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Re: Grip it and Sip It post# 191048

Tuesday, 10/26/2021 10:45:32 AM

Tuesday, October 26, 2021 10:45:32 AM

Post# of 233035
Wrong. There is a MAJOR difference between "Fast Track" designation and "Breakthrough Therapy Designation".

Fast-Track:
More frequent meetings with FDA
More frequent written communication from FDA
Rolling review

BTD:
More frequent meetings with FDA
More frequent written communication from FDA
Rolling review
Intensive guidance on an efficient drug development program
Involvement of FDA senior managers to expedite development


Semantics!


My comments are just my opinions and should NOT be taken as investment advice.

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