Phase iii registration trial

Learn more at www. This press release contains forward-looking statements. Actual results may differ materially from those described in these forward-looking statements. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law. View source version on businesswire. Skip to main navigation. Sample 3. Registration Trial means a with respect to a Product , a clinical study of such Product in human patients i with a defined dose or a set of defined doses of such Product designed to establish statistically significant efficacy and safety of such Product for the purpose of enabling the preparation and submission of an MAA for such Product to the competent Regulatory Authorities in a country or other jurisdiction , and ii that would satisfy the requirements of 21 C.

Part , or its foreign equivalent. Registration Trial means any human clinical trial under 21 CFR Clinical trial activity intended solely to foster customer acceptance i. Registrational Clinical Trial means a Clinical Trial of a Product designed to be adequate to achieve Regulatory Approval of such Product and that would satisfy the requirements of 21 C. R Registrational Clinical Trial means a clinical trial in humans of a product performed to gain evidence with statistical significance of the efficacy of such product in a target population , and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit - risk relationship of such product, to form the basis for Regulatory Approval by a Regulatory Authority and to provide an adequate basis for physician labeling , as described in 21 C.

Registrational Clinical Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to a establish that a drug is safe and efficacious for its intended use ; b define warnings , precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and c support Regulatory Approval of such drug, in each case as described in 21 C.