BRIEF-Alcobra says FDA indicated in letter that clinical hold was placed due to electrophysiological neurologic findings
Oct 7 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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