The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
Clinical evidence has consistently highlighted lacosamide’s efficacy and safety.
No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks
Importantly, the combination of giredestrant and everolimus was well tolerated
Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent
The Phase Ib MAD study is a randomized, double-blind, placebo-controlled trial conducted in the United States
Funding supports development of first-in-class pan-ROCK inhibitor ROC-101 through Phase 2a clinical testing
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