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EXCELLENT SUMMARY JJ !
Longs, the delays are trivial compared to the progress being made .
Dr . Missling did predict that 3 trials would start in 2017 , HOWEVER the FDA / Dr Gottlieb ALSO predicted that They would issue 10 new guidance reps , including 5 CNS , by end of 2017 - - this “ promise “ was also missed .
Both Gottlieb and Missling may have underestimated the gigantic task to achieve the “paradigm shift “ conversion from traditional Clinical trials to ADAPTIVE TRIALS with closer dialogue and interaction between submitting companies and the FDA , HOWEVER ,you can be guaranteed that this close cooperation is occurring with Anavex and FDA !
We are dealing with a REGULATORY AGENCY folks , this is breakneck speed compared with the old system !
For those with no patience , sell and reinvest in Home Depot or Mc D , it will be less stressful.
GLTAL
Agree Bourbon , and even after that “ small” 2007 sale , he still owned OVER 7,5000,000 shares !
Many thanks to you and JohnJones for attending the meeting and for your excellent summaries !
Hang here Longs “ Denner “ May soon be served !
AGREE with 2018 possibility Bourbon !
Many Orphan Drugs have been registered in 6-12 months ( A 2-73 has OD Designation for Rett Syndrome ) , and any even "promising " results will be strongly pushed/ supported by Rett Foundation.
IMHO , GLTAL
EXCELLENT LETTER BAS !
Will be interesting to see when / if you get a response , hopefully they will respond positively and provide suggestions for applying for Right-to-Try .
There are many on this board who themselves , or family members , would certainly try !
HOWEVER , FDA has got to be close to releasing many new guidelines and Anavex should have a cascade of filings in the coming months . The SCIENCE IS SOLID !
GLTAL
Good find Vango54 !
Thanks dado , excellent summary , your last paragraph "predictions " are being supported by recent trial data !
GLTAL
SHORTS : BEWARE THE IDES OF MARCH ( and AVXL SCIENCE ) !!
Hi BIO an Swallow !
Just a reminder that the murine preclinical studies which you ridicule are part of the scientific data base development process for most new drugs .
Additionally , In the drug development process there are standard FDA REQUIRED murine studies which must be conducted to determine / estimate safety criteria before the initiation of human trials .
Please remember also that rats/ mice have been shown to share over 90% of their genomes with their human "counterparts " , so such trials are often sound predictors .
Another fact which you may not know is that the "long and winding road " of drug development lasts an average of 12 to 15 years from discovery to registration and first sales .
If you can't stand the wait, why not invest your time and money elsewhere ?
With regards to the " long and winding road " please note that the drug development process is undergoing a change to Precision Medicine and this new " development highway " is one which Anavex and Dr. Missling have wisely chosen to wait for ,
You can get aboard the rapid transit , or you can keep peddling your penny-farthihg along the path !
GLTAL
Several significant Institutional Holding increases in last Quarter ( thru 2/14/18 ):
Park West added ca 600 K shares ( +28 % )
Bank of New York Mellon added ca 66K shares
VanGuard Group added ca 80 K shares
BlackRock added ca 20 K shares
I guess some savy Fund Managers liked those low prices !
Helpful , informative posts dado and falconer !
Most on this board enjoy and learn from your science based contributions .
My own "in-house " expert ( eldest son who is an accomplished & specialized neurosurgeon ( skull - base surgery ) has often referred to off-label uses permitted following the first registration .He is also heavily invested in AVXL , acknowledging the trial results ( both human and murine ) which suggest A2-73 may the first compound to actually address the causes of several diseases of the brain , rather than merely treating symptoms .
Much of the impatience on this board is by individuals who do not know or appreciate that in many medical and agricultural fields the length of time from first synthesis of a compound until its first sales averages ca 12 to 15 years of safety and efficacy testing .
In 10 years of following , and investing in Anavex , I have yet to see a single SCIENTIFIC failure reported .
I believe that we are approaching "liftoff "!
GLTAL
Thanks Bas , I agree, no luck involved here , just sound science !
You can ignore ka ching since he appears busy applying lipstick !
All true longs are waiting on CHA - CHING !
With You 100 % Jonjones325 !
