Repros Therapeutics, Inc. (RPRX)

[exwannabe]

"The Phase One trials are already done - in fact the Phase One trials do not have to be in patients with the particular indication - or have any disease or condition at all (they can be "healthy" volunteers)."

I know this.

What has me confused is the new IND. I always thought the IND was kind of the "safe enough for human testing" signoff that submits the pre-clinical safety and defines the phase 1. Once passed that the IND and P1, the company just does P2 and P3 for other indications.

So what does the new IND mean? Normally I would have assumed there is something signficantly different about the usage in te new indication that would make the previous IND/P1 not valid. But in this case (it's still women with fibroids) I don't see why this would be so.

I really have no idea if I am just misunderstanding when the FDA asks for new INDs, or there is something weird in this case. I did hear the company's "it's cleaner this way" statement, but that seams odd to me unless it is always done and I don't here about it.

Oh well, I probably never will understand the inner workings of the FDA.

Good luck all.