Bad luck [Study As­sess­ment]

posted by Mikalai  – Belarus, 2018-08-01 13:50  – Posting: # 19123
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Hi Helmut

» You can’t change the protocol once the study is done, right?

I meant the final report not the protocol, sorry. I thought that something like clinical pharmacology of the drug may, to some extent, reassure our NCA that safety and efficacy are not at risk?

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