The biggest positive in the advice regarding Phase 3 is that it will NOT be the normal Phase 3 Trial... costing many millions of dollars... the Board will be "registering for a Pivotal Phase 3".
Cutting straight to the chase... this means the FDA will have to agree the results from existing Trials are so good that VLA will be permitted to undergo a Phase 3 with a vastly reduced number of patients... and hence a vastly reduced cost, to the normal number of patients ( in the hundreds).
If the Pivotal study is permitted, there will not be a need to dilute the rewards(??) with a funding partner.
Whether or not the Board chooses to self fund still remains to be seen.
The biggest positive in the advice regarding Phase 3 is that it...
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