Biotech Values

[jq1234]

pCR as endpoint for neoadjuvant setting is accelerated approval endpoint only. It needs a confirmatory trial that would need to enroll thousands of patients at time of accelerated approval. It is impossible to do for a small company. It needs a partner. Tykerb failure might make FDA think twice before giving accelerated approval based on pCR as they said at adcom they would only do it for very select few drugs. Perjeta's previous approval in different setting might have made the difference.