SUD, page-10

Post drugs that Artimist and Zolpimist are based on are commercialised drugs so plenty of data already available, as for Zolpimist this in its self is already approved by FDA and being sold in the USA.

I have not read anything which indicates that TGA holds up approval process of issuing the MAA, yes they may request additional data around how the product will be manufactured and sold but any requests and response time is all taken into account when giving the 12 months approval or otherwise timelines

Not being an expert in this field I can only go on what is issued