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Post by celo on Feb 16, 2023 13:05:00 GMT -5
Clofazimine, hmm.
As an oral medication people don't keep taking it because it causes terrible side effects. Can't lower the dosage to a point where it is still effective and side effects are low enough that people stay on it. Medicine has to be digested and enter blood stream.
Inhale clofazimine. Can have dosage very low because it goes directly into blood stream through lungs. Side effects are now minimal. Effects only area where needed. It is now more effective, lower dosage, less side effects and people that use it will be on it longer.
There could be many drugs out there that this could be the case. Tip of the iceberg! I like this drug but hate the side effects when taken as a pill form. Well here is a safe, effective way to have a medication enter your blood stream at a much much lower dosage with a lot less side effects.......
Oh my!
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Post by sayhey24 on Feb 16, 2023 14:06:15 GMT -5
Yes NN makes both. They also make Ozempic and Wegovy. At the same time the Big 3 CGM vendors are expecting CMS approval for Medicare approval by July for basal only usage which they hope will open up the T2 market. Robert Ford has done numerous interviews on this. Up until now the antiglycemics have never been exposed for post prandial control but if CMS approves they will. Might it make sense for NN to be MNKD's partner Mike referred to? It does make sense since Mounjaro is taking Ozempic market share and if they want to sell afrezza as an add on to Ozempic they could do a large scale study and show Ozempic and afrezza beat Mounjaro A1c and are pretty close on weight loss. Adding afrezza to Tresiba or icodec is a no-brainer and no matter what Aged says few like wearing a pump and if Tresiba/afrezza get them close (75% TIR instead of 76%) and no concerns the pump goes bad while they sleep and better post prandial control. IDK I think its a winner. It makes sense for NN to go after the T1s first and then figure out the T2 plan. This is 180degress different than Sanofi's plan was. I think this could be a winner. Its pretty exciting what Novo's are up to. the trial for Idcodec "onwards 6" involved Icodec + injectable RAA. I don't have the exact specifics but patients were found to be at higher risk of experiencing lows which gave Novo some negative press when they released the results. Now im no doctor but i wonder if the lows were a result of "stacking" due to the long duration of the RAA, if however they used afrezza for the meal time control my assumption would be that the likelihood of lows would be greatly reduced because of the "fast out" nature of afrezza. Novo are now bigger that LLY in mkt cap. culture wise i see MNKD working better with NOVOB than LLY. IMO So you raise a good point - additional severe hypos which are nearly doubled. That IMO is a show stopper. In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. From Mike's comments he said MNKD is very excited about the use of afrezza with icodec. Did MNKD just do a pilot on their own or did they work with NVO on this? I would think doubling severe hypo's makes this a non-starter for most endo's and even more so for GPs. What the primary target is for icodec I am not sure. I can see a real benefit for the T2s who are going to put on a basal. However, adding the prandial points us more toward the T1s. As Aged said, would NVO consider having afrezza compete against Novolog and Fiasp? I guess I could argue Fiasp has not lived up to the expectations NVO had for it. Would NVO be OK with afrezza taking some of the Novolog business? They were with Fiasp. UTHR was ok with Tyvaso DPI. I guess if they see afrezza more than the "niche" drug and has the potential many of us believe maybe they would be more than OK. One thing for sure is Mike said MNKD has a partner for the Big pump study and if the partner if NVO, that would be a really big deal. We do know Tresiba was the basal used during the ABC Pilot. We also know Mike said some info would be released at ATTD 2023 which is 22-25 February 2023. Will they announce the partner for the "BIG" study then, maybe. Peppy - what do you think. Would a NVO partnership pop the stock over $6 or more? |
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Post by peppy on Feb 16, 2023 14:23:03 GMT -5
