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Post by brotherm1 on Sept 14, 2017 1:58:54 GMT -5
Just got off the phone with my cousin. He's been around and playing stocks for a long time. He told me you can never know if there is a better drug in the wings until it actually comes out and hits the market. I would think we would have heard if there is a competitive drug going through trials with the FDA or comparable foreign agency? Did we know about Fiasp - for example - before it was approved oversees? Any chance the shorts could be aware of a drug in the making comparable or better than Afrezza that we are unaware of? Of course even if there was a better drug waiting to be approved, it would still take time to be a success, but if it would be owned by a BP like Merck with mega cash, the time to success would be a much shorter route than a drug owned by a small company short on cash.
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Post by falconquest on Sept 14, 2017 4:35:04 GMT -5
Just got off the phone with my cousin. He's been around and playing stocks for a long time. He told me you can never know if there is a better drug in the wings until it actually comes out and hits the market. I would think we would have heard if there is a competitive drug going through trials with the FDA or comparable foreign agency? Did we know about Fiasp - for example - before it was approved oversees? Any chance the shorts could be aware of a drug in the making comparable or better than Afrezza that we are unaware of? Of course even if there was a better drug waiting to be approved, it would still take time to be a success, but if it would be owned by a BP like Merck with mega cash, the time to success would be a much shorter route than a drug owned by a small company short on cash. What always confounded me is the fact that any BP would go through all the expense of development, trials, approvals etc. when they could simply write a check and have the greatest insulin product ever developed. Of course Sanofi muddied the waters by refusing to market Afrezza properly and souring potential interest in the the drug.
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Post by akemp3000 on Sept 14, 2017 5:03:23 GMT -5
Anything's possible but Afrezza has properties that are very close to mimicking a healthy pancreas. These unique properties and delivery method make it almost impossible to duplicate without investing a couple of Billion dollars and years of testing and approvals. I agree with Falconquest, it would be much faster, cheaper and easier to buy Afrezza than to try to create a new drug with efficacy that fits in the very small space between Afrezza and a healthy pancreas.
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Post by sayhey24 on Sept 14, 2017 5:25:33 GMT -5
We knew about Fiasp for years but Fiasp is no afrezza. The best you can do is a healthy pancreas. Thats the best. afrezza almost perfectly mimics first phase release and works with the liver. You really can't do much better. If there was a way to add second phase that would be great. The answer to that right now is another puff an hour later when needed which is not a big deal.
For basal Nova said in Forbes they can't any better. I believe them. IMO, insulin development is a very mature market which was seen at ADA 2017. Most BP was talking about monitoring - Nova/Gookla, Roche/MySugr, SNY/Ondou, Medtronic/IBM, etc.
2018 will be the year of "Cloud Diabetes" where everyone is monitoring in real time. After monitoring you need to address the issue in real time which is meal time spikes. Only afrezza does this.
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Post by uvula on Sept 14, 2017 7:21:46 GMT -5
My uneducated guess is that most people think the closed loop cgm insulin pump "artificial pancreas" is the perfect near term solution and implantable beta cells are the perfect long term solution. This is where companies will spend their research money.
We know that Afrezza is better than the AP but we don't count.
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Post by mnholdem on Sept 14, 2017 7:48:36 GMT -5
Just got off the phone with my cousin. He's been around and playing stocks for a long time. He told me you can never know if there is a better drug in the wings until it actually comes out and hits the market. I would think we would have heard if there is a competitive drug going through trials with the FDA or comparable foreign agency? Did we know about Fiasp - for example - before it was approved oversees? Any chance the shorts could be aware of a drug in the making comparable or better than Afrezza that we are unaware of? Of course even if there was a better drug waiting to be approved, it would still take time to be a success, but if it would be owned by a BP like Merck with mega cash, the time to success would be a much shorter route than a drug owned by a small company short on cash. Your cousin is wrong. By the time a new drug hits the market, trial data must be made public. There aren't any surprises lurking in the shadows.
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Post by derek2 on Sept 14, 2017 7:49:15 GMT -5
The restrictive and uninspiring label has been a major limiting factor. If almost nobody knows about a new drug, and you can only advertise claims supported by the label, then the consumer can't be blamed for not recognizing a better mousetrap.
This month will be key. Every improvement on the label is another chance to differentiate Afrezza from other treatments and to communicate that through marketing. The label shows proven benefit, as signed off by MNKD and the FDA. Positive changes will carry weight.
