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Friday, 11/07/2014 11:52:52 AM

Friday, November 07, 2014 11:52:52 AM

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$CERS Should hear soon on announced submission of their protocol to apply INTERCEPT to the treatment of Ebola convalescent plasma. The 30 day mark to hear from FDA on IDE is Nov 21st from Oct 21st notification.

"For Ebola, we recently announced submission of our protocol to apply INTERCEPT to the treatment of Ebola convalescent plasma. Plasma collected from individuals who have recovered from Ebola virus disease contain antibodies against the virus, these antibodies that can help fight Ebola infections in the recipient of the transfused plasma. Convalescent plasma has demonstrated benefit in prior disease outbreaks, and is one of the few therapies immediately available for Ebola virus disease. It is of note that each of the surviving patients treated in the U.S. received convalescent plasma during the active phase of their disease. A concern associated with collection of convalescent plasma from recovered patients is that they may carry undetected pathogens due to prior exposure, and their history of travel to Africa make these individuals temporarily ineligible to donate blood under U.S. regulatory guidelines. We believe that INTERCEPT pathogen inactivation can provide a critical risk mitigation strategy by inactivating harmful organisms that may be present without impacting the anti-Ebola antibodies that the patient needs."
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