Abloke - they are starting again with TGA because they feel it should be registered in OSLs home country. Nigel mentioned at the AGM that they felt the goalposts shifted last time.
I'm not sure what that means.
Regardless they will have another try next year, with a lot more clinical evidence both overseas and here (there have been quite a number of treatments given through the Special Access Scheme). If they get TGA, then reimbursement is through MSAC and I noted previously that they already have a submission prepared (in fact i think it' still publicly available on the MSAC website).
Abloke - they are starting again with TGA because they feel it...
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