Replies to post #22692 on Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[haysaw]

I'm guessing that the "safety issue" is a general term, not specific:

The NDA process requires a company to prove the safety and efficacy of a new drug product to the FDA’s satisfaction.

So the safety 'issue' is, by default,a preemptive word (safety must be 'proven' first). Is there no validity to all the previous research and product usage? In addition, what came of this?:

We are currently complying with the FDA’s comments by undertaking additional preclinical studies which address those concerns. We expect to complete those additional studies during the fourth quarter of 2014.