This is on SEDAR nov 13 , 2019and in no way edited by me....maybe show it to Gunner lol
Just the facts ...this is what they have communicated ....
MD&A English,
"In early 2019 the Company established the following critical path towards regulatory approval for RyplazimTM in the U.S. is as follows:
1. Development and validation of new analytical assays and in-process controls (complete)
2. Finalization of PPQ protocol (complete)
3. Manufacturing of additional conformance lots (complete)
4. Fill & Finish at external Contract Manufacturing Organization (“CMO”) (complete)
5. Data analysis & preparation of required documents for FDA (in process)
6. Regulatory filing of BLA amendment documents – now likely to take place in H1 2020
7. Anticipated new PDUFA date after the acceptance of the amended BLA"