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djs7

01/12/18 3:45 PM

#212645 RE: Rdunn88 #212643

How about the wording in the CDA agreement that could say

"At any time, the interested parties may request a delay or postponement of the interim analysis
while intermittent case reports and analysis are shared from the sponsor IPIX."


As for the 2Q interim analysis, remember the trial originally had a completion date of July 2017. It did not finish til end of December 2017. The delays in enrollment may have pushed an intended Q2 interim analysis to Q3. By such time, a majority of patients had completed at least 6 weeks therapy.

groton68

01/12/18 3:46 PM

#212646 RE: Rdunn88 #212643

Interim postponed because it could affect people’s behavior who were participating