As CEO bounces back from Covid-19, Apellis says FDA meeting clears path to file for an OK on Soliris rival

As CEO bounces back from Covid-19, Apellis says FDA meeting clears path to file for an OK on Soliris rival

Source: 
Endpoints
snippet: 

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.