Biotech Values

[biomaven0]

do you think the Phase 1 trial would be along the lines of the L-Dopa trial in terms of duration or would there be other factors making it a longer process

From an overall development perspective it has to be much easier than L-dopa, which must be about the most difficult of all drugs from a PK and dosage perspective. For L-dopa you have to strike a balance between "on" time and "off" time. (But I guess that mostly speaks to the Phase II rather than the Phase I).

For this drug you just want to see nice smooth PK and decent AUC while minimizing side effects by avoiding peaks.

What I don't know at all is stuff like between-user variability for both the original drug and the pro-drug, and the impact of food in both cases.

Bottom line though is I know of no reason why it shouldn't be a routine, easy trial.

Peter