From the Xoma web site:
"Was this additional review part of the original statistical plan for the trial? (9/98)
The protocol allows the DSMB to recommend additional reviews (as they did in March when they recommended the September interim analysis). An
additional review gives the DSMB the opportunity to take a final look at the results. If the trial design requires any final adjustments, we can make
them. If the data are sufficiently positive, we can get a head start with the regulatory authorities."
While it is complete conjecture on my part, I believe the statement above suggests Neuprex is exhibiting little, if any, efficacy. If after 2 years, the trial results indicated therapeutic efficacy, the DSMB would surely not jeopardize the statistical integrity of this trial by altering it near the very end. If the data were sufficiently positive, the DSMB would recommend ending the trial now, realizing an additional 2 months of data would not produce a relatively significant change to the 2 years of data heretofore accumulated. Or perhaps the trial design left something to be desired. Either way, it appears as a negative development. For the sake of the company, investors, and potential targeted patients, I hope my opinions are proven incorrect.
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