Replies to post #114295 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

T., nailed it.

That assumes that the trial design does NOT use the new rules on adaptive trials which are not supposed to be issued until September.



This why some of us have been convinced that the AVXL trial start delays have been at least partially attributed to links with FDA planning/new rules. A reasonable assumption considering FDA PR.

[LakeshoreLeo1953]

In the interest of informing those who have not done
sufficient DD.....

Until amended the current rules are:

https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

[XenaLives]

Orphan status entitles us to expedited review. Political pressure on Alzheimer's makes it a good bet that it will also get pushed along quickly.