"We previously believed that we would reach a prespecified target total mortality number by the end of
1998. However, when the DSMB met in September 1998, they advised us that we should continue the
trial into 1999 in order to reach that figure."
IMO, they didnt seem to get the mortality rate they were expecting.
IMO, if it was unsafe, dsmb would not continue, nor would xoma insist
on "no safety concerns" in any trial thusfar.
IMO, if there was no benefit shown the DSMB would NOT ask for a
continuance past dec 98.
IMO, the DSMB is looking for some. Some say its a mortality number.
IMO, I do think that mortality in the UK may have been lower than expected..
IMO, I do think perhaps,that that may cause a extention to met a specified power.
I do think that xoma will or did meet with FDA prior to next dsmb for what if scenarios..
I do think there is a lot of secrecy surrounding this whole thing as there should be to prevent leaks and to preserve the intergity of the trial data.
I do not believe xoma knows the trial outcome yet
I do think we ALL have to just wait and see.
All IMO all disclaimers. Consider nothing as fact. Ever. |
