Oncolytics Biotech Inc T.ONC

Type C

[pelaboost]

I found the following in a search. I have no idea how to post it.

A search of  -  Considerations for Discussion of a New Surrogate FDA  - . should find the article.

I find mBC much tougher to follow than GOBLET, but I think there is germane material in the article.

Best

[Noteable]

This is it pelaboost. Considerations for Discussion of a New Surrogate Endpoint(s) at a Type C PDUFA Meeting Request " Requests to engage with FDA on this topic will be considered a Type C meeting request. The purpose of this meeting is to discuss the feasibility of the surrogate as a primary endpoint, and identify any gaps in knowledge and how they might be addressed." " Unlike

[Noteable]

The agency will accept or deny the Type C meeting request within 21 calendar days of the request. If accepted, the meeting will occur within 75 calendar days of the request. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/early-engagement-fda-discuss-novel-surrogate-endpoints-november-27-2018-issue