Biotech / Related Ideas

[ruengies3]

Gfp, does this sound like a reasonable explanation to you? The response is from Randychub. (Note: I'm down to having only one post reamining for the day, so I'm going to be very selective. Or -- God forbid -- I may have to buy a membership!)

ruengies3 - "The statistical analysis utilized a modified intent to treat and an ANOVA (ANalysis Of VAriation) model to determine the treatment effects for the four arm study and certain assumptions used were not specified in the statistical analysis plan (SAP)."


The key here is the "not specified in the statistical analysis plan". Cobalis did not specify the entire plan used to the FDA when they recieved approval to run the first trial. The same plan is being used, only this time the entire plan was approved by the FDA. The FDA is very Picky.

Hope this is helpful!

Randy