Hi Baron, take comfort HREC approval is a standard...

Hi Baron, take comfort HREC approval is a standard administrative process at the local hospital/participant enrolment hospital/clinic level from where PYC will be drawing its volunteers for VP-001 - it’s the due diligence of the patient institution to approve the ethics/safety of injecting their patients as part of PYC’s clinical trial.

It 10+ orders of magnitudes lower a milestone in comparison to an FDA approval for a genetic precision medicine that works at the intracellular level (for example HREC won’t have a panel demanding you prove the efficacy/safety of your drug’s chemical backbone/manufacturing process - and whether you can produce your drug in high enough quality/volume for the duration of the trial)

If HREC of a PYC’s local recruitment site is not comfortable - you can seek approval any at any other site of your choosing (can’t do that with the FDA) - if they are applying for a local site say in Perth where the patient “identified” (very key point as per West Australian article as one of the leading success factors for clinical trials is finding enough participants/patient in time) already exceeds the 15 target participant target - an FDA IND approval is the highest bar of validation you could ask for and would be referenced in support of the HREC application.