Just some thoughts on timelines and capital requirements.If the...

Just some thoughts on timelines and capital requirements.

If the FDA come back imminently with approval for our phase 3 with no modification I would expect we would have our first patient enrolled within approx 2-3 months of now so call it end Oct 2024..( If they come back with modifications required or further trials then obviously these timelines blow out)
Then we allow 10 months for enrolment of ALL participants which takes us to last patient enrolled end Aug 2025. Then we follow the last patient out for 400 days which will be the trial conclusion. Realisticly we are looking at trial completion date of end of September 2026.
Then if we allow 2 months for compilation of all data and final phase 3 readout we would get a pass or fail in November 2026.
Then if we allow another 3 months for compiling of all data and filing of NDA an NDA submission could be expected in Feb 2027.
Then we need to allow 6 months for a final drug approval from the FDA and if there are no hiccups and label negotiations go smoothly we may be granted FDA approval in September 2027.
If marketing preparations/insurance and pricing are all done smoothly Zilosol could hit the market in the 1stquarter 2028.
Obviously our share price will be multiples of where it is now at many of thise inflection points so we see returns along the way but the real magic will be 2028. Caveats to this are TGA provisional in 2025 so this could make a huge difference to wait times.
If we also pursue this in Canada this will also make a huge difference.
As I have said before we have 2 quarters of cash so I expect they will do a top up raise to begin phase 3 trials and then a deal or 2 or 3 to pay for the remainder. We are currently burning 7 million a quarter so to get us through the next 24 months we need approx 60 million Aud in addition to the 90million Aud to finish the phase 3.

All just my thoughts and approximations.