EluSys May Launch HP System For Defense Uses Without Human Efficacy Data
EluSys Therapeutics anticipates commercialization of its first product, a heteropolymer monoclonal antibody injection for the treatment of blood-borne viruses, will be accelerated by FDA's recent proposal regarding products for the management of bioterrorism.
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FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials