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Bullboard - Stock Discussion Forum Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and... see more

TSX:ONC - Post Discussion

Oncolytics Biotech Inc > In today's world the paths to FDA Approval are many
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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 1:12pm
The FDA's paths to oncology drug approval have been opened by the Congressional probe 2 months ago.  In March, the FDA’s actions in preventing and responding to the shortages were probed in Congress as the House Committee on Energy and Commerce launched an investigation to uncover if the agency is “effectively using its existing authorities.” Consequently, in response to this ...more  
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? 
Comment by Noteable on Jun 07, 2023 2:00pm
Here's a recent example --- June 05, 2023, The FDA has signed off on an amended trial protocol for Theratechnologies’ solid tumors medicine, lifting its clinical hold and setting the Canadian biotech free to proceed.     The phase 1 study for TH1902, also known as sudocetaxel zendusortide, has been on pause since December 2022, when Theratechnologies got a glimpse ...more  
Comment by Noteable on Jun 04, 2023 7:53pm
Clinical trials in oncology have terminology, including primary endpoints and surrogate endpoints, which are results that are measured at certain points during a study and/or at the completion of a study to see if a given medication has worked (e.g., did the drug demonstrate a significant improvement versus the comparative treatment?) and its safety (e.g., what are the possible side ...more  
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