No, no, no...don't misunderstand what I said.
I said that the first analytical results from the trial won't be available for at least 6 months. That's the first step.
The NDA submission won't be able to happen until some time after that data has been fully captured, analyzed, and packaged. Genta leadership penciled in the NDA submission for the end of 2009, December. A question was asked in the conference call if Genta would submit on a rolling basis and the CEO said that while that was a possibility, they would not do such a thing.
It will take even longer for an FDA response after the NDA submission. You're looking mid to late 2010 for an approvable/denial response from the FDA and EMEA.
