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CherryTree1

04/20/20 6:21 PM

#279145 RE: exwannabe #279142

This is what Linda said about the SAP at the ASM.

Similarly, we think that the careful process that we've gone through, which was lengthy, last year developing the statistical analysis plan, and now the data collection and confirmation and cross-checking will give us the most solid basis for looking at the results. This is a very important trial. It's one of the most important trials in the Glioblastoma space.


It is likely the need to capture that addition data came out of the pre-reviews of the SAP with the regulatory agencies - IMHO

Additionally during this time, we've been working on making the data collection as comprehensive as we can. For example, in regard to certain genetic analyses, one that folks have asked us a lot about, I mean everybody knows we've been gathering the data on MGMT methylation status. Another genetic measure that folks have asked us quite a bit whether we will be including is IDH mutation status. There have been challenges because of a lot of the bio samples that we've collected we collected years ago in the trial. However, I'm happy to say that we have identified a method that we believe will enable us to include the IDH mutation status that effort is underway at present it looks like it will be doable even on bio samples from years ago.