Tuesday, June 10, 2025 10:41:59 AM
Moving to Q and A --
What are EMA expectations? Conditional or full approval? " We don't know." No updates but "very excited." (Of course)
Head count plans? Have been very conservative. Will depend on marketing approach.
When to expect new trial announcement? Focusing on MAA review. Probably PD trial up next. No timing provided. "Excited about it."
How confident in EMA approval? Can't tell, because not in charge of the decision. "Excited."
Manufacturing of 2-73? Fulfilled EMA required batches for marketing.
Sex dependent effect in 2b/3? No difference.
Have a plan to show 2b/3 OLE against ADNI? Eventually
Is new FDA positive or negative for Anavex? Can't tell
Post HP Morgan? Pick up of interest, meetings have proceeded
Plans to create more analyst coverage? High confidence it will pick up.
Marketing? Eventually Anavex wants to do the marketing
Why no accelerated approval in EMA? Not our purview
Expect to be bought out? Whatever's best for shareholders
Any thoughts in new European S1 org? We will attend, we are very plugged in
Gene data in OLE? Might look into that
Update on EMA approval process? Just repeats standard time line
These were Mayo's questions, I believe.
Call over.
No mention or any indication of a withdrawal.
PS -- I had a few questions, but it seemed like they weren't seen.
What are EMA expectations? Conditional or full approval? " We don't know." No updates but "very excited." (Of course)
Head count plans? Have been very conservative. Will depend on marketing approach.
When to expect new trial announcement? Focusing on MAA review. Probably PD trial up next. No timing provided. "Excited about it."
How confident in EMA approval? Can't tell, because not in charge of the decision. "Excited."
Manufacturing of 2-73? Fulfilled EMA required batches for marketing.
Sex dependent effect in 2b/3? No difference.
Have a plan to show 2b/3 OLE against ADNI? Eventually
Is new FDA positive or negative for Anavex? Can't tell
Post HP Morgan? Pick up of interest, meetings have proceeded
Plans to create more analyst coverage? High confidence it will pick up.
Marketing? Eventually Anavex wants to do the marketing
Why no accelerated approval in EMA? Not our purview
Expect to be bought out? Whatever's best for shareholders
Any thoughts in new European S1 org? We will attend, we are very plugged in
Gene data in OLE? Might look into that
Update on EMA approval process? Just repeats standard time line
These were Mayo's questions, I believe.
Call over.
No mention or any indication of a withdrawal.
PS -- I had a few questions, but it seemed like they weren't seen.
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