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Liminal BioSciences Inc. 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

Comment by eric40on Sep 21, 2020 10:24am
166 Views
Post# 31590782

RE:RE:RE:RE:RE:BLA

RE:RE:RE:RE:RE:BLAObviously they will have to come up with money one way or another before the BLA unless they get the BLA very fast.

And they are not gonna wait until there is no more cash available unless Thomvest wants another restructuration in order to wipe again the shareholders and Consonnance.

With the resubmission being accepted by the FDA, it brings more credibility and should help get financing.

Also, the new PDUFA date of 5 march 2021 is not the day they will get the BLA.

It is the latter they will get it.

Since this is a resubmission, a large part of the original BLA, 4 of 5 modules are already reviewed. 

And CMC module was also reviewed.

So basically, FDA has to review the modification in the CMC module with the 4 new check points.

So the normal 6 months period for the 5 modules should be much shorter as in many other past cases (from other BLA resubmission from other pharma for other drugs) since it is not a complete review of the BLA

Once/if  they get the BLA, and I believe they will, everything is going to change since revenu will start coming in as well as credibility.

IMHO


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