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Post by sayhey24 on Mar 22, 2017 19:58:09 GMT -5
I listened to Josh Riffe the other week. I think he may have plans to make things happen a bit faster. They are expecting to bring product to market next year. Whether they use afrezza or not you would have to ask Mr. Riffe. But I really like the patent so that Mannkind can now license and get paid for both product and the "protocol". I have no knowledge of what happened to Vdex but I would not be surprised if they got briefed on the patent and the protocol would need to be licensed. This also makes sense in context of Mike's comment about selling direct if clinics are franchised using the MNKD protocol. MNKD would directly supply the franchises be it Vdex, Onduo or anyone else. "Bringing something to market," whatever that something is, doesn't change ADA guidelines, much less prescribing behavior of doctors. As we've learned, Endos are pretty conservative and reluctant to adopt change. Even though many PCP treat diabetes, the Endos are the ones that set the treatment guidelines, most PCP follow them, and insurers base payment on them. Early prandial insulin intervention isn't going to be something widespread for many years from now. I'll believe the licensing of this patent when I see it. And even if this really were a patent they could enforce against VDEX or doctors like VDEX, it would merely drive up costs they'd have to pass on to patients... and some say Afrezza is already too expensive of a treatment. Not to mention that I'm sure doctors would think pretty darn poorly of a drug company coming after them for additional revenue stream on top of the drug cost. I suspect that would be a bad business move. Though I also suspect this patent really isn't worth much when it comes to enforcing it. I do not believe Onduo is going after the Endo market. They left that to MNKD. My understanding is they are planning to work with the PCPs and T2s and compete against the Endos. This is the T2 market which Stefan Schwarz talked about two years ago. What everyone knows is the ADA guidelines do not work. If you believe in early insulin intervention then the guidelines make even less sense unless you are an Endo and its feeding your practice. There is only one thing which removes glucose from the blood and that's insulin. Now there is an insulin which is the exact same as what the pancreas secretes and works nearly as safe. No analog can do that. With the view real time sensor technology provides this near-natural insulin can now be properly exploited. This is a disruptive technology and will require a disruptive approach. Now whether Onduo is able to succeed, place your bets. One thing we do know is they are well funded and Google really wants a big win to come out of Verily. Dexcom needs a big win too as they are losing money and will soon be in a commodity market. Whats their market cap $6B? The T2 market is huge for Dexcom for the G6 and V1. I think you are missing the point of the patent. Its not for the small guy doctor. Its about companies like Onduo who are planning nationwide/worldwide clinics who would not want to get into a patent dispute. Its much easier to make the deal and pay the license fee. No one thinks twice about paying Microsoft license fees but 30 years ago many companies were not paying the license fees. They just pirated the software. It also gives MNKD an option to setup their own franchising business if their other deals don't pan out but I don't see a need for this to happen. |
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Post by dreamboatcruise on Mar 22, 2017 21:11:01 GMT -5
@seyhey... I'll be glad if Mannkind starts succeeding at what they state they are trying to do.
I know a fair amount about patents, having been on the review committee at a couple of different companies. I really don't think there is much of any practical point of this patent. There are a heck of a lot of patents that don't add up to much... this appears to be one of those to me.
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Post by peppy on Mar 22, 2017 23:08:59 GMT -5
"Every picture tells a story, don't it? " -Rod Stewart (Thank you aged. I love you.)
Like a kettle, full of water, on the back burner, My blood is being to boil. What a sack of lies we have been being feed. Look at what these people have to go through for their own good. Notice the caption. Secrets. No wonder the people on Afrezza are so happy.
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Post by sayhey24 on Mar 23, 2017 5:28:59 GMT -5
"Every picture tells a story, don't it? " -Rod Stewart (Thank you aged. I love you.)
Like a kettle, full of water, on the back burner, My blood is being to boil. What a sack of lies we have been being feed. Look at what these people have to go through for their own good. Notice the caption. Secrets. No wonder the people on Afrezza are so happy.
Yes but what about your A1c!!! I bet when you average the roller-coaster they are just as good maybe even better than being on afrezza. Come on Peppy didn't you read the 171/175 studies and label! |
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Post by peppy on Mar 23, 2017 6:41:58 GMT -5
Not sure this is the best place for sarcasm.
These individual and we all have been so lied to.
