Hi @Boffin, reply function downI don’t think you are missing...

Hi @Boffin, reply function down

I don’t think you are missing anything. A PRV would be value adding @ US$100 million for DXB.

Also Orphan status granted in EU & UK also. So we could be looking at 3 territories as early as mid next year to apply for accelerated approval on the next readout.

Paediatric ANNs:

FDA

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02620505-3A610841

PIP Plan EMA

(note in this one that following a successful outcome of ACTION Ph3 in adolescents, they can then run a small confirmatory trial in younger children 11yo & under) for market approval.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02683281-3A621163

Regarding PRV vouchers if people want that info:
DXB may have already applied for rare paediatric disease status now that we know part 2 is going ahead (there is a sunset clause in the link, so hopefully that is obtained from the FDA soonish, DMX-200 already designated Orphan drug for FSGS).

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs

As for further licensing deals or a decent T/O offer, I hope the interested parties are falling over themselves in the ‘data room’ to get on board.

Upcoming catalyst section in the last investor preso also mentioned news on secondary assets, but the focus has been on Action 3 & getting DMX-200 to market. My guess possibly after interim 2 readout for further trials? Hoping the recent CR is the last one, Nina has stated enough cash runway to complete ACTION 3 to the end of the trial.