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Biotech / Medical : Biotech Valuation
CRSP 53.80+2.6%Jan 2 9:30 AM EST
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To: Biomaven who wrote (5082)12/7/2001 10:06:27 AM
From: Ian@SI   of 52153
 
RE PDLI / Zamyl: What am I missing? The following news "bites" seem to state that Zamyl missed its primary endpoint, yet PDLI intends to proceed with BLA!!! Are heads buried in the sand???

06:55 ET Protein Design (PDLI) 40.57: Reports positive clinical results from the Phase III trial of its humanized antibody Zamyl in patients with acute myeloid leukemia. An initial review of the data by PDLI indicates that Zamyl increased the overall response rate to 43% in the Zamyl plus chemotherapy patients. Co currently anticipates completing the filing of a BLA in the second half of 2003.

08:58 ET Protein Design (PDLI) 40.57: -- Update -- Co states in this morning's press release on its Zamyl trial that further analysis that required the complete response to occur within 70 days of the initiation of therapy -- which was the prospectively defined primary endpoint of the trial -- did not demonstrate statistically significant differences between the two arms of the trial. PDLI shares trading at $39 in pre-market.

09:08 ET Protein Design (PDLI) 40.57: --Update-- CIBC World Markets believes Phase III Zamyl data will clearly support approval of Zamyl for the treatment of refractory/relapsed AML, despite the trial not achieving statistical significance; says Zamyl has twice the response rate of AHP's drug Mylotarg and a better safety profile.
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