What a torture chamber subq fast acting has to be. How can subq fast acting be better than well titrated afrezza. I have watched every physician that has given their opinion regarding afrezza for years. Those lying sacks of chit. It gives Guantanamo and torture a whole new meaning.
put a another log on the fire.
We have this visual information now buried in a thread. It should be front and center on a banner. A compare/contrast banner. Subq inulin/ afrezza/ dueling continuous glucose monitors pictures.
No wonder medicine is in no hurry for continuous glucose monitors. It is like, "Who killed JFK?"
No wonder Sweedee's dad was yelling at the physician. He did feel better on Afrezza. He was yelling, because he was being sent back into subq fast acting hell.
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Post by matt on Mar 23, 2017 7:21:41 GMT -5
Seems that other companies are trying to develop more rapid insulins. Will this really prevent others from doing so? This is a method patent covering the method of administration of a rapid acting insulin at meal time, with a second possible dose to hit a target window. Essentially method patents are attempting to patent a list of instructions for how to do something useful, but they are inherently weak because the person who is giving out the instructions to the patient is a physician or nurse. It is bad for business to sue your customer and since there are thousands of care givers monitoring infringement is nearly impossible. About the only protection such a patent provides is that it prevents a competitor from training physicians on this exact protocol, but there is nothing to keep the physician from implementing the protocol with another rapid-acting insulin. I am not sure this patent passes the non-obvious test. To issue a patent the inventor must prove three things: it must be novel, it must be useful, and it must not be obvious to one skilled in the art. As the method is a means of administering insulin at mealtime depending on the glycemic load, and possibly administering more two hours later if BCG readings are too high, it is a tweak on what already happens with these patients, thus it may fail the test for obviousness. The only patents that really create value in the pharma world are "composition of matter" patents for new drugs and, occasionally for difficult to produce molecule and proteins, patents on methods of manufacturing. |
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Post by agedhippie on Mar 23, 2017 7:50:48 GMT -5
Seems that other companies are trying to develop more rapid insulins. Will this really prevent others from doing so? I am not sure this patent passes the non-obvious test. To issue a patent the inventor must prove three things: it must be novel, it must be useful, and it must not be obvious to one skilled in the art. As the method is a means of administering insulin at mealtime depending on the glycemic load, and possibly administering more two hours later if BCG readings are too high, it is a tweak on what already happens with these patients, thus it may fail the test for obviousness. That's what I thought. Diabetics are already told to test after two hours and correct (nobody does it) so I am not sure how this patent avoids prior art. Likewise tailoring dose timing to glycemic load - pumps have that built in! |
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Post by slapshot on Mar 23, 2017 8:13:16 GMT -5
I am not sure this patent passes the non-obvious test. To issue a patent the inventor must prove three things: it must be novel, it must be useful, and it must not be obvious to one skilled in the art. As the method is a means of administering insulin at mealtime depending on the glycemic load, and possibly administering more two hours later if BCG readings are too high, it is a tweak on what already happens with these patients, thus it may fail the test for obviousness. That's what I thought. Diabetics are already told to test after two hours and correct (nobody does it) so I am not sure how this patent avoids prior art. Likewise tailoring dose timing to glycemic load - pumps have that built in! Matt, you are right on with your analysis, as usual. However one small correction regarding "To issue a patent the inventor must prove three things", actually, its the opposite, all inventors need do is to make this claim and it is up to the patent office to prove them wrong. In other words, the patent office must prove that its not novel nor non-obvious nor useful. Just add this patent to the list... |
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Post by cjc04 on Mar 23, 2017 10:29:57 GMT -5
Not sure this is the best place for sarcasm.
These individual and we all have been so lied to.
What a torture chamber subq fast acting has to be. How can subq fast acting be better than well titrated afrezza. I have watched every physician that has given their opinion regarding afrezza for years. Those lying sacks of chit. It gives Guantanamo and torture a whole new meaning.
put a another log on the fire.
We have this visual information now buried in a thread. It should be front and center on a banner. A compare/contrast banner. Subq inulin/ afrezza/ dueling continuous glucose monitors pictures.
No wonder medicine is in no hurry for continuous glucose monitors. It is like, "Who killed JFK?"
No wonder Sweedee's dad was yelling at the physician. He did feel better on Afrezza. He was yelling, because he was being sent back into subq fast acting hell.
