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Post by cjc04 on Aug 25, 2016 13:51:06 GMT -5
As for MNKD, Matt, using this moment to put themselves in the spotlight..... I think it's crazy, and I'm pretty surprised at some of the members here calling for it. This is just noise coming from politicians during a presidential election year. Clinton is just trying to get the attention of all the parents who just had to buy epi pens for back to school. Come November, there will be NO politicians backing MNKD, nor will any of them be making noise at the FDA for MNKD. MNKD will have put themselves on a new chopping block for a momentary flash of attention, and for a product that is years away from becoming a reality. In the end, the only attention MNKD would get is for their financial situation and lack of Afrezza sales after 18 months, regardless of who was, or wasn't, trying to sell it...... Not to mention the attention from a new area of BP doing all they can to make sure the product never sees the light of day. MNKD/Matt inserting himself into the political conversation.... DUMB idea! It seems as though you do not understand how powerful positive PR can be to a company during times like these...and unfortunately for investors on this board, neither does Mannkind. While I appreciate your opinion of what I may or may not understand (or not),,,,,, I do not see this as an opportunity to get a positive PR. I see it more like a wounded deer walking into a circle of lions and trying to point out which zebra they should go after. If some other 3rd party were to bring up MNKD then maybe it could be a positive, but imo it'd have to be the right person and for the right reasons. Like say, what the BP powers do to small companies who have valuable drug alternatives. But I believe this is just political noise and no one really gives a Shiz about the epi pen. After November we'll never hear about it again. This is Hilary's attempt to win votes from Americans having to pay high prices and she's attacking American business to do it. If she really cared, she'd go after the real problem.
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Post by afrezzamiracle on Aug 25, 2016 14:24:49 GMT -5
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Post by nylefty on Aug 25, 2016 14:49:19 GMT -5
...MNKD will have put themselves on a new chopping block for a momentary flash of attention, and for a product that is years away from becoming a reality. In the end, the only attention MNKD would get is for their financial situation and lack of Afrezza sales after 18 months, regardless of who was, or wasn't, trying to sell it...... Not to mention the attention from a new area of BP doing all they can to make sure the product never sees the light of day. MNKD/Matt inserting himself into the political conversation.... DUMB idea! cjc04 is absolutely right. The earliest time to issue "positive" PR about the epi effort will be after Technosphere/Afrezza shows signs of being a success...not now, when all the generally accepted evidence points to it as a failure and to MannKind as being on the brink of bankruptcy. Any competent journalist would point out those negatives, which would make our Positive PR look desperate and delusional. I'm still optimistic that the new sales effort will pay off, but the hard evidence of a turnaround is still months away.
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Post by lakers on Aug 25, 2016 15:55:26 GMT -5
The EpiPen delivers a shot of epinephrine, a synthetic version of adrenaline, which is an old medicine that has long been off patent. Mylan’s special ingredient is the hand-held delivery device that allows users to easily inject themselves in an emergency. Making such sterile injectables is expensive because of the need to keep out contaminants at every step, adding another hurdle for any rival. The upfront costs on that are “pretty high,” says David Lebo, a Temple University professor specializing in pharmaceutical manufacturing. A few competitors have tried but so far have failed at challenging EpiPen. Auvi-Q was prescribed 353,600 times last year, according to IMS Health, before Sanofi was forced to recall the product because of dosing problems. It is still off the market. Other brands weren’t nearly as successful. They “couldn’t get a lot of market share. Doctors just wrote EpiPen on prescriptions,” says Ronny Gal, a Sanford C. Bernstein & Co. analyst. Teva Pharmaceutical Industries Ltd. has sought to sell a generic version. But Mylan has argued that Teva’s version endangers patients trained to use the EpiPen, because Teva’s isn’t an exact copy. In February, the Food and Drug Administration rejected Teva’s application for approval, the company said, without specifying the reasons. “Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017,” the company said. Impax Laboratories Inc. raised the price of another rival, called Adrenaclick, to about the same level a week before Auvi-Q’s recall in late October 2015. Impax “can only manufacture so much product” because plant workers assemble the components by hand, says Mark Donohue, a company spokesman. The company is investing in automating the manufacturing of Adrenaclick, he says, but it will take a few years. EpiPen became an iconic brand, like Xerox or Band-Aids. It was prescribed by name by doctors and sought out by parents and patients who liked the pen’s ease of use, Sanford C. Bernstein’s Mr. Gal says. The threat to Mylan, he says, is that the controversy turns off patients, prompts health plans to find alternatives and prods regulators to approve Teva’s generic version. news.google.com/news/ampviewer?caurl=http%3A%2F%2Fwww.wsj.com%2Famp%2Farticles%2Fmylans-epipen-price-increases-highlight-its-grip-on-the-market-1472154769#pt0-386729[Mnkd is looking for a TS Epi partner. The price gouging helps its case. It's mfgr prowess is an advantage.]
