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Post by kite on Jun 27, 2018 8:59:47 GMT -5
Is anyone here attending this event today? In another thread, you said you registered and reported that Mannkind said they would send you a confirmation. Did they, and are YOU attending? They did and I got the confirmation yesterday. I'm planning to attend but can't stay the entire time because I need to make it back for a 130 meeting. |
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Post by oldfishtowner on Jun 27, 2018 9:14:33 GMT -5
There is a lot of misguided information being tossed about regarding the STAT study.
Clinicaltrials.gov does describe the STAT study as a phase 4 study, but it also says it is a pilot study and not a pivotal study, that is, it is to provide information to guide further research, likely a pivotal study that would have more subjects and be of longer duration, namely, the dynamic dosing study.
The STAT study is what it is. Let's not over hype it or dismiss it out of hand. There are issues with how the data were analyzed and presented, but the results are positive and sufficiently convincing, and together with the hypo paper, as Peppy rightly points out, sends a powerful message.
However, the 2018 standards of care, has a new suggestion. Trials with Continuous glucose monitors with a two week time frame. The STAT doubles the new CGM suggested two week trial time frame. As you say, it is only a suggestion at this time.
And even if we accept the shorter time frame, that would not impact the larger number of subjects that are required in pivotal studies or that the STAT study has or should have the weight of a pivotal study.
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Post by peppy on Jun 27, 2018 10:43:53 GMT -5
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Post by goyocafe on Jun 27, 2018 11:00:09 GMT -5
Edelman is working with Onduo, too, right?
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Post by mnkdorbust on Jun 27, 2018 11:02:51 GMT -5
Anyone hearing anything? All i get currently is screen that says off air
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Post by goyocafe on Jun 27, 2018 11:03:14 GMT -5
Anyone hearing anything? All i get currently is screen that says off air Same here. |
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Post by akemp3000 on Jun 27, 2018 11:03:23 GMT -5
Anyone hearing anything? All i get currently is screen that says off air Same here |
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Post by sla55 on Jun 27, 2018 11:03:30 GMT -5
Anyone hearing anything? All i get currently is screen that says off air Off air here also |
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Post by esstan2001 on Jun 27, 2018 11:04:05 GMT -5
When the link went live, it said 'off air'; now I do not even get the frame overlay for the slide deck...
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Post by akemp3000 on Jun 27, 2018 11:05:28 GMT -5
Coming on now
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Post by mnkdorbust on Jun 27, 2018 11:05:45 GMT -5
Mine went live but still at the opening screen. Baby steps!
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Post by goyocafe on Jun 27, 2018 11:07:57 GMT -5
I'm sure they test these things before the start of the meeting, right? RIGHT!?
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Post by akemp3000 on Jun 27, 2018 11:08:17 GMT -5
False alarm. Showing first slide but no action yet.
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Post by mnkdorbust on Jun 27, 2018 11:09:47 GMT -5
Audio!
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Post by mnkdorbust on Jun 27, 2018 11:10:28 GMT -5
ohhh man. reminds me of some old day conference calls when the mic is on and nobody knew it.
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