Biotech Values

[DewDiligence]

>>They already have data segregated by treatment, so I don't think revealing the results by dose level undermines the masking of the trial in any way.<<

Agree. Companies often argue (dubiously, in most cases) that interim data cannot be disclosed in order to “protect the integrity of the trial.” But this argument goes out the window when the control-arm data is disclosed, as was the case in the “208” trial.

>>One other possibility here is that the results by dose levels may have revealed something unpleasant or confounding. For example, if your best results are at 20 mg and you see poor results at 10 and 40 mg, that almost suggests that the 20 mg results are a fluke as well. How else, biologically, can you explain that an intermediate dose had an effect while half the dose and double the dose were entirely ineffective?<<

A very good observation that I overlooked.