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Post by oscarlonzo on Apr 29, 2015 9:32:28 GMT -5
Just reading some of the comments suggests that perhaps some aren't aware of the limitations on how Sanofi "pitches" afrezza. Sanofi can claim NOTHING more than that afrezza is "non-inferior" to lispro. That and the fact that it doesn't require a needle for administration is ALL that the FDA will allow them to claim. Sales reps can point to the PK graph and note the more rapid decline in circulating insulin when compared to lispro, but they cannot claim that decline offers any superior therapeutic value. The docs will have to judge the data themselves and arrive at their own conclusions.
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Post by savzak on Apr 29, 2015 9:59:04 GMT -5
Just reading some of the comments suggests that perhaps some aren't aware of the limitations on how Sanofi "pitches" afrezza. Sanofi can claim NOTHING more than that afrezza is "non-inferior" to lispro. That and the fact that it doesn't require a needle for administration is ALL that the FDA will allow them to claim. Sales reps can point to the PK graph and note the more rapid decline in circulating insulin when compared to lispro, but they cannot claim that decline offers any superior therapeutic value. The docs will have to judge the data themselves and arrive at their own conclusions. The anecdotal evidence thus far is that users are seeing magnificent real world benefits to using Afrezza over any other therapy. Those benefits far exceed what Sonofi can "pitch".
Assuming that evidence is legitimate and assuming new users consistently see the same results, their doctors will become utterly convinced without having to be "pitched" any further. It won't be long before the Sanofi reps are smiling and nodding their heads as they listen to the Docs tell them how wonderful Afrezza is.
Also, I still have this goofy, naïve notion that Sanofi is working to improve the label.
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Post by bradleysbest on Apr 29, 2015 10:29:55 GMT -5
Hopefully they get a better label BEFORE the hard launch! With superior results , additional lines running, EU application, DTC advertising..... We might break above $5!
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Post by oscarlonzo on Apr 29, 2015 22:23:18 GMT -5
"The anecdotal evidence thus far..." Unfortunately, anecdotal evidence is just that -- "anecdotal." The real evidence won't show up for months, possibly years. My main point was that I see a lot of people looking forward to some "advertising campaign" by Sanofi and people disappointed that Sanofi isn't pushing it harder, and I thought everyone should remember that drug manufacturers have strict limits assigned by the FDA as to how much they can claim. So far, at least, the FDA is allowing Sanofi only to say that afrezza is "non-inferior" and that it doesn't require injection. Sanofi really doesn't have too much in the way of options beyond giving away free samples and hoping "word of mouth" accomplishes something.
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Post by joeypotsandpans on Apr 29, 2015 22:47:35 GMT -5
"The anecdotal evidence thus far..." Unfortunately, anecdotal evidence is just that -- "anecdotal." The real evidence won't show up for months, possibly years. My main point was that I see a lot of people looking forward to some "advertising campaign" by Sanofi and people disappointed that Sanofi isn't pushing it harder, and I thought everyone should remember that drug manufacturers have strict limits assigned by the FDA as to how much they can claim. So far, at least, the FDA is allowing Sanofi only to say that afrezza is "non-inferior" and that it doesn't require injection. Sanofi really doesn't have too much in the way of options beyond giving away free samples and hoping "word of mouth" accomplishes something. SNY may be limited what they print and say/pitch BUT that doesn't mean they can't have the actual users say what they want when it comes to the DTC advertising and conferences, etc. I've said it before and I'll say it again, TRUTH IS A FACT in any setting whether it be the public forum or a courtroom...and that is where the numbers from the early adopters can be exploited as their numbers don't lie ....love those A1c projections, lets see them come to fruition in actual lab results...the owners of those numbers can tout/shout to the world or put labels on their bodies ie., t shirts, tattoo's, across their foreheads etc.etc. and there is not one thing the FDA can do about that is there? Spiro lets see that new tatoo lol
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Post by jpg on Apr 29, 2015 22:50:49 GMT -5
"The anecdotal evidence thus far..." Unfortunately, anecdotal evidence is just that -- "anecdotal." The real evidence won't show up for months, possibly years. My main point was that I see a lot of people looking forward to some "advertising campaign" by Sanofi and people disappointed that Sanofi isn't pushing it harder, and I thought everyone should remember that drug manufacturers have strict limits assigned by the FDA as to how much they can claim. So far, at least, the FDA is allowing Sanofi only to say that afrezza is "non-inferior" and that it doesn't require injection. Sanofi really doesn't have too much in the way of options beyond giving away free samples and hoping "word of mouth" accomplishes something. We certainly all know the rules about marketing limits by the FDA (the label) and agree with you that Sanofi has limited marketing options for now but fortunately they have an amazing product to sell and diabetics are slowly finding this out on their own. It will take many months (as I've been saying fro a while) but I really doubt it will take years for this message to catch on. It's not word of mouth anymore. Diabetics are organized and cautiously interested in having better options. There are some highly sophisticated and influential diabetics out there. The number one thing for the majority of patients is patient experience. Some may call it anecdotal but nothing move opinion more then a good experience with a product or drug. The most powerful motivator for a clinician is a well treated and satisfied patient. Medicine is as much if not more shaped by these anecdotal experiences as by FDA rules. This is why I so disagree with the 'diabetic expert' Kliff today (Forbes article) who says good patient experience is meaningless in 'the business of diabetes'. It actually sounds repulsive to my ears that patient experience doesn't count. It's all about the patients really...
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Post by dstevenson on May 1, 2015 11:24:50 GMT -5
Someone that will be there, can you ask Mannkind business model?
We have no idea what they are doing now that their only drug in the pipeline is approved
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Post by mnkdorbust on May 1, 2015 11:28:14 GMT -5
The rate things are going and how attitudes have changed due to SP i hope they have metal detectors. Will be listening in but unable to attend in person. All loose change is going into shares.
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Post by orlon on May 3, 2015 16:39:16 GMT -5
Maybe someone should ask Matt, Hakan or anyone else in management, at what point, prior to becoming a penny stock again, do they start to communicate with the stockholders...you know, the little people, about future plans.
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Post by Deleted on May 3, 2015 17:19:22 GMT -5
Becoming a penny stock again?
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Post by benh on May 4, 2015 3:31:49 GMT -5
Why would label improvements take years? I've seen label improvements <6months. 12weeks is a common real world A1c check. It's a universally accepted measure. I don't see why this would take more than 6months.
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Post by bradleysbest on May 13, 2015 12:11:51 GMT -5
What are the general feelings for those who will be attending the share holder meeting next week? Is anyone going to ask the difficult questions? For those attending ...SAFE TRAVELS!
PS.... Can the share price get any lower!
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Post by wiscdh on May 14, 2015 10:18:40 GMT -5
For those attending the shareholders meeting, can one of you ask what is being done right now to ensure a smoother startup in other countries. The excuses given last week on the slow launch should be a lessons learned prior to Afrezza being approved in other countries. Specifically, spirometer (?) equipment. What is Mannkind doing now to prepare for launches in other countries?
Thank you.
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Post by seanismorris on May 14, 2015 10:36:36 GMT -5
Yes, it can go lower...
Until Sanofi shows their hand (either by improving the label or marketing) there is no way for shareholders to know if Afrezza is not just a fantastic but niche product. If we are looking at sales of 300M (100M for Mannkind) then it's possible Mannkind won't be able to keep the doors open. And, without greater details on Mannkinds R&D the Shorts have free rain.
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Post by ezrasfund on May 14, 2015 10:53:53 GMT -5
Going lower? I would say that each Friday's prescription count will tell the story. If NRX spikes we are headed up. If it is flat we are headed lower.
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