RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsEmploying biomarkers and surrogate endpoints in Orphan/Rare diseases, like in metatstatic breast cancer, result in smaller registration studies and more particularly opens the door for "Accelerated Approval" and smaller/quicker post approval confirmation studies.
It has been already posted on this message board that the FDA is willing to consider innovative treatments in an effort to bring effective benefits to patients.
Consequently it would appear that ONCY has asked for a meeting with the FDA to have them confirm the biomarkers and then grant a Accelerated Approval based on the long-term surrogate endpoints. ONCY has always been on the "leading edge" of immuno-oncology and has had the full confidence of the FDA. This is even more important now, given that "vaccines" have regained their former interest in the oncologist community AND the FDA has now has a company in ONCY to actually validate and standardize biomarkers that would be employed by ONCYand other "vaccine" companies to facilitate having their products approved based on both biomarkers and surrogate endpoints.