>>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?