mechanically without all the electronics. All of you can ONLY see insulin being delivered? Even though Al Mann himself was intrigued and following this product closely before he passed? Then you have no imagination. I’ve immediately pictured fertility drugs for the device because of my personal experience and watching my wife become a human pincushion for the better part of a decade. Then I go to anti nausea drugs for cancer patients who get awakened by alarms beeping from current electrical devices due to crimped hoses or low batteries or dislodged IVs. There are probably countless drugs to be loaded onto V-go but we only just started making enough to thoroughly consider the possibilities. Pleas restore my faith in the intellectual abilities of this board and come up with something……somebody? I’ve given my favorite two here. There a ton of drugs that are delivered via syringe drivers where V-Go could be substituted, a hospital pharmacist could give you a full list. You would need drugs that have a fixed delivery rate as the V-Go is controlled by the spring strength so it can only be set at manufacturing time so it cannot be varied. And that is kind of the key - its set at manufacturing time. In other words today, V-Go for insulin is 2 separate products; a 20u product; and 30u product. The delivery rates are fixed. Would each "new" product have to go through FDA review? Do these fixed rate delivery rates change by drug/patient? Would there be a benefit of the V-Go over current method? V-Go today gets refilled by the PWD daily. I think MNKD's time can be better spent than trying to dream up applications for V-Go. I am sure Mike has thought about it for two years and came to the realization its time to move on. |
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Post by prcgorman2 on May 11, 2024 11:12:38 GMT -5
I do not know but will speculate the MannKind board wants to see the Insulin Business Unit (IBU) stand on its own in terms of revenue paying for product development. If Mike has to choose between developing Afrezza versus V-Go, we know where he will put the emphasis. He’s said more than once they’re waiting to see how things turn out with the pump/switch and pediatric trials before pulling the trigger on more. Those trials require substantial resources. What MannKind has dialed up for this June’s ADA is the most substantial financial outlay they’ve done for ADA to date.
I like smart (conservative) money management. Cash is king. V-Go doesn’t have to be a success. Not everything that gets tried (e.g $10M on flying hamburger TV commercials) has to be a success. Where I came from, most R&D was considered more likely to not become productized. V-Go got past that stage, and maybe more can be done, and radgray and agedhippie are right that the possibilities exist for more to be done, but it is up to MannKind management to decide what and when. I’m good with that. It’s not like the company’s future is hanging in the balance (like it was when Mike took over with job #1 being to re-launch Afrezza).
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Post by letitride on May 11, 2024 12:24:23 GMT -5
I am pretty confident MC didnt go all in at ADA without being even more confident of trials in progress. As we saw the preliminary results of the pump switch trial were significant. The ADA may be the door opening to Afrezza long past due.
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Post by letitride on May 11, 2024 18:47:22 GMT -5
Opening comments by MC in the call (we have made tremendous progress in the field of inhaled insulin that will continue to be a growth driver for years to come). Sounds like the future of Afrezza is on the top of his mind right behind our 250% revenue increase over the past 8 qtrs and his expectations of 250 mill in revenue this year.
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Post by celo on May 14, 2024 16:49:06 GMT -5
We may not get this kind of gains every quarter. From Steve Binder answering a question: PPQ = Package Performance Qualification...had to look that one up. However, I think seasonality (historically, Tyvaso sales overall seem to lag Q4 and Q1, then upswing Q2 - see mnkd.proboards.com/post/264448/thread ) and manufacturing improvements will overcome that gap for Q2. On the RPC call Mike said the additional revenue from the PPQ testing should occur again in Q2. I believe, this with the upswing usually seen on Q2 in sales, we could easily see the same revenue/profit number again in Q2. Tyvaso Undifferentiated Revenue for 2023Q1 was 228.4 million. Tyvaso on undifferentiated revenue for 2023Q2 was 319 million Tyvaso DPI revenue for 2024Q1 was 227 million. If revenue for 2024Q2 were to increase the same quarter over quarter it would then equal 319 million. (It won't, mainly because of the growth curve of Tyvaso DPI. But it may get close) |
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