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Post by esstan2001 on Jun 19, 2015 6:53:57 GMT -5
I refuse to click on the latest Street dot com article this AM. Curiously, I also have no interest to do so- I am certain that it contains NO VALUE and feel no need to look. Did I just graduate to something? ...
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Post by esstan2001 on Jun 18, 2015 12:55:22 GMT -5
.... She is getting some of the research into Afrezza in her email today from me. It is quite clear to me that she had no clue what she is talking about as she couldn't discuss the studies that are being done to show that Afrezza causes less hypoglycemia or that there is less weight gain, or even the mechanism by which it works and how it clears the system quickly. My guess is this is what people are finding with doctors when they ask about this drug. Not facts, just prejudice. Are you going to give his Dr. one more chance after she has had time to review your package, or are you going to switch to gain access to Afrezza?
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Post by esstan2001 on Jun 18, 2015 11:00:49 GMT -5
I have this guy on ignore but it doesn't do any good because people keep quoting him. I think he's shown his true colors, why doesn't everybody just ignore him and he'll eventually go away. I agree. We have tried engaging to have a positive discussion but this is not leading to anything constructive. We simply are talking past each other. I am willing to exchange but at a certain point it is no longer an exchange but simply 'a discussion with a broken record'..... jpg, days ago, from the way he kept harping on how not PR'ing this FDA dosing study would be fodder for the shorts, my gut told me this guy has an agenda. It has become clear he just wants to bait people into an exchange that he can twist and turn to generate more questions. That is why I gave him my one and only response (emphasis added just now): IMHO, it is not a material event until the data is collected and results meet their intended targets, or when the submission is prepared. talking up initiation of a study is just fluff. SNY may also prefer not to tip it's hand to competitors. ...and that's my final answer.Read more: mnkd.proboards.com/user/207/recent#ixzz3dQh7HkLb
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Post by esstan2001 on Jun 16, 2015 6:45:46 GMT -5
I saw only a portion of this article mentioned on twitter this evening. I looked it up on JAMA but could only get the first page. Thanks for the whole paper. Basically this is what we have known for the last year but what caught my attention was the Conclusion.
"CONCLUSION — Afrezza, the only inhaled formulation of insulin currently available in the US, appears to be only modestly effective in reducing HbA1c. Cough is a common side effect and the long-term pulmonary safety of inhaling insulin is unknown."
Since we're currently getting feedback from multiple users, I think it is fair to say that the results from Afrezza is much much more than "only modestly effective" and the pulmonary issue is why we are looking at the labeling. Users have stated that the first few doses have caused a cough but that is only initial (probably the same as a non-smoker trying their first cigarettes). The conclusion over generalizes. As stated, It should have been qualified with, ...only modestly effective in reducing HbA1c when restricted to the titration and dosing regimen specified under the FDA trials that were designed to demonstrate non-inferiority. Then note the exceptional anecdotal data being consistently presented via social media, and mention how this warrants further investigation. That's what I'd do. :-)
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Post by esstan2001 on Jun 16, 2015 0:32:23 GMT -5
"did not the FDA require further studies surrounding dosing questions?" .... yet when you're handed an item with the potential to give the shorts a serious kick in the bottom -- e.g. a clinical trial that might be aimed at a EU approval -- suddenly it's.... IMHO, it is not a material event until the data is collected and results meet their intended targets, or when the submission is prepared. talking up initiation of a study is just fluff. SNY may also prefer not to tip it's hand to competitors. ...and that's my final answer.
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Post by esstan2001 on Jun 11, 2015 11:32:36 GMT -5
Hopefully the SNY Afrezza reps are out in force educating the Endo's & PCP's. The sooner that this happens, coupled with supply, positive results, DTC..... The script numbers will rise. Once script numbers start rising significatly then it is game over for the shorts! When will all of this happen....now thats another question. I think we encounter the scripts inflection point early - late August. That's when all the stacked up advertising / educating / tier redux efforts start to get through the ~ 8 week prescription pipeline. This is how long the shorts have to play their games barring material corporate announcements.
