Anavex Life Sciences Corp (AVXL)

[hnbadger1]

Interesting ST posts- plotdog 9:34 AM
$AVXL Key Near Term
Pipeline Updates:
• Alzheimer's disease: Full data
ANAVEX®2-73-AD-004, including
newly available preliminary results of
surrogate biomarkers of pivotal
Phase 2b/3 clinical trial. The
Company intends to discuss these
findings with regulatory authorities
in the context of the ongoing clinical
development of ANAVEX®2-73 in this
indication, with the goal of providing
a much-needed treatment to the
millions of patients living with
Alzheimer's disease with a
convenient once-daily oral
treatment. The Company plans to
proceed in parallel with the initiation
of a confirmatory Alzheimer's disease
study.
This possibly could have the
potential to completely change how
science and medicine looks at
Alzheimer's disease. Exciting stuff.

100fold 52m
@plotdog This might explain the
delay in the PD and Fragile X trial
initiation. The FDA may have
recommended they go for AA to
provide cover for the similar
approvals of the MAB's, rather than
cut a new path to gain traditional
approval on what many consider
subjective endpoints, even though I
believe they not only met endpoints,
but the data will be robust in its
improvement of patient quality of
life. By going the AA route, they
would need to initiate a confirmatory
trial per AA protocol. So all hands on
deck for AD trial? And all hands on
deck for RETT approval. That's my
guess.