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Bullboard - Stock Discussion Forum
Oncolytics Biotech Inc
ONCY
Primary Symbol:
T.ONC
Healthcare
Biotechnology
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...
adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.
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Bullboard (TSX:ONC)
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(5346)
•••
Noteable
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Comment by
Noteable
on Nov 22, 2024 5:10pm
RE:RE:RE:RE:“Second mouse gets the cheese “
With Replimmune leading the way on Accelerated Approval (AA) and the FDA granting Replimmune's intratumorally (IT) delivered OV therapy Breakthrough Therapy Designation (BTD), ONCY's
...more
(5346)
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Comment by
Noteable
on Nov 22, 2024 4:52pm
RE:RE:RE:RE:How does Accelerated Approval work
Fast Track and Acceleratred Approval Pathways: The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical
...more
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(5346)
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Comment by
Noteable
on Nov 22, 2024 4:40pm
RE:RE:RE:How does Accelerated Approval work
With Merck now throwing its hat into the ring, investors can rest assured that the business development teams of Bristol Myers Squibb, Roche, Sanofi, BMS, AstraZeneca and others are seeking out their
...more
(5346)
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Comment by
Noteable
on Nov 22, 2024 4:35pm
RE:RE:How does Accelerated Approval work
Notwithstanding Merck's bispecific investment, Merck has its Keytruda franchise to protect, so is especially motivated to continue doing M&A deals to ring-fence its anti-PD-1 enterprise. The
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(5346)
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Comment by
Noteable
on Nov 22, 2024 1:48pm
RE:RE:RE:Pfizer appoints chief oncology officer as new CSO
November 19, 2024 - In the development and approval of subcutaneously (SC) delivered immune checkpoint inhibitors (ICI), Merck's announced that it is a step closer to gaining FDA approval for SC
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(5346)
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Comment by
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on Nov 22, 2024 1:34pm
RE:RE:USA Inflation Reduction Act (IRA) 2022 Re: Biotech and China
October 30, 2024 - FDA cites Chinese drug manufacturing company with multiple CGMP violations including: ... failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize
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Comment by
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on Nov 22, 2024 12:46pm
RE:RE:RE:“Second mouse gets the cheese “
https://stockhouse.com/companies/bullboard?symbol=oncy&replyto=36326232&threadid=35837395&source=bullboard
(5346)
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Comment by
Noteable
on Nov 22, 2024 12:44pm
RE:RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work
November 21, 2024 - OV company Replimmune's intratumoral (IT) delivered virus has been granted FDA Breakthrough Therapy designation made under the Accelerated Approval pathway in combination with
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(207)
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Buckhenry
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Buckhenry
on Nov 22, 2024 11:17am
RE:new article
Sure glad sp does not matter ...
(5346)
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Noteable
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Comment by
Noteable
on Nov 22, 2024 9:29am
RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work
As previously posted ... ONCY has reported positive final results on the chosen FDA surrogate endpoint demonstrating 'clinical benefit' of PFS and mOS in ONCY's Phase 2 trials and
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(1)
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Hydro1
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Comment by
Hydro1
on Nov 21, 2024 10:56pm
RE:new article
Try this link: :''https://healthandpharma.net/oncolife/5''. It is on page 26 to 29.
(5346)
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Comment by
Noteable
on Nov 21, 2024 8:03pm
RE:RE:RE:RE:My thanks , philosophical thoughts
Using an adaptive model of trial design, starting a Phase 2 trial and then getting an Accelerated Approval has the Phase 2 trial transformed into a Phase 3 / Phase 4 post approval confirmatory trial
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(114)
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spesestsemper
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Post by
spesestsemper
on Nov 21, 2024 6:01pm
new article
How Oncolytic Viruses Could Be a New Frontier in Transforming Cancer Treatment
(95)
•••
Quentin30
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Comment by
Quentin30
on Nov 21, 2024 5:43pm
RE:RE:RE:My thanks , philosophical thoughts
well, yes, accelerated approval would be excellent... pray tell how that can happen without data ?? the HAVE to run another Phase II first... one that has been statistically powered to confirm
...more
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