Thanks Dude! While it may only be a possibility at this point, it is certainly a departure from the “facts” as Ex presents them. I’ll be interested in his reply here.
IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs).
Reference Regulators (RRs) Acceptable RRs are shown in the table below.
Country or Jurisdiction Regulatory Authority Australia Therapeutic Goods Administration (TGA) Canada Health Canada Switzerland SwissMedic Singapore Health Science Authority Singapore (HSA) Japan Pharmaceuticals and Medical Devices Agency (PMDA) United States Food and Drug Administration (FDA) European Union/European Economic Area European Medicines Agency (EMA) and Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein. (This includes approvals through the centralised, MRP/DCP and individual member state national routes)
Instead of using artificial intelligence for info it would sure be nice if the NWBO board would hold an ASM so we could ask them in person to clarify all these questions face to face. You know, like most reputable publicly traded companies do.