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AUDACIOUSWON

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AUDACIOUSWON

Re: molee post# 344

Thursday, 02/02/2017 5:12:19 PM

Thursday, February 02, 2017 5:12:19 PM

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You have probably seen this, but just in case anyone missed...

Innocoll CEO Tony Zook said: “We expect to work with the FDA over the coming weeks in an effort to address the open issues and to define a path forward for a successful re-filing of our application at the earliest point in time.”

Innocoll revealed that it will request the FDA for a Type A meeting in this regard. It proposes to respond to various issues which it believes are addressable.

The company also stated that it would ask clarification from the US regulator of what additional details it needed, if any.

It added that more details in this development would be revealed following its discussions with the regulator in the coming days.

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