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Biotech / Medical : Pharmacyclics (PCYC)
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To: Miljenko Zuanic who wrote (627)8/13/2001 10:28:15 AM
From: keokalani'nui  Read Replies (2) of 717
 
Miljenko:

The co-primary end-points of the study are survival and time-to-neurologic progression. Statistically significant improvement in either will satisfy the primary end point of the trial. A DSMB will monitor the study by analyzing interim data two-thirds of the way for possible early termination in the event of significant efficacy or unacceptable toxicity.

[This is really old, but gives a sense of the co's guess of the period for data analysis.] In May ’00 it was 2/3 enrolled, they expected enrollment to be complete by end of 2000, then 6 months for data analysis and announcement, with a filing in 2002. They hadn’t heard anything about DSM’s interim look at that time, but it may have been too early.

The results of the lead-in portion sounded promising, however.

Wilder
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