RE:Type CThis 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 other Type C meetings, sponsors that wish to qualify for a Type C meeting under this commitment will submit a complete meeting background package at the time of their meeting request, which includes preliminary human data indicating impact of the drug on the biomarker at a dose that appears to be generally tolerable. 2 In addition, the cover letter for the background package for this Type C meeting should clearly state that the purpose of the meeting is to discuss a new surrogate endpoint not previously used for accelerated or traditional approval for the proposed context of use."
https://www.fda.gov/media/115120/download