Its pretty exciting what Novo's are up to. the trial for Idcodec "onwards 6" involved Icodec + injectable RAA. I don't have the exact specifics but patients were found to be at higher risk of experiencing lows which gave Novo some negative press when they released the results. Now im no doctor but i wonder if the lows were a result of "stacking" due to the long duration of the RAA, if however they used afrezza for the meal time control my assumption would be that the likelihood of lows would be greatly reduced because of the "fast out" nature of afrezza. Novo are now bigger that LLY in mkt cap. culture wise i see MNKD working better with NOVOB than LLY. IMO So you raise a good point - additional severe hypos which are nearly doubled. That IMO is a show stopper. In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. From Mike's comments he said MNKD is very excited about the use of afrezza with icodec. Did MNKD just do a pilot on their own or did they work with NVO on this? I would think doubling severe hypo's makes this a non-starter for most endo's and even more so for GPs. What the primary target is for icodec I am not sure. I can see a real benefit for the T2s who are going to put on a basal. However, adding the prandial points us more toward the T1s. As Aged said, would NVO consider having afrezza compete against Novolog and Fiasp? I guess I could argue Fiasp has not lived up to the expectations NVO had for it. Would NVO be OK with afrezza taking some of the Novolog business? They were with Fiasp. UTHR was ok with Tyvaso DPI. I guess if they see afrezza more than the "niche" drug and has the potential many of us believe maybe they would be more than OK. One thing for sure is Mike said MNKD has a partner for the Big pump study and if the partner if NVO, that would be a really big deal. We do know Tresiba was the basal used during the ABC Pilot. We also know Mike said some info would be released at ATTD 2023 which is 22-25 February 2023. Will they announce the partner for the "BIG" study then, maybe. Peppy - what do you think. Would a NVO partnership pop the stock over $6 or more? haha. you know it would. |
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Post by lennymnkd on Feb 16, 2023 14:49:03 GMT -5
So you raise a good point - additional severe hypos which are nearly doubled. That IMO is a show stopper. In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. From Mike's comments he said MNKD is very excited about the use of afrezza with icodec. Did MNKD just do a pilot on their own or did they work with NVO on this? I would think doubling severe hypo's makes this a non-starter for most endo's and even more so for GPs. What the primary target is for icodec I am not sure. I can see a real benefit for the T2s who are going to put on a basal. However, adding the prandial points us more toward the T1s. As Aged said, would NVO consider having afrezza compete against Novolog and Fiasp? I guess I could argue Fiasp has not lived up to the expectations NVO had for it. Would NVO be OK with afrezza taking some of the Novolog business? They were with Fiasp. UTHR was ok with Tyvaso DPI. I guess if they see afrezza more than the "niche" drug and has the potential many of us believe maybe they would be more than OK. One thing for sure is Mike said MNKD has a partner for the Big pump study and if the partner if NVO, that would be a really big deal. We do know Tresiba was the basal used during the ABC Pilot. We also know Mike said some info would be released at ATTD 2023 which is 22-25 February 2023. Will they announce the partner for the "BIG" study then, maybe. Peppy - what do you think. Would a NVO partnership pop the stock over $6 or more? haha. you know it would. Novo AllE 1 Bagsvaerd 2880 Denmark 45 44 44 88 88 https://www.novonordisk.comSector(s): Healthcare Industry: Biotechnology Full Time Employees: 54,393. 54 thousand employees… how do they control all those people 😀👍 |
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Post by agedhippie on Feb 16, 2023 15:28:58 GMT -5
So you raise a good point - additional severe hypos which are nearly doubled. That IMO is a show stopper. In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. From Mike's comments he said MNKD is very excited about the use of afrezza with icodec. Did MNKD just do a pilot on their own or did they work with NVO on this? I would think doubling severe hypo's makes this a non-starter for most endo's and even more so for GPs. What the primary target is for icodec I am not sure. I can see a real benefit for the T2s who are going to put on a basal. However, adding the prandial points us more toward the T1s. As Aged said, would NVO consider having afrezza compete against Novolog and Fiasp? I guess I could argue Fiasp has not lived up to the expectations NVO had for it. Would NVO be OK with afrezza taking some of the Novolog business? They were with Fiasp. UTHR was ok with Tyvaso DPI. I guess if they see afrezza more than the "niche" drug and has the potential many of us believe maybe they would be more than OK. One thing for sure is Mike said MNKD has a