FDA’s DCT draft guidance: A hit or miss?
The much-anticipated draft guidance on DCTs is here, however, it might have missed several important points on delegation and data management.
06 July 2023
06 July 2023
The much-anticipated draft guidance on DCTs is here, however, it might have missed several important points on delegation and data management.
Top-line results after the induction phase (primary endpoint at week ten) are expected in the following months.
The study intends to enrol a total of 188 patients from Europe and the US early in the third quarter of this year.
BP02 showed a similar clinical response compared to Herceptin.
The study is anticipated to start enrolling patients in the upcoming weeks.
ADL018 is a biosimilar candidate to Novartis’ Xolair (omalizumab), which had global drug sales of $3.8bn in 2022.
The study intends to assess the efficacy and safety of Tinlarebant in patients with GA associated with Dry AMD.
The University of Kentucky Sanders-Brown Center on Aging is the first activated site for enrolment.
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