Going...going..gone!

It's a good day when your client literally asks if there is any way you could imagine a response from FDA being any better. Overall our development strategy was approved saving the client approximately a million dollars in pre-clinical and clinical studies and a year of development. From a CMC perspective we received a positive response to a more aggressive question that could save the client nearly six figures on stability testing. Knowing how and when to push the envelope comes with experience, but it is still a good feeling when you hit the ball out of the park!