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Biotech / Medical : Immunomedics (IMMU) - moderated
IMMU 16.44-7.3%3:59 PM EST

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From: Renmanco1/13/2020 8:08:33 AM
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Reminder: Here is what is currently being re-examined:

“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."

Let's not forget that getting this right will/should make future submissions somewhat easier as the CMC trio will have already been approved per the current submission and just updated clinical drug safety and efficacy data needs to be added unless, of course, future submission specifics will require new CMC procedure inputs.

Once IMMU's team gets this all done (finally) correctly this time, they will have enhanced their skills for future least that would be my expectation.
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