Agreed. Infuriating. Especially on behalf of those currently struggling with a loved one that is declining cognitively and losing their independence and memory, despite taking available medications that have unpleasant side effects.
We’ll continue to debate a2-73 efficacy here, and I realize that we are not assured approval, but just on the safety front alone and comparing the side effects of new experimental drugs with the existing SOC options:
Is there critical thinking taking place at our regulators’ offices RIGHT NOW on this issue for our aging baby boomer population? (I’m obviously not referring to the Australians nor the EU’s EMA).
Anavex has almost 3 years of safety data for a2-73, with only some mild side effects at the highest dosages per my recollection.
Compare that to the sometimes serious and uncomfortable side effects of the current AD standard of care medications for patients and families to choose from.
Regulators, if they were so inclined, could also use logic and consider the ancillary quality of life improvements that Anavex and our trial PI have previously reported regarding a2-73: that 8 out of 8 of our AD trial participants that started with insomnia/sleep disturbances were without said symptoms at the end of the first ph2a trial period (on non-optimized dosing) per my understanding.
And for anyone still reading, this all dovetails nicely too with the real-world comments & perspectives of our trial participants' caregivers (see below), and that our ph2a trial participants/ caregivers/ physicians have requested MULTIPLE extensions to stay on our compound.
I personally view our compound as a prime candidate for an expedited track at the FDA. No one’s surprised, I get that.
Just my observations. All can DYODD. GLTY
Excerpted from Jefferies slide from June 2017:
"PATIENT EVENTS: THERAPEUTIC RESPONSE UNEXPECTED
101001 MORE ALERT REGARDING SURROUNDINGS
101002 FEELS MUCH HAPPIER MAKING JOKES
101003 MUCH HAPPIER WHEN ATTENDING CLINIC APPTS AND ENJOYS MAKING JOKES
AND ENGAGES WELL IN CONVERSATION
101004 BETTER HAND COORDINATION. CALMER AND MORE COMMUNICATIVE
101006 IMPROVING MOODS. READING MORE BOOKS
101007
ABILITY TO PLAY THE PIANO AND READ MUSIC NOTES AT ABOUT 9 MONTHS
INTO TRIAL. SHE USED TO PLAY THE PIANO AT AGE 5 AND LOST HER ABILITY PREALZHEIMER
TRIAL
101010 ABLE TO FOLLOW PLOT WHEN WATCHING MOVIES WHEREAS PREVIOUSLY
COULD NOT
101010 MORE COMPASSION FOR CHILDREN
101011 WIFE THINKS PATIENT IS A BIT MORE CHEERFUL
101013 ABLE TO DO MUCH MORE HOUSEWORK THAN BEFORE
101013 MORE DRIVEN AND UPBEAT LESS ANXIOUS ACCORDING TO CARER
101014
AN INTERNATIONAL ARTIST WHO RESUMED HER PAINTING ABILITIES AND NOW
HAVING AN EXHIBITION IN NOV 2016. WRITTEN A 3 PAGE LETTER TO LONG LOST
BROTHER
101015 PLAYING MORE GOLF NOW BY HIMSELF. MORE CONFIDENT AT GOING OUT BY
HIMSELF
101017 ENJOYED HER TRIP TO BELGIUM - TALKS ABOUT SOME BITS OF HER TRIP
102001 IMPROVED ENGAGEMENT WITH FAMILY/FRIENDS/OUTSIDE WORLD
102008 IMPROVEMENT IN MOOD
102010 FEELING GREAT - IMPROVEMENT IN COGNITION AND MOOD, BALANCE AND
GAIT HAS IMPROVED
103001 PATIENT REMEMBERING SOMETHING HE WOULDN'T HAVE PREVIOUSLY"
