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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (627)	8/10/2001 7:00:42 PM
From: Biomaven	Read Replies (1) \| Respond to of 717

Miljenko, From their 10-K: We will follow all patients for a minimum of 6 months after treatment or until death. The study will measure survival, time-to-neurologic progression, tumor response by magnetic resonance imaging and quality of life. The co-primary end-points of the study are survival and time-to-neurologic progression assessed by neurological examinations and neurocognitive testing. Statistically significant improvement in either survival or time-to-neurologic progression will be considered as satisfying the primary end point of the trial, and may provide the basis of a marketing approval. Note that patients with brain mets typically have about a 4 month survival time. I haven't been following PCYC as closely as I use to, but I think that enrollment was recently completed. So maybe you're right about first half '02 as a more realistic date for them to report their results. Peter

To: Miljenko Zuanic who wrote (627)	8/13/2001 10:28:15 AM
From: keokalani'nui	Read Replies (2) \| Respond to 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