Liminal BioSciences Inc. LMNL

RE:RE:drybones, u have no idea whats going on

[Jackhigh]

Jackhigh wrote:
"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.

GunnerG wrote: Stups, I will continue your thought.........and when the FDA had an information request (IR), they tacked on three months to the PDUFA date.  I will leave it up to you to read LMNL's news release as to why the FDA did that.

Only took two years to complete the additional checkpoints, hired this person you keep yapping about and then the BLA was submitted. 

When FDA starts looking at the sumbission, they come back to LMNL in weeks with a question for additional information.  The lacking information "not previously submitted to or reviewed by the FDA " entitled the FDA to tack on three months.  Did the new expert we hired miss something?  Do you have an answer?

realstocky wrote:

checkpoints were set and they ran the plant for months no issues before BLA. They also hired this person only for quality assurance and specifically for the FDA and to complete the checkpoints settings. Riplazym was flawless the first time around, FDA only wanted more checkpoints...im pretty sur lmnl can set that up and they did and tested it for months. They only submitted the BLA when they knew they had it done successfully.

https://biotuesdays.com/2019/11/13/liminal-biosciences-names-moira-daniels-to-head-regulatory-affairs-quality-assurance/

 

Liminal BioSciences names Moira Daniels to head regulatory affairs, quality assurance

Jennifer Poland

November 13, 2019

Liminal BioSciences (TSX:LMNL; OTCQX:LMNL) appointed Moira Daniels as the new head of regulatory affairs and quality assurance based at the company’s offices in Cambridge, UK.

“Moira brings many years of global experience and success across the industry from a range of major pharmaceutical companies and other organizations which will be instrumental to achieving success for the advancement of our product portfolio, including Ryplazim and PBI-4050,” Kenneth Galbraith, CEO, said in a statement.

Ms. Daniels has more than 30 years of global experience in managing product development timelines at major pharmaceutical companies, including Astra Zeneca, Pfizer and Eli Lilly. Most recently, she served as VP, head of global regulatory operations for UCB Pharma based in Brussels.

Liminal also announced that CMO, Dr. John Moran, will be retiring, effective Dec. 31. He will continue to act in an advisory capacity under a consultancy agreement with Liminal.

The company continues to search for a head of research and development, and VP of clinical operations.