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Post by jgv on May 30, 2015 15:55:15 GMT -5
Until it is published in a peer review journal an abstract is virtually useless. I will stand by that.
I'll address your other questions when I am in front of a computer. Not behind my phone.
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Post by babaoriley on May 30, 2015 16:16:29 GMT -5
I will be interested to see the abstract bodies posted, especially the one from board 96 (late breaking) on a meta-analysis of the safety and efficacy of Technosphere Insulin. My cursory search on Google Scholar found no other previous publications by Dr. Westcott, an internist, in the area of diabetes or metabolic disease. I hope he is presenting from the perspective of a clinician practicing evidence based medicine and I will be interested in his conclusions. Oddly, he is listed as being associated with Tufts Medical Center but does not appear in the clinical directory. Chris-C This may sound like a combo of sour grapes and conspiracy theory, but 112,000,000 short shares can't be wrong, and if they are, they need to convince others that they're not. The short interest will stop at nothing, I would not be surprised if Dr. Westcott were, shall we say, "incentivized" by certain interests. |
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Post by liane on May 30, 2015 16:25:55 GMT -5
baba,
Financial disclosures must be made.
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Post by Deleted on May 30, 2015 17:07:11 GMT -5
My take on this is yes, the analysis will favor injectables and put afrezza on as a niche drug. The presentor will probably be an excellent speaker with good influence skills. However, the room wont be filled with idiots who dont know or suspect whats going on. Everyone knows that money funds these "analysis" and I suspect most will at least understand that there's motive here against afrezza. The adcom panel demonstrated that many docs cared less for the traditional view put forth by the FDA. Docs understand the limitations of current therapies. So i have a hard time believing that the audience will sit there and take this for anything other than what its worth.
As far as waiting for additional safety data, if that held any weight we would need to pull every drug approved in recent years. Its a joke statement as if to suggest MNKD doesnt have mounds of safety data demonstrating that the general population will not drop dead from use as directed.
Short term it might cause stock price problems. Sales will fix all including that huge army of shorts. Whats way higher on my list is this - when will sny start their full court press and what will that look like? To me, sny is looking like geniuses (change of opinion on my part) for going very slow, confirming the issues, working feverishly behind the curtain on solutions (they better be), giving mnkd time to ramp production, giving time for the insurance process to work thru, and building some impressive real world results as tracked in social media. The scripts confirm this approach - it confirms that sano has in fact rolled out afrezza to a small set of prescribers, handed out tons of samples, introduced the medication, set up training and meetings, and does not care about bulk sales yet. I would also add that the only reason why sny announced the launch in feb was just to set the clock for insurance and DTC purposes.
I have studied the pros and cons till I'm blue in the face and can only come to these conclusions. It even explains the apparent recent lameness of MNKD management - they arent lame, their hands are tied while this gameplan plays out. The dejection observed in tone during recent calls is management frustrated they cant share all this with us in an official way. If my assessment is wrong, the only other options are sny is doing this intentionally to sandbag afrezza, or, sny is completely inept. I dont believe my assessment is wrong.
I suggest that the presenter of this abstract given the bigger picture will look like a fool in the not-so-distant future.
(Note-i am tapping on my phone. Apologies for spelling/grammer)
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Post by jpg on May 30, 2015 17:13:43 GMT -5
baba, Financial disclosures must be made. They must be made but are never checked. Look at the rash of 'recalls' of scientific articles... Not saying this is the case here but when literally billions are at stake and with the timing I am cautious in my beliefs of the neutrality of the scientific process. To respond to another issue and as for the value of an abstract I agree with our academic collegue in pronciple but in reality this is as much marketing as science. A meta analysis is as good as the undrstanding of the data and science behind it. As another poster points out Afrezza is so different from a PK/PD perspective that ignorance of this fact is a serious omission. |
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Post by jpg on May 30, 2015 17:28:59 GMT -5
Agree with the unicorn.
Sanofi is either sanbagging, totally right and understands the market brilliantly or just purely incompetant.
I have been in the brilliant camp from the begining and will 'soon' find out if I am simply a rainbow loving unicorn...
