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Bullboard - Stock Discussion Forum 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... see more

NDAQ:LMNL - Post Discussion

Liminal BioSciences Inc. > EricC - Find that article on BLA's granted b4 PDUFA date?
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Post by stockbuphoon on Sep 22, 2020 7:41pm

EricC - Find that article on BLA's granted b4 PDUFA date?

Here's one article on early approvals here:

https://endpts.com/fda-approves-5-new-costly-drugs-well-ahead-of-pdufa-dates/
Absolutely no guarantee that Ryplazim could be reviewed and approved well before Mar 5th PDUFA date but it's happened before.... 

FDA approves 5 new costly drugs well ahead of PDUFA dates Zachary Brennan
      
Since 21 October, the FDA has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected to be approved. 

For instance, the FDA signed off on Vertex Pharmaceuticals’ Trikafta (elexacaftor/ivacaftor/tezacaftor), a new treatment for those with the most common cystic fibrosis mutation, after only three months of review and well ahead of its 19 March 2020 user fee action date.

On 14 November, more than three months ahead of its 27 February 2020 action date, the FDA granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

One day later, Novartis’ Adakveo (crizanlizumab-tmca) won approval for its sickle cell disease treatment two months ahead of its PDUFA date in mid-January 2020. And yesterday, the FDA granted an accelerated approval to another sickle cell drug, Global Blood Therapeutics’ Oxbryta (voxelotor), three months ahead of its PDUFA date.
Alnylam Pharmaceuticals’ Givlaari (givosiran), meanwhile, had a PDUFA date of 4 February 2020, but won approval on 20 November. But other recent approvals, like SK Life Sciences’ Xcopri (cenobamate tablets) to treat partial-onset seizures in adults, and Shionogi’s complicated urinary tract infection drug Fetroja (cefiderocol), won approvals near their PDUFA dates.
The string of quick approvals may provide more ammunition for those who criticize the agency for moving too quickly. An article in JAMA Internal Medicine last summer found that few cancer drugs approved via the accelerated approval pathway improved survival in confirmatory trials.

However, viewers of the recent Senate committee hearing considering a new FDA commissioner have seen there are still senators who believe the FDA is not moving quickly enough with some approvals.

As the proportion of new drugs receiving expedited approvals in recent years has been increasing, so has the number of approvals for rare diseases.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explained recently that the agency is working on its own analyses to provide “a more robust response” to these critiques of its approval standards.

She also explained how the high number of approvals in recent years for rare diseases may be influencing this perception of a lower bar, especially as more treatments are approved on the basis of a single-arm study or with an external control group. In addition, she pointed to the “astoundingly” high launch prices for some of these rare disease treatments that may also be part of the reason for the pushback.

Indeed, before discounts, Trikafta will cost $311,503 annually, Brukinsa will cost $12,935 for a 30-day supply, Adakveo will cost between $7,000 and $9,500 per month ($84,000 to $114,000 per year), Oxbryta will cost $125,000 per year and Givlaari will cost $575,000 per year.
Comment by eric40 on Sep 22, 2020 8:47pm
Thanks Stockb. Thanks for your search. I had no time to search in my old research, I am to busy at the moment.  Since you know me, you know I am not a pumper like Newcamo and cie. 2 years ago I did quite a search on that  and I found a list of cie with early approval within 2 months after resubmission after a CMC issue. So this is still really happening often as your search also ...more  
Comment by stockbuphoon on Sep 22, 2020 9:14pm
EricC, yes, you have always been a credible poster. I was hoping you would find your old research, too, so I did a google search and those 5 companies came up! Good luck with the trading! You could have made a good return buying at $7-12 and selling at $17-32 this year! Who knew! 
Comment by realstocky on Sep 22, 2020 10:29pm
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