Ann: PARADIGM FILES FIRST IND WITH US FDA, page-16

GG, I cant offer anything on this one as we simply have no real source to find out other than ringing/emailing PAR but Im reluctant to do this as I just want them to concentrate on the many jobs and tasks they have and as we know its not a large staff that they currently employ.

My guess is that they have started this work and are in communication with the TSA. There seems to be (as you would think) a strong link and association with the TGA and the FDA as it seems that the TGA often will pause their Provisional Approval process if the FDA asks questions and/or asks for more data during an IND application. To me this suggests that it is common that these two applications run in parallel to some degree.

Hopefully we will get an update from PAR on this at some stage in the next few weeks? At the very least we can ask such questions at the AGM which is normally in October some time.