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Biotech / Medical : Regeneron Pharmaceuticals
REGN 705.07+1.7%10:44 AM EST
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From: Miljenko Zuanic4/27/2018 4:49:32 PM
   of 3559
 
RE: Is there any option left for possibility of positive surprise???

SNY mentioned (1Q cc) that they may be able (based on current enrollment rate) to file for 2019 REGN2810 approval (1L NSCLC, primary is PFS, crossover design) , trial is versus chemo, PDL1 positive:

for clinicaltrials.gov

This is International trial, ex-US, so what are the chances (even IF positive) that FDA may accept data for early sBLA??? EMA, maybe they can???

They think (or they HYPE???) that they may be able to repeat Keytruda KN-042 results???

Based on my research, and what is available for 2810, I see this as very unlikely event. However, IF SOMEONE have other opinion/view....would like to hear about!

Thanks in advance!
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