Agreed. They would need supply of continuity for about 2,000-3,000 patients to avoid a massive lag in drug manufacturing. No clue what their current supply is. Great question for management but I’m sure they thought of this already always thinking 5 steps ahead to critical issues like this vs “small ball thoughts of the day” thinking 600 patient ph3 is adequate because after all
It’s Covid etc in which fda should say great now due a 2000 patient second ph3! The bar and goal post for Fda is and will be continually moving over time so ipix had to have been prepared or likely is…tbd
It’s also possible they recognize they aren’t suited for a massive ph3 and just do a trial
Say 4x current size (600 ish) just for “promotional purposes”.
Safest bet aside from selling the drug and or company post ph2, hop into one of them government trials and pray for success! Provided drug supply on hand to meet gov ph3 requirements vs other companies ready to go.
Thoughts?