Biotech Values

[jq1234]

I agree ph1/2 is to weed out drugs for ph3. If this weren't a targeted drug, or the result came from much larger sample size, I would agree with your suggestion and approach completely. However, to me, this ph2a have too few patients in important subgroups, thus signal so far is just adding to original ph1/2 signal - doesn't refute the hypothesis at all, one thing does rule out is 5% GPNMB expression threshhold is too low. To dismiss some subgroups entirely from such small sample size in highly diverse refractory BC population doesn't do service to the drug.

The reason I focus on HG with TN stratification more is due to the drug's mechanism of action. I agreed with Peter in subsequent post that TN with HG stratification is an option as well due to highly unmet medical need in TNBC.

My interpretation of trial result is consistent, if trial is properly designed, powered correctly, run correctly, statistical interpretation is the most important thing, for example, Serada trials. However, interpretation of underpowered trial is more art than statistics alone, you have to try to find balance between too optimistic or too pessimistic.