Ann: Paradigm Presentation to Emerging Leaders Conference, page-65

A couple of thoughts on this -

- I believe the provisional approval is a one-strike-and-you're-out process and that having an IND with the FDA and P3 about to commence is viewed very favorably in these provisional applications. So on a risk/return basis maybe better to delay a few months, get the IND in the bag first and then Provisional Approval?.
- provisional approval is granted for 2 years only initially with the expectation that a full application is made prior to expiry. Extensions can be given, though significant progress in studies need to be demonstrated. Hence, might there be a risk in going for provisional too early? Perhaps better to leave the application until say 2 years before the expected P3 readout (which would be about end of 2020) so that it can roll over into a full application without extending the provisional period?
- On the timing of the IND I'm also wondering if the next batch of SAS patients with WOMAC scoring (the scores to be used in the P3) might be used to inform the trial design and specific endpoints. Has there been a strategic move to wait for this data and use it to refine the endpoints and get even more confidence that the P3 passes with this pain/function scoring system.

So maybe the schedule delays for both IND and TGA filing are all in aid of derisking the process even further.

Anyways, look forward to a bit more newsflow in the next quarter than there's been in this one.