Oncolytics Biotech Inc T.ONC

Fast Track + PR (CR) = Accelerated Approval

[SundayMovies]

Things have dramatically changed and the market is behind the curve.
Fast Track by FDA opens the door for an Accelerated Approval.
Partial Responses and 1 complete responses will be enought for a licensing deal for a an Accelrated Approval.

We move much much higher.

I added more and will wait for the market to follow.

[Noteable]

The possibility of having an accelerated approval granted on the basis of the Phase 2 Goblet study results in pancreatic cancer is what I would strongly urge ONCY to pursue with the FDA  - which would subsequently be followed up with a post-marketing confirmatory study in 2023. Other Big Pharma companies have been granted similar approvals for their I/O products on lesser results. ONCY is

[westcoast1000]

Noteable, You have mentioned this in the past but I did not really understand its implications. If I understand correctly, there is actually nothing stopping ONCY from applying, given the dire nature of panc cancer and our results. If that status were granted in combo with Roche, we could be selling pela during 2023.  That is a huge win-win-win-wim: for patients, regulatators, Roche and

[SundayMovies]

More bullish headlines for ONCY https://www.wbko.com/prnewswire/2022/12/01/wave-fda-fast-track-designations-sparks-renewed-interest-biotech-sector-thats-heating-up/?outputType=amp https://www.prnewswire.co.uk/news-releases/optimism-building-for-advancing-pancreatic-cancer-treatment-therapies-301691582.html

[Noteable]

Furthermore, the potential of an accelerated approval for pelareorep in the pancreatic cancer indication is a significant advantage in ONCY's negotiations with a potential acquirer of the company and can be a postive leverage in the overall process, now that we have seen the Goblet results in this cohort of patients.  Both of the Big Pharma players (Pfizer/Merck KGaA) in the Bracelet-1

[Noteable]

As previously posted .... The possibility of having an accelerated approval granted on the basis of the Phase 2 Goblet study, the results in pancreatic cancer and the results of the Bracelet-1 clinical trial are the reasons that I would strongly urge ONCY to pursue an accelaerated approval with the FDA  - which would subsequently be followed up with a post-marketing confirmatory study in

[westcoast1000]

Sunday, "I added more and will wait for the market to follow." I like your thinking. Maybe in part because I have been doing what you describe for a very long time. But now it really is the time, given the previous results, new panc results and two fast tracks.