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10/22/19 5:10 AM

#215603 RE: ElsaSara #215602

The PDD trial originally only in Spain has been expanded with two sites in Australia:
New Anavex trial for Parkinson’s Disease to open in Sydney and Melbourne trial of new drug to treat Parkinson's dementia

My guess is that those two sites are recruiting a number of patients in addition to the 120 originally planned and therefore total full enrolment takes a little longer than originally anticipated.

Note that expanding the PDD trial is different from the two separate Rett trials in the US and AVATAR in AU, plus of course the announced paediatric Rett trial AU, that all have/will have their own separate clinicaltrials.gov registrations.

The two Australian sites would have taken some time to activate and getting up to speed recruiting. During the Q3 conference call Missling said:

We are also very pleased that the Phase 2 blarcamesine Parkinson’s disease dementia study is proceeding well and we are getting close to achieving full enrollment.


Why the PDD trial expansion is the key question. Did Australia/MacFarlane request participation? Did Anavex want to increase the statistical power of the PDD trial? Did Anavex want to support the approval process for A2-73 in AU and collaborating authorities in the region with the PDD indication?

Given the PR from Anglican and KaraMinds to me the most likely answer is a combination of AU wanting to participate given their extensive (positive) experience with A2-73 to date and interest in AU PDD approval shared with Anavex. I think this argument is made stronger also by the two Rett trials in AU.

Let's say we will find out soon (with all the definitions possible of that forecast).