To: Leo Fisher who wrote (61 ) 2/1/2017 5:37:43 AM From: axial Respond to Hi Leo -"Hematech most likely did not meet the strict manufacturing standards set in the “CMO relationship” instead of facing fines etc. they settled for some stock and a little royalty. ADMA had this issue with RI002 the "FDA identified in the CRL certain outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, its contract fill and finisher and compliance issues with a third-party contract testing laboratory, and requested documentation of corrections for a number of those issues." I am guessing that is what PLI is trying to avoid during the BLA. From what I gather when it comes to the Plasma business purity and cleanliness is key." "Lock up on shares?" " "Scuttlebutt" tells me that marketing/sales cost for these things are low due to the small number of patients PLI quotes 1.6 per 1million for Type 1 deficiency; not really to sure on the plasminogen diabetic wound healing, although if it works how much marketing does it need? Use this or lose your leg; not a hard sell. I don't recall management talking margins; does anyone else recall? I haven't had a chance to listen to their conference calls." very
