Post by
Noteable on May 31, 2023 10:51am
In today's world the paths to FDA Approval are many
May 31, 2023 - the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data, despite its March 2022 rejection of the drug because of safety concerns..
https://www.biospace.com/article/akebia-to-resubmit-anemia-drug-application-to-fda-after-initial-rejection/
Comment by
Noteable on May 31, 2023 1:27pm
... and in oncology, the many paths to FDA approval are not determined by CRs, athough this is the ultimate, long-term goal.
Comment by
Lesalpes29 on May 31, 2023 1:30pm
Thank you for the work you do here. More than 700 posts in 5 months only for Onc is a lot of work. GL
Comment by
Noteable on May 31, 2023 1:42pm
700 posts on ONCY in 5 months on this message board just illustrates the "brilliant" opportunities that pelareorep presents.
Comment by
Noteable on May 31, 2023 1:45pm
Should read: "...just illustrates the "brilliant" opportunities that pelareorep represents."
Comment by
Buckhenry on May 31, 2023 2:16pm
The dreamers sure get their tail feathers ruffled when anyone disagrees with their narrative. Reminds of the liberal democrats that's burned downtown Portland a few years ago cause they didn't get their way
Comment by
Azzak34 on May 31, 2023 2:32pm
Ooh tell me more! Wait, are you an orange guy fan? Hang on a minute, is this you? My old pal?