CytRx responds to FDA's Ph IIb hold on ALS drug
US drugmaker CytRx has filed a response with the Food and Drug Administration addressing issues cited by the regulator in its decision to place a clinical hold on the company's Phase IIb trial of arimoclomol for the treatment of amyotrophic lateral sclerosis or Lou Gehrig's disease.
Delay "not due to human AEs"
On February 11, CytRx announced receipt of written correspondence from the FDA. This communication confirmed its prior understanding that the decision related to a previously-completed toxicology study in rats and was not related to data generated from any human studies with the drug candidate.
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