NetworkNewsBreaks – Innocoll (NASDAQ: INNL) Receives FDA Meeting Minutes for XARACOLL® NDA; Shares Rally

Innocoll Holdings (NASDAQ: INNL) shares soared as much as 43% this morning – currently up 14% – after the company said it received formal Type A Meeting minutes from the United States Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for XARACOLL. This clarifies the data that the company will need in order to address the questions raised in the Refusal to File (RTF) Letter the company received from the FDA in December 2016. During the Type A meeting, representatives of the FDA provided guidance which was confirmed in the formal FDA meeting minutes. The company intends to resubmit the NDA at the end of 2017. “I am pleased that we have clarified the data needed to address the questions raised in the RTF letter. With the official minutes from the FDA now in hand, we believe that we have a path forward for a possible resubmission of the XARACOLL NDA by the end of 2017, assuming adequate financing to commence the proposed studies, and further assuming positive results,” CEO Tony Zook stated in the news release.

To view the full press release, visit: http://nnw.fm/Hw3V5

About Innocoll Holdings plc

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application. For more information, visit www.innocoll.com.

About NetworkNewsBreak

NetworkNewsBreak (NNB) provides a rapid summary of corporate news that caught the attention of NetworkNewsWire (NNW). NNB keeps you up-to-date on active US Public Companies complementary to NNW’s broader scope as a provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

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