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Post by kball on Dec 10, 2015 13:56:24 GMT -5
And we know 2 of the 12 Afrezza users that presented their situation to the advisory board! . He's a huge Afrezza advocate and is well respected by the masses. This is the first time I actually feel a BO might be in the works. Ladies and Gentlemen, your new CEO, Sam Finta! |
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Post by Deleted on Dec 10, 2015 14:00:12 GMT -5
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Post by bill on Dec 10, 2015 14:01:13 GMT -5
I meant he might have signed an NDA. May well have signed an NDA... likely did. I just don't understand why this meeting having patients and doctors talk about Afrezza would at all give you a reason to think that a BO is in the works. These medical advisory meetings are common practice. I agree with you. That meeting, no matter what the results and a buyout can't have any strong correlation. OTOH, it could be an indication that SNY's getting closer to a full launch for Afrezza as they gather and hopefully plan to use real-world results in their advertising to mitigate some of the label limitations. I don't think that's prohibited. If none of the existing drugs have allowed PWDs to achieve non-diabetic numbers consistently with low episodes of hypoglycemia, and you can get patient data and testimonials to the fact that they're not only getting great results, but that it's easier and less intrusive on their lives, that would be cool. It would even be cooler if the ads warned patients that their endos and physicians may not be up to completely up to speed on the unique properties of Afrezza. They could then provide a physician help line and web site where physicians could go to get better educated on Afrezza  . |
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Post by stevil on Dec 10, 2015 14:05:23 GMT -5
May well have signed an NDA... likely did. I just don't understand why this meeting having patients and doctors talk about Afrezza would at all give you a reason to think that a BO is in the works. These medical advisory meetings are common practice. I agree with you. That meeting, no matter what the results and a buyout can't have any strong correlation. OTOH, it could be an indication that SNY's getting closer to a full launch for Afrezza as they gather and hopefully plan to use real-world results in their advertising to mitigate some of the label limitations. I don't think that's prohibited. If none of the existing drugs have allowed PWDs to achieve non-diabetic numbers consistently with low episodes of hypoglycemia, and you can get patient data and testimonials to the fact that they're not only getting great results, but that it's easier and less intrusive on their lives, that would be cool. It would even be cooler if the ads warned patients that their endos and physicians may not be up to completely up to speed on the unique properties of Afrezza. They could then provide a physician help line and web site where physicians could go to get better educated on Afrezza . I think we found our new MNKD CEO |
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Post by dreamboatcruise on Dec 10, 2015 14:06:57 GMT -5
I don't think we can infer enthusiasm from the San Diego attendees to reflect anything more than the event went as well as expected from their perspective. That may turn out to mean something, or nothing at all but it's sure better than if the attendees were bummed out when they left . Wow, that's interesting. I've always wondered whether SNY could use real-world data like that to help gain an improved label, or at least use it in their marketing. After all it is objective data, e.g., "some T1 Afrezza users have been able to achieve non-diabetic A1c values." I can't imagine anyone quibbling with that statement if it's backed up with numbers and lab reports. No, the FDA does not allow that. It is not like a supplement where you can show one person that has lost 100 lbs with small type at the bottom of the screen saying "results may vary". This would circumvent the entire FDA process... and it is bad science. You can't pick a group of users because they have been proactive in promoting benefits of Afrezza (i.e. in scientific experiment terms... self selection) and present that as expected results for a wider population. That said, I think in doctor to doctor education meetings they might be able to use observational anecdotes as long as it is clearly presented as anecdotal (perhaps some of our docs would know the constraints in that case). Also, I really do not think a study to show superiority would need to be huge, long and expensive. SNY simply needs to do that. That will be what allows a better label and better marketing material and adverts for consumers. The results of the early adopters are real and I certainly think they are more indicative of the potential of Afrezza than were the FDA clinical trials with their very suboptimal protocols. |
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Post by bradleysbest on Dec 10, 2015 14:07:33 GMT -5
Agree that there is no buyout right now. I would rather see some headway in insurance, scripts, DTC, trials etc before MNKD even considers a buyout! Al is smarter than the average bear!
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Post by mssciguy on Dec 10, 2015 14:08:25 GMT -5
kball please quit changing colors like that. It's just GSEC fleecing weak hands, k?
