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Tuesday, May 07, 2024 10:56:21 AM
Actually, we ARE seeing a change in the FDA's view towards drugs like lenzilumab.
I mentioned previously that Invivyd received an EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA. "The immunobridging pathway for COVID-19 treatment is enabled by data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype monoclonal antibody (mAb), for the treatment of COVID-191 and data from the ongoing CANOPY Phase 3 clinical trial of pemivibart for PrEP of COVID-19. The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible. "
https://www.globenewswire.com/news-release/2024/05/07/2876606/0/en/Invivyd-to-Pursue-Rapid-Immunobridging-Pathway-to-Potential-EUA-for-Treatment-of-COVID-19-in-Moderately-to-Severely-Immunocompromised-People-Based-on-U-S-FDA-Feedback.html
I think this change simply reflects the FDA's recognition that having no viable treatment therapeutic for covid 19 is untenable.
Equally untenable is failure to utilize lenz to enhance non-mRNA vaccines. The EU challenged, but then quickly accepted the enhanced performance results of the latest Novavax covid vaccine. But Novavax is, rightfully, also under investor pressure to capitalize on this opportunity.
"Shah Capital Launches Campaign Urging Stockholders to Vote AGAINST the Re-Election of All of Novavax’s Directors Up for Election at its 2024 Annual Meeting"
https://www.sec.gov/Archives/edgar/data/1000694/000092189524001044/dfan14a11882nvax_05062024.htm
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