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Post by sophie on Aug 26, 2016 10:40:16 GMT -5
FDKP appears stable and safe right now, but it wouldn't be known for many years whether it has any harmful effects, and likely partly to blame for why physician uptake has been so poor to this point. I think that's quite a stretch as to poor physician prescribing. I didn't mean to insinuate that it was the main cause or even the biggest. Whenever I have asked older physicians with decades of experience why they don't prescribe Afrezza, they reference Thalidomide, Diethylstilbestrol, Isotretinoin, etc as drugs that were proven safe but decades later were related to teratogenic effects. I'm sure the argument has been raised here before, so it's probably a waste of time to address it again, nor is it my intent to do so, but I wish there was a way to gauge the newest roadblocks that Afrezza is facing. From my very limited experience with older docs, they tend to let others prescribe new medications and then give it a few years before they start prescribing it. They don't want lung cancer on their conscience. What about poorly managed diabetes on their conscience by staying with the status quo? Their response was that the biggest problem with the status quo is adherence. There are outliers that just have a really hard time controlling their HbA1c, but for the most part, people find relief when they take their medication properly. Better the devil they know than the devil they don't, they say. Just passing along info. Might not be worth anything
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Post by rayskum on Aug 26, 2016 11:57:57 GMT -5
A suggestion for Mannkind to consider ...
In today's charged up atmosphere about rising drug prices including insulin drugs, it would be nice for Mannkind to come out with a pledge to NOT increase Afrezza's price for the next 2 or 3 years. That would generate much needed and awesome PR. Mike C. already confirmed that Afrezza's price didn't change over last 2 years. If we don't have plans for a price increase, why not take advantage of the moment?
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Post by sportsrancho on Aug 29, 2016 13:04:15 GMT -5
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Post by liane on Aug 29, 2016 13:34:46 GMT -5
Also available are epi prefilled syringes. Cost is ~ $10. Negates the need to draw up and measure the drug.
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Post by sportsrancho on Aug 31, 2016 13:59:03 GMT -5
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Post by sportsrancho on Aug 31, 2016 14:16:26 GMT -5
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Post by end2war on Aug 31, 2016 15:19:48 GMT -5
AF posted an old study on Twitter from 2000 that concluded epinephrine inhalation was not very effective for children. See: Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? www.ncbi.nlm.nih.gov/pubmed/11061773Does anyone know how MNKD has overcome the limitations found in this study?
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Post by mechstan on Aug 31, 2016 18:06:34 GMT -5
AF posted an old study on Twitter from 2000 that concluded epinephrine inhalation was not very effective for children. See: Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? www.ncbi.nlm.nih.gov/pubmed/11061773Does anyone know how MNKD has overcome the limitations found in this study? From reading the abstract, the 2 main reasons why it wasn't as effective in children were:
1. Bad after-taste which indicates there might be an issue with the carrier and/or the drug 2. Inhalation flow which indicates there might be a design issue with the inhaler
We know the Dreamboat inhaler is a robust design that maximizes air flow.
We don't know about the after-taste left by technosphere + epinephrine.
If we can prove airflow is a non-issue, I don't think the after-taste is much of an obstacle.
After all, which do you think a kid will choose between stabbing (pain) and inhaling (bad taste) given everything else being equal?
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Post by peppy on Aug 31, 2016 18:14:26 GMT -5
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Post by slapshot on Aug 31, 2016 19:43:00 GMT -5
AF posted an old study on Twitter from 2000 that concluded epinephrine inhalation was not very effective for children. See: Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? www.ncbi.nlm.nih.gov/pubmed/11061773Does anyone know how MNKD has overcome the limitations found in this study? From reading the abstract, the 2 main reasons why it wasn't as effective in children were:
1. Bad after-taste which indicates there might be an issue with the carrier and/or the drug 2. Inhalation flow which indicates there might be a design issue with the inhaler
We know the Dreamboat inhaler is a robust design that maximizes air flow.
We don't know about the after-taste left by technosphere + epinephrine.
If we can prove airflow is a non-issue, I don't think the after-taste is much of an obstacle.
After all, which do you think a kid will choose between stabbing (pain) and inhaling (bad taste) given everything else being equal?
maybe, down the road, they can work on adding a flavor?
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Post by Deleted on Sept 2, 2016 0:30:49 GMT -5
Don't forget common table salt, NaCl ionizes in water to form sodium and chlorine. HCl (hydrochloric acid) in the stomach digests food, chloride is a common ion to regulate osmotic pressure in cells, etc. Chlorine/chloride isn't necessarily a harmful ion for the body. Chlorofluorocarbons are extremely stable because of their (non)polarity. Every dipole cancels the other out in a flat plane. The problem with CFCs were that at higher levels in the altitude, high energy photons of light could break apart the bonds and create very unstable radicals which would then deplete O3 or ozone into plain oxygen or even combine with NOx to further deplete the ozone since the binding of oxygen to O2 or NOx is more energetically favorable than it is to O3. CFCs were used for decades because they were shown to be safe. It wasn't until the ozone layer started to get depleted that scientists formed a groupthink to conquer the problem. It was then discovered to deplete the ozone layer. This is why the FDA is always so careful before approving synthetic chemicals for drugs. FDKP appears stable and safe right now, but it wouldn't be known for many years whether it has any harmful effects, and likely partly to blame for why physician uptake has been so poor to this point. This is why the FDA is always so careful before approving synthetic chemicals for drugs. — The FDA is careful? Maybe towards certain agendas. — If a drug is not synthetic then what does that make it? You like FUD much? FDKP appears stable and safe right now, but it wouldn't be known for many years whether it has any harmful effects, and likely partly to blame for why physician uptake has been so poor to this point.— FUD.
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