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10 个月前
BRIEF-Alcobra says FDA indicated in letter that clinical hold was placed due to electrophysiological neurologic findings
2016年10月7日 / 下午1点07分 / 10 个月前

BRIEF-Alcobra says FDA indicated in letter that clinical hold was placed due to electrophysiological neurologic findings

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Oct 7 (Reuters) - Alcobra Ltd :

* FDA indicated in letter that clinical hold was placed due to electrophysiological neurologic findings

* FDA letter did not reference any clinical safety data observed in measure study or in previous human studies with MDX

* Division recommended that alcobra schedule a meeting to discuss a plan to collect additional human safety data in its development program

* Fda indicated that hold was placed due to electrophysiological neurologic findings in long-term animal studies with metadoxine

* Update from alcobra on recent fda communications

* Received written full clinical hold notice from division of psychiatry products of u.s. Food and drug administration Source text for Eikon: Further company coverage:

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