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Dendreon Nailed By Fda
Posted on 05/09/2007 10:11:10 | Link | Post Comment
Jon C. Ogg
24/7 Wall St.
Dendreon Corporation (DNDN-NASDAQ) was hammered this morning. It received a Complete Response Letter from the FDA that is the equivalent of an "approvable letter" with a request for additional clinical data for Provenge in the fight as a last line of defense in prostate cancer.
The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The Company is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA, which the Company believes it can supply to the FDA in a timely manner.
Initial trading is showing indications...
Continue article at 247WallSt.com
RELATED READING:
- Dendreon Option Premiums Remain Astronomical
- Dendreon, A Biotech Gift That Keeps On Giving!
- Dendreon's New 'Hold' Rating at A.G.Edwards
______________________
24/7 Wall St.
Dendreon Corporation (DNDN-NASDAQ) was hammered this morning. It received a Complete Response Letter from the FDA that is the equivalent of an "approvable letter" with a request for additional clinical data for Provenge in the fight as a last line of defense in prostate cancer.The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The Company is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA, which the Company believes it can supply to the FDA in a timely manner.
Initial trading is showing indications...
Continue article at 247WallSt.com
RELATED READING:
- Dendreon Option Premiums Remain Astronomical
- Dendreon, A Biotech Gift That Keeps On Giving!
- Dendreon's New 'Hold' Rating at A.G.Edwards
______________________
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