Oncolytics Biotech Inc T.ONC

Accelerated Approval

[Quentin30]

Interesting, another Phase II (so smaller than a phase III), and then apply for accelerated approval..

So Noteable, the first time ONCY has specifically mentioned AA...  that's a positive. The downside of course is how long it will take to get the data to run the study... Given that they haven't acknowledged submission of a CTA. I would expect ONCY to be in a position to apply for accelerated approval in mid 2026. If then approved late 2026/early 2027, they would be able to market Pela (with realtime Phase IV trial). Pity they only have cash till early 2025...

look out for dilution.

[Noteable]

You once again have a disconnect between when the accelerated approval would be granted and when the Phase 3 would be run, particualrly since the BRACELET-1  OS data is expected later this half and more likely later this quarter.

[Quentin30]

Accelerated Approval granted in PLACE of running a Phase III trial... x 2 randomised Phase II trials... so they need to complete the mentioned next phase II... still doesn't really matter... I've had enough of ONCY... sold out my last positions over a month ago.. you're just trumping to an audience of half a dozen really... nobody really gives a stuff about this company... step up

[Noteable]

Two ONCY Phase 2 metastatic Breast cancers have been completed namely IND-213 and Bracelet-1. ONCY will be reporting on the 2 year overall survival (OS) results this half or more likely this quarter of this year. Accelerated Approval is usually granted on this endpoint, and a confirmatory trial will follow.  OK. I will note that you have no position in ONCY and are here only to agitate.

[Noteable]

Well let me remind you that there are 72 million reasons why "somebody" gives a ' down-under stuff ' about this company.

[13X2413]

Like I said earlier. More news from this POS, more sellers tomorrow. This is fading fast, just like my money tied up in this. My hopes for a miracle turnaround are in the dumpster. 

[Azzak34]

Good. Come back tomorrow and tell me more happy news about your dumpster life. 

[Noteable]

Stocktwits' Scooter0732 who is a big holder of Agenus Inc.  doesn't appear to understand that with an Accelerated Approval comes a revenue stream or an accretive Big Pharma acquisition. Maybe he will someday.

[Azzak34]

Big Ole bag holder. He is a dope. 

[Noteable]

https://seekingalpha.com/news/4125535-agenus-stock-plunges-on-fda-feedback-on-botbal-therapy https://www.wfxrtv.com/business/press-releases/accesswire/890282/agen-shareholder-alert-bronstein-gewirtz-and-grossman-llc-announces-an-investigation-into-agenus-inc-and-encourages-shareholders-to-contact-the-firm-today/ Regarding the above on AGEN https://www.wrbl.com/business/press-releases/accesswire