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Biotech / Medical : Protein Design Labs (PDLI): Stock strong
PDLI 2.4700.0%Jan 18 4:00 PM EST
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To: nigel bates who wrote (191)12/7/2001 12:43:54 PM
From: Ian@SI  Read Replies (1) of 407
 
Hi Nig,

Doesn't the press release state that a Zamyl patient is 15% more likely to die within the first 70 days; and that primary endpoint wasn't reached.

What's the likelihood that these results will lead to an FDA approval???

Ian.

From the press release:

A 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.

Only a limited analysis of adverse events occurring in this trial has been completed to date. In this preliminary review, serious adverse events occurred with greater frequency in patients receiving Zamyl plus chemotherapy (66 of 94 patients, 70%) than in patients receiving chemotherapy alone (49 of 97 patients, 50%)(p=0.005). However, investigators attributed the serious adverse events to Zamyl therapy in only 13 of these 66 patients. No significant differences for serious adverse events were seen between treatment groups for any body system. Further, the mortality during induction therapy, defined as the first 70 days after initiation of therapy, was similar for the Zamyl plus chemotherapy (15%) and chemotherapy alone (13%) groups.
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