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Liminal BioSciences Inc. PFSCF


Primary Symbol: LMNL

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

Post by GunnerGon Nov 12, 2020 12:17pm
806 Views
Post# 31885545

BLA resubmission lacking?

BLA resubmission lacking?I take it the person hired for her knowledge of the BLA submission process to the FDA may have inadequatley completed the paper work.

FDA submitted an IR to the company and the information provided "constituted a major amendment because the submission contained substantial new manufacturing or facility information not previously submitted to or reviewed by the FDA, which entitles FDA to extend the review process by three months." per LMNL

Remember, you are only allowed one major amendment per review cycle.  Here's hoping no more missteps
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