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Saturday, January 31, 2015 1:42:53 PM
Once that happens, a true valuation can be placed on the late stage developmental drug. QIDP designation advantages:
Fast-track
* expedited review
* rolling review
Breakthrough Therapy
* intensive guidance for development
* organizational commitment-involvement of FDA senior managers, cross-discipline project lead for review, regulatory project manager assigned.
* rolling review-regulatory project manager may recommend advanced review ahead of NDA review.
Accelerated approval
All of the above plus "Approval based on an effect on a surrogate
endpoint or an intermediate clinical endpoint that is reasonably
likely to predict a drug’s clinical benefit."
Any one of the above adds to the value of a pre-FDA approval license, and all of the above (The Trifecta) will easily put B-ABSSSI above $1 billion in upfront and milestone payments.
Reference: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
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