Monday, February 06, 2017 6:45:21 PM
JL-
The Co does not have "any, real" influence on the process.
1.) Start of the IA process: I do not know, how / who start the process exactly ... it is initiated by the Co or somebody else ... but let's assume by the Co when they know:
- enough events (adjudicated occurrence) AND enough occurrence in the adjudication process for required events (it was the case at 1st IA) or
- enough events for required events (it takes more time, occur at a later date)
2.) site visit by patients - it will take more or less the same time as at 1st IA
3.) data checking - it will be significantly shorter as 16k vs 36k (at 1st IA) data (site visits)
4.) Statistical analysis and DMC - it will take more or less the same time as at 1st IA
Co could "manage" 1 above only, but not the 2-4.
In case of stop: it will be announced, but the process above will be repeated
In case of cont.: the process above will be repeated after final / last event
Best,
G
The Co does not have "any, real" influence on the process.
1.) Start of the IA process: I do not know, how / who start the process exactly ... it is initiated by the Co or somebody else ... but let's assume by the Co when they know:
- enough events (adjudicated occurrence) AND enough occurrence in the adjudication process for required events (it was the case at 1st IA) or
- enough events for required events (it takes more time, occur at a later date)
2.) site visit by patients - it will take more or less the same time as at 1st IA
3.) data checking - it will be significantly shorter as 16k vs 36k (at 1st IA) data (site visits)
4.) Statistical analysis and DMC - it will take more or less the same time as at 1st IA
Co could "manage" 1 above only, but not the 2-4.
In case of stop: it will be announced, but the process above will be repeated
In case of cont.: the process above will be repeated after final / last event
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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