partner for the Big pump study ... I wouldn't get excited about the hypoglycemia numbers. This is a good example of why it's important read the report and not just the PR. The variance in the hypoglycemia numbers happened because the first dose for the half the Icodec arm was doubled with a big spike in the first two weeks. In the other half where the first dose wasn't doubled Icodec has significantly lower than Tresiba. Right now I don't believe the label is set so my expectation is that the label will not advocate doubling that first dose. This is a mechanical problem with how basal works and endos know how to fix that. Novo Nordisk doesn't care if you buy Fiasp or Novolog, the price is the same. They just care that you buy one of them, they don't want you buying something else. My suspicion is that the partner is a high profile clinic. |
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Post by cretin11 on Feb 16, 2023 15:59:02 GMT -5
Its pretty exciting what Novo's are up to. the trial for Idcodec "onwards 6" involved Icodec + injectable RAA. I don't have the exact specifics but patients were found to be at higher risk of experiencing lows which gave Novo some negative press when they released the results. Now im no doctor but i wonder if the lows were a result of "stacking" due to the long duration of the RAA, if however they used afrezza for the meal time control my assumption would be that the likelihood of lows would be greatly reduced because of the "fast out" nature of afrezza. Novo are now bigger that LLY in mkt cap. culture wise i see MNKD working better with NOVOB than LLY. IMO One thing for sure is Mike said MNKD has a partner for the Big pump study and if the partner if NVO, that would be a really big deal. We do know Tresiba was the basal used during the ABC Pilot. We also know Mike said some info would be released at ATTD 2023 which is 22-25 February 2023. Will they announce the partner for the "BIG" study then, maybe. Peppy - what do you think. Would a NVO partnership pop the stock over $6 or more? Exciting notion. Make it happen, Mike! |
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Post by hellodolly on Feb 16, 2023 16:06:05 GMT -5
So you raise a good point - additional severe hypos which are nearly doubled. That IMO is a show stopper. In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. From Mike's comments he said MNKD is very excited about the use of afrezza with icodec. Did MNKD just do a pilot on their own or did they work with NVO on this? I would think doubling severe hypo's makes this a non-starter for most endo's and even more so for GPs. What the primary target is for icodec I am not sure. I can see a real benefit for the T2s who are going to put on a basal. However, adding the prandial points us more toward the T1s. As Aged said, would NVO consider having afrezza compete against Novolog and Fiasp? I guess I could argue Fiasp has not lived up to the expectations NVO had for it. Would NVO be OK with afrezza taking some of the Novolog business? They were with Fiasp. UTHR was ok with Tyvaso DPI. I guess if they see afrezza more than the "niche" drug and has the potential many of us believe maybe they would be more than OK. One thing for sure is Mike said MNKD has a partner for the Big pump study ... I wouldn't get excited about the hypoglycemia numbers. This is a good example of why it's important read the report and not just the PR. The variance in the hypoglycemia numbers happened because the first dose for the half the Icodec arm was doubled with a big spike in the first two weeks. In the other half where the first dose wasn't doubled Icodec has significantly lower than Tresiba. Right now I don't believe the label is set so my expectation is that the label will not advocate doubling that first dose. This is a mechanical problem with how basal works and endos know how to fix that. Novo Nordisk doesn't care if you buy Fiasp or Novolog, the price is the same. They just care that you buy one of them, they don't want you buying something else. My suspicion is that the partner is a high profile clinic. Mayo, Cleveland, Joslin, Grady and V-Dex. That's about it for high profile clinics. |
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Post by Clement on Feb 16, 2023 16:15:39 GMT -5
..... One thing for sure is Mike said MNKD has a partner for the Big pump study ... My suspicion is that the partner is a high profile clinic. I'm trying to imagine what a high profile clinic would give and what they would get as a partner with MNKD on a large study. How does this work? |
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Post by lennymnkd on Feb 16, 2023 16:19:45 GMT -5
Isn’t joslin juvenile diabetes… would they be likely to start there ?