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Post by esstan2001 on Jun 10, 2015 20:50:03 GMT -5
yeah another piece of journalistic karp.
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Post by esstan2001 on Jun 10, 2015 17:00:43 GMT -5
I've commented elsewhere - from the tour of the plant at the ASM - it's no big deal to switch dose sizes on the filling lines. They could easily do a small run on 1 line to provide enough 2U cartridges for a pedi clinical trial. But for right now, I would think that they keep running 4, 8, and 12U's to stockpile for immediate demand. and from what I recall they can run small trial batches in a prototyping line that is separate from any of the production lines- the same proto line was used for the PII & PIII batches if I recall correctly...
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Post by esstan2001 on Jun 10, 2015 10:03:35 GMT -5
This is the frustrating part - they still don't seem fully committed - No TV Ads. From Amy's post: "Sanofi does plan to begin a consumer advertising campaign towards the end of this year that will focus on digital and print, but no TV ads, according to Andrew Purcell, Head of the Diabetes Business Unit at Sanofi. They’re hoping to “demonstrate success” with the drug first, and also by then, the newly approved 12-unit cartridge will be available too (although personally I’d be more excited about a 2-unit option)." The line on "demonstrating success first" shows they are not all in on this yet. I caught this too, and can only hope that it is sandbagging to manage expectations- under promise, over deliver. I also note it is not consistent with what has been fed the investment community. we shall see.
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Post by esstan2001 on Jun 9, 2015 8:03:49 GMT -5
The NRx graph for Toujeo is just insane. When Afrezza was launched, I was expecting something like this. Basal Insulin Now the Gold Standard in Emerging Markets and Sanofi is Leading the Basal Segment - Pierre Chancel I hope this does not represent a paradigm that they blindly support to the inclusion of new T2 patients... maybe I am reading into this too much.
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Post by esstan2001 on Jun 5, 2015 9:45:08 GMT -5
It's illegal (other than for MM) if you naked short sell the stock. If you own the stock and do this it's OK. If your broker locates the shares, and you borrow the stock (paying interest on loaned shares) it is OK- this is non-naked shorting.
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Post by esstan2001 on Jun 5, 2015 7:45:28 GMT -5
I want to join MNKD's BOD! I only looked at one and saw that Nordhoff got almost 25 THOUSAND shares for ZERO cost! I saw somewhere that those guys get upwards of 500 grand a year to be on the board and just to pick up the phone for a conference call four times a year! I can do that easily. "substantive support"? Well, I thought pretty much everyone here got the proxy materials: proxy and from the proxy link you provided: In the fiscal year ended December 31, 2014, the total cash compensation paid to non-employee directors was $57,500.
Oscar, you can calm down now.
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Post by esstan2001 on Jun 3, 2015 14:27:59 GMT -5
Theres another manuf milestone. $25mil left. Most have suggested that its tied to the lines 2/3 startup. But could potentially be other things, like ordering of lines 4/5/6. As for the $50 mil matt referred to, it was the $50mil in January. He was just pointing out that it was "recent". Also, I mentioned this elsewhere, but he seemed to let the cat out of the bag regarding pain med/pulmonary being out of order on the list he gave. Everyone has been focused on pain first, but did he just suggest pulmonary med may be first? Its unusual for someone to say "not necessarily in that order" when the order on the slide was actually right. Agree that it is likely Pulmonary first, Pain next. (but hopefully Pain first for the shorts)
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Post by esstan2001 on Jun 3, 2015 13:23:13 GMT -5
Certainly looks qualified. Do we know that he is on board with Afrezza?
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Post by esstan2001 on Jun 3, 2015 12:10:34 GMT -5
In harry's two posts immediately preceding this one, I see no content using Firefox, and a strange "embed" error using IE. Is anyone else experiencing this? I see several "likes" on the one 3 posts back, so somebody must be seeing some content... very strange. On Firefox 36 I see it / Linux Fedora OS; Using Firefox on my home Woindows 7 Premium, not so much. Windows / Firefox plug in, or compatibility issue, I guess.
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