Replies to post #437684 on Anavex Life Sciences Corp (AVXL)

[Hoskuld]

Right. Companies do not talk about meetings with the FDA unless there is something materially bad to report. But, the meetings are happening. We don't know that Anavex has coffee in their offices but it is a sure thing they do.

I don't follow what you are saying about an SPA. Why do you think FDA meetings would result in an "SPA" and can you confirm what you think an SPA is and why it is needed?

[Investor2014]

Correct! No evidence of key engagement with the FDA that have moved anything forward towards approval, only considerations on intent to initiate discussions with the FDA. Very vague, but clearly enough to satisfy an ex-biotech executive.

Not many biotech companies I follow or invest in have historically released a 'my dog ate the homework" half baked readout with a promise to shortly after present the full data and then a year later haven't.

Instead Anavex occasionally presents some piecemeal update without contextual data, like the recent two biomarkers that came with no correlation to clinically meaningful outcomes. Other companies are chastised here for doing that, such as the leqembi subcutaneous administration that removes 14% more plaque than IV without correlation to cognitive and functional outcomes. Both companies should be called out for that. But oh well Anavex can present half arsed data and the WGT crowd gets excited.

Just look at the $AVXL shares price since CTAD 2022 and the short interest evolution. Yes the market overall and risky investments like biotech have broadly suffered, while Anavex have presented nothing to date that counters that trend. Maybe in the end $AVXL will be amazing, but evidence pointing in that direction is at present certainly not solid. The EXCELLENCE readout may change that, but allow me to remain somewhat sceptical and also hopeful.