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Re: Investor2014 post# 137421

Tuesday, 01/16/2018 9:20:00 AM

Tuesday, January 16, 2018 9:20:00 AM

Post# of 462144
Agree.....RWE-Real World evidence, comes to mind as a leverage point.

Quote:

Explore the development of a policy framework under which an accelerated approval approach could be used to support marketing of a drug that demonstrates a survival benefit early in clinical development. The goal is to expedite availability of a therapy while the magnitude of the benefit it provides is being confirmed


A daring and probably silly thought - could it be that based upon the many confirmations from independent research and clinical longitudinal results regarding safety and indicative efficacy correlated across multiple measures, that the wait is a calculated one potentially leading to accelerated approval.

An interesting contradiction in terms, which if it comes to pass will shake the market by its foundations.

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