RE:NR : FDA accepts LMNL's BLA (Riplazym)This is very good news. Now it is a matter of time to get the BLA.
Public data from the FDA over the last 20 years shows that resubmission of a BLA/NDA after CMC issues brought a BLA acceptance very fast, in much less than 6 months, many within in 1 to 2 months from resubmissiom.
GLTA