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Post by BlueCat on May 8, 2015 20:05:12 GMT -5
It always comes back to execution.
IMHO, as the product and market potential is there, it still comes down to the basic regarding execution - do you believe they are:
A) Incompetent (or unskilled) at managing company,
or
B) Smart and very sneaky (whether or not for good of investors),
or
C) On a very different timeline personally (not the same sense of urgency - their finances are personally square)
or
D) Getting hit unexpectedly by SNY now - either with original intent from SNY, change in leadership/priorities there, or SNY problems with execution.
Seems to me I've heard all scenarios in this thread.
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Post by kball on May 8, 2015 20:08:23 GMT -5
You know it is bad when there are allegations of a conspiracy to look bad when they were, unfortunately, just simply that bad. I am worried that we now have to see in real life Warren Buffett's axiom, "Invest in a company idiots could run because sooner or later, they will." I believe this is where we are. My onky consolation is that Afrezza is maybe that good of a product that an idiot could sell it. We will see. I'd add that if Al's not happy with current leadership, it would seem within his power to change it. At some future point. My view is it seems premature. Ask me 12 months from now with more data
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Post by dreamboatcruise on May 8, 2015 20:16:06 GMT -5
This seems mildly encouraging...
"We're getting reports post approval in clinical result in early use of Afrezza that we like to share with you, but it is too soon to have publication of any such report in peer review journal. Therefore, all we have at this time must be considered anecdotal, and cannot be presented in the earnings call."
Hopefully this means that data is being collected in a manner that is publishable. I sure wish I could have asked some follow up questions about that. Are publications planned? Are these not official FDA trials? How many docs involved? Is it possible that the results could be enough to submit to FDA to improve label? Can you assure us the "reports" of "clinical results" you are alluding to are not merely from Twitter?
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Post by Deleted on May 8, 2015 20:38:38 GMT -5
This seems mildly encouraging... "We're getting reports post approval in clinical result in early use of Afrezza that we like to share with you, but it is too soon to have publication of any such report in peer review journal. Therefore, all we have at this time must be considered anecdotal, and cannot be presented in the earnings call."Hopefully this means that data is being collected in a manner that is publishable. I sure wish I could have asked some follow up questions about that. Are publications planned? Are these not official FDA trials? How many docs involved? Is it possible that the results could be enough to submit to FDA to improve label? Can you assure us the "reports" of "clinical results" you are alluding to are not merely from Twitter? I jumped to the conclusion they were simply referencing what we've all been watching - twitter, you tube, social media in general. If that's the material they are referencing, it's all ancedotal and won't be used in that fashion. However, the pathway for that info would come from doctors who also do research, so, that would likely be those endo's working in research environments. The more we hear on twitter and see on you tube, we can safely (is that a reach?) assume (oh boy) that that information will come to the attention of a research doc who might be interested in finding out more. That doc might talk to some associates, find some funding, and start collecting data in a formal fashion. That might come about by that doc or team of researchers reaching out to the early adopters, working with their personal docs, and begin a more formal process of data collection. Over a period of time, all that data would get assembled, organized, and evaluated. The research team would begin to draw conclusion and so on and so on until a thesis emerges. Or, maybe the doc would start with an end goal in mind already and collect only that data which supports their thesis - that is done all the time when a pharma hires a researcher to write an article to support their own desired conclusions (ghostwriters). Either way, it's time consuming, data intensive, and most researchers won't put their name on it until it's ready (or, they receive a ton of money). Some quick reads if your interested: This one is interesting to understand how to read a medical journal article. As such, you get the idea what should actually go into the effort: www.aafp.org/fpm/2004/0500/p47.htmlThis one highlights the business angle: www.washingtonpost.com/business/economy/as-drug-industrys-influence-over-research-grows-so-does-the-potential-for-bias/2012/11/24/bb64d596-1264-11e2-be82-c3411b7680a9_story.htmlThis one talks about the shady side of the business: thepeopleschemist.com/how-big-pharma-lies-to-doctors-about-the-medicine-you-are-taking/Ghostwriters: www.healthnewsreview.org/2013/01/introducing-a-three-part-series-on-medical-journal-article-ghostwriting/While these articles point out the negatives, it does provides a framework to what should go into an article for journals vs what typically goes in. Either way, it's not a quick easy process and will take some time. I found this line of research very enlightening.
