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Re: ronpopeil post# 223241

Friday, 01/18/2019 6:07:26 AM

Friday, January 18, 2019 6:07:26 AM

Post# of 253225
IMMU CRL based on CMC issues only (according to the company):

http://globenewswire.com/news-release/2019/01/18/1701746/0/en/Immunomedics-Receives-Complete-Response-Letter-From-FDA-for-Sacituzumab-Govitecan-Biologics-License-Application.html

The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated.

CC at 8am ET.

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