RE:nasdaq will see the sp appreciate hugely, hit intraday 43$CAYour life has been ruined stups by posters on a BB.
Time for a med check with the Dr.
realstocky wrote: 2 weeks back... Just ignore these clones, arakis/plitheone/gob, deranged individuals that cant rationalise losing money...instead they ruin everybody else lifes out of revenge. What goes around comes around though...
LMNL completed 100% the check points as asked by the FDA, now they will submit riplazym as detailed below, FDA already reviewed riplazym and passed conditional on those check points being set. They are set, resubmission is basically a formality. The 2 owners indeed own 85% of all shares, stay tuned:"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 ( updated to this quarter)
7. Anticipated new PDUFA date after the acceptance of the amended BLA"
Anticipated Key Milestones (from corp. slides)
1H-2020Expected commercial partnership for Ryplazim™ ( H1 updated to this quarter )
1H-2020Expected filing of amended BLA with FDA for Ryplazim™ (priority review expected)