I just can't think of another product that is age restricted to over 45 and has to have that on a label to prevent false advertising who wants to be on shelf ? So further suitably powered trial to prove efficacy ? Time and $.
Once existing stock in hands of wholesaler are distributed then I am presuming MHRA IMO will require for that market similar label change ( at current volume that may be a while)
I am not sure what they have will excite the TGA but time will tell. Good question for Cheryl- have they lodged anything with TGA and are they waiting for a response? When was the last formal response/ lodgement by SPL? Followed by what is timeline to next response / reply under rules?
What has Cheryl got - a bloody big headache is my guess and a whole lot of incumbents, advisors and hangers on that IMO probably want status quo to remain and for everything to be swept under rug - will shareholders or investors accept that?
All guesswork as no one outside the tent really knows what the data looks like for under 45 but IMO quick reverse analysis indicates it fell off a cliff hence reason they did 5y subset breakdown. The indicated/ suggested reasoning in regards to non compliance under 45 IMO doesn't fully add up.
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