Elite Pharmaceuticals Inc (ELTP)

[Just give me $1.50]

SunGen Anti-infective #1

Market: $94 million

Status: FILED

Nasrat: "SunGen has not filed the response with FDA yet, they plan to do that in September or October."

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SunGen Anti-infective #2

Market: $70 million

Status: BE studies COMPLETED

Nasrat, August 12, 2019:

Shareholder: "What's the status of the second antibiotic drug developed with the SunGen?"

Nasrat: "That test is bio-equivalent on 10/23/18. When can we expect filing? The filing fee for this product is one $171,000 or $176,000 and SunGen and us decided to hit the brakes on that because we have other more important products that we are working on. Once we get to the point where we're raising more capital, we'll go back and revisit this."

Oct 23, 2018 - Elite Pharmaceuticals Reports Positive Topline Results From A Pivotal Bioequivalence Study

NORTHVALE, N.J., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today reported positive topline results from pivotal bioequivalence studies conducted for an undisclosed immediate-release antibiotic generic product which Elite co-developed with SunGen Pharma. The topline results demonstrated that the generic product was bioequivalent to the branded product in both fasted and fed studies.

This is the second antibiotic product which Elite has developed in collaboration with SunGen Pharma. We reported successful pivotal bioequivalence with the first antibiotic product in August 2018 and now confirm success with a second antibiotic product.

IQVIA (formerly QuintilesIMS Health Data) reported annual revenue of approximately $70 million for the brand and generic market for this product.

Please provide insight how there are 2 antibiotics. The only one I am aware of is the $94M one that was filed for which they received FDA guidance to provide additional detail, which is the response Elite and Sungen are working on and Sungen will file in Sep/Oct.