Posted On: 08/17/2016 9:22:57 AM
Post# of 72447
A Phase 2A trial is in the works for Kevetrin. No one plans a Phase 2A trial for a drug if they think it doesn't work.
Phase 1 is for SAFETY, not efficacy. No one expects efficacy of a Phase 1 dose-escalation trial, intended to determine whether a drug is safe, and how much can be tolerated. Anecdotal stories of efficacy for individual patients which may arise out of a Phase 1 study, do not rise to the level of proof needed to make claims of efficacy. No one should expect proof of efficacy out of a Phase 1 clinical trial.
Quote:
Bertolino said he’s hoping to start a Phase 2a study this fall.
Phase 1 is for SAFETY, not efficacy. No one expects efficacy of a Phase 1 dose-escalation trial, intended to determine whether a drug is safe, and how much can be tolerated. Anecdotal stories of efficacy for individual patients which may arise out of a Phase 1 study, do not rise to the level of proof needed to make claims of efficacy. No one should expect proof of efficacy out of a Phase 1 clinical trial.
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