InvestorsHub Logo
icon url

WilliamMunny

11/28/22 12:36 PM

#385646 RE: Anshu2 #385636

In the Q&A. It is the answer to the first question from Soumit Roy(sp?) on sufficient powering.
icon url

sokol

11/28/22 12:41 PM

#385650 RE: Anshu2 #385636

I have not listened to the call. However, I just received a copy of the transcript from the call. You will find this from the last few questions before the call ended:

“The next question comes from Yun Zhong at BTIG.

Yun Zhong

So a follow-up question on the Alzheimer's data. And I know it's probably difficult to speculate what the data will look like. But Christopher, can you talk about your plan if the study meets the primary endpoint? Or if the study fails to meet primary endpoint, what sort of plan on individual scenarios, please?

Dr. Christopher Missling

Again, I would comment just to recommend to wait for December 1. It's not a good point today to speculate on that. We are very close. So I think it's best to discuss it when the data is there. We always know that the FDA responds best when there's existing data to discuss. So that's my recommendation.

Yun Zhong

Okay. Then maybe a question on the cash runway guidance. The full year runway is very encouraging. But does that include a potential additional Alzheimer's study if you need to do another one, please?

Dr. Christopher Missling

Guidance is really based on the historical advancement of our cash utilization rate, which was always very consistent over the last years. So it's an extrapolation, if you so like. So it's a conservative extrapolation, so with the increase. And it has definitely all the studies which we have planned to initiate and to execute included in that budget.

Yun Zhong

Okay. Last question to confirm the Parkinson's disease program. So there is a possibility that the next study that you conduct in Parkinson's disease will be a pivotal study based on your discussion with the FDA?

Dr. Christopher Missling

We are aiming for that. We have very strong evidence from the PDD study that the effect on MDS-UPDRS, which is the main primary endpoint of this indication has been very favorable with ANAVEX 2-73. So the plan would be to make sure we are able to move forward as quickly as possible. That would mean to aim for a Phase 3.

Clint Tomlinson

I don't see any further questions at this time. Dr. Missling?

Dr. Christopher Missling

So thank you again. We are very much looking forward, and we're very excited about the company's potential as we build on biomarker-driven precision medicine studies with significant unmet medical need and economic burden. And we're looking forward to clinical trial readouts in autism disease and pediatric Rett syndrome. Thank you.