Corporate News
Genta Incorporated (GNTA) Tops Q1 EPS by 5c, Comments on Clinical and Regulatory Issues
05-08-2007 07:23:43 AM

Genta Incorporated (Nasdaq: GNTA) reports a Q1 loss of $0.04, 5 cents better than estimates. Reveneues were $94K vs. $110K consensus.

The Company has requested re-examination of the initially negative opinion on Genta's Marketing Authorization Application (MAA) for Genasense in melanoma by the Committee on Human Medicinal Products (CHMP) from the European Medicines Agency (EMEA).

In a separate action, Genta indicated its intent to file a formal complaint and request for correction of information with the U.S. Food and Drug Administration (FDA) under the Federal Data Quality Act. 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 (ODAC) meeting on May 3, 2004.

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