Biotech Values

[drbio45]

Is it surprising that it's considered ethical to withhold treatment in the placebo arm? Maybe it's not thought ethical in Europe, hence the lack of European sites, unlike in the prior P3?

The first ten days both groups get prednisone which is SOC.

If you fail you get prednisone with is SOC.

the lack of European sites is a benefit for Dor because it will be easier to run the trial without having to do sites in Europe.

The emea seems to be content that the US has sites that will have the proper protocols in place to do a proper study.