As mentioned in my post # 128280 , in my past extensive contacts with the EPA/FDA it certainly is a fact that these regulatory agencies also want /need to have their own visible "successes " .
With the FDA / Dr.Gottlieb's frequent mentions of a "paradigm shift " towards adaptive trials and closer interaction with submitting companies in their design , it would appear highly likely that the pending A 2-73 trial designs will be the result of close interaction between Anavex / Fadiran / FDA/ Aisen/ et al .
Meanwhile, the continuing flow of positive SCIENTIFIC data continues to lay the foundation for the successful future registration of A 2-73 and related compounds for the treatment of many major health conditions and diseases .
Been holding and adding since 2007 --- Don't mind waiting a little longer !!
GLTAL !
Great summary Mike ! And valuable comments also from Talon , Fireman, Tred and others .
Why so many impatient posters ? What is a 6 month delay when the the potential for more rapid trial data and MILLION$$$$ SAVED is before us ??
On a sad personal note , my wife's beloved sister, and one of my Power of Attorney "charges" , passed away this am after 5 years battling dementia/Alzheimers --- AVXL is too late for our dear "Lea" , but I choose to continue to believe in the Science and to pray that these drugs can be rapidly tested , proven successful , and made available to help millions of sufferers around the world - - KEEP THEM ALL IN OUR PRAYERS !
GLTAL
Great post as always falconer ! One correction , treatment was long-term : 4.5 MONTHS ; however equally amazing results !!
GLTAL and all the best for a Happy , Healthy and Successful 2018
Excellent posts falconer and dado ! Some of the impatience on the board remind me of our grandkids waiting on Santa !
The facts are , timewise , we are dependent on the FDA new regs for trial start times . These are nearing completion / publication and if Anavex continues to say several trials will start before year end , I choose to accept their projections.
Of Greatet importance , in over 10 years invested in this stock , I have yet to see a single SCIENCE - based failure in the progress that has been made with A 2-73 ,
Accepting the age old proverb that “ there can be many a slip twixt the cup and the lip “ I remain patient and confident that Anavex is in control of revolutionary medical breakthrough which , at a minimum , will surpass SOC drugs such as Aricept .
To each his own , but I will hold every share I have accumulated, and will continue to pray for the rapid registration of these drugs which have the potential to save countless lives .
GLTAL !
Wrong again Swallow !
The Anavex Story may well parallel that of the Roundup ( glyphosate ) discovery story . Glyphosate was first synthesized in ca 1950 but "sat on the shelf " until it was " re-discovered" by Dr. Franz of Monsanto in the 1960's and improved and sold as a herbicide !
Multi - BILLION $$ market today , and you could have bought it for a couple of bucks in the Aldrich chemical catalog - - WOW , how did YOU miss that opportunity ?!
READ POST 130935 again - - Regenerative Medicine Advanced Therapy (RMAT ) , kinda sounds like A 2-73 will fit !
Excellent find /post falconer66a !
Great addition to the "iceberg " of positive data which has been building over the past 10 years !
Thanks for your many informative posts !
Thanks to you Talon and all retired and active members of our armed forces , both at home and around the world .
On this Veterans Day we especially remember and honor those US and Allied forces that paid the ultimate sacrifice in defense of freedom (including 4 close family members who gave their lives in Europe ) .
GOD BLESS AMERICA !
Exactly power walker !
Dr . Gottlieb made that statement also in his Nov 3 speech - - - I would think that the thousands of placebo ( and Aricept ! ) plots/ graphs from previous ALZ trials could certainly be tailored and /or refined to serve as controls in many new guideline trials .
Thanks for checking PK !
QED !!
HF-Computer Controlled Selling vs FDA Trials : What really matters - - Great post 123tom , CONGRATULATIONS , you have certainly been "more right than wrong " !
