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Posted On: 07/03/2020 10:14:53 AM
Post# of 154120
There could be a number of reasons to wait:
1). Most likely is because it strengthens the statistical power of the trial, thereby increasing odds of acceptance of the data from an "early peek"
2). FDA may have encouraged us to wait due to above. Or they may want us to have our distribution channel in place before any data is released.
3). We may be in negotiations of some type that would be impacted by a release of data.
4). The Data and safety monitoring group may have decided not to allow an interim review yet.
1). Most likely is because it strengthens the statistical power of the trial, thereby increasing odds of acceptance of the data from an "early peek"
2). FDA may have encouraged us to wait due to above. Or they may want us to have our distribution channel in place before any data is released.
3). We may be in negotiations of some type that would be impacted by a release of data.
4). The Data and safety monitoring group may have decided not to allow an interim review yet.
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