Liminal BioSciences Inc. LMNL

BLA update

[sah1]

As previously mentioned by Stockbuffon, the company gave a progress report  several months ago on the critical steps that are  needed to obtain FDA approval of Ryplazim. The following text is taken from the August 12 2019 Q2 results MDA p.9  which can be found on Sedar.

'The Company announced in October 2018 the successful completion of a Type C meeting during which the FDA agreed with its proposed action plan for the implementation of additional analytical assays and in-process controls related to RyplazimTM manufacturing process. As a result of the feedback received during that Type C meeting, the Company has finalized the Process Performance Qualification (“PPQ”) protocol required for the manufacturing of RyplazimTMconformance lots. The Company continues to interact with the FDA regarding the filing of its amended BLA. It has also engaged external consultants to assist with this process. The 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”) (in process)
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 acceptance of the amended BLA

6 months on,  I would fully expect the Company to be on the cusp of submitting the amended BLA to the FDA. If I remember correctly, a meeting is planned early in 2020 with the FDA following which I would expect the amended BLA to be submitted.I certainly hope that this will take place no later than the end of March. But who knows!

[ualcin1]

Thank you sah1. As usual, your comments are very relevant and enlightening.

[GoBBs]

Sah1 ... this is good detail...and answers my question... actual progress. A March resubmit puts an FDA decision as early as Sept. if things are still progressing.

[stockbuphoon]

sah1, good to see you posting occasionally and digging this document out again. LMNL seems to be communicating rather obliquely instead of being direct on where they are on that list. They mentioned in q3 call that they had reduced R&D/ manufacturing due to being finished Ryplazim batches but didn't elaborate further. As you say, BLA submission could be anytime now if there has not been