Ann: AGM Resolution 4 Withdrawn, page-5

We might not know when the NDA is submitted and post submission the FDA has 60 days to respond that the application is complete ---

"Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness."

"Generally, the FDA's approach to data disclosure has been that no public disclosure of information will take place until (and unless) a drug is approved. [13] Indeed, the agency will not even acknowledge that an IND or an NDA has been filed, although companies filing with the Securities and Exchange Commission report such information and often ensure that positive findings from their studies receive media coverage. For those drugs that are evaluated by FDA advisory committees, there is an additional, brief window in which the NDA is formally acknowledged and the data supporting the application are disclosed."

Good link--
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm394839.htm