Elite Pharmaceuticals Inc (ELTP)

[The Gentle Wolf]

Its a fact MR. Langston. Step 1) The FDA has 60 days to accept or reject the NDA application. Since obviously we did not hear anything in regards to rejection, it was accepted.

Step 2) The FDA now has up to 14 days now to designate the application as standard or priority review.

Here is how it works!

Once the application is submitted, the FDA has 60 days to conduct a preliminary review, which assesses whether the NDA is "sufficiently complete to permit a substantive review." If the FDA finds the NDA insufficiently complete (reasons can vary from a simple administrative mistake in the application to a requirement to re-conduct testing), then the FDA rejects the application by sending the applicant a Refuse to File letter, which explains where the application failed to meet requirements.

Assuming the FDA finds everything acceptable, they decide if the NDA needs a standard or accelerated review, and communicates acceptance of the application and their review choice in another communication, known as the 74-day letter. A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months.

Bottom line is this, no rejection letter today and IT IS ACCEPTED! Just waiting on the type of review the NDA designates. Congrats to all! It is time to buy folks.