Replies to post #140679 on Anavex Life Sciences Corp (AVXL)

[F1ash]

Was the Rett IND put on hold? No don’t think so. The FDA had feedback or perhaps in fact Anavex withdrew the IND to amend it for inclusion of genetic findings to the protocol.

“FDA conducts a review to determine whether the proposed investigation is safe to proceed, and if not, the IND may be placed on clinical hold.”

Sorry, but your probably not being realistic if you think Anavex pulled the application rather than the FDA forcing them to resubmit.

I cautioned folks to expect the possibility of a hold because of the Rett girls communication deficits coupled with the side effects at higher doses in the Alzheimer’s trial.

I predict that, if they do go with a set dose, it will be (edited: an absolute maximum dose of) 7mg (low dose) and 15mg (high dose) in the Rett trial. What dose do you predict? What dose was effective in preclinicals?