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Re: Scottwny post# 174115

Saturday, 03/04/2017 11:19:36 PM

Saturday, March 04, 2017 11:19:36 PM

Post# of 403091
Topical drug with little absorption, severe unmet need, complications and mortality numbers from current standards of care: if no or few minor adverse effects, then straight to Phase 4 is possible. The one major hurdle/condition would be the right partner that can convince the FDA that they will fully comply and report all cases/patients under the Phase 4 protocol (a major cost).

More likely the FDA will approve an expedited, relatively small Phase 3 trial.

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