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Post by sonic22 on May 8, 2015 20:40:44 GMT -5
davinci,
Im in the same boat...I think we have to give it to the end of the year to see how things shake out. We have the big June ADA conference, August refinancing with no dilution(should put to bed the cash position for the shorts) and the DTC in early Q3. If we still see slow sales I will re-evaluate my position but I believe once the summer comes along we will start to see sales ramp up significantly. Ive been in MNKD for 7 years now and basically am even now with my average shareprice. If you would have told me a year ago MNKD would get FDA approval and partner up with the best diabetes pharma company there is I would have put the house we would be above $10.
Its extremely encouraging to hear the user feedback and so far you have to give it an A from the early users....just need SNY to start ramping up. I don't buy into the theory they don't want want Afrezza to succeed, I think they knew about the issues they would have but didn't expect it to be this slow.
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Post by Deleted on May 8, 2015 20:54:07 GMT -5
davinci,
Im in the same boat...I think we have to give it to the end of the year to see how things shake out. We have the big June ADA conference, August refinancing with no dilution(should put to bed the cash position for the shorts) and the DTC in early Q3. If we still see slow sales I will re-evaluate my position but I believe once the summer comes along we will start to see sales ramp up significantly. Ive been in MNKD for 7 years now and basically am even now with my average shareprice. If you would have told me a year ago MNKD would get FDA approval and partner up with the best diabetes pharma company there is I would have put the house we would be above $10.
Its extremely encouraging to hear the user feedback and so far you have to give it an A from the early users....just need SNY to start ramping up. I don't buy into the theory they don't want want Afrezza to succeed, I think they knew about the issues they would have but didn't expect it to be this slow. Getting passed the august refi issue will be very helpful. DTC....excited! SNY continually working on the insurance side of the problem - exciting. And while I haven't placed much on the early users (in my eyes that is), and please - not insulting diabetics that this is helping right now, I'm talking about my investment not the patients - but to use a boxing analogy, going to the body early in the match pays dividends at the end of the match. So goes the early adopters here. People will and do listen to social media outlets. Hopefully that continues to grow and pay dividends as it relates to adoption/uptake as we move forward. I wasn't looking at the value of the early adopters because I was looking for a broad uptake - I suppose I had a bit of enthusiasm that afrezza would be accepted much quicker. Stepping back and taking a different viewpoint, the early adopters can very well save the day here.
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Post by obamayoumama on May 8, 2015 21:07:10 GMT -5
This seems mildly encouraging... "We're getting reports post approval in clinical result in early use of Afrezza that we like to share with you, but it is too soon to have publication of any such report in peer review journal. Therefore, all we have at this time must be considered anecdotal, and cannot be presented in the earnings call."Hopefully this means that data is being collected in a manner that is publishable. I sure wish I could have asked some follow up questions about that. Are publications planned? Are these not official FDA trials? How many docs involved? Is it possible that the results could be enough to submit to FDA to improve label? Can you assure us the "reports" of "clinical results" you are alluding to are not merely from Twitter? I have the answer to this. I was told that a doctor sent the results of five early patients on Afrezza to Al. The numbers were great, but because it was not done under a "trial" MNKD can't use it for any marketing purpose, otherwise it would be " off label " marketing. There are 4 trials that have been submitted to to FDA for approval. Long term, pediatric, and two other studies. Those two studies are short studies and could be very useful for label improvements. They should show " ultra Rapid" for the label. The FDA wouldn't allow MNKD to show the ultra rapid action of Afrezza because all those previous trials were done with the old inhaler.
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Post by kc on May 8, 2015 21:09:47 GMT -5
Lame is correct. I hear no cheerleading or support from Management. They do not say or defend the company or product. That is almost criminal or negligent on the part of management. As was stated this will be patient driven. At least for the beginning of the uptake. Do type 1 diabetics want other/ better/ more options than tradition injections? I am rather certain that the answer to this is yes.
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Post by dreamboatcruise on May 8, 2015 21:40:00 GMT -5
If they are going to figure out a way of getting discounted spirometers into Endo's offices, it sure seems like having that sorted out by the ADA meeting would be a great idea.
