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BTH

11/10/10 3:52 PM

#3258 RE: gdollasign #3256

It would surprise me if we didnt know the results by the end of November.



So Harvey was lying when he said First Quarter of 2011?

You do know that November of 2010 isn't Q1, 2011, right?

exwannabe

11/10/10 4:00 PM

#3259 RE: gdollasign #3256

My thought is that statistics in general is an immediate science. They know within a day on a macro basis and within a week on a micro basis. It would surprise me if we didnt know the results by the end of November.



Take a look at the process.

The data is collected into the database, and VERY, VERY carefully double checked (scrubed) to insure nothing is wrong (it is still blinded wrt trial arm at this point).

Once everybody is happy with this, the dataset is "locked" and the arm data is released to unblind the trial. At this point, errors in the data can not be fixed. The FDA will NOT let you say, "oops, there was a typo there, as you can tell from the original biopsy". Sloppiness here could cost you the entire trial. So this process can take months.

At that point the stat folks can get busy, and I agree the top line data is known internally almost immediately (after the locking and unblinding)