Ann: DMX-200 Competitive Position Further Enhanced, page-34

GMP is required for all human clinical trials & manufacture of drugs! DXB already have upscaled GMP & FDA approved manufacturing of DMX-200 in the USA for COVID-19 trials via an approved Pharma for patient needs & not considering upcoming renal disease trials, you are potentially looking at dosing for 1000 patients, just to cover the initial 200 in REMAP CAP & move to Ph3, then 600 in CLARITY-2.0, and then all the patients that remain on Special Access Scheme via scripts from their treating Physicians (coming up to>4 years now for some patients from Ph2A, these ones were sicker, you are looking at a potential diversion from dialysis right here. The FDA requirements for approval were started way back in 2019 for packaging, shelf life stability, all those things required were done prior to Ph2. TGA obviously happy with SAS earlier on & not many drugs are given the ok this way, there has to be very good evidence. That data is sitting there now for PH3 & open label.

Not sure what you are talking about @HS2912??

GLTAH