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Post by seanismorris on Jul 18, 2017 21:49:59 GMT -5
According to MannKind's Pipeline chart, Afrezza for Pediatric use is in Phase 2.
Maybe they should inform the FDA a trial has begun ; )
---- I've been reading about the other drugs in the pipeline, and I'm not very excited.
I have fond memory's of Al talking about the potential of TS pain... but with where we are today, 100% of MannKind's effort needs to be on Afrezza.
The exception is if someone else wants to pay for the R&D.
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Post by mnholdem on Jul 18, 2017 21:59:46 GMT -5
The FDA requires reporting within 21 days of the first patient enrollment, so it's safe to say that MannKind did not meet their June 15 target date for the pediatric trial to start.
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Post by seanismorris on Jul 18, 2017 22:05:06 GMT -5
Sure. We're not talking about cartridges but the version available in blister packs (which I no longer see on their website). It should be very cheap... but at that low price say $20 does the expenditure make sense? In China/India they probably sell the injectable version for $5... The problem is would we sell enough at that price to make it worth it. If we developed a forced air inhaler it would probably be better, but uncompetitive price wise. It looks like 3.5-4 million people are prescribed Epi. Let's say 20 million of the pens are sold (guessing). If we sell 5 million and net $10 a piece, and split the profit 50% with a partner. 25 million - taxes 7.5 million, etc. The money isn't bad, but it's peanuts compared to Afrezza's potential. With no partner and likely higher competition than I spec'd, there has to be better opportunities to pursue. Epi feels like a generic race to the bottom, price wise... Now if the pre-clinical trial comes back with phenomenal results in effectiveness maybe a partner will show up. But a product that will likely be slapped with a lung cancer warning...meh. If someone could find the actual number of Epi sold that would be helpful... From the MannKind/R&D/Oral Inhalers web page: Single-Use Inhalers
Pre-loaded for Short-Term Use. Our Single-Use (acute treatment) Inhalers are ideal for therapies that are non-chronic, time of need or short duration. Pre-loaded with a prescribed dry powder, patients simply push a trigger and inhale their medicine.
Link: www.mannkindcorp.com/research-development/tech-platforms/oral-inhalers/COGS would very low. Regardless, I think a $50 price would be accepted by the market. Unlike insulin needles, EpiPen needles are big and invoke fear. Also, the single-use inhaler (i.e. Cricket) is smaller than any epinephrine pen currently on the market. It's easier to carry with you. Drugs.com reports that 915,000 EpiPen 2-Pak sales reached 915,000 units sold in Q3/2013 - over 3 million units annually in the U.S. Market. Total units sold globally were unavailable. www.drugs.com/stats/epicenter-2-pakI saw 3.6 million prescriptions in 2015 for Epi in another article, but they didn't mention the number of units. I put the price lower than $50 because by the time our product comes to market (2 years?) the price would probably decrease, also we'd be fighting against insurance coverage... I'm sure MannKind has done the analysis, but they did it when the Epipen was several hundred $$$. The math has changed significantly since then... I'm betting MannKind de-emphasizes the pipeline (if they mention it at all) on the next call. Investors may mention the pipeline, but we are all in on Afrezza.
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Post by scoy on Jul 18, 2017 22:21:37 GMT -5
DBC why is it you and others reply for matt ? He states worse case scenarios and in some cases complete nonsense, ten million per month for the contract sales, then when challenged he never responds. In your second sentence (in the last three words) you answer the question asked in the first. Long term success doesn't come from under-performance versus expectations. Stocks, companies, drugs, etc. have long-term success when results exceed expectations. Disappointment is not a success symbol. If you had a legitimate factual dispute that would be different. If Mannkind produces it and it sells billions of dollars a year the stock won't go down because Matt's prediction was less than that.
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Post by mango on Jul 18, 2017 22:41:58 GMT -5
From the MannKind/R&D/Oral Inhalers web page: Single-Use Inhalers
Pre-loaded for Short-Term Use. Our Single-Use (acute treatment) Inhalers are ideal for therapies that are non-chronic, time of need or short duration. Pre-loaded with a prescribed dry powder, patients simply push a trigger and inhale their medicine.
