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Investor2014

08/03/24 7:57 PM

#466295 RE: Hosai #466293

Read and think about this in context of the trial design and its Intention-To-Treat population.

“Lower n is less ideal but it makes it harder to show a low p value so does in a sense show consistent efficacy strength in that regard.”

To help with the exercise, read my post about ITT vs Complete analysis.
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frrol

08/03/24 10:15 PM

#466310 RE: Hosai #466293

It was great to see the EMA was receptive to us asking to submit an MAA. Keep in mind that it is rapporteurs, appointed by the CHMP, that will evaluate the submission.

Re completion percentages, my point was on our absolute number of completers.