Hi all,We are well on our way.OLE continued Australian trialling...

Hi all,

We are well on our way.

OLE continued Australian trialling leads to this next step as described by MT in a recent presso.

TGA Provisional approval.

Provisional Approval pathway:Allows provisional registration based on preliminary clinical data, where there is potential for substantial benefit to patients.

Enables earlier access to promising new medicines, up to two years sooner than the standard process.

Only granted if the potential benefit of early availability outweighs the risks of incomplete data.Key features of these pathways includere-submission meetings with TGA are recommended or required.

Applications for designation must be submitted 10-12 weeks before the full registration dossier.

Rolling data submissions may be allowed for Provisional Approval.Both pathways aim to expedite evaluation while maintaining TGA's standards for safety, efficacy and quality.

These accelerated pathways align Australia more closely with expedited programs in other countries like the US FDA and European EMA, helping provide earlier access to novel medicines for serious conditions.

Kpax