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sushifishman

05/05/21 12:37 PM

#37559 RE: Dr. Johnny Fever #37558

There are 2 aspects to a BLA

CSR and the CMC

CSR is likley being worked on now.

The CMC cant be summited until the Facility is finalized. Months away likley

Normally, you have to submit both the CSR and the CMC together

However, CVM can request a ROLLING SUBMISSION that will speed up the process

They can submit JUST the CSR section and get that going while the CMC is finalized.

Cheers!