Thanks Titans.
A SIFC is a large legal document comprising numerous legal arguments. It is accompanied by independent expert reports that the SIFC cites to support its arguments - again these are substantial documents. Overall, we had more than 150 pages of SIFC and expert evidence to review, understand and address. Typically, prior to the conciliation, the Applicant (FRE) would have time to prepare a SIFC-in-reply to counter some of the arguments and/or set the record straight on evidence. Both sides would also need to have time to instruct their senior counsel (barrister) to allow them to prepare their side's arguments to present at the conciliation. Senior counsel are busy people and not necessarily available at short notice.
We submitted our SIFC and expert evidence on 2 March. TGA's expert evidence and SIFC were due on 12 May. 30 May was always going to be tight for us, but doable IMO. However, we did not receive TGA's expert reports until 20 May and we received their SIFC late on 25 May, effectively giving us 3 business days to complete all of the above. TGA's delays made the original timetable impossible for us. But instead of being squeezed by TGA's delay, the conciliation deferral gives us the time to properly prepare our case. Frankly, if AAT had not pushed the date, we would have been forced to request a deferral ourselves.
We continue to believe our case is very strong and look forward to the conciliation meeting. We are working to get agreement from all parties on a new date and will advise the market when it is rescheduled. In the meantime and regardless of the conciliation timing or outcome, the primary long term value creation for our company will come from the results of our Phase 3 common cold study, which is completing this year and we will shortly provide an update on trial progress.
Peter M
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