Peppy, I continue to ride a roller coaster of emotions on this proven fact.... I live with this exact situation and I'm still enraged, shocked, sad, dumbfounded, that it's not common knowledge yet..... I have been talking about my wife's experience for well over a year.... BEFORE Afrezza,,, 6.8 a1c, with dangerously low hypo's 3-5 nights per week.... AFTER Afrezza,,, 5.7 - 5.8 a1c (for over a year now) and ZERO middle of the night hypo's This is WITHOUT a cgm.... It shouldn't take a genius to figure out that if your average is a whole point higher, and you experience such extreme lows this often, then your highs MUST be very high and very often to get to 6.8, which is the roller coaster....... Therefore, at 5.7, with no severe hypo's, it's impossible to be experiencing such highs..... How does the world NOT know this by now?  ? |
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Post by mnholdem on Mar 23, 2017 11:43:01 GMT -5
How does the world not know this by now?
The Bad News: The FDA is forbidding the dissemination of certain information/ Largely because pre-approval clinical trials for Afrezza were poorly designed, the outcomes you are describing were never empirically proven by MannKind Corporation.
The Good News: New post-marketing trials can remedy this.
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Post by peppy on Mar 23, 2017 12:08:44 GMT -5
Not sure this is the best place for sarcasm.
These individual and we all have been so lied to.
What a torture chamber subq fast acting has to be. How can subq fast acting be better than well titrated afrezza. I have watched every physician that has given their opinion regarding afrezza for years. Those lying sacks of chit. It gives Guantanamo and torture a whole new meaning.
put a another log on the fire.
We have this visual information now buried in a thread. It should be front and center on a banner. A compare/contrast banner. Subq inulin/ afrezza/ dueling continuous glucose monitors pictures.
No wonder medicine is in no hurry for continuous glucose monitors. It is like, "Who killed JFK?"
No wonder Sweedee's dad was yelling at the physician. He did feel better on Afrezza. He was yelling, because he was being sent back into subq fast acting hell.
Peppy, I continue to ride a roller coaster of emotions on this proven fact.... I live with this exact situation and I'm still enraged, shocked, sad, dumbfounded, that it's not common knowledge yet..... I have been talking about my wife's experience for well over a year.... BEFORE Afrezza,,, 6.8 a1c, with dangerously low hypo's 3-5 nights per week.... AFTER Afrezza,,, 5.7 - 5.8 a1c (for over a year now) and ZERO middle of the night hypo's This is WITHOUT a cgm.... It shouldn't take a genius to figure out that if your average is a whole point higher, and you experience such extreme lows this often, then your highs MUST be very high and very often to get to 6.8, which is the roller coaster....... Therefore, at 5.7, with no severe hypo's, it's impossible to be experiencing such highs..... How does the world NOT know this by now? ? weekly TRx for the best-selling rapid acting insulins (Humalog for example) was around 86,000 per week, and Novalog was not far behind. |
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Post by cjc04 on Mar 23, 2017 12:21:14 GMT -5
How does the world not know this by now? The Bad News: The FDA is forbidding the dissemination of certain information/ Largely because pre-approval clinical trials for Afrezza were poorly designed, the outcomes you are describing were never empirically proven by MannKind Corporation. The Good News: New post-marketing trials can remedy this. And I understand that mnholdem, but we've known that for years too...... how ever the label became what it is, corruption, misunderstanding, an oops, whatever,,, in the real world the label has been proven wrong!!! That should be painfully obvious too, and yet a company with a breakthrough drug for a pandemic of a disease is left withering, while every agency and company with the power to do the right thing watches. It is honestly SO unbelievable, it makes me believe in some of these pie in the sky conspiracy theories, especially while watching my wife's success. |
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Post by agedhippie on Mar 23, 2017 13:39:32 GMT -5
How does the world not know this by now? The Bad News: The FDA is forbidding the dissemination of certain information/ Largely because pre-approval clinical trials for Afrezza were poorly designed, the outcomes you are describing were never empirically proven by MannKind Corporation. The Good News: New post-marketing trials can remedy this. And I understand that mnholdem, but we've known that for years too...... how ever the label became what it is, corruption, misunderstanding, an oops, whatever,,, in the real world the label has been proven wrong!!! That should be painfully obvious too, and yet a company with a breakthrough drug for a pandemic of a disease is left withering, while every agency and company with the power to do the right thing watches. It is honestly SO unbelievable, it makes me believe in some of these pie in the sky conspiracy theories, especially while watching my wife's success. The