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Post by bioexec25 on May 30, 2015 17:31:59 GMT -5
Yes well either they disclose the objective truth of months of experience including existing user experiences or they don't. This is real and less subjective to tainting the facts. But hey if not, then fine we can plan around that. We have been doing for years. Cost averaging down and loading up this doesn't have to end badly. Darn it seems many of us are in a very similar range and we can stay strong as this plays out. Even if some exit for awhile and come back later although as of now I do not recommend that, it will still be somewhat okay. Do not give up your shares right now and more than ever hang on to see at least what the August action brings.
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Post by notamnkdmillionaire on May 30, 2015 18:44:20 GMT -5
Correct me if I am wrong, but aren't the researchers using trial data that was highly controlled and trials that were not exactly designed to show how well Afrezza works in the real world? If so, isn't this research study an exercise in futility?
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Post by inittowinit on May 30, 2015 19:13:54 GMT -5
There are so many variables here. All are speculative but interesting as things unfold. As a newbie (the oldest rookie on PB) I am curious as to what will become of the BOFA SHARES?
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Post by Deleted on May 30, 2015 19:24:27 GMT -5
Correct me if I am wrong, but aren't the researchers using trial data that was highly controlled and trials that were not exactly designed to show how well Afrezza works in the real world? If so, isn't this research study an exercise in futility? Call me crazy but i do believe its being done to provide an air of legitimacy for a serious set of short attacks. We could see 3's again or worse. The timing is perfect - sny/mnkd are quiet, there's the usual negative list regurtated by the guns and nothing will or can be done to counter it. Wash, rinse, repeat. I hope i am not right. |
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Post by falconquest on May 31, 2015 7:52:45 GMT -5
If that's the case then we hit the three's, the shorts cover, longs get (yet another) buy opportunity and we move forward again. I can't help but believe in the long run all of the bashing will be moot as Afrezza becomes the standard of treatment where applicable. By the way, I certainly appreciate the in depth analysis on this subject. This is why I joined this forum. Thank you!
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Post by notamnkdmillionaire on May 31, 2015 8:31:07 GMT -5
Call me crazy but i do believe its being done to provide an air of legitimacy for a serious set of short attacks. We could see 3's again or worse. The timing is perfect - sny/mnkd are quiet, there's the usual negative list regurtated by the guns and nothing will or can be done to counter it. Wash, rinse, repeat. I hope i am not right. I am hoping that many in the medical community will get better acquainted with Afrezza during the ADA and June will be the month where they just start to "get it" in regards to how well Afrezza works and that it is the closest thing we have to a rainbow farting unicorn! |
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Post by mnkdorbust on May 31, 2015 9:38:15 GMT -5
Call me crazy but i do believe its being done to provide an air of legitimacy for a serious set of short attacks. We could see 3's again or worse. The timing is perfect - sny/mnkd are quiet, there's the usual negative list regurtated by the guns and nothing will or can be done to counter it. Wash, rinse, repeat. I hope i am not right. I am hoping that many in the medical community will get better acquainted with Afrezza during the ADA and June will be the month where they just start to "get it" in regards to how well Afrezza works and that it is the closest thing we have to a rainbow farting unicorn! Based on picture of the trajectory I'd call it a $hit or Shart. |
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Post by harryx1 on May 31, 2015 10:07:26 GMT -5
Although the author's conclusion of the abstract is disappointing, I believe it's a very small sideshow, as a few have sated here. I'm hoping that we see some PRs this week from Mannkind and Sanofi highlighting the 2 important events focused on Afrezza, the dinner symposium and product theater presentation. I believe that we could see a small boost in price from these but more importantly put more pressure on shorts as their attack points start fading away.
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Post by ezrasfund on May 31, 2015 10:09:54 GMT -5
The Afrezza dosing regimen was not optimum in any of the various clinical trials. If we look at the much improved results that Afrezzauser and others in his study group get in the real world compared with the results they would get if they were only allowed one dose 15 minutes before the meal, we see the benefits that have been demonstrated since Afrezza was approved. Clinical trial protocols did not allow the best use of Afrezza, so meta-analysis of this data will not show what Afrezza can do when used correctly. At this point only someone who wanted to disparage Afrezza would do a meta-analysis of the data from previous trials.
If we could have some kind of analysis of the patients now using Afrezza, many of whom are getting lifetime-best HbA1c results, that would be something.
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