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Dendreon Corp. Message Board

  • walldiver walldiver Feb 26, 2004 5:33 PM Flag

    Two analysts asked...

    ...if followup results from the D9901 trial would be made available, and Gold just said that they would announce results from the Provenge trials at upcoming conferences. He didn't specifically mention the D9901 trial as being one of those to be announced.

    Prediction: if more followup results from the D9901 trial show anything approaching p = 0.05 for all Gleason scores, or even better than 0.05, then these results will be announced at an upcoming conference and a rolling Provenge BLA will be filed shortly thereafter.

    If D9901 trial followup results show no improvement from the last announcement for patients with Gleason scores of 2 to 10 (last announcement showed p = 0.061), then DNDN will only discuss the followup results for patients with Gleason scores of 7 and below, and won't discuss the results for all Gleason scores. They will then continue along the milestone timeline currently set.

    But wouldn't it be incredible if the overall D9901 trial showed statistically significant efficacy and DNDN could then file the rolling BLA? The current D9902 trial could then become a Phase IV trial upon approval, which would happen this year.

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DNDN
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