Genta Incorporated (GNTA) Tops Q1 EPS by 5c,
Comments on Clinical and Regulatory Issues
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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