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. > IMO this is even better:

<< Previous

Bullboard Posts

Next >>

Comment by GunnerGon May 03, 2020 11:46am

154 Views

Post# 30981007

RE:IMO this is even better:

"Passed conditionally"? Not! Liminal has already admitted to receiving the RTF decision. FDA did ask for more check points about 2 1/2 years ago and when not completed in a timely fashion, the BLA filed on April 5, 2017 was refused.

The BLA starts from scratch, no priority review, but standard review which FDA try to complete in 10 months.

Now they start from scratch per FDA guidelines "A refusal-to-file decision ends the review process. The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the resubmission is considered an original new application)

Management has stated they are not sure if they have a priority review. So why would you say it "Passed conditionally" when management doesn't agree because of the RTF.

Why do you insist on posting lies like "Passed conditionally"?

realstocky wrote: direct to the point: 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:In early 2019 the Company established the following critical path towards regulatory approval for RyplazimTM in the U.S. is as follows