Dendreon Kicked By Banc of America
by Jon C. Ogg
24/7 Wall St.
Banc of America (BAC) has noted that yesterday's 'positive data' is actually not new and that the interim data will not be available until the second half of 2008. Mitchell Gold, MD/PhD/CEO of Dendreon (DNDN), detailed the FDA's decision to accept either a positive interim or final analysis of the IMPACT study. He also updated the company's financial guidance at the BofA Healthcare Conference.
Dendreon has already discussed the S.P.A. of the IMPACT study during the earnings conference call for the first quarter of 2007. The exact death event number for interim analysis and the p-value hurdle were again not disclosed, but management hinted that the interim analysis may be triggered when death events exceed at least 164, approximately the combined death events of the 9901 and the 9902A studies.
Dendreon maintains that it believes the study can show a statistically meaningful interim analysis, although this should be expected and there was not really any detail. A further potential flag is thatthe company has said the interim goals will be hard to reach.
Continue article at 247Wallst.com
RELATED READING:
- Dendreon Catches a Break From The FDA
- Dendreon Volume and Volatility Compress Ahead of ASCO
- Dendreon Interest Remains Extremely High
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24/7 Wall St.

Dendreon has already discussed the S.P.A. of the IMPACT study during the earnings conference call for the first quarter of 2007. The exact death event number for interim analysis and the p-value hurdle were again not disclosed, but management hinted that the interim analysis may be triggered when death events exceed at least 164, approximately the combined death events of the 9901 and the 9902A studies.
Dendreon maintains that it believes the study can show a statistically meaningful interim analysis, although this should be expected and there was not really any detail. A further potential flag is thatthe company has said the interim goals will be hard to reach.
Continue article at 247Wallst.com
RELATED READING:
- Dendreon Catches a Break From The FDA
- Dendreon Volume and Volatility Compress Ahead of ASCO
- Dendreon Interest Remains Extremely High
____________________
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