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Replies to #46150 on Biotech Values
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Biowatch

05/04/07 9:16 PM

#46151 RE: daved #46150

GNTA European regulators also said no.

>>CHMP Adopts Negative Opinion on Genasense(R) Application in Melanoma
Friday April 27, 9:23 am ET
Genta to request re-examination and review by EMEA Oncology Scientific Advisory Group
Company will also file data quality complaint and correction request in U.S. regarding erroneous FDA analysis and presentation to ODAC of melanoma trial data <<

"The complaint will challenge as erroneous a key statistical analysis of the Company's data on Genasense for melanoma used by FDA at the Oncology Drug Advisory Committee meeting on May 3, 2004."

Why did they wait this long if it was such a glaring error?

Three years?!?

http://biz.yahoo.com/prnews/070427/nyf052.html?.v=96

http://biz.yahoo.com/prnews/070502/nyw174.html?.v=57