Cerevast Therapeutics’ Ultrasonic Stroke Treatment Gains Momentum
Cerevast Therapeutics is gaining momentum as the company raises new funds and advances enrollment in its pivotal Phase III clinical trial evaluating its Clotbust ER, an ultrasonic head-frame that delivers acoustic energy to the brain to enhance clot dissolution in acute ischemic stroke patients who receive intravenous tPA.
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Phase III Trial Of Cerevast’s Transcranial Ultrasound To Treat Stroke Misses Endpoint
The 90-day results of CLOTBUST ER, published in The Lancet, show sonothrombolysis to treat acute ischemic stroke is feasible and probably safe, but the trial did not show a clinical benefit of the therapy in conjunction with alteplase treatment.
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.