Dissection>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>>>>>>Partial company release with my comments>>>>>>>>>>>>
Berkeley, CA -- March 9, 1999 -- XOMA Ltd. (Nasdaq: XOMA) today announced that an independent Data Safety Monitoring Board (DSMB) has advised the Company that it should continue to enroll patients in its Phase III NEUPREX® meningococcemia trial until the prespecified overall mortality number is met.
>>>>Thats their advise but is it mandatory ?<<<<<
The DSMB has not identified any safety issues. The double-blinded, placebo-controlled pivotal trial has enrolled 370 patients to date in hospitals in the United States and United Kingdom.
"With the United Kingdom providing the majority of our patients, total enrollment has been higher than anticipated, but the overall mortality rate in the trial has been lower than originally projected,"
>>>>Why is that ?<<<<<
said Jack Castello, Chairman, President and CEO of XOMA. "Nonetheless, we believe that we are now close to reaching the specified number, allowing us to conclude accrual with the statistical power called for in our trial design."
>>>>so does close enough> ALLOW conclusion at any time??<<<<
The Company is in consultation with European and U.S. regulatory authorities about its filings to both agencies.
>>>>Interesting, dont you think <<<<<
Once enrollment is complete there will be a 90-day follow-up period on the last patients enrolled before results are available and analysis can begin.
>>>>>is that full results or preliminary results ?<<<<<<
>>>wondering if they could take arbitrary number like 300 to do a preliminary trend analysis? <<<< (I doubt it BTW)
>>>>Pure speculation on my part, absolutely no basis in fact<<<<<
All very clintonesque (perhaps) IMO. Accept nothing as fact.........StandardK. |
