27 years in medical oncology
20% of this time in clinical trials
Phase III RCT's are design to compare standard of care vs potentially " new" standard of care. Thats how we pick up new drugs to be in our cancer treatment guidelines
If there is no standard of care ( SOC ) and in case of OM , there is not ,FDA can approve the " new" standard based on Phase II randomized ( presence of control arm) or even occasionally phase II non-randomized ( no control arm) trials if some of the important end-points are met e.g.. Quality of Life (QoL) or survival data are good and compelling
In our case OM has no SOC at all so ,FDA can analyze and accept data from recent PII B-OM trial and approve it
Has been seen and done many, many times before
This is all IMO
cheers to all longs
20% of this time in clinical trials
Phase III RCT's are design to compare standard of care vs potentially " new" standard of care. Thats how we pick up new drugs to be in our cancer treatment guidelines
If there is no standard of care ( SOC ) and in case of OM , there is not ,FDA can approve the " new" standard based on Phase II randomized ( presence of control arm) or even occasionally phase II non-randomized ( no control arm) trials if some of the important end-points are met e.g.. Quality of Life (QoL) or survival data are good and compelling
In our case OM has no SOC at all so ,FDA can analyze and accept data from recent PII B-OM trial and approve it
Has been seen and done many, many times before
This is all IMO
cheers to all longs
10
