I have read results a different way.Is there clear statements to...

I have read results a different way.

Is there clear statements to support your 3 claims? I see them as generalised statements with nothing specific about viraleze in general - wishy washy words from SPL . It is not clear to me that viraleze will continue to be able to be sold beyond stock in country in UK without label and packaging changes let alone anywhere else in 1st world. I want to see statement from SPL saying they have lodged data with MHRA and are awaiting response or will they delay that lodgement? How long before MHRA conforms anything?

1) The point is that according to commentary on the results the study has achieved its goal to provide regulatory compliance for the new rules uk
2) and it will support expansion into new jurisdictions.
3)Let’s hope the TGA now finally has enough information to support approval here. It is proven safe and effective across all cohorts as a treatment

As it was blinded we have no idea if expansion was due a particular reason at the time , with a age group not recruiting younger participants , particular centre , male female response etc etc Hard to make positive assumptions when they have specifically avoided at every opportunity to clarify results and hide basic data and graph. Why not just say we struggled to get under 45 participants to participate and then comply and was too late in study to expand and target that age etc etc