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Hi Helmut,
Thanks for your kind and considered response.
To answer your question on the origin of the concerns-
I was not at first unduly concerned- the study was submitted. However, a well regarded EU regulatory agency has raised objections on public health grounds. Treatment by period interaction has been mentioned. I can't see how that could arise given that the design of the study is fine and assuming there was no major issue in the conduct of the study. I can only infer that the agency suspects that the study has not been executed correctly but is not prepared to say so in black and white. Have you encountered this kind of response?
Thanks & Regards
Thanks for your kind and considered response.
To answer your question on the origin of the concerns-
I was not at first unduly concerned- the study was submitted. However, a well regarded EU regulatory agency has raised objections on public health grounds. Treatment by period interaction has been mentioned. I can't see how that could arise given that the design of the study is fine and assuming there was no major issue in the conduct of the study. I can only infer that the agency suspects that the study has not been executed correctly but is not prepared to say so in black and white. Have you encountered this kind of response?
Thanks & Regards
Complete thread:
- Good News, Bad News Datacollector 2019-07-27 12:09 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Good News only Helmut 2019-07-27 13:15
- Good News only, but not according to someDatacollector 2019-07-27 13:34
- ’Some’ should read the GL (and again, and again) Helmut 2019-07-27 13:48
- Good News only, but not according to some ElMaestro 2019-07-27 13:50
- My stuff Helmut 2019-07-27 16:55
- My stuff ElMaestro 2019-07-27 17:38
- My stuff Datacollector 2019-07-27 19:13
- ≡ Helmut 2019-07-27 23:53
- Sequence effect Vs Subject effect? mittyri 2019-07-28 15:19
- Sequence effect Vs Subject effect? Helmut 2019-07-28 15:59
- Sequence effect Vs Subject effect? mittyri 2019-07-28 16:20
- Oops! Helmut 2019-07-28 16:36
- Sequence effect Vs Subject effect? mittyri 2019-07-28 16:20
- Sequence effect Vs Subject effect? Helmut 2019-07-28 15:59
- Sequence effect Vs Subject effect? mittyri 2019-07-28 15:19
- ≡ Helmut 2019-07-27 23:53
- My stuff Datacollector 2019-07-27 19:13
- My stuff ElMaestro 2019-07-27 17:38
- My stuff Helmut 2019-07-27 16:55
- Good News only, but not according to someDatacollector 2019-07-27 13:34
- Good News only Helmut 2019-07-27 13:15
Ing. Helmut Schütz