Replies to post #3329 on Repros Therapeutics, Inc. (RPRX)

[io_io]

<So what does the new IND mean? >


I assumed that it belongs not to a Drug, but to an Indication.

Take for example some old drug approved years ago for something old (actually Campath for example). Now they get the idea to try it for something new (say Campath for MS).

So, of course they can't do it under the old IND; they need a new IND to set a framework for the clinical trials specific to this indication - different dosing, different end-points, etc.

Actually in the case of Proellex, the relevance of the pre-surgical indication would appear to need different input within the FDA.


However, I think someone posted an FDA link here a few weeks ago about the IND process, it would be good if it could be checked out.

[Nerf]

I think that this was exactly DueDiligence's issue with the new IND.

Personally I think that because it's for a new indication, "anemia" rather than "bleeding and pain associated with fibroids" that they wanted a new IND for a new protocol, myself. They are going to dose for 2 months and then measure hemoglobin, I believe. It's shorter than the 3 months and then off drug, and they won't be put back on drug so the different protocol might be the reason.

It is confusing, but if they get the acceptance then maybe some of the fence sitters will start to take a fresh look.

Personally I think that a few people give the moderator of the BV board a little too much credit, worry a little too much about what he thinks, myself.....