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LearningEveryTrade

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LearningEveryTrade

Re: HyGro post# 517344

Tuesday, 09/27/2022 8:10:52 PM

Tuesday, September 27, 2022 8:10:52 PM

Post# of 693121
FDA did not "stop" it. They halted screening of new patients for regulatory review, existing patients continued as normal, so, not a stop.

totally redid the protocol, endpoints, comparator and SAP


Thank you for confirming the new protocols, endpoints, ECA and SAP... after which, FDA allowed more patients to be added.
Thank goodness they were able to have a favorable FDA in regards to pseudoprogression.

ASM= Actively Supporting Management

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