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Amatuer17

07/19/18 7:57 AM

#25320 RE: PNW_Ironman #25312

I hv heard most of cc from Nader and he is same - upbeat and overpromising

Take combo - he was talking approval by end of 2019 - then he said rolling BLA filing completion by May-Jun 2019 - Add 90 days for Bla acceptance and 6 months for PDUFA - you reach Q1-2020

On Mono Pivotal - he mentioned BLA filing by end of 2019. But said pivotal to start by end of 2018
Add 1 year for enrollment and 48 weeks for safety - add 3-6 months for BLA filing and we reach Q2-2021
Over promise by at least 1 1/2 year

Also he does not have skills, resources or funding to take the product to market and compete. Another over promise