Replies to post #134190 on Anavex Life Sciences Corp (AVXL)

[attilathehunt]

Fireman - Just curious to your thought process on why it was moved to the EU.


Missling stated 3 trials could start by year's end. We may get one.

I believe Missling submitted IND for both Rett and PD at the same time. It would make sense to do so. Since both are basically the same trial but to different ailments , I believe the FDA said lets not get ahead of ourselves and lets go with Rett first and then lets decide on PD when we have a readout on Rett.

I say this because, we now learned that PD is going for EU approval and Missling said it won't be until Q1 2018. Now if the EU submission was the original plan AND he was going for a 2017 start date, one would realistically conclude the IND for the EU would have been already submitted just like the Rett trial IND was submitted.

I believe Missling was telling the honest truth and that he would bring 3 trials in 2017. I believe Rett and PD was submitted however, the FDA didnt like the idea of two and elected to go with one and thus the EU became an option for PD. This is a setback although in the long run it may be good in that we may get approval in both the US and EU within six months of each other. Off label could be used for Rett in the EU and PD in the US. I would bet this is what happen. How could you otherwise conclude PD was to start by years end? The IND would have had been already submitted if Eu was the story all along. I think not. I believe the EU for PD was the result of the FDA not willing to do both concurrently.