NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

An example of FDA approval with modified primary endpoint based on Special Protocol Assessment (SPA)

In connection with the SPA, the FDA recommended, and the Company accepted, modifying the primary efficacy endpoint for the GATHER2 trial

“We are excited to receive this SPA agreement from the FDA,” stated Pravin U. Dugel, MD, President of Iveric Bio. “We thank the FDA for their collaborative interactions and valuable input on the primary efficacy endpoint for the GATHER2 trial, which we believe reflects the FDA’s current thinking. The modification of the primary efficacy endpoint does not require collecting any new data but instead reflects a change in how the data are analyzed. We look forward to continuing to work with the FDA and following their guidance as we work toward preparing the eventual NDA submission for Zimura.”

https://investors.ivericbio.com/news-releases/news-release-details/iveric-bio-receives-fda-agreement-under-special-protocol