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Post by peppy on Jan 7, 2019 13:36:39 GMT -5
Yes MN as I recall this was a substitute for addictive pain killers. Actually in my opinion the killer app and biggest TS opportunity if as good as previously discussed. Drug was supposed to be non addictive and also very hard to overdose with. A perfect “fix” for the current epidemic. MannKind nicotine inhaler now more than ever, with new teen e-cig addition crisis. FDA is desperate for the help. Need teen specific smoking cessation products. FDA's Scott Gottlieb is at a standoff with Phillips Morris and JUUL. Smoking cessation is totally underrated and over looked. Huge market with poor-to subpar current therapies as competition. Exciting times The FDA regulates cigarettes. I was watching a youtube video. The film was of the Star Spangled Banner words. The subliminal was shown to be, "Trust your Government." FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htmFines are collected for infractions. |
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Post by mango on Jan 7, 2019 13:48:32 GMT -5
MannKind nicotine inhaler now more than ever, with new teen e-cig addition crisis. FDA is desperate for the help. Need teen specific smoking cessation products. FDA's Scott Gottlieb is at a standoff with Phillips Morris and JUUL. Smoking cessation is totally underrated and over looked. Huge market with poor-to subpar current therapies as competition. Exciting times The FDA regulates cigarettes. I was watching a youtube video. The film was of the Star Spangled Banner words. The subliminal was shown to be, "Trust your Government." FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htmFines are collected for infractions. There's too many hands in this, you know the drill. However, I can tell based on Scott Gottlieb's words and actions that he is doing "what he can". And don't forget about the payout. Tobacco Master Settlement Agreement. My state was the first in 1994. Their still paying everyone, think this is year 25. |
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Post by peppy on Jan 7, 2019 13:57:29 GMT -5
There's too many hands in this, you know the drill. However, I can tell based on Scott Gottlieb's words and actions that he is doing "what he can". And don't forget about the payout. Tobacco Master Settlement Agreement. My state was the first in 1994. Their still paying everyone, think this is year 25. Mango, I am old, you are young. I remember all the big tobacco executives in front of congress. Turns out, people will lie for money. IN 1994, THE CEOS FROM 7 MAJOR TOBACCO COMPANIES TESTIFIED BEFORE CONGRESS, UNDER OATH, THAT THEY BELIEVED NICOTINE WAS NOT ADDICTIVE. www.thetruth.com/the-facts/fact-235The price of twenty cigarettes was 3 dollars in the 1990's. The price is 9 dollars now. it is a money making machine, because it is addictive. The FDA regulates it. I believe the FDA likes it that way. About the Bureau of Alcohol, Tobacco, Firearms and Explosives. The bureau enforces? |
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Post by #NoMoreNeedles on Jan 7, 2019 14:06:49 GMT -5
The future lies in having a robust pipeline. Should Afrezza take off, great, if not, there is still a future to be excited about.
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Post by mango on Jan 7, 2019 14:20:28 GMT -5
There's too many hands in this, you know the drill. However, I can tell based on Scott Gottlieb's words and actions that he is doing "what he can". And don't forget about the payout. Tobacco Master Settlement Agreement. My state was the first in 1994. Their still paying everyone, think this is year 25. Mango, I am old, you are young. I remember all the big tobacco executives in front of congress. Turns out, people will lie for money. IN 1994, THE CEOS FROM 7 MAJOR TOBACCO COMPANIES TESTIFIED BEFORE CONGRESS, UNDER OATH, THAT THEY BELIEVED NICOTINE WAS NOT ADDICTIVE. www.thetruth.com/the-facts/fact-235The price of twenty cigarettes was 3 dollars in the 1990's. The price is 9 dollars now. it is a money making machine, because it is addictive. The FDA regulates it. I believe the FDA likes it that way. About the Bureau of Alcohol, Tobacco, Firearms and Explosives. The bureau enforces? Have you ever had an addiction peppy? I have, and cigarettes was one. I've gone 3 days now without a cigarette I smoked for ~11-12 years. It's the hardest addiction to beat, and I've had to beat a lot of em. People with tobacco addiction can't be forgotten. They need a real solution and there's currently nothing out there that can get the job done. We can't just replace combustibles with vaporizers, that's just switching up the addiction. These JUULS and similar ecigs use pods that contain a high amount of nicotine, I usually notice 5 or 6 percent on the box. So now teens everywhere are using them because they are discreet and don't smell etc, but now they're addicted. Addiction is what keeps Big Tobacco in business. As long as a cessation product that's reliable, safe and effective doesn't come out then Big Tobacco will keep winning. |
