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Re: lorbas95 post# 40808

Saturday, 05/11/2019 8:39:19 PM

Saturday, May 11, 2019 8:39:19 PM

Post# of 233305
Here are my guesses (min)


Protocol submission/FDA feedback: about 5 weeks from now.

Initiating trial and full enrolment: 12 months

Trial completion - 48-weeks from last patient

Top line and final data analysis - 2 months

sBLA filing: 4 months

sBLA decision: 4 months

Total - 34 months minimum

Approval - Q2-2022
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