I seem to have forgot/missed this ... I know there
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Posted On: 10/08/2021 7:52:52 AM
I seem to have forgot/missed this ... I know there has been some discussion on IH but theoretically once the IND is approved trials can be going on in China and that data could be used to satisfy US FDA ... does China have an equivalent way to check for trials as the FDA? (maybe Zolis wife could look on NMPA websites? ... I think he mentioned his wife is Chinese?)
"If YouFeng-BI conducts phase I, phase II, phase III clinical trials in accordance with ICH guidelines to support commercial approval of the Ii-Key SARS-Cov-2 vaccine by the NMPA (the Chinese FDA), then:
(1) YouFeng will provide the clinical data to Generex for its US FDA and the international approvals in its current contracts as available"
https://www.globenewswire.com/en/news-release...ement.html
"If YouFeng-BI conducts phase I, phase II, phase III clinical trials in accordance with ICH guidelines to support commercial approval of the Ii-Key SARS-Cov-2 vaccine by the NMPA (the Chinese FDA), then:
(1) YouFeng will provide the clinical data to Generex for its US FDA and the international approvals in its current contracts as available"
https://www.globenewswire.com/en/news-release...ement.html
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