Liminal BioSciences Inc. LMNL

Healthcare Biotechnology

Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from fibrotic or inflammatory diseases that have a high unmet medical need. Liminal BioSciences operates on an integrated basis from our talent hubs in Laval, Quebec, Canada, and Cambridge, UK. Our common shares are listed for trading on the Nasdaq Global Market.

NDAQ:LMNL - Post by User

Liminal BioSciences Inc. > We need BLA submission now that...

<< Previous

Bullboard Posts

Next >>

Comment by GunnerGon Apr 01, 2020 6:24pm

76 Views

Post# 30870225

RE:We need BLA submission now that...

Realstups said " 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."

Liminal completed those checks prior to Sept 2019 (Q3). Seven months Realstups, where is the BLA filing. See below.

GunnerG wrote: the FDA required process checks are 100% completed from the postings of the pumpers. The completion of the analytical assay was prior to Sept 30, 2019 (Q3).

What is the hold up? The paper work was done two years ago while waiting for the final piece of the puzzle which was completed prior to Sept 30.

Seriously, it is now more than six months to complete the paper work of which most was done already. Six months! Newcamo IDs have constantly said paper work would be completed quickly and submitted to FDA. Six months and counting is not quick.

Which shoe dropped this time?