RE:RE:spammers working hard on this board, why are they here?I'm only responding to this because I posted this originally and Newcamo then started using it everyday certainly not coming to the moron's aid lol...
Its in the MD&A on Sedar Nov 12, 2019 English version, page 11 of 44 ...
For 1. , validated by who ?
For 5.., so they have been doing Data Analysis and preparing docs for Dec 19 - May 20 ? 6 months ???? Please, it smells a lot.
"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"