Bimatoprost phase 2 results

[logikmtr]

I also don't understand their move. Are they going to run a phase 1 followed by a phase 2?

Or are they going to run the two together at the same time?

Who knows something about these regulations? Is a company forced to re-do a phase 1 study before going into a phase 2 when a formulation is changed or..?

Probably depends. If they change the active ingredient to another one, then probably. If they change dose, then most likely they already tested that dose or higher in phase one, so a committee will probably say it's okay. If they add approved substances, then probably okay (but they may need to do some work on interactions), and if they add a new un-approved substances then more work may be needed.

http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070567.pdf