prescription medicine registration process, page-33

Hi All

Now that we have reached mid November and there has been no news about the progress of the Marketing Application of ArTiMist......this is fantastic and is now the time to start getting excited about how close or far away we can expect the next ArTiMist announcement. ..... depends on whether or not you are a glass half full or empty person.... I remain unchanged.
Why is no news good?..... quite simple... it means that ArTimist has probably achieved the end of Milestone 5 without being rejected. Milestone 6 the Expert Advisory Review Phase is not required for a generic and that only leaves Milestones 7 and 8.

Recapping Milestones 7 and 8.
Milestone 7. Decision made by the delegate.
The delegate will generally informally advise the applicant of the decision. Formal correspondence of the decision is sent to the applicant.
If the delegate proposes to approve an application, prior to approval, any outstanding issues relating to PI, CMI or RMPs may be negotiated with the applicant. Approval may be conditional on resolution of issues. If the delegate proposes to reject an application the reasons for the decision are included in the letterof decision with an explanation of appeal rights.

Milestone 8. Post-Decision
Registration of a new product or variation to a register entry completed.
For applicable application types, a draft AusPAR will be completed.
I think this relates to an ARTG entry being made approx. a month after Milestone 7.

How does all this relate to the calendar?.
If running to time Milestone5 should have been completed by the end of Sept and in the absence of the need for MS 6, should mean that MS7 could be available mid November!!!!! Could this be a reason for delaying the AGM and Directors buying???...could they also be in the dark and expecting good things to happen? Last time I spoke with SC regarding the timing, he was a little vague but thought the TGA was running a couple of months late and has since mentioned that he was expecting the result in early 2018........ when ever it is, it is very close and yes the excitement level is rising.

GLTA

kippax