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Post by Clement on Feb 16, 2023 16:30:15 GMT -5
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Post by longliner on Feb 16, 2023 16:38:05 GMT -5
I may have missed it, but I didn't hear Mike say NEW partner, Occam's Razor would have me believe Cipla is the partner due to the existing partnership.
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Post by sayhey24 on Feb 16, 2023 18:03:08 GMT -5
So you raise a good point - additional severe hypos which are nearly doubled. That IMO is a show stopper. In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. From Mike's comments he said MNKD is very excited about the use of afrezza with icodec. Did MNKD just do a pilot on their own or did they work with NVO on this? I would think doubling severe hypo's makes this a non-starter for most endo's and even more so for GPs. What the primary target is for icodec I am not sure. I can see a real benefit for the T2s who are going to put on a basal. However, adding the prandial points us more toward the T1s. As Aged said, would NVO consider having afrezza compete against Novolog and Fiasp? I guess I could argue Fiasp has not lived up to the expectations NVO had for it. Would NVO be OK with afrezza taking some of the Novolog business? They were with Fiasp. UTHR was ok with Tyvaso DPI. I guess if they see afrezza more than the "niche" drug and has the potential many of us believe maybe they would be more than OK. One thing for sure is Mike said MNKD has a partner for the Big pump study ... I wouldn't get excited about the hypoglycemia numbers. This is a good example of why it's important read the report and not just the PR. The variance in the hypoglycemia numbers happened because the first dose for the half the Icodec arm was doubled with a big spike in the first two weeks. In the other half where the first dose wasn't doubled Icodec has significantly lower than Tresiba. Right now I don't believe the label is set so my expectation is that the label will not advocate doubling that first dose. This is a mechanical problem with how basal works and endos know how to fix that. Novo Nordisk doesn't care if you buy Fiasp or Novolog, the price is the same. They just care that you buy one of them, they don't want you buying something else. My suspicion is that the partner is a high profile clinic. You are correct. I did not read the report only the PR released by NVO. It seems odd they would shoot themselves in the foot. To me partner means someone bringing some money. If its a clinic I would not call them a partner. Hopefully Mike is thinking like me but I hope we will find out next week. I see he is holding the shareholder call on 2/23. I was thinking he would be at ATTD. Maybe we get some more clarity on 2/22. I will light some candles and hope for NVO and not a clinic who will be expecting a payday from MNKD. |
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Post by sayhey24 on Feb 16, 2023 19:15:12 GMT -5
One must remember that as part of the price they paid for buying V-go they got all of the inventory of insulin and the device. When this inventory is gone then MannKind must start paying the cost of creating the devices that are made in Asia. When this happens it will be interesting what the COG reveals. They got insulin? What insulin? I was not aware. When you get a V-Go prescription it doesn't come with insulin. Thats a separate prescription. The 8k didn't mention insulin investors.mannkindcorp.com/sec-filings/sec-filing/8-k/0001193125-22-157444the Company has agreed to purchase from the Sellers certain assets used primarily in the business of developing, producing, marketing and selling V-Go®, a once-daily, wearable, insulin delivery device (the “Asset Purchase”). In consideration for the purchased assets, the Company will pay the Sellers $10.0 million plus the book value of certain product inventory for finished goods (not to exceed $7.0 million) and will assume certain liabilities from and after the closing date. In addition, the Company will be obligated to make one-time, sales-based milestone payments to the Sellers totaling up to a maximum of $10.0 million upon the achievement of specified annual revenue milestones between $40 and $100 million. |
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Post by agedhippie on Feb 17, 2023 9:19:24 GMT -5
Isn’t joslin juvenile diabetes… would they be likely to start there ? That would be the jackpot. I don't think it would be them as they tend more towards pure research. Although they do have to support clinical trials so it's not impossible. |
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Post by agedhippie on Feb 17, 2023 9:22:45 GMT -5
UCLA would be a good choice. It has a good profile and I seem to remember they have worked together in the past (but I might be imagining that). |
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