Does the totality of scientific evidence on Biocryst Pharma’s (BCRX-$10.00) peramivir support the intravenous administration of the drug in patients with suspected 2009 H1N1 influenza — and outweigh the known and potential risks? FDA Commissioner Margaret Hamburg opines that the answer is “yes” in her Letter of Authorization granting EUA to peramivir, despite knowing the following facts:
Dosing in pediatric patients is based on modeling of pharmacokinetic data from adult healthy volunteers and adult patients with influenza. No children (under the age of 18) have received peramivir in clinical trials… .Continue Reading at BNET PHARMA….
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