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Bullboard - Stock Discussion Forum
Oncolytics Biotech Inc
ONCY
Primary Symbol:
T.ONC
Healthcare
Biotechnology
Oncolytics Biotech Inc. is a 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 phase 3 licensure-enabling 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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(110)
•••
ENEMENEMYNEMO
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Post by
ENEMENEMYNEMO
on Jun 11, 2024 3:22pm
Ummmmmm
When's that date you delusional breadcrumb addicts???
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 3:10pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
"accelerated BLA is not accelerated approval" ... up until the time that the FDA grants an Accelerated Approval .. which in turn results in an Accelerated BLA, with full approval
...more
(1402)
•••
Azzak34
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Comment by
Azzak34
on Jun 11, 2024 3:01pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
Orange man gonna be wearing orange overalls soon!
(211)
•••
Buckhenry
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Comment by
Buckhenry
on Jun 11, 2024 2:59pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
It's very clear that pumpers here are desperate and grasping at straws. This reminds me of watching the goofballs on cnbc speculate on the first fed cut... they have no clue yet they
...more
(83)
•••
Quentin30
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Comment by
Quentin30
on Jun 11, 2024 2:47pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
accelerated BLA is not accelerated approval... there are many routes to have a BLA approved in less time than is the normal goal date... Fast Track, Breakthrough designation, Priority Review and
...more
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 2:15pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
FDA's "Guidance for Industry - Expedited Programs for Serious Conditions – Drugs and Biologics" https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions
...more
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 1:57pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
And because I have to keep repeating myself an Accelerated Approval/Subpart H – Unlike Fast Track, Priority Review, Breakthrough, and RMAT which reduce FDA’s review time, Accelerated
...more
(1009)
•••
canadafan
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Post by
canadafan
on Jun 11, 2024 1:46pm
Accelerated approval , various titles
Yes I agree with niteable. It was clearky stated they are working with FDA, including a thiurough document that was assisted by existing pharma colaborators. essentialy they have indicated the phase 3
...more
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 1:35pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
Or as Matt Cofey said .. (quote) " an accelerated BLA ".
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 1:31pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
And the path towards obtaining an Accelerated Approval has been clearly prescribed by the FDA, and one that appears ONCY is taking, particularly given Matt Coffey's recent comments on acquiring an
...more
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 1:23pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
Perhaps I do.
(83)
•••
Quentin30
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Comment by
Quentin30
on Jun 11, 2024 1:21pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
You state this again and again, and yet ONCY management has NEVER mentioned Accelerated Approval to shareholders... do you know better than them ? Anyway, here's hoping that by the end of
...more
(5649)
•••
Noteable
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Comment by
Noteable
on Jun 11, 2024 1:16pm
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timings
And my experience has shown me that the FDA has clearly outlined their path towards granting an accelerated approval when a study that compares the investigational drug to an available therapy
...more
(1009)
•••
canadafan
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Post by
canadafan
on Jun 11, 2024 1:12pm
Phase 2 questions
Casyl yes the phase 2 trials were beyond successful, thst is why they have FDA fast track designation for the MBc & most importantly the PanCan & Now CGAR , $5 million grant to proceed. in
...more
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