Thanks (once again) Tony,
I recall watching the first video previously but it sunk in better this time. Potentially a problem with a small brain.
My thoughts were initially along the lines of "By the time we get thru Phase 2 and then have to approached the NDA for (possible) Phase 3 trials, a lot of time will have elapsed".
Think I missed the page 11 comment you quoted - if results are good they will ask to end Phase 2 and discuss a pivotal trial. That would of course be magnificent.
Appreciate you spending the time to reply so fully (as you seem to do regularly). There are a lot of terms used (fast track / Orphan Drug ) some of which could be taken to be a descriptive term but in fact has a specific meaning in NDA lexicon. Esp Breathrough therapy / pivotal trial. The second few videos were terrific in explaining this (as you pointed out G.C).
All the best
Rgds
KMS
timeline question, page-5
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