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Exelixis, Inc. Message Board

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  • erniewerner erniewerner Jun 1, 2009 6:10 PM Flag

    It sure looks like one person is happy today. onthejobsf is very happy.

    <<We'll see what the take on today's data and analysis presentation is but I suspect that's secondary to the GBM data which represents the fasted road to approval for any XL program.>>

    Doc the quickest road to approval is still the ongoing MTC trial.

    "Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)"

    Granted, it is a tiny indication, but any revenue is better than none. It'll be good press and there is a psychological advantage to submitting a supplemental NDA when they go for the second approval.

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    • Not so fast. What is primary completion date taken to mean? Completely enrolled? Enrollment and follow up done? I don't know if XL will comment on that trial tonight (previously they've said they don't comment on enrollment except to say it's on track), but my recollection was they need to enroll a large number (for a rare disease) of patients (315) and follow until there are enough events of tumor progression. MTC tends to be a slowly progressing tumor so it may take a lot of follow up to generate enough events to be able to see a difference between treated and control. I'd guess this is something like 9-12 months, but we'll see. It may also be that there is an interim analysis which gives a chance for early stopping, but it's hard to see that before the middle to end of 2010 which would mean if everything goes perfectly and NDA submission in 2011. I suspect the hope would be that with GBM, if 100 patients are enrolled very quickly and have a good tolerability and RR that the data for an NDA would be ready earlier (response is a faster end point that progression free survival and GBM progresses faster than MTC).

      Lots of assumptions about things going right in both cases.

      The Wiz

    • I call a family reunion!

      Anyone else aboard?!?!?!?

      Sentiment: Strong Buy

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