Tuesday, January 17, 2017 12:32:52 PM
Thanks
Furthermore: meanwhile official explanation - lock data / save time @ final analysis & FDA confirmation / buy-in - is true I do not think it is the "full" reason
- FDA "buy-in" was granted with acceptance of Final Statistical Analysis Plan and additional SEs. 2nd IA wasn't necessary for this purpose
- (For simplicity I am using the full 1st IA duration: 165 days) App. 220 data was checked and locked per day during 1st IA (app. 36k data, inc. site visit due to 1st IA). App. 8k new data (exc. site visit due to 2nd IA) will be locked @ 2nd IA and they will save max 36 days at final (of course the real "saving" will be less since 1st IA 165 days contain the site visit, statistical analysis and DMC process also). It does not look for me as worth the effort and money of 2nd IA.
Best,
G
#STRONGERTOGETHER
Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.
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