The FDA said that the company did not provide enough information about the safety and efficacy of its InsuPatch insulin pump.
The share price of InsuLine Medical Ltd. (TASE: INSL) fell 14.3% by mid-afternoon today, to NIS 1.96, giving a market cap of NIS 170 million, after announcing that the US Food and Drug Administration (FDA) has asked for more information about its InsuPatch insulin pump. The FDA said that the company did not provide enough information about the safety and efficacy of the product.
The FDA said that because the InsuPatch causes a pharmacokinetics change (the time taken from the delivery of the drug until it appears in the blood) and in the pharmacodynamics (the time from delivery of the drug until it has an effect) of insulin delivered by the InsuPatch, Insuline must submit an investigational new drug (IND) application in order to approve the product.
Insuline said the IND process would greatly extend the approval process and raise costs, compared with the 501(k) de novo application process under which it applied for approval of the InsuPatch. The company said that it has 180 days to supply the information requested, and that it was considering its response.
Published by Globes [online], Israel business news - www.globes-online.com - on April 25, 2013
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