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There's one big wildcat in the bag with this combination trial for the same reason that also supports my view on why FDA supported this Orphan Designation with such speed based on outcomes from the 3rd Cohort.

Not only did it stabilise the disease in two patients but the impeccable safety data coupled with the fact that these patients had FAILED on EVERY OTHER AVAILABLE TREATEMENT opens the window - if this trial works favourably or even if the 4th Cohort with double dosage demonstrates further benefit in areas where the rest have failed THEN there's short odds on the FDA granting accelerated approval meaning drug goes straight to market based on Phase II data assuming the safety profile remains impeccable & the benefit exists for patients with no other option on current drugs. That is a BIG deal - accelerated approval still means Phase III has to be completed but drug can be provided based on Phase II.