ADMA - http://www.admabiologics.com/ Message Board

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Biotech / Medical : ADMA - http://www.admabiologics.com/

ADMA 19.53

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From: Leo Fisher	9/21/2017 11:12:13 PM
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For those interested please be aware of the timeline for BLA re-submission (2018-2019). Excerpts from ADMA SEP 2017 Investor Update found at ir.admabiologics.com are below Our top priority is to remediate the outstanding compliance issues identified at out acquired manufacturing facility and ensure that the status of the previously issued FDA Warning Letter is lifted and the objectionable status is eliminated Our goal with respect to this remediation project is to be “inspection ready” in approximately 6 months We anticipate that we will be in a position to refile the Biologics License Application (“BLA”) for RI-002 in the middle of 2018

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