Any thoughts or analysis of this audit report (assessment)? Looks like the leadership/management of FDA and crew has serious issues to address. Every day that passes w/o a complete rethink and top down change of this organization puzzles me. There must be an explanation that I am just not seeing.
In that context we have to ask. Is this the best we can do for what looks like the biggest problem we have?
Talon-it appears to me that these poster presentations and the late breaking oral presentation are all to prove validity of using AI in clinical trials while referencing blarcamesine studies. All of the listed presenters are from Ariana and not by Anavex. AI appears to be the overall theme of this CTAD IMO. Certainly the emphasis using blarcamesine is great but I don't expect any solid trial information to be presented here. I don't expect to hear anything new until 12/11 at the annual fiscal report presentation. What are your thoughts?
Talon, you have to wonder how data from 2015 to 2017 is considered "Late breaking" and worthy of a presentation as such, especially, if AI is part of the analysis? Seems there is more to this than meets the eye.
But, possibly, the PR this morning might help explain things better once reviewed.
ANAVEX NOW ... MONO-STYLE ... RWEm for Life ... and for ALL AGES!!!
BIIB's "retrial" of Aducanumab is of great importance in that if the FDA approves of some sector of Aducanumab's data, there is hope for a number of other Pharma's failed Alzheimer's drugs. Several of those drugs are on the "appeal" docket at this year's CTAD.
Biogen's Aducanumab ( 1 hour leadoff presentation on Thursday...no others at 1 hour long) Eisai/Biogen's BAN2401 Merck's Verabecestat Roche's Crenezumab and Gantenerumab