Oncolytics Biotech Inc T.ONC

What is Accelerated approval?

[westcoast1000]

From the FDA:

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.  If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
________

ONCY has two biomarkers that could serve as the basis for accelerated approval.

That is potential money in the bank in terms of cost savings for trials that would be led to obtain final approval in ONCY's two unmet needs.

[Kswdelux]

Thanks and great posts West! What this means for ONC is the Standard Type C meetings and application process is no longer ONC's required pathway for mBC and now Panc. It will be a shorter process. IMHO we could very well see Approval of the Phase II/III Panc registration trail before end of 2022 or very soon into 2023.  When that happens ONC will officially be a Phase III drug

[fox7mf]

Great posts all. I agree Ksw, we could definitely see approval of the ph II/III pancreatic registrational trial late '22/ early '23. Along with that, we could also receive word of a Roche purchase offer. Great times!!

[Buckhenry]

im glad to hear that you and the CEO of Roche are that close. I will be waiting on my check.....unless you want to buy my shares now for $200 per share.