Does Novartis delay in probing data manipulation claims spell trouble?

Why did Novartis wait about two months before launching an internal probe into the alleged data manipulation surrounding gene therapy Zolgensma? Thats what officials at the FDA want to know. After an on-site inspection at AveXis control testing lab in Irvine, California, which appears to have been prompted by the firms communication of the problem to the FDA, inspectors issued a Form 483 on Aug. 2. The report noticed a delay from when the initial Zolgensma data allegation was flagged by a scientist on Mar. 14 to when a formal internal probe was opened on May 15. Two months seems like a lot, given that an FDA decision was looming, unnamed FDA officials toldThe Wall Street Journal. What happened during those two months? By Novartis’ account, before it started the full-on investigation in May, it “conducted an independent investigation with the support of external counsel to determine the extent of data discrepancies and whether they could be explained,” a company spokesman said. The reason why it took so long was because the preliminary probe “consisted of an extensive review of thousands of hand-written and electronic records concerning the life history of individual mice and a comparison of those records to entries on the hundreds of spreadsheets on which their data was recorded,” he said.

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