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Post by peppy on Jan 7, 2019 15:09:36 GMT -5
Mango, I am old, you are young. I remember all the big tobacco executives in front of congress. Turns out, people will lie for money. IN 1994, THE CEOS FROM 7 MAJOR TOBACCO COMPANIES TESTIFIED BEFORE CONGRESS, UNDER OATH, THAT THEY BELIEVED NICOTINE WAS NOT ADDICTIVE. www.thetruth.com/the-facts/fact-235The price of twenty cigarettes was 3 dollars in the 1990's. The price is 9 dollars now. it is a money making machine, because it is addictive. The FDA regulates it. I believe the FDA likes it that way. About the Bureau of Alcohol, Tobacco, Firearms and Explosives. The bureau enforces? Have you ever had an addiction peppy? I have, and cigarettes was one. I've gone 3 days now without a cigarette I smoked for ~11-12 years. It's the hardest addiction to beat, and I've had to beat a lot of em. People with tobacco addiction can't be forgotten. They need a real solution and there's currently nothing out there that can get the job done. We can't just replace combustibles with vaporizers, that's just switching up the addiction. These JUULS and similar ecigs use pods that contain a high amount of nicotine, I usually notice 5 or 6 percent on the box. So now teens everywhere are using them because they are discreet and don't smell etc, but now they're addicted. Addiction is what keeps Big Tobacco in business. As long as a cessation product that's reliable, safe and effective doesn't come out then Big Tobacco will keep winning. agreed Mango. Just not sure the FDA is working for the people. * I wasn't always like this. I have started to look at things differently since afrezza. We can see with our eyeballs the insulin works very well. It is not being prescribed. There is something rotten in Denmark. And, away she goes. |
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Post by porkini on Jan 7, 2019 15:19:33 GMT -5
Mango, I am old, you are young. I remember all the big tobacco executives in front of congress. Turns out, people will lie for money. IN 1994, THE CEOS FROM 7 MAJOR TOBACCO COMPANIES TESTIFIED BEFORE CONGRESS, UNDER OATH, THAT THEY BELIEVED NICOTINE WAS NOT ADDICTIVE. www.thetruth.com/the-facts/fact-235The price of twenty cigarettes was 3 dollars in the 1990's. The price is 9 dollars now. it is a money making machine, because it is addictive. The FDA regulates it. I believe the FDA likes it that way. About the Bureau of Alcohol, Tobacco, Firearms and Explosives. The bureau enforces? People with tobacco addiction can't be forgotten. They need a real solution and there's currently nothing out there that can get the job done. We can't just replace combustibles with vaporizers, that's just switching up the addiction. These JUULS and similar ecigs use pods that contain a high amount of nicotine, I usually notice 5 or 6 percent on the box. So now teens everywhere are using them because they are discreet and don't smell etc, but now they're addicted. Addiction is what keeps Big Tobacco in business. As long as a cessation product that's reliable, safe and effective doesn't come out then Big Tobacco will keep winning. Good luck to you, it is a difficult one. After many unsuccessful attempts, I finally was able to do it and have been rid of them for ~25 years now. Don't start is the best. Feel free to message me mango if you wish. |
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Post by lakers on Jan 8, 2019 3:28:16 GMT -5
See the official slide on buckets. mnkd.proboards.com/thread/9037/mannkind-formulations-bucketsTop bucket is known compounds already delivered to the lung, not a lot of work and we have been at FDA to pass on this one, know exactly what’s required, very simple development program, very high predictability of success. Undisclosed: likely bucket-1 Inhaled DNase (deoxyribonuclease) for cystic fibrosis Tobra-T (replaces TOBI pod haler) is for CF. Both are parts of SoC. med.stanford.edu/cfcenter/education/english/Meds-Nebs.html Inhaled Medications and Nebulizers SoC: The Cystic Fibrosis Foundation and the Stanford CF Center staff recommend the following sequence for inhaled medications: Bronchodilators (Albuterol, Combivent, Xopenex) to open the airways Hypertonic Saline (7%) to mobilize mucus and improve airway clearance Pulmozyme (DNase) to thin mucus*Airway Clearance Technique: Vest, Flutter, Chest PT, IPV, etc. Antibiotics (TOBI, Colistin, Cayston). The previous therapies open and clear the airways of mucus, allowing these antibiotics to work on remaining bacteria. Steroids (Flovent, Pulmicort, QVAR) * When using the Vest for airway clearance, make sure there is aerosol delivery during the entire vest session. If you start coughing blood, temporarily stop Pulmozine, saline, airway clearance technique, and inhaled antibiotics. Call your CF doctor or