trouble was Mannkind coasted once Sanofi took over. They took the attitude that Sanofi can sell anything so just leave it to them. If you look at what people like Novo Nordisk, Lilly, and Sanofi are doing with their products they are continually running trials to improve the label. Mannkind did just enough, the non-inferior trial and stopped dead. You have to do that trial, but you have to then follow up with superiority, or label widening trials. Mannkind's (and Sanofi's) blunder was thinking that no needles was a sufficiently large USP to make superiority a moot point - the PBMs don't care about no needles, and already had great pricing from exclusive insulin deals which they were not about to tear up. Now someone is going to say that is Sanofi's job. No, Sanofi's job was to perform the FDA mandated trials within the timelines laid out by the FDA and they did that. The asset, Afrezza, remained Mannkind's and it was their job was to improve that asset by sponsoring more trials but instead they sat on their hands. I feel better for that rant  |
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Post by slapshot on Mar 23, 2017 14:02:43 GMT -5
And I understand that mnholdem, but we've known that for years too...... how ever the label became what it is, corruption, misunderstanding, an oops, whatever,,, in the real world the label has been proven wrong!!! That should be painfully obvious too, and yet a company with a breakthrough drug for a pandemic of a disease is left withering, while every agency and company with the power to do the right thing watches. It is honestly SO unbelievable, it makes me believe in some of these pie in the sky conspiracy theories, especially while watching my wife's success. The trouble was Mannkind coasted once Sanofi took over. They took the attitude that Sanofi can sell anything so just leave it to them. If you look at what people like Novo Nordisk, Lilly, and Sanofi are doing with their products they are continually running trials to improve the label. Mannkind did just enough, the non-inferior trial and stopped dead. You have to do that trial, but you have to then follow up with superiority, or label widening trials. Mannkind's (and Sanofi's) blunder was thinking that no needles was a sufficiently large USP to make superiority a moot point - the PBMs don't care about no needles, and already had great pricing from exclusive insulin deals which they were not about to tear up. Now someone is going to say that is Sanofi's job. No, Sanofi's job was to perform the FDA mandated trials within the timelines laid out by the FDA and they did that. The asset, Afrezza, remained Mannkind's and it was their job was to improve that asset by sponsoring more trials but instead they sat on their hands. I feel better for that rant Nice rant, but where are all the threads where you and the other knowledgeable investors demanded Mannkind perform such superiority or label widening trials? |
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Post by peppy on Mar 23, 2017 14:56:23 GMT -5
Peppy, I continue to ride a roller coaster of emotions on this proven fact.... I live with this exact situation and I'm still enraged, shocked, sad, dumbfounded, that it's not common knowledge yet..... I have been talking about my wife's experience for well over a year.... BEFORE Afrezza,,, 6.8 a1c, with dangerously low hypo's 3-5 nights per week.... AFTER Afrezza,,, 5.7 - 5.8 a1c (for over a year now) and ZERO middle of the night hypo's This is WITHOUT a cgm.... It shouldn't take a genius to figure out that if your average is a whole point higher, and you experience such extreme lows this often, then your highs MUST be very high and very often to get to 6.8, which is the roller coaster....... Therefore, at 5.7, with no severe hypo's, it's impossible to be experiencing such highs..... How does the world NOT know this by now? ? weekly TRx for the best-selling rapid acting insulins (Humalog for example) was around 86,000 per week, and Novalog was not far behind. No ACA replacement vote tonight. Politics does effect insurance coverage/rates. 70% of afrezza coverage for preauthorized prescriptions. Time to get people to know this. 86,000 plus @ 80,000 "best-selling rapid acting insulins (Humalog for example) was around 86,000 per week, and Novalog was not far behind." 166,000 Humalog and Novalog TRx a week. Many of these too old, (nursing home) to change. let's go with half. 80,000 possible Trx up for grabs, if we can get the word out and get endo's to prescribe and learn the titration as well as they know the subq chit, I mean rapid acting. *per Matt's #. What can we do? All I can think of as effective is to let people see. The pictures of quality of life are seen on the continuous glucose monitors. AND patient testimonials, "I do not worry every night this person will die in their sleep" All we have is the internet, our votes and quality of life. A bit like the health care vote. Get less, pay more, the way I see it. Good luck to us. We are going to need it. (Can you tell I am still shell shocked.) Mods, I realize this thread went way off topic, thank you for allowing this exchange on a thread that went off topic.
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