Liminal BioSciences Inc. LMNL

RE:I don't think it has bottomed yet

[Jackhigh]

Pure garbage speculation. It was clearly pointed out in thier news release the reason.

"On November 6, 2020, the FDA notified us that the submission of this additional information by the Company 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. The new PDUFA target action date is now June 5, 2021."


Also if you work in the industry like I do (regulatory affairs), you know that introduction of additional information that was not previously disclosed carries a risk of additional review time. In this case the new manfuacturing or faciity information was nessesary to answer FDA's questions, otherwise you dont take that kind of risk. FDA saw the scope of the data and basically says: "we need more time to read, review and understand the data being generated" and to see if they agree with the methodology, data, etc.

DryBones wrote:
The check points are for quality control of drug manufacturing.  I'm  now thinking that the explanation, one more check point was the "light" or PR description of the problem.  I think they have a quality control problem.  I suspect now that their blood plasma filtration process does not work very well, otherwise by now it would have been adopted by other blood fractionators.