NorthWest Biotherapeutics Inc (NWBO): As I have explained previously the FDA d...

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Re: SkyLimit2022 post# 542633

Friday, 12/02/2022 7:06:26 PM

Friday, December 02, 2022 7:06:26 PM

As I have explained previously the FDA does not approve individual studies. Upon submission of an INDm id the agency has not places a hold, the company can proceed with clincial trials, The company i s NOT bound by any guidance the FDA may have offered. The FDA may place a hold on an IND or one or more clinical studies if they are concerned about patient safety.

This FDA document may help

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold

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