However , the important " numbers " for most long -term investors will be the release of the FDA Trial guidances which Dr . Gottlieb referred to on November 3 : " The FDA to release a suite of 10 products with some guidances before the end of the year " and " 5 of them are a suite of guidances to address various neurological disorders , many of which are unmet medical needs . "
Got to believe that the three DOUBLE -BLIND , PLACEBO CONTROLLED ANAVEX 2-73 STUDIES IN RETT, PARKINSONS AND ALZHEIMERS , which have been repeatedly referenced by Dr. Missling , are likely to be among those 5 ! If not , we will expect them to start in the first quarter 2018 . No big deal , what's a couple of month's delay to investors who have been adding for years on each additional piece of scientific data .
GLTAL !
EXCELLENT summary Jimmy ! The march forward continues !
AGREE falconer ! With A2-73's excellent safety record and stabilizing efficacy over a > 2 year period , hopefully the new FDA regulations will allow for " compassionate care " use by diagnosed patients who are willing to sign a liability release !
I , and many board members , have close family members who would certainly benefit from the early use of this life-saving drug !
Thanks for the Gottlieb link - - - I just listened to the presentation and , as you and Xena also have noted , at ca 26 minute point he refers to "5 CNS studies " which he expects to be initiated before the end of the year .
Hmmm , A 2-73 in Alzheimers , Parkinsons , Rett , MS and Fragile-X Master Protocol ??!!
This may just be our REM dream now , but lots of scientific facts are pointing in that direction ifor the not too distant future ( IMHO ! )
EXACTLY : FDA APPROVED TRIAL DESIGNS !
Agree completely with you Jimmy !
In my many contacts with FDA /EPA over a 30 year research & management career I have experienced that these agencies , in addition to regulating our industries , also desire to have their own " success ".
With FDA / Gottlieb's implementation of new Trial Guidelines , I believe ( hope ? ) they have been working " hand in hand " with Anavex and also consider A 2-73 to be a great candidate to showcase their adaptive trial designs . Time will tell !
While I am providing my " 2 cents " to the discussion , my DD continues to lead me in the direction of the close "relationship" between Insomnia / REM Sleep / Brain Cleansing / amyloid Plaques and many CNS diseases ( Alzheimers , Parkinsons , MS .etc ) and A2-73's role in all of these areas .
Not sure at this stage which is the chicken and which is the egg , however , all evidence to date suggests that A 2-73 certainly "facilitates " the smooth functioning of many essential processes occurring in the brain ( and possibly other organs of the mammalian body ) . Here again , time will tell !
GLTAL and Sleep Well !
RETT TRIAL
Great summary polarbear !
Re Talon38 's post 121652 earlier today concerning Rett trial , please note that on Sept 8 an FDA workshop entitled " PEDIATRIC TRIAL DESIGN AND MODELING : MOVING INTO THE NEXT DECADE " was held in Washington , and info was posted on FDA website on 9/21 .
Not sure if this counts as official release of trial guidance, but the timing sure fits !
GLTAL !
Thanks Bourbon ,
I hope you get a response from HMS - - - however, you should also consider sending your 2-73 summary info directly to Dr .Tanzi's email :
tanzi@helix.mgh.harvard.edu
He recently posted links to his appearance on the Dr. Oz show on Twitter and the Dr. Oz website .
Good luck !
Thanks polarbear , I agree ! Thanks also for the Dr. Perry link ! I missed it earlier as I was out of the country performing my PoA and caretaker duties in Canada .
Fortunately I can check off most of Dr. Perry's advice for healthy living , except for extra stress brought on by the above-mentioned duties !
Insomnia , Dementia and A 2-73
Thanks for posting this new article Bourbon !
I have owned AVXL shares since 2007 and have been following closely this research since ca 2012 which clearly shows an "association " between insomnia and dementia . The two elderly family members with alzheimers for whom I am PoA and part -time caregiver both began ( 2012/2013 ) with sleep disturbances , insomnia , night wandering , etc which progressed by 2014 to full alzheimers .
I don't believe that it is known yet "which is the chicken and which is the egg " , however the fact that our A2-73 appears to work on both Alheimers and insomnia only strengthens the likelihood of a strong connection , as does the recent research which has shown that most "brain cleansing " only occurs during deep REM sleep .
Earlier this week , Dr . Rudi Tanzi, a leading Alzheimer researcher ( Harvard , Mass. General , etc ) was on the Dr. Oz Tv show and reported on some recent ALZ research presented in July at the AAIC in London , and also some