Side By Side: FDA’s pCR Guidance
A comparison of areas of change between FDA’s 2012 draft guidance on using pathological complete response as a surrogate endpoint for accelerated approval in neoadjuvant breast cancer and the newly released final guidance.
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Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.
Part 1: Execs from rare disease-focused companies weighed in on investor sentiment during a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference.
Patients with the most severe type of disease were all randomized to treatment with the study drug, which may have had a negative impact on outcome, the Israeli company suggested.