Noxopharm has confirmed its intention to jump from Phase I straight into a registration study, via an adaptive-design Phase II/III trial that starts with relatively small patient numbers but then can be expanded once initial results are known. This is cost effective, and provides the quickest route to approval.
The data to date is clearly superior to any competition, so much so that Accelerated Approval must be a distinct possibility.
The decision to bypass the usual Phase II trial shows that Veyonda is going places - in a hurry.
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