Genta, Inc (fka GNTAQ)

[Sprycel]

Simple, a year ago March 2008 the FDA told GENTA they wanted a confirmatory clinical trial done to support the results in the NDA appeal. Genta instead decided to gather additional documents and to forgo the clinical trial for Genesense in CLL hoping the additional information would suffice. They were wrong! Instead the company focused on the AGENDA trial and Tesatexel because of its larger impact to the companies revenue stream. Now for Genasense to get approved Genta will have to find a partner willing to fund the confirmatory clinical trial because all of the funding in Genta is pointing towards the Agenda Trial and Tesatexel. Genta rolled the dice on Genesense and CLL and they lost. The FDA wants a confirmatory clinical trial done before they will entertain the approval of Genesense in the treatment of CLL. It does not mean Genesense is not an effective drug, they just can claim to use it for CLL. They are headed now into the use of Genesense to treat melanoma because the results have shown a larger impact in this treatment over CLL. Not rocket scientist stuff and anyone who invested here for CLL approval only needs to sell all their shares on Monday!! Others with a longer term will be there to buy them up on the cheap! Simple!!