Ann: Application for quotation of securities - PAR, page-28

Unfortunately I cannot recall where I seen it (it may have been in an announcement or presentation) but I can no longer track it down. I'm pretty sure it specifically stated that they don't have an IND for PARA_003, so I can only assume that they require the results from PARA_002 stage 1 before they can apply to the FDA to initiate 003. It would nonetheless be useful to get clarification from PAR, but if I come across the resource again i'll tag you in it.

The confirmatory trial is a requirement for product registration, where PAR needs at least two well controlled randomised studies for approval. PAR initially thought they could leverage all the data that currently exists and only perform a single P3 study through the 505 (b) pathway, but were knocked back presumably due to the differences in routes of administration (oral vs subcutaneous). I have always been of the view that an IND is required for each separate clinical trial, but I could be wrong.

If it is true that PAR 1) needs the results from stage 1 and 2) needs to apply for an IND for 003, then they will have to update the IND with all of the results they would have accrued up to that point, so the FDA will likely also take into account both the new safety and efficacy data that will be generated from 008, the canine study and 002 stage 1. Apart from safety, if the treatment doesn't achieve a positive efficacy signal (which is remote yet nonetheless still possible) then this could be another reason for the FDA not to issue an IND for 003.

My views, not advice, dyor