nurse for further advice. With a respiratory illness or change in symptoms: Begin or increase airway clearance techniques. Use breathing treatments as ordered; you can use bronchodilators every three to four hours, and often additional Vest and/or hypertonic saline treatments are useful. Contact your CF doctor or nurse to see if antibiotics or additional intervention is needed. Read more: mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=6#ixzz5c0FcqSXDwww.marketresearch.com/product/sample-8026537.pdfShows potential partners on page 15, Appendix. Bucket two, known compounds non-lung delivery, acute use, those aren’t going to have as much work to be done because you’re acute in nature, not a lot of chronic administration and tox studies. Palonosetron for CINV, Rizatriptan (Merk), or Sumatriptan (GSK) for Migraine will likely round out the four compounds moving forward. As per the latest research citings of National Cancer Institute, in 2016 there were approximately 15.5 million cancer survivors due to early intervention of chemotherapy. Business analysts predict the rise in survivors to 20.3 million by 2030. The etiology of CINV is not very well understood, however the involvement of the chemo trigger zone and gastrointestinal mucosa have been reported in multiple studies. Chemotherapy induced nausea and vomiting are classified as acute, refractory and delayed. The intensity of CINV depends on the use of drugs in chemotherapy and patient factors. The challenges associated with the antiemetic prescribed for CINV are nonadherence and lack of effective guidelines for CINV treatment. Newer antiemetic drugs such as palonosetron and aprepitant have shown good pharmacokinetic properties in adult cancer patients, still more clinical trials are required for its safety in children. The major players steering the chemotherapy induced nausea and vomiting treatment market are Baxter Pharmaceuticals, Eisai, Inc., Helsinn Healthcare, GlaxoSmithkline, Plc, Merck & Co., Inc., ProStrakan, Inc., Pfizer, Inc., Sanofi-Aventis, Solvay Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. www.tampabayreview.com/news/business/chemotherapy-induced-nausea-vomiting-treatment-market-expected-reach-us-3626-1-mn-2026/38010/Potentially, Merk can partner with Mnkd for Inhaled Palonosetron and Rizatriptan. Alternatively, GSK could partner with Mnkd for Inhaled Palonosetron, Sumatriptan, and Tobra-T. It has preclinical GSK-2225745 for CF. This would be similar to multi-molecule deal with UTHR. Read more: mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=6#ixzz5c0IKqEJL |
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Post by Clement on Jan 8, 2019 10:20:27 GMT -5
• Sumatriptan (Think Mike said "a triptan", just putting that up since it has been on their Bucket 2 slide before) • 5-HT3 Inhibitor (Think Mike said "a 5-HT3 inhibitor") • Tobramycin • Undisclosed In another thread, Sports posted the JPM video "Mannkind expanding into the cannabinoid space". In the video, MC talks about the "Undisclosed" in Mango's list above. MC said it's "consumer driven". So is Peppy right? Tada! (tadalafil) Any other ideas about possible "consumer driven" undisclosed molecule? |
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Post by mango on Jan 8, 2019 10:49:53 GMT -5
See the official slide on buckets. mnkd.proboards.com/thread/9037/mannkind-formulations-bucketsTop bucket is known compounds already delivered to the lung, not a lot of work and we have been at FDA to pass on this one, know exactly what’s required, very simple development program, very high predictability of success. Undisclosed: likely bucket-1 Inhaled DNase (deoxyribonuclease) for cystic fibrosis Tobra-T (replaces TOBI pod haler) is for CF. Both are parts of SoC. med.stanford.edu/cfcenter/education/english/Meds-Nebs.html Inhaled Medications and Nebulizers SoC: The Cystic Fibrosis Foundation and the Stanford CF Center staff recommend the following sequence for inhaled medications: Bronchodilators (Albuterol, Combivent, Xopenex) to open the airways Hypertonic Saline (7%) to mobilize mucus and improve airway clearance Pulmozyme (DNase) to thin mucus*Airway Clearance Technique: Vest, Flutter, Chest PT, IPV, etc. Antibiotics (TOBI, Colistin, Cayston). The previous therapies open and clear the airways of mucus, allowing these antibiotics to work on remaining bacteria. Steroids (Flovent, Pulmicort, QVAR) * When using the Vest for airway clearance, make sure there is aerosol delivery during the entire vest session. If you start coughing blood, temporarily stop Pulmozine, saline, airway clearance technique, and inhaled antibiotics. Call your CF doctor or nurse for further advice. With a respiratory illness or change in symptoms: Begin or increase airway clearance techniques. Use breathing treatments as ordered; you can use bronchodilators every three to four hours, and often additional Vest and/or hypertonic saline treatments are useful. Contact your CF doctor or nurse