Elite Pharmaceuticals Inc (ELTP)

[Hike]

Why do they need to start a study to provide data?
You do know how 505b2 works no?

As one of three types of new drug applications, the 505(b)(2) NDA allows drug companies to obtain Food and Drug Administration (FDA) approval of essentially “new” drugs without having to conduct the full complement of safety and efficacy trials, which is often the most time-consuming and expensive part of the drug development process. Because the 505(b)(2) NDA permits the drug manufacturer to rely on the agency’s findings for a previously-approved drug, published literature, or both, the typical 505(b)(2) application seeks to obtain approval for a modification of a previously-approved drug product, such as a change in dosing regimen, a new active ingredient or a new indication for use.

http://www.fdli.org/docs/default-document-library/fdli-monograph-vol1no6-preview.pdf?sfvrsn=0