WHAT IS HAPPENING IN BRAZIL? The news release said (highlites added)...
"The current partnership with Synova Health leverages high quality clinical trial sites IN ADDITION TO a dozen centers already enrolling COVID-19 patients for another Sorrento Phase 2 clinical trial (Abivertinib). ADDITIONAL STUDIES are also being discussed for early clearance in parallel or immediately following this study. PRIORITY ACCESS to multiple trials is being given to Brazilian patients following the rapid and openly collaborative interactions Sorrento has been able to establish with ANVISA regulators.
“We are very satisfied with the progress made in Brazil so far, and we have developed strong local relationships in support of multiple studies,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “By focusing on the geographies most impacted by COVID-19, we are able to implement synergistic programs to answer safety and efficacy questions related to our product candidates while helping patients where the disease has been spreading the most. We expect this next Phase 2 Pivotal study to confirm the clinical benefits initially observed in our recently completed open label Phase 1b study. If confirmed, we are ready to establish a plan for development and MANUFACTURING COMMITMENTS that are required by ANVISA to take the product candidate from clinical trials to emergency use authorization (EUA) approval, including generating the data needed to support making the drug accessible prior to any full registration.”
I see at least three important implications.
1. They are adding new high quality sites IN ADDITION TO the DOZEN sites already enrolling for the Abivirtinib trials (results soon).
2. ADDITIONAL STUDIES are being discussed. Could this include COVI-AMG, COVIDROPS and Gene-Mab? Or some combinations of the top 5 Covid candidates? Sorrento is being given PRIORITY ACCESS "to multiple trials".
3. Sorrento has made MANUFACTURING COMMITMENTS. Clearly that means establishing manufacturing arrangements in Brazil. Sorrento could then have manufacturing capacity in the US, China and Brazil! All part of becoming a worldwide Pharma!
"The refusal of the real is the number one dogma of our time" Rene Girard
