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Post by lakers on Oct 9, 2019 17:09:12 GMT -5
I did communicate with MC about CF on and off over several years. Most funding was devoted to A, leaving little left for anything else (rationing). That was a mistake. Mnkd could have multi-tasked and spread out spending over several pipeline compounds. It’s always been giving A a majority of funding another year; next year will be A year. BoD should have been more involved...
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Post by lakers on Oct 8, 2019 13:05:32 GMT -5
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Post by lakers on Oct 6, 2019 14:40:13 GMT -5
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Post by lakers on Oct 6, 2019 14:02:11 GMT -5
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Post by lakers on Oct 6, 2019 12:12:11 GMT -5
Right on cue when A, TS progress, LFD strikes again. It’s a good sign that LFD feels insecure. MannKind's Technosphere Platform Issues Are Worth Discussing $MNKD seekingalpha.com/article/4295249 |
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Post by lakers on Oct 6, 2019 5:19:58 GMT -5
MC explanation on scripts increase: ‘Yes we retrained our reps on some key areas for improving our marketing messages over past two weeks and focused them even more on priority accounts. We see when they come out of the field for vacation or training scripts slow and when they are out there they grow. Afrezza is very responsive to promotion. We have pretty much a full team now so Q4 should show you what MannKind can do with a fully focused field team executing the right message at the the right frequency.’ stocktwits.com/lungbiotech/message/179612718 |
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Post by lakers on Oct 5, 2019 15:54:08 GMT -5
Q4 could be robust as many PWDs’ co-insurances are Maxed out enabling Docs to predominantly prescribe the 4-8-12 (60 each) = 1,440 units SKU thereby saving PWDs’ out of pocket cost, and increasing rev.
Guess next week TRx could be in high 700’s or low 800’s. VDEX twitted “Fun begins”. I expect VDEX will fully take advantage of the above fact. Bill, Steve, it’s time to pedal to metal, esp, retention. Would love to see you expand in low cost, populous areas such as Texas, Florida first. Thank you for the team work!
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Post by lakers on Sept 19, 2019 1:00:57 GMT -5
One Drop, the digital health specialist that markets diabetes management tools, has found a new partner and investor in Bayer. The German pharma led One Drop’s $40 million series B round and licensed its technology for its “bio-digital efforts” in areas beyond diabetes.
New York-based One Drop offers hardware and software to help people manage their diabetes, including a Bluetooth-enabled blood glucose meter, test strips and lancets as well as a mobile app and various coaching programs. These are available individually or as part of a “gestational diabetes package” or a subscription-based “diabetes package.”
The One Drop app works with FitBit trackers and Dexcom glucose monitoring systems on iPhone and Android devices. Apple has even begun selling One Drop’s chrome-plated glucose meter alongside its iPhones and Apple Watches in some of its U.S. retail stores. These integrations, One Drop says, are why its reach is so deep. It estimates that nearly 1.5 million people in 195 countries use its technology.
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Post by lakers on Sept 12, 2019 19:50:16 GMT -5
Bill, So far no one has figured out a way to successfully commercialized Afrezza yet despite billions dollars spent on dev, sales, marketing, COGS, SG&A over more than a decade. I’ll give you that. Imagine that money is spent on multiple candidates. Al chose the hardest drug possible in a very crowded field against powerful cartel, PBM, insurance.
Now that Mnkd no longer has a deep pocket backer, It is currently trying more shots on goal by progressing the pipeline.
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Post by lakers on Sept 12, 2019 12:09:32 GMT -5
SO:
“the biggest drawback in getting institutes to buy in is the warrant overhang at $1.60 per share. Those warrants expire in late December. Once that issue is resolved, bigger doors open for institutional players.”
He agrees with me on this one. 12/27/19 is Fri. Institutional investors and/or the possible one have the following Mon and Tues to take equity stake in the same year.
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Post by lakers on Sept 10, 2019 21:48:26 GMT -5
SO said keep an eye on "CG". Unfortunately, I doubt CG stands for "Calcitonin Gene-related". Regardless, I like the summary of comments and possible partnership opportunities. To your point about "cracking the code", the emphasis on testing CGRP for migraine relief is reminiscent of Dr. Castagna's early comments on Treprostinil... There are three CGRP inhibitors currently on the market and they are all monoclonal antibodies. A quick google indicates that mabs are not absorbed well through the lungs. Also, they are given subcutaneously monthly or quarterly so inhalation would not offer much benefit. There is a new class of drugs called gepants which are small molecule drugs that block the CGRP receptor. They are being investigated for both migraine relief and prevention. The oral gepants have had problems with liver toxicity and might be good candidates for inhalation. It has to be an FDA approved compound in bucket 1. Hence, gepants don’ qualify. |
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Post by lakers on Sept 10, 2019 21:34:38 GMT -5
MC elaborated: “Take the migraine for example. I look at Novartis, Lilly and Teva all have built large chronic prevention sales forces for migraines. No one is now treating the acute episode, that’s still occurring after time. And I believe that there will be an opportunity in the migraines space where a better triptan deliver faster onset because that’s what people were going to expect that day. They’ve diminished the number of frequencies of chronic migraines, but now they can address the acute ones which are still pretty severe, a lot less frequent but if we get a better onset in that particular setting that’s an area we’re focused on sort like the triptan." "On the chemotherapy-induced nausea and vomiting one, we look at this as again we saw some pulmonary data out there in the marketplace that would highlight an inhaled version of these products. We get a fast onset. We think it needs a unique profile and there’s a lot of companies building Oncology sales forces who will just need another product in the bag. A single product sales force as we look out, we’ve made it through the worst but not an easy journey for the company and I think that’s something that we’re hearing more and more from Wall Street is they want people to have more shots on goal, and we have a pipeline fortunately moving forward now. That’s just a couple of examples of how we look at the pipeline." For CF, I’d like Vertex as a partner. Reshma Kewalramani, a physician and scientist who left Amgen to become Vertex’s chief medical officer in 2017, will succeed Leiden as CEO. cysticfibrosisnewstoday.com/2019/07/29/vertex-names-reshma-kewalramani-to-succeed-leiden-as-ceo-advance-therapies-to-90-of-cf-patients/www.marketresearch.com/product/sample-8026537.pdfShows potential partners on page 15, Appendix. MC: “In the DNase there's one that's a complex product to bring to market is a product called Pulmozyme with Roche, that still in $700, $800 million a year list on my check and that product is difficult because you have to get the API which needs to be biosimilar to original compound plus you got to make it inhaled. So, it's one of more complex ones that we don't see a lot of competitive interest in that we feel very unique just like our Tyvaso platform that we can make this one happen as well.”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/10792/4-new-pipeline-molecules?q=DNase#ixzz5zBKFv5Vd |
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Post by lakers on Sept 10, 2019 19:28:56 GMT -5
One CINV testimonial. I think Palonosetron (Aloxi, Helsinn) could be a good next application for MNKD as the sister compound Ondansetron has had increasing off label use for many kinds of nausea and vomiting conditions. For example my primary care doc recently offered it to me during a GI viral illness. I have used Ondansetron (Zofran, GSK) during a bout of prolonged vertigo and for motion sickness and it is very effective. The oral medication has a 45 minute time to effect and so an inhaled formulation and shorter action would be really nice. Also, constipation is a major side effect after use and I wonder if this might be less with a technosphere product as my guess is this side effect is driven by the serotonin receptors in the gut which might have less impact with an inhaled treatment. Both meds are serotonin 5-HT3 antagonists. Read more: mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=2#ixzz5zAgjQmbn |
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Post by lakers on Sept 10, 2019 19:16:21 GMT -5
Amgen and Novartis, Aimovig: $575 per month list price, two months of free samples, followed by a patient assistance program that provides up to a year of coverage if commercial insurance doesn't cover it. For those with commercial insurance, there's a $5 copay program that's capped at $2,700 a year. Teva, Ajovy: $575 per month list price, and a savings card that lets patients access Ajovy for free until December 2019. Lilly, Emgality: $575 per month list price, as well as starter kits in doctors' offices. Lilly also plans to have a patient access program that provides up to 12 months of Emgality for free. Wei-Li Shao, the vice president of Lilly's neuroscience business told Business Insider that the company is also in conversations with organizations responsible for paying for medications, such as pharmacy benefit managers, to strike up "value-based agreements" in which the drugmaker would get paid for a medication based on how well it reduces migraines in a particular patient. For the drugmakers, providing the drug for free serves as a way to get access to more patients at the upstart. Because the treatments are preventative and migraines are a chronic condition, the expectation is that patients will be on the medication for a long enough time to make up for it, even if the drugmakers aren't making money off of it for months after it comes on the market. "We view this strategy as testament to the recognized long-term size/value of this largely prevalent pool of patients where we expect a significant degree of 'stickiness' once patients are on treatment with a specific agent as opposed to competing on price," RBC Capital Markets analyst Kennen MacKay said in a note Friday. Analysts expect Aimovig alone to reach $1 billion in annual sales by 2022, while Wells Fargo projected Ajovy to have $818 million in sales by 2022.Read more: mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update#ixzz5zAdeldvk |
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Post by lakers on Sept 10, 2019 18:59:00 GMT -5
SO said keep an eye on "CG". Unfortunately, I doubt CG stands for "Calcitonin Gene-related". Regardless, I like the summary of comments and possible partnership opportunities. To your point about "cracking the code", the emphasis on testing CGRP for migraine relief is reminiscent of Dr. Castagna's early comments on Treprostinil... yep, once they do the initial tests it can be licensed like TrepT. Aerodynamic test, ambient temperature stability test must have been completed (good news) before progressing to tox studies - the preclinical stuff. Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. Phase I Before the human studies can begin, an IND must be submitted to the FDA containing, among other things, information on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the drug in animals. During or after Phase I is completed, a partner is sought out. IND filing could be a catalyst. |
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