simple answer on many levels No IMO Have I seen many " good " explainations ever from J - No IMO
Cost and time . Seems crazy now in hindsight so not sure what advice was sought or received or what Managents internal belief was Looking are FRE they decided to do both pathways concurrently . If tehy got away with no human trial - graet and if tehy didn't they were already 12 months down track with approved human trials eithe rto support position or to widen market where trial would be required to make claims - ie USA. I had previously indcated that if SPl had said they were doing a trial that world authorities may have stalled current applications without trial data under different lodgement but FRE situation and others shows that there is a parallel way of having both approvals treated seperately.
The gamble of SPL ( that IMO they lost) was to bludgeon their way through - some say it was arrogant or foolish but if it came off and through usage it was shown to be sucesful thsi would be a mute dscussion except for access to strict countries, If Covid continued in its most deadly form and vaccination etc had not been effective it may have meant different considerations.
Their SPL "partners" didn't do massive marketing - probably new of local risks and limitations of using Euro approval Which consumer magazine called them and many other products out. MHRA did what they did
TGA does what it does . SPL seems to have gone a pathway to change definitions taht took time and still not sure if their product fits catagory and what length of time is to approval. No feedback from SPL i regard to I assume a still active application as to what stage they are up to nor what feedback they have received.
NZ is soft entry Vietnam - hmmmmm - see my previous posts re recriprical Italy - hmmmm Rest of Europe - laughable Rest of Asia - laughable
A lot of speculation on HC has come from "pump " style posts unfortunately that end up getting a life of their own and bypass reality of world and approvals required and process that must be adhered to.