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Post by benh on May 8, 2015 21:51:11 GMT -5
This seems mildly encouraging... "We're getting reports post approval in clinical result in early use of Afrezza that we like to share with you, but it is too soon to have publication of any such report in peer review journal. Therefore, all we have at this time must be considered anecdotal, and cannot be presented in the earnings call."Hopefully this means that data is being collected in a manner that is publishable. I sure wish I could have asked some follow up questions about that. Are publications planned? Are these not official FDA trials? How many docs involved? Is it possible that the results could be enough to submit to FDA to improve label? Can you assure us the "reports" of "clinical results" you are alluding to are not merely from Twitter? I have the answer to this. I was told that a doctor sent the results of five early patients on Afrezza to Al. The numbers were great, but because it was not done under a "trial" MNKD can't use it for any marketing purpose, otherwise it would be " off label " marketing. There are 4 trials that have been submitted to to FDA for approval. Long term, pediatric, and two other studies. Those two studies are short studies and could be very useful for label improvements. They should show " ultra Rapid" for the label. The FDA wouldn't allow MNKD to show the ultra rapid action of Afrezza because all those previous trials were done with the old inhaler. It's easy to see how people think the FDA are inept and corrupt. Sorry sir, the caffiene trial is null and void. Some drank from blue mugs, not the red ones. Do you know when the 2 short studies were submitted.? Do you have any links,
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Post by Chris-C on May 8, 2015 22:39:58 GMT -5
I have the answer to this. I was told that a doctor sent the results of five early patients on Afrezza to Al. The numbers were great, but because it was not done under a "trial" MNKD can't use it for any marketing purpose, otherwise it would be " off label " marketing. There are 4 trials that have been submitted to to FDA for approval. Long term, pediatric, and two other studies. Those two studies are short studies and could be very useful for label improvements. They should show " ultra Rapid" for the label. The FDA wouldn't allow MNKD to show the ultra rapid action of Afrezza because all those previous trials were done with the old inhaler. It's easy to see how people think the FDA are inept and corrupt. Sorry sir, the caffiene trial is null and void. Some drank from blue mugs, not the red ones. Do you know when the 2 short studies were submitted.? Do you have any links, I interpeted that comment to mean that plans for post approval studies, including REMS, were submitted to FDA for approval. I am under the impression that a company seeking to use clinical data in support of an approved drug is wise, if not required, to first seek FDA guidance on its design. Chris C
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Post by yossarian on May 8, 2015 23:12:17 GMT -5
For those who want MNKD to hype the stock more, this may be why it is conservative in what it says From: cases.gcginc.com/mannkind/ The In re Mannkind Corp. Securities Litigation class action has been litigated since January 2011. In this lawsuit, Plaintiffs are represented by Co-Lead Counsel appointed by the Court, Glancy, Binkow & Goldberg LLP and Pomerantz Grossman Hufford Dahlstrom & Gross LLP. Plaintiffs alleged that MannKind's stock price was artificially inflated as a result of a series of untrue or materially misleading statements related to MannKind's communications with the FDA about its application and testing for AFREZZA, an inhaled insulin combination drug product. Plaintiffs further contend that Defendants made these statements knowing them to be materially false or misleading, or recklessly disregarding their materially false or misleading nature, and that investors suffered injury as a result of the alleged stock price inflation. Defendants deny all wrongdoing. Nonetheless, both parties have concluded that further conduct of the Action could be protracted and expensive, and that it was desirable that the Action be fully and finally settled in the manner and upon the terms and conditions agreed to in the settlement agreement.
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Post by kc on May 8, 2015 23:49:07 GMT -5
Thank you for posting and reminding us about history. Management is doing the right thing for the shareholders.
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Post by kball on May 9, 2015 3:06:45 GMT -5
I posted this in the shoutbox but i feel its worth repeating here in case it wasn't seen or appreciated there (and it cracked me up on a difficult day)...
-Here's a weird thought. I feel like crawling into bed with Nate Pile so he can comfort me.
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Post by gomnkd on May 9, 2015 4:43:44 GMT -5
I love the weekends; I can get fully recharged to take another week of pounding.
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