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Post by matt on Sept 14, 2017 8:39:32 GMT -5
The restrictive and uninspiring label has been a major limiting factor. If almost nobody knows about a new drug, and you can only advertise claims supported by the label, then the consumer can't be blamed for not recognizing a better mousetrap. ^^^ This. The definition of "better mousetrap" is a highly subjective one, and most physicians don't take the time to read a label unless they have a reason to do so. The black box warning is enough to stop many physicians to stop reading on the first page because there are other alternative ways to treat diabetics that do not have a black box. You can argue all you want about various benefits of Afrezza versus the other RAI products, but the fact is that many physicians simply won't prescribe anything with a black box warning. The counter to that is publishing, lots of publishing, in peer-reviewed medical journals as that is where most physicians get their information. An author can write pretty much whatever they want in a medical journal, so long as they have data to back it up, and FDA cannot limit that publication. The fact that MNKD did not aggressively promote their product three years ago through a campaign of journal articles from opinion leaders and presentations at medical conferences limited their marketing interactions to what is on the label. The company is now trying to correct that by asking for different label claims but that is a difficult task. If the FDA had established standards for certain claims, such as "rapid acting" means evidence of a pharmacological effect within 30 minutes, but "ultra fast" means within 15 minutes, then the company would know exactly what data they need to present to FDA to get the claim approved. However, without a bright line, quantitatively defined benchmark, getting FDA to change the adjective might be like trying to nail Jell-O to a wall. You can bet that if an "ultra fast" designation is a commercially valuable claim than other companies will want the same label, so FDA will be cautious about giving the designation to one company unless they have first set a standard that others will have to meet. That is why regulators are such a pain to deal with when debating in the absence of clear standards.
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Post by sportsrancho on Sept 14, 2017 9:07:27 GMT -5
The counter to that is publishing, lots of publishing, in peer-reviewed medical journals as that is where most physicians get their information. An author can write pretty much whatever they want in a medical journal, so long as they have data to back it up, and FDA cannot limit that publication. The fact that MNKD did not aggressively promote their product three years ago through a campaign of journal articles from opinion leaders and presentations at medical conferences limited their marketing interactions to what is on the label.
------- You guys maybe think I'm always happy and nothing makes me mad. (Except DBC..lol ) But this makes me mad! I know a PB member who pleaded with management to do this:-( And nothing!
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Post by brotherm1 on Sept 14, 2017 9:10:49 GMT -5
Just got off the phone with my cousin. He's been around and playing stocks for a long time. He told me you can never know if there is a better drug in the wings until it actually comes out and hits the market. I would think we would have heard if there is a competitive drug going through trials with the FDA or comparable foreign agency? Did we know about Fiasp - for example - before it was approved oversees? Any chance the shorts could be aware of a drug in the making comparable or better than Afrezza that we are unaware of? Of course even if there was a better drug waiting to be approved, it would still take time to be a success, but if it would be owned by a BP like Merck with mega cash, the time to success would be a much shorter route than a drug owned by a small company short on cash. Your cousin is wrong. By the time a new drug hits the market, trial data must be made public. There aren't any surprises lurking in the shadows. I too thought FDA trial data is public information. Though would you know when it becomes available to the public? In other words does it become available from the start of say a first phase trial?
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Post by brotherm1 on Sept 14, 2017 9:29:52 GMT -5
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Post by straightly on Sept 14, 2017 9:32:56 GMT -5
Just got off the phone with my cousin. He's been around and playing stocks for a long time. He told me you can never know if there is a better drug in the wings until it actually comes out and hits the market. I would think we would have heard if there is a competitive drug going through trials with the FDA or comparable foreign agency? Did we know about Fiasp - for example - before it was approved oversees? Any chance the shorts could be aware of a drug in the making comparable or better than Afrezza that we are unaware of? Of course even if there was a better drug waiting to be approved, it would still take time to be a success, but if it would be owned by a BP like Merck with mega cash, the time to success would be a much shorter route than a drug owned by a small company short on cash. I have been waiting for this for some time now: the gost competition. I hold a little and trade a little of tsla. When I see a phony or ghost competitor article, I buy a few. For tsla, there are many: Nissan will eat tsla. Toyota will blow it up with hydrogen, volkswagon will have better charge network, google was already advanced to the Mars with their auto drive (or is it Cummins?), and of course Chinese will not leave any auto maker any money at all. Why? If this is the best opposition, I am golden. So far so good.
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Post by brotherm1 on Sept 14, 2017 9:48:31 GMT -5
Your cousin is wrong. By the time a new drug hits the market, trial data must be made public. There aren't any surprises lurking in the shadows. I too thought FDA trial data is public information. Though would you know when it becomes available to the public? In other words does it become available from the start of say a first phase trial? Is there more than one trusted site for the public to view FDA clinical trials other than clinicaltrials.gov ? According to the final rule which took place January 18, 2017: "Timeframe for results information submission to ClinicalTrials.gov: Not later than 12 months after primary completion date; possible delay of up to an additional 2 years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance of a new use is being sought." www.nih.gov/news-events/summary-table-hhs-nih-initiatives-enhance-availability-clinical-trial-information
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Post by peppy on Sept 14, 2017 9:52:56 GMT -5
I just google the medication/drug along with FDA. The FDA packets do have the submitted studies. Hard to believe a sugar pill/placebo has the adverse effects charted at times.
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Post by itellthefuture777 on Sept 14, 2017 10:13:42 GMT -5
What you would like in a perfect world is a currently non insulin maker to aquire in part Afrezza with $40 billion down and percent of sales going to mnkd..for..ever..AMGEN has $40 Billion..just sitting there...hmm..for aquisition too..hmmm
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