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Post by dreamboatcruise on Dec 10, 2015 14:10:54 GMT -5
kball please quit changing colors like that. It's just GSEC fleecing weak hands, k? Even a Chameleon isn't changing colors over it. |
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Post by mssciguy on Dec 10, 2015 14:13:30 GMT -5
kball please quit changing colors like that. It's just GSEC fleecing weak hands, k? Even a Chameleon isn't changing colors over it. funny you should mention that dreamboatcruise .. .just this past summer, I saw the first chameleon in my backyard 15 years ago, this was a cornfield, it is so amazing how life goes on. |
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Post by Deleted on Dec 10, 2015 15:34:04 GMT -5
Wow, that's interesting. I've always wondered whether SNY could use real-world data like that to help gain an improved label, or at least use it in their marketing. After all it is objective data, e.g., "some T1 Afrezza users have been able to achieve non-diabetic A1c values." I can't imagine anyone quibbling with that statement if it's backed up with numbers and lab reports. No, the FDA does not allow that. It is not like a supplement where you can show one person that has lost 100 lbs with small type at the bottom of the screen saying "results may vary". This would circumvent the entire FDA process... and it is bad science. You can't pick a group of users because they have been proactive in promoting benefits of Afrezza (i.e. in scientific experiment terms... self selection) and present that as expected results for a wider population. That said, I think in doctor to doctor education meetings they might be able to use observational anecdotes as long as it is clearly presented as anecdotal (perhaps some of our docs would know the constraints in that case). Also, I really do not think a study to show superiority would need to be huge, long and expensive. SNY simply needs to do that. That will be what allows a better label and better marketing material and adverts for consumers. The results of the early adopters are real and I certainly think they are more indicative of the potential of Afrezza than were the FDA clinical trials with their very suboptimal protocols. I thought there was a recent court ruling that said a pharma company can make product performance claims if they believed them to be true or had some type of supporting documentation beyond trials. I know this would be a can of worms, sorry I do not have the link for it. When you say superiority you mean lower A1c, less volatility in day to day blood glucose readings, weight loss or some or all of these combined with xx% reduction in basal dosage? |
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Post by mssciguy on Dec 10, 2015 15:39:17 GMT -5
@scotta there are dozens of FDA studies, but sadly over the past couple of decades, big pharma pays FDA for the process, it's been corrupted by money. Not much more to say, but the patent life here is long enough to withstand the attacks of other big pharma in my opinion, and any investor who does not agree with this investment should not be here.
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Post by factspls88 on Dec 10, 2015 15:48:38 GMT -5
Wow, that's interesting. I've always wondered whether SNY could use real-world data like that to help gain an improved label, or at least use it in their marketing. After all it is objective data, e.g., "some T1 Afrezza users have been able to achieve non-diabetic A1c values." I can't imagine anyone quibbling with that statement if it's backed up with numbers and lab reports. No, the FDA does not allow that. It is not like a supplement where you can show one person that has lost 100 lbs with small type at the bottom of the screen saying "results may vary". This would circumvent the entire FDA process... and it is bad science. You can't pick a group of users because they have been proactive in promoting benefits of Afrezza (i.e. in scientific experiment terms... self selection) and present that as expected results for a wider population. That said, I think in doctor to doctor education meetings they might be able to use observational anecdotes as long as it is clearly presented as anecdotal (perhaps some of our docs would know the constraints in that case). Also, I really do not think a study to show superiority would need to be huge, long and expensive. SNY simply needs to do that. That will be what allows a better label and better marketing material and adverts for consumers. The results of the early adopters are real and I certainly think they are more indicative of the potential of Afrezza than were the FDA clinical trials with their very suboptimal protocols. Dreamboat I agree completely with you, particularly with respect to the length and cost of a study to prove superiority. |
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Post by lakers on Dec 10, 2015 16:06:49 GMT -5
No, the FDA does not allow that. It is not like a supplement where you can show one person that has lost 100 lbs with small type at the bottom of the screen saying "results may vary". This would circumvent the entire FDA process... and it is bad science. You can't pick a group of users because they have been proactive in promoting benefits of Afrezza (i.e. in scientific experiment terms... self selection) and present that as expected results for a wider population. That said, I think in doctor to doctor education meetings they might be able to use observational anecdotes as long as it is clearly presented as anecdotal (perhaps some of our docs would know the constraints in that case). Also, I really do not think a study to show superiority would need to be huge, long and expensive. SNY simply needs to do that. That will be what allows a better label and better marketing material and adverts for consumers. The results of the early adopters are real and I certainly think they are more indicative of the potential of Afrezza than were the FDA clinical trials with their very suboptimal protocols. I thought there was a recent court ruling that said a pharma company can make product performance claims if they believed them to be true or had some type of supporting documentation beyond trials. I know this would be a can of worms, sorry I do not have the link for it. When you say superiority you mean lower A1c, less volatility in day to day blood glucose readings, weight loss or some or all of these combined with xx% reduction in basal dosage? Insulin Human (Afrezza) Compared with other rapid-acting insulins: • Peaks faster and offsets faster • When added to basal insulin, equivalent A1C lowering • Lower postprandial blood glucose • Less delayed hypoglycemia Can be used in Type 1 diabetes in addition to a basal insulin (long acting insulin or basal rate via an insulin pump) Can be used in Type 2 diabetes in addition to orals alone, orals and basal, or MDI regimens Clin. Ther., 2014;Vol 36:Number 8: 1275-1289. Read more: mnkd.proboards.com/thread/4459/hilton-santa-clara-ultra-afrezza#ixzz3txDZDhwE |
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Post by slapshot on Dec 10, 2015 17:06:01 GMT -5
No, the FDA does not allow that. It is not like a supplement where you can show one person that has lost 100 lbs with small type at the bottom of the screen saying "results may vary". This would circumvent the entire FDA process... and it is bad science. You can't pick a group of users because they have been proactive in promoting benefits of Afrezza (i.e. in scientific experiment terms... self selection) and present that as expected results for a wider population. That said, I think in doctor to doctor education meetings they might be able to use observational anecdotes as long as it is clearly presented as anecdotal (perhaps some of our docs would know the constraints in that case). Also, I really do not think a study to show superiority would need to be huge, long and expensive. SNY simply needs to do that. That will be what allows a better label and better marketing material and adverts for consumers. The results of the early adopters are real and I certainly think they are more indicative of the potential of Afrezza than were the FDA clinical trials with their very suboptimal protocols. I thought there was a recent court ruling that said a pharma company can make product performance claims if they believed them to be true or had some type of supporting documentation beyond trials. I know this would be a can of worms, sorry I do not have the link for it. When you say superiority you mean lower A1c, less volatility in day to day blood glucose readings, weight loss or some or all of these combined with xx% reduction in basal dosage? This may be the decison that Scotta is referring: www.nytimes.com/2015/08/11/business/dealbook/fdas-off-label-drug-policy-leads-to-free-speech-fight.html?_r=0(Based on a quick skimming) It looks like the case involved 'off-label' promotions (or promoting a FDA approved drug for a non FDA approved use) and references a 2012 appeals court decision. Both rulings seem to support a free speech argument and posit the idea that as long as the promotion is truthful (not fraudulent) it is ok... the FDA will likely appeal. |
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Post by nylefty on Dec 10, 2015 17:56:53 GMT -5
I thought there was a recent court ruling that said a pharma company can make product performance claims if they believed them to be true or had some type of supporting documentation beyond trials. This may be the decison that Scotta is referring: www.nytimes.com/2015/08/11/business/dealbook/fdas-off-label-drug-policy-leads-to-free-speech-fight.html?_r=0(Based on a quick skimming) It looks like the case involved 'off-label' promotions (or promoting a FDA approved drug for a non FDA approved use) and references a 2012 appeals court decision. Both rulings seem to support a free speech argument and posit the idea that as long as the promotion is truthful (not fraudulent) it is ok... the FDA will likely appeal. The ruling was by one federal judge in New York City. The FDA is sure to appeal, to a three-judge panel in the first judge's district and/or to the Second Circuit Court of Appeals; and no matter what those courts decide, the case could go to the U.S. Supreme Court. Until the appeals have been decided the first judge's ruling will have no effect on other cases. By the way, no matter what the 2nd Circuit decided, technically its ruling would only apply in the 2nd Circuit, not nationwide. Another circuit could rule differently, setting up a final decision by the Supremes. |
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