to see if antibiotics or additional intervention is needed. Read more: mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=6#ixzz5c0FcqSXDwww.marketresearch.com/product/sample-8026537.pdfShows potential partners on page 15, Appendix. Bucket two, known compounds non-lung delivery, acute use, those aren’t going to have as much work to be done because you’re acute in nature, not a lot of chronic administration and tox studies. Palonosetron for CINV, Rizatriptan (Merk), or Sumatriptan (GSK) for Migraine will likely round out the four compounds moving forward. As per the latest research citings of National Cancer Institute, in 2016 there were approximately 15.5 million cancer survivors due to early intervention of chemotherapy. Business analysts predict the rise in survivors to 20.3 million by 2030. The etiology of CINV is not very well understood, however the involvement of the chemo trigger zone and gastrointestinal mucosa have been reported in multiple studies. Chemotherapy induced nausea and vomiting are classified as acute, refractory and delayed. The intensity of CINV depends on the use of drugs in chemotherapy and patient factors. The challenges associated with the antiemetic prescribed for CINV are nonadherence and lack of effective guidelines for CINV treatment. Newer antiemetic drugs such as palonosetron and aprepitant have shown good pharmacokinetic properties in adult cancer patients, still more clinical trials are required for its safety in children. The major players steering the chemotherapy induced nausea and vomiting treatment market are Baxter Pharmaceuticals, Eisai, Inc., Helsinn Healthcare, GlaxoSmithkline, Plc, Merck & Co., Inc., ProStrakan, Inc., Pfizer, Inc., Sanofi-Aventis, Solvay Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. www.tampabayreview.com/news/business/chemotherapy-induced-nausea-vomiting-treatment-market-expected-reach-us-3626-1-mn-2026/38010/Potentially, Merk can partner with Mnkd for Inhaled Palonosetron and Rizatriptan. Alternatively, GSK could partner with Mnkd for Inhaled Palonosetron, Sumatriptan, and Tobra-T. It has preclinical GSK-2225745 for CF. This would be similar to multi-molecule deal with UTHR. Read more: mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=6#ixzz5c0IKqEJLIn the old MannKind slide that has the long list of pipeline candidates, they have Palonosetron + 5-HT3 inhibitor Will they still do this combo or will they now be separate? |
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Post by peppy on Jan 8, 2019 17:26:03 GMT -5
This does not meet the criteria of customer driven. however, FDPK can deliver monoclonal antibodies.  |
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Post by lennymnkd on Jan 8, 2019 17:31:06 GMT -5
Peppy / this is sort of thing I always wondered about ... but didn’t want to get ahead of it all ... 👍
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Post by mango on Jan 8, 2019 17:56:58 GMT -5
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Post by lakers on Jan 8, 2019 18:01:50 GMT -5
Undisclosed molecule is not Cialis tadalafil or sildenafil. UTHR pipeline 17 is Inhaled DPI PDE5 for PAH, trademarked as Winilin. Cialis (tadalafil) and Viagra (sildenafil) are phosphodiesterase-5 (PDE5) inhibitors used for treating impotence (erectile dysfunction, or ED). ... Cialis provides penile hardness (the ability to obtain an erection) over a longer period than Viagra because it lasts up to 18 hours, while Viagra only lasts for about 4 to 6. www.unither.com/pipeline.htmlWhat is DPI in medical terms? A dry-powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema and COPD although DPIs (such as inhalable insulin Afrezza) have also been used in the treatment of diabetes mellitus. en.m.wikipedia.org/wiki/Dry-powder_inhalerDPIs are an alternative to the aerosol-based inhalers commonly called metered-dose inhaler (or MDI). [Another free ads for Afrezza by Wikipedia.] |
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Post by peppy on Jan 8, 2019 18:20:50 GMT -5
Undisclosed molecule is not Cialis tadalafil or sildenafil. UTHR pipeline 17 is Inhaled DPI PDE5 for PAH, trademarked as Winilin. Cialis (tadalafil) and Viagra (sildenafil) are phosphodiesterase-5 (PDE5) inhibitors used for treating impotence (erectile dysfunction, or ED). ... Cialis provides penile hardness (the ability to obtain an erection) over a longer period than Viagra because it lasts up to 18 hours, while Viagra only lasts for about 4 to 6. www.unither.com/pipeline.htmlWhat is DPI in medical terms? A dry-powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema and COPD although DPIs (such as inhalable insulin Afrezza) have also been used in the treatment of diabetes mellitus. en.m.wikipedia.org/wiki/Dry-powder_inhalerDPIs are an alternative to the aerosol-based inhalers commonly called metered-dose inhaler (or MDI). [Another free ads for Afrezza by Wikipedia.] Lakers;   |
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