Valid points, Fireman, and there's definitely an understandable consternation factor as it relates to lack of info recently.
And while there's a list of valid and positive reasons that they've likely remained quiet, a positive outcome is not a sure thing until we receive further confirmation/validation etc from either a BP partnership or licensing deal or the company releases more robust and recent 18-21 month ph2a trial data analytics/charts or FDA ft/bt/aa designation/approval etc.
And agreed it's confusing and consternating that we've not heard more from Australia patients or its media re success stories. Gag order or non disclosure for patients? Is that done in trials? I frankly do not know.
So until the above changes, I suppose we will be priced at a low valuation by Mr Market.
Now, all that said, why in the &#%@ am I staying invested during this enduring quiet period?
Because I personally do not believe that the Company is allowed to sit on and not release data which would be considered poor/disappointing/conflicting FOR THIS LONG after pulling the March 2017 15 month abstract (which was positively worded as we all recall). I would consider this action (if true) to be unethical and ill-advised and against legal/SAB/BOD guidance. Unlikely therefore IMO.
Because I don't believe Dr Fadiran would've joined a sinking ship and touted the results to date and made reference to "the considerable number of regulatory filings that Anavex has planned" if the results were less than positive and continuing to be worthy of confirmatory trials. With the 21st CCA changes etc (that have been better explained by others), assumably this is a VERY realistic reasoning for the quiet on Dr Fadiran's regulatory front and why we've not YET heard much publicly re various FDA matters.
Because Dr Andrew Cole would've been similarly unlikely to join our SAB if our results into July 2017 were less than positive, as he also stated in his p/r "I am impressed with Anavex and its potential CNS platform drug, ANAVEX 2-73, which has shown encouraging clinical safety data combined with promising preclinical anti-seizure data,” said Andrew J. Cole, M.D., F.R.C.P.(C.), Director of the Massachusetts General Hospital Epilepsy Service and Professor of Neurology at Harvard Medical School. “I look forward to advising the company as it’s about to initiate three clinical trials with significant unmet needs.”
Because I do not believe that the Company ethically or legally continue to make their affirmatively and unambiguously stated claims of "restores cellular homeostasis" and "provided dose dependent cognitive improvement" without sufficient and SAB-reviewed underlying ph2a extension trial data through 18-21 months (data that they do have in hand we all acknowledge). They would be setting themselves up for ALOT of problems were they to make those claims without the trial data to back them up. That's common sense.
Because I do not believe that Dr Macfarlane, our trial PI, would've given a speech in Melbourne recently in his hometown discussing this a2-73 compound and trial and continuing to provide credence and elicit hope if the results and outcomes were less than positive or less than current SOC.
Because I do not believe the Company would've indicated Multiple Sclerosis in its abstract last wk at the CNS Partnering Conference (as a NEW discussion point) if this was a floundering and disappointing topic for them and/or the testing by WSU/biib was going poorly. That would be a STRANGE tack to take for a small biotech that has already faced enough challenges (why voluntarily fumble the ball?).
Because the Company has two additional conferences over the coming few months that would seem pointless if they were not holding a strong hand of data cards.
Because, again, I cannot think of a REALISTIC possibility that the CEO would adopt an insider purchase plan 5 weeks ago IF he was holding poor or disappointing or conflicting 18 month results from the public. That would be NONSENSICAL.
Because they've contracted with a world-class team of international patent attorneys to painstakingly document and protect its IP in a wide range of indications and chemical formulations during a process that must have utilized a tremendous amount of time and Company resources. Why in heavens would they waste everyone's time and money if the endeavor was fruitless? NONSENSICAL.
Because 8 out of 8 of our trial participants that started with insomnia systems were without said insomnia symptoms at the end of the 1st trial extension. That's a high percentage. And it's a STRONG clue that the brain is being impacted positively (reducing oxidative stress? Restoring cellular homeostasis?).
Because the real-world comments and perspectives (after a year of non-optimized dosage) of our trial participants' caregivers (pasted below) are not characteristic of a sugar pill.
Because lastly our success hinges largely on the sole factor of efficacy. Does it work or not? The above factors are speaking loudly to me that the CEO/SAB/BOD/LEGAL TEAM (those with results in hand) apparently believe that it does work.
Unless we're being purposely led down the wrong path, logic tells me that the future should be very promising.
All in my opinion of course. DYODD. Have a nice weekend.
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"
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