#14356
Re: Novavax (NVAX): Un Nuevo Comienzo
Lo que imaginaba...
Visto en IV:
The FDA has lobbed "additional questions" at Novavaxs plan to lean on partner Fujifilm Diosynth Technologies North Carolina plant for commercial-scale manufacturing of its vaccine for a phase 3 North American trial, the company said Monday. The added scrutiny has pushed the studys start date into late December at the earliest.
The FDAs line of questioning on the Fujifilm plant is uncleara Novavax spokeswoman wouldnt clarify what the agencys questions were in an emailbut the biotech is switching to a commercial-scale facility to power the study after using smaller, clinical-scale batches for earlier trials. Novavax previously forecast it would launch the U.S. trial by November.
"At this point, we have satisfied most of the FDA requirements and any questions that they had around the trial protocol and Phase 1/2 data," the spokeswoman said. "We are now submitting remaining data packages that we expect to clear the way for their final approval to begin the trial soon."
Visto en IV:
The FDA has lobbed "additional questions" at Novavaxs plan to lean on partner Fujifilm Diosynth Technologies North Carolina plant for commercial-scale manufacturing of its vaccine for a phase 3 North American trial, the company said Monday. The added scrutiny has pushed the studys start date into late December at the earliest.
The FDAs line of questioning on the Fujifilm plant is uncleara Novavax spokeswoman wouldnt clarify what the agencys questions were in an emailbut the biotech is switching to a commercial-scale facility to power the study after using smaller, clinical-scale batches for earlier trials. Novavax previously forecast it would launch the U.S. trial by November.
"At this point, we have satisfied most of the FDA requirements and any questions that they had around the trial protocol and Phase 1/2 data," the spokeswoman said. "We are now submitting remaining data packages that we expect to clear the way for their final approval to begin the trial soon."
