After holding up the company more than 4 months after reporting positive head-to-head data against the blockbuster drug Soliris, Apellis $APLS says it’s cleared things up with the FDA and is ready to file for an approval with their rival PNH drug pegcetacoplan.
The Waltham, MA-based biotech — whose CEO, Cedric Francois, has recovered from a bout with Covid-19 — put out the word Thursday morning that execs had a “successful outcome of the pre-NDA meeting” with the agency and they’re ready to press ahead with their filing in the second half of this year.
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