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Re: nelskof post# 21634

Thursday, 11/12/2020 9:22:29 AM

Thursday, November 12, 2020 9:22:29 AM

Post# of 43124
Found it in the November presentation:

OWS Regulatory Participation and Expertise

• Interim results (unblinded) shared with OWS
• OWS therapeutic efforts headed by Janet Woodcock, director of the Center for Drug
Evaluation and Research (CDER) at FDA
• Review of all submissions and correspondence to FDA
• OWS FDA SME attendance at company meetings with FDA
• OWS will be included as a Named Contact on all FDA filings
• OWS concurs with expansion of the Phase 3 study and path forward

$RLFTF & $HGEN
- The two leading therapeutics in the fight against Covid-19

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