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9 个月前
BRIEF-Nicox gets letter from FDA related to GMP on NDA for AC-170
2016年10月11日 / 凌晨12点17分 / 9 个月前

BRIEF-Nicox gets letter from FDA related to GMP on NDA for AC-170

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Oct 10 (Reuters) - Nicox Sa

* Nicox receives complete response letter from the FDA related to GMP on NDA for ac-170

* Nicox sa - crl did not include any concerns related to finished product manufacturing facility

* Nicox sa - since receipt of crl, nicox has been contacting its suppliers to assess timeline for api manufacturer to address fda's concerns

* Nicox sa - once issues have been addressed, nicox will then resubmit ac-170 nda

* Nicox sa - fda's stated reason for crl pertains solely to a good manufacturing practice (gmp) inspection at a third party facility Source text for Eikon: Further company coverage:

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