Ann: Bisantrene cGMP API Manufacturing Completed at Laurus Labs, page-23

Daniel, can you talk in a general sense about the steps involved from taking a cGMP sample of a drug and getting it ready to be administered into humans in a clinical trial.

for instance, is RC220 regarded as a new drug formulation that requires FDA approval before it can be used in a clinical trial…. I think the term is “ new investigational drug” or IND and I think an application has to be made to the FDA to approve an IND?…but I don't know for sure.

I also don’t know about pharmacokinetic studies and what they involve…do they test on cows or dogs or humans?

can you talk generally about all this stuff, as these steps must be pretty standard for the development of all new drug formulations prior to running clinical trials?