forget about the poster. for the value inflection point which is a ce mark you need to ask:
1. is it safe? OncoSil is safe. at least, no worse than chemo. I believe this study outcome will be met based on data and review papers. Keep in mind this was the primary endpoint of the study.
2. does its benefits outweigh the risk? personally i think the answer for this one is not yet proven. It is very difficult to assess the benefits when you got no control arm. sure, OSL is putting together a literature review of current first in class survivial, but if regulators go off that then no one will want to spend millions of dollars in controlled trials anymore!
can anyone point me to a drug or medical device that was approved solely based on safety?
forget about the poster. for the value inflection point which is...
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