Link: www.mannkindcorp.com/research-development/tech-platforms/oral-inhalers/COGS would very low. Regardless, I think a $50 price would be accepted by the market. Unlike insulin needles, EpiPen needles are big and invoke fear. Also, the single-use inhaler (i.e. Cricket) is smaller than any epinephrine pen currently on the market. It's easier to carry with you. Drugs.com reports that 915,000 EpiPen 2-Pak sales reached 915,000 units sold in Q3/2013 - over 3 million units annually in the U.S. Market. Total units sold globally were unavailable. www.drugs.com/stats/epicenter-2-pakI saw 3.6 million prescriptions in 2015 for Epi in another article, but they didn't mention the number of units. I put the price lower than $50 because by the time our product comes to market (2 years?) the price would probably decrease, also we'd be fighting against insurance coverage... I'm sure MannKind has done the analysis, but they did it when the Epipen was several hundred $$$. The math has changed significantly since then... I'm betting MannKind de-emphasizes the pipeline (if they mention it at all) on the next call. Investors may mention the pipeline, but we are all in on Afrezza. Just gonna put this here. Mylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-InjectorMylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector• In other words, Mylan simply makes the same product by using the word "generic" and thus continues on with the Monopoly, and being the corrupt company they are. They can't even reliably make a life-saving product. On top of that, they can't even reliably NOT be corrupt. • Maybe the below flows within all Mylan? The evidence thus far is proving so. Corrupt and greedy people tend to produce crap results. We see with the government everyday, and it is no coincidence Mylan is also closely affiliated with the government. Mylan Drug Products are AdulteratedFDA Warning Letter to Mylan 4/3/2017
FDA Definition of Adulterated
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Post by dreamboatcruise on Jul 19, 2017 0:22:07 GMT -5
DBC why is it you and others reply for matt ? He states worse case scenarios and in some cases complete nonsense, ten million per month for the contract sales, then when challenged he never responds. Because, I hope he keeps on participating here. He has valuable insight into this industry and I've learned a lot from him. I still disagree with you about "worst case scenario". He said it was not a no-brainer for a financially viable pipeline drug and presented valid reasoning... though also stated that there probably would be some market for inhalable epi. Would you like me to present to you are worst case representation of these facts so that you can see what that would actually look like. It probably would have gotten into the specifics of current pricing and market size as some others have already explored and ended with showing that even if one assumed MNKD captured half of the market it wouldn't be worth the costs... I don't think any of us know the details sufficiently to really do that analysis but I think it would be easy to present a worst case assessment that it wouldn't be worth investing in it. What's your best case business analysis other than simply attacking those pointing out realities? What is MNKD's market revenue for epihale and how do you justify it? Do you know that Matt's assertion that Amphastar is bringing Primatene Mist back to market is untrue? Should we just ignore that because it's "worst case" and therefore heresy to think about? Do we ignore that a generic epipen has already entered the market and selling for a tiny fraction of what pens were a year ago? I don't know the context of the contract sales team comment you refer to, but I'm suspecting that he presented something about what it would likely cost to engage a contract sales team making assumptions about what would be needed for national coverage... well, guess what, MNKD did a very constrained effort... and how well did it work? Someone saying from experience that it generally costs X to do something doesn't mean a cash strapped company can't spend less than X, but it certainly may not be enough money to achieve the results that would normally be expected. Someone could tell you that a national drug TV ad campaign normally costs X tens of millions. Sure MNKD isn't going to spend that much... but guess what, that is going to be reflected in the results. We're not going to achieve the same results with ads in some doctors offices and one small TV show per week as Sanofi does blanketing the airwaves. Even though I don't at all agree that Matt always presents the worst case... over a number of years it is the ones that have that have been right. I didn't even believe the worst cases that have come to pass. Even if he were presenting worst cases I think I'd like to be aware of them. Way too many people presenting best case scenarios that are over the top complete nonsense... we're in a race as to whether our ship heading to the UAE arrives before Google and Amazon form a joint venture to buy Amgen because Amgen has a deal inked with MNKD. That is nonsense, not that it may have cost $10M a month to have had complete national coverage. MNKD management has admitted that doctors were not serviced probably by the contract team, and even now aren't at all claiming to have a national coverage strategy.
