Liminal BioSciences Inc. LMNL

Interesting past news...

[foofadooo]

https://www.biopharmaglobal.com/2018/02/05/prometics-pbi-4050-phase-3-pivotal-clinical-trial-design-idiopathic-pulmonary-fibrosis-ipf-finalized/



and fda policy........  https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation?utm_medium=email&utm_source=govdelivery


 foof

[foofadooo]

How does Nov 20....3 years relate to Liminal (if at all).....https://www.fda.gov/media/119936/download  foof

[foofadooo]

Perhaps of interest....under RMAT......PAGES 23&24.....https://collaboration.fda.gov/p81luow1w03/ foof

[foofadooo]

And finally....the "21st Century Cures Act" ..... is this where we are at???....  The RMAT program is housed at CBER. Products granted designation are eligible for increased early interactions with the FDA, including all the benefits available to breakthrough therapies. Because these are considered investigational products, the FDA does not identify which products have gained RMAT

[sah1]

Foof, having access to expedited approval processes has never been a problem for Ryplazim. Getting the CMC issues in order has been the problem and it took the company over 2 years to get these straightened out or at least we hope they have been straightened out. I am hoping that FDA  will expedite the approval  of the Laval plant by using virtual inspections in order to avoid FDA staff

[foofadooo]

ash 1.......Access was not a question in my mind....Note the dates on this letter written in Dec 2018......   December 20, 2018 UPS EXPRESS MAIL RECIPIENT NAME AND ADDRESS To Whom It May Concern: It has come to the attention of the United States Food and Drug Administration (FDA or the Agency), Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics