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RobinX

11/10/20 12:48 PM

#21543 RE: nelskof #21542

I would fire their PR firm! Fricken ridiculous!
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nelskof

11/10/20 1:20 PM

#21545 RE: nelskof #21542

I found another one to add to the list.

CDER (Center for Drug Evaluation and Research)

From the November presentation...

• 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