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Post by zuegirdor on Jul 19, 2017 12:26:42 GMT -5
There is plenty of time to inhale before things get so bad you can't even breath. Most episodes start of small and and you usually have plenty of time to treat before you can't inhale. Carrying both would be advised but the cheaper inhalable version would more then likely be used first.. So there is a very huge market for the epihale! Common sense would tell me if I thought I was having a allergic reaction to use the less expensive and less painful treatment first. Common sense people! I can attest to usefulness of an epihaler. Been "slightly" alergic to shellfish my whole life. Had minor chest tightness (lungs) reactions to shrimp and crab as a child. Developed some tolerance after puberty and freely ate things like clams and oysters. This year I had a couple breathless incidents. Thought it might have been reaction to chlorine from the Gym pool- but after the second spell realized the common denominator was the clams in my favorite dish: the cioppino! The onset was quicker and more pronounced the second time and I was afraid. I did consder using the epi pen we have for my son (he inherited my shellfish sensitivity). But I was disuaded by the specter of using the device, especially since the severity of my reaction did not seem to warrant that drastic step at the time (kidding myself?). Instead I took some oral benedryl which worked slowly but effectively as the night passed. I have no idea if my symptoms would have developed into a life threatening episode of anaphalxis or if the benadryl helped me dodge a bullet. Needless to say I'm off shellfish now. If this ever happens again, I assume I will have at least an hour or so warning. In both cases I did not feel the effects until about two hours after the meal and the chest tightness lasted over an hour before I figured out I should do something (I did not treat for the first episode and the symptoms subsided overnight). Without a doubt, had an epihale device been within reach, I would not have hesitated a second to use it. I believe I would have rested better that night had I used the epihale rather than the benedryl. The anxiety alone can create chest tightness. I believe providing that quick early releif could make all the difference in some cases.
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Post by michaelfrancis on Jul 19, 2017 12:54:18 GMT -5
Partner with Jimmy Johns? Freaky Fast Delivery.
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Post by peppy on Jul 21, 2017 8:12:40 GMT -5
going through pictures; here is one.
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Post by itellthefuture777 on Jul 31, 2017 18:04:00 GMT -5
If you take the time to read the Monash patent you will see the word Technosphere..as ine of the possible carriers...
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Post by peppy on Jul 31, 2017 18:10:55 GMT -5
If you take the time to read the Monash patent you will see the word Technosphere..as ine of the possible carriers... itell: post it. if you say read it, post it. Then bold the important part, or part you are referring to.
post the link. wizard of oz
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Post by itellthefuture777 on Jul 31, 2017 18:33:46 GMT -5
The particles may be obtained and engineered into any known particle engineering system, such as but not limited by the following: Pulmosphere™ or Pulmosol™ technology developed by Nektar, AIR™ porous particle technology develed by Alkermes, Technosphere™ technology developed by Mannkind, Powderhale™ technology developed by Vectura, particles created by Prosonix sonocrystalisation methods, particles created by wet or dry nano-milling technologies for example developed by Elan, Hovione or Savara. The micronized particles of the dry powder for inhalation are of a size suitable for aerosohsation and inhalation, having a physical size less than 15 μιτι, such as less than 10 μηι, or less than 6 μιη, or less than 5 μηι, or less than 3 μηι or less than 2 μηι. The particles according to this embodiment will have a mass median aerodynamic diameter of less than 10 μπι, but preferably less than 5 μιη, or less than 3 μηι. T ypically, in addition to the size equivalents discussed above. 90% of the particles by volume may have an aerodynamic diameter of less than 10 μπι, less than 8 μιη, or less than 6 μιτ> or less than 5 μητι or less than 3 μπ\. The mass median aerodynamic diameter can be measured by a pharmacopeia impactor method as defined by the US Pharmacopeia, by using an Andersen cascade impactor, or by Next Generation Impactor (NGI). T he particles according to this embodiment may have a mass median diameter of less than 5 μπι, or less than 3 μπι, which could be measured by a laser light scattering method, such as using a Malvern Mastersizer 2000 instrument. www.google.com/patents/WO2013016754A1?cl=en
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Post by itellthefuture777 on Jul 31, 2017 18:35:14 GMT -5
So the size..aerodynamics...fit a Technosphere partical...that..they would....obtain...
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Post by itellthefuture777 on Jul 31, 2017 18:40:16 GMT -5
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Post by #NoMoreNeedles on Jan 3, 2019 10:58:22 GMT -5
Would be really nice if Mike could address this on Friday!
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