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Hi Sam,
I don't know how they will react. If you have a PE of 0.79 in one pivotal trial and the next trial passes with flying colors and PE close to 1.00 then I think an eyebrow might be raised here and there.
❝ One last suggestions I need from your end, if we go to repeat the whole study without any solid reason except the unexpected PE compared to the pilot study. What will be regulatory queries consequence with the regulatory approval. Will they approve our products based on the new data if it qualifies after repeat.
I don't know how they will react. If you have a PE of 0.79 in one pivotal trial and the next trial passes with flying colors and PE close to 1.00 then I think an eyebrow might be raised here and there.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Regulatory Query for study repeat sam 2013-07-27 07:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Repeats ElMaestro 2013-07-27 11:01
- Repeats sam 2013-07-27 11:18
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:57
- RepeatsElMaestro 2013-07-27 12:27
- Repeats sam 2013-07-27 12:45
- Bad science Helmut 2013-07-27 14:15
- Bad science sam 2013-07-28 09:05
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Posting style & incomplete information sam 2013-07-29 06:46
- RTFM! Helmut 2013-07-29 07:53
- RTFM! sam 2013-07-29 08:40
- copy & paste error or what? Helmut 2013-07-29 11:14
- copy & paste error or what? sam 2013-07-29 12:46
- copy & paste error or what? Helmut 2013-07-29 11:14
- Calm down! jag009 2013-07-29 16:06
- RTFM! sam 2013-07-29 08:40
- Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
- Futility rule? Helmut 2013-07-29 12:16
- Futility rule? ElMaestro 2013-07-29 12:46
- Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
- PE of AUC? Helmut 2013-07-29 12:45
- PE of AUC? sam 2013-07-29 12:56
- EOD Helmut 2013-07-29 13:18
- PE of AUC? sam 2013-07-29 12:56
- PE of AUC? Helmut 2013-07-29 12:45
- Futility rule? Helmut 2013-07-29 12:16
- Posting style & incomplete information jag009 2013-07-29 16:32
- Posting style & incomplete information sam 2013-07-30 06:08
- RTFM! Helmut 2013-07-29 07:53
- Posting style & incomplete information sam 2013-07-29 06:46
- Bad science ElMaestro 2013-07-28 12:43
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Bad science sam 2013-07-28 09:05
- RepeatsElMaestro 2013-07-27 12:27
- Repeats jag009 2013-07-27 22:17
- Repeats ElMaestro 2013-07-27 23:11
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:18
- Regulatory Query for study repeat jag009 2013-07-27 22:29
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- More questions.. jag009 2013-07-30 16:53
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Repeats ElMaestro 2013-07-27 11:01
Ing. Helmut Schütz