Anavex Life Sciences Corp (AVXL)

[georgejjl]

Read what Dr. Christopher U. Missling PhD MS MBA has said about giving potentially pivotal data to the FDA regarding the Rett syndrome trials.

hristopher Missling

Yes. So we have the first study finished, which was the very first study in Rett syndrome, the US Rett syndrome, the RS-001 study; and then, we had seen a very positive outcome where we presented top line data at -- recently last year. And we will now be able to share the entire data of the study. And with that data, we will go to the FDA and discuss with them the path forward given that we have two ongoing studies: one is the RS-002 in the age group with higher doses; and RS-003, which is also higher doses with a younger patient population.

And we believe that the first study, the RS-002, could be potentially pivotal together with the US study. And that is the discussions we like to have with the agency.

Christopher Missling

Right. So the RS-001 full data will be this quarter. The RS-002 top line will be mid of the year. And the RS-003 will be in the second half of this year.

And in between discussion with the agency, which will determine how the data can be utilized in order to get approval for the drug for patients, which have no therapeutic available for Rett syndrome.

https://www.fool.com/earnings/call-transcripts/2021/05/14/anavex-life-sciences-avxl-q2-2021-earnings-call-tr/

Good luck and GOD bless,

PS
My posts are not at all dishonest or deceptive.