Oncolytics Biotech Inc T.ONC

Trials

[pelaboost]

I am glad these changes were mentioned. ONC/Y now has some very qualified people who know how best to navigate these matters. So, I am hoping that Noteable is right, and from my lay perspective I think he or she could very well be right.

I am just guessing at the following but is it possible that the confirmatory trial is actually the Phase 3 (albeit much shorter than a normal Phase 3) and the Phase 4 is run with the drug approved. If Noteable is correct Roche would have to be involved

[pelaboost]

Correction. I meant to say the Registration Enabling Trial is akin to a Phase 3, but shorter than a normal Phase 3, And the Confirmatory trial with the drug approved is a Phase 4. Just some idle thoughts.

[Noteable]

With an Accelerated Approval, the FDA requires that the sponsor initiates a post confirmatory clinical trial (sometimes called a Phase 4) - effectively replacing the traditional Phase 3 nomenclature with that of one termed a "Registrational Enabling Trial" .  The Registration Enabling Trial is an extention of the Phase 2  and precludes the need for a new ttrial.This is the last

[pelaboost]

@Noteable. Thank you for that clarification. Accelerated Approval application seems to fit. Are we missing something. Is there another explanation for the changes in the New Presentation. TIA

[inthno]

What is a registration enabling study?     Registration Enabling Trial means any Clinical Trial that is intended to, or does, generate data sufficient to enable the Filing of a Marketing Application in any country in the Territory. I still do not think that AA is in the cards at this time as we would have heard by now and this is not information that the

[lonc17]

Oncolytics has removed all references to Phase 3 trials from its investor presentation.  Think about that for a minute.  Two days ago they were a company that was due to begin TWO PHASE 3 TRIALS (BC and Panc). Now they don't even want to use the phrase "Phase 3 trial" I suggest "investors" spend some time asking chatgpt about the difference between

[Noteable]

lonc17 nonsense.

[itntdf]

it makes sense that moving to a registration enabling clinical trial would certainly involve roche or one of the other bp's. if that is the case, the lawyers on both sides are working as we speak. neither party would want a stain from a failure of trial design and there would need to be an agreement which allocated costs and expenses as well as agreement on which surrogate endpoints to use