If evidence presented points to a rational for a label extension but is not directly asked for a regulator can grant that label extension on their own and qualify it as conditional if they believe more patients might benefit from the treatment than for the indications originally asked for. Data from the Specials program is likely part of the application and is Real World Data/Evidence. As you have stated, approval(s) don’t depend on having a NICE agreement in place but are focused on whether or not the treatment is safe (yes) and effective (to be determined by evidence submitted). If demand is limited by self pay and IFR funding as well as Cancer Fund reimbursement then that does not put additional pressure on NWBO to apply for reimbursement under less than ideal timing constraints and does not overburden the artisan method capacity for a reasonable amount of time for NWBO to get Flaskworks up and running and reimbursement worked out. As you have seen from flipper44’s recent posts, NICE reimbursement rate likely has a chance to be improved with an update from comparison of controls from the Mimivax trial. Sure seems like lots of concerns are being addressed and options are being considered as convergence of NWBO actions to address them coincide with the likely timing of an MAA decision; ). Best wishes.
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