Good News only, but not according to some [Study As­sess­ment]

posted by Datacollector – United Kingdom, 2019-07-27 13:34  – Posting: # 20450
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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

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