Today’s below article on aduscam further illustrates the disaster this decision is/was, and how in-the-tank for big pharma that the regulators (at least) appear to be.
In all reality, it wouldn’t take more than 45 minutes for govt leaders and drug agencies to read articles such as the below, along with a cursory review Anavex’s recent presentations and trial results and this week’s independent peer reviewed publication confirming Anavex’s AD/CNS disease MOA, and then employ some COMMON SENSE and BASIC CRITICAL THINKING about which road to travel down in order to solve this massive unmet need for dementia-afflicted patients.
If the FDA and government leaders truly view AD as a war that must be won, and quickly, then how the #%!! are they not taking the 45 minutes to review such material?
Is there a war on dementia related diseases or not? If yes, then how weak is leadership that they cannot lift their heads to read the writing on the wall? Or if they have read it, why aren’t we seeing them approve a more effective ammo (safer and efficacious compound(s)) such as blarcamesine?
Anavex has been front & center with their positive results and lack of adverse events, and their positive 2-73 blarcamesine ancillary effects and oral pill administration and dose dependent Improvements in dementia patients for several YEARS at recent AAIC and CTAD conferences with Late Breaking and Developing Topics, so no one can argue that they don’t know about our results to date, and know of the key divergences between Aduscam and blarcamesine.
The general public cannot be kept in the dark on this situation much longer. Alzheimer’s Association, where are you on these key divergences? Have you any common sense and/or interest in better safety and efficacy and ease of administration for your constituency??
“For days, critics have blasted the approval in opinion columns and tweets, saying there is insufficient evidence of efficacy and expressing skepticism about whether getting rid of amyloid clumps improves brain function. They argue the drug — with a list price of $56,000 a year per patient — offers false hope while threatening Medicare’s financial health and patients’ pocketbooks. Three members of an FDA advisory board that recommended against approval of the drug have quit.
Public Citizen, a watchdog group that frequently criticizes the FDA, on Wednesday called for three top FDA officials to resign, saying the approval was “reckless.”“
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