PharmaCyte Biotech Inc (PMCB)

[concordia]

Actually they do schedule the pre-ind. PMCB will submit a request the FDA will reply within 14 days with a date up to 60 days from the time of request. Meeting package must be submitted 4
weeks prior to meeting, includes:

Pre-clinical data

Product manufacturing scheme

Data regarding product
characterization/proposed specifications

Proposed clinical protocol

Specific questions grouped by discipline
(product, pre-clinical, clinical)