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Re: efood125 post# 141775

Friday, 05/21/2021 11:53:52 AM

Friday, May 21, 2021 11:53:52 AM

Post# of 144812
Not sanction by the FDA.

They do not exist in the ClinTrials database.

Sorry but the FDA requires more than 13 patients for a Phase 2 clinical trial. Where in Lohr's ad hoc study, 4 had a followup Gemcitabine treatment, and another only had 1 treatment of the Ifosfamide. Which leaves a Phase 2 trial consisting of 8 patients receiving a defined treatment. Insufficient number per FDA standards for a Phase 2.

The reader is invited to scan Phase 2 clinical trials, and note the number enrolled.

Was the manufacturing FDA GMP compliant? Was the cell strain the same then as it is now? No.

Where was the Metronomic Ifosfamide vs Metronomic Ifosfamide+CIAB control arm conducted? Answer: It wasn't. There's nothing to indicate the presence of CIABs did anything.


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