Elite Pharmaceuticals Inc (ELTP)

[rollin2nyte]

Why would we need to work with Purdue?

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079298.pdf

IV. TYPES OF WAIVERS AND REDUCTIONS
According to section 736(d) of the Act, FDA will grant a waiver of or reduction in one or more user fees assessed under section 736(a) of the Act where it finds that an applicant meets the eligibility criteria under one of the following provisions:
• A waiver or reduction is necessary to protect the public health.
• The assessment of the fee would present a significant barrier to innovation because of
limited resources available to the person or other circumstances.12
• The applicant is a small business submitting its first human drug application to the Secretary for review.

Can Purdue somehow magically convince the FDA that it's next submission would be the first application? We've already received the waiver without Purdue.

You are a long ways from breaking into the starting lineup:
https://en.wikipedia.org/wiki/Sixth_man