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Keryx Biopharmaceuticals Inc. Message Board

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  • shooter123432 shooter123432 Feb 2, 2012 2:22 PM Flag

    What date do you start to feel very comfortable?

    What I don't understand then is why management thought the data would read out by YE11. I'm assuming they had made that estimate based on the assumption that the trial would work as planned or approximately 5 months in the control group and 7 months in the peri group. It would seem then that one or both of those arms is acting differently than expected. So why then would you say that for the study to act as planned (5 mo vs 7 mo and 6 mo aggregate) we should expect the 360th event to occur in mid-Feb?

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    • Later enrollment completion and longer survival tail.

      • 1 Reply to ockerfan
      • Longer survival tail wouldn't be known by anyone, then or now. IF there is a longer survival tail, it would most likely be in the PCAP arm, which would only be a positive.

        Later enrollment was probably an issue, but as of May (when over 300 patients had been enrolled), Bentsur was saying expected completion was for Q4. Now, he did say in that same press release that he expected enrollment to be complete in June, when in fact it was July, so I guess you could say they were up to a month late, but they did over enroll by about a months worth of patients which should have made up for most of the time lag. They enrolled 469 patients by July 27, so that means they were likely pretty close to the 430 enrollment by end of June, so they weren't off by much.

        I don't think any mention was made of pushing back the expected completion of the trial until the DSMB mentioned the number of events that had occurred in early August and they were significantyl less than expected, so I'd say that information is the most likely the reason the expected completion was extended.

    • It could be something as simple as the enrollment didn't progress as fast as expected.....


    • They over enroll and short end the expected timelines on purpose. This is management 101 stuff. So that it builds the positive case. A lot of what made me feel good about perifosine producing some positive results came from sources other than kerx.

      If they miss on this one they should be through,over,taken to the barn and ____, considering how bad the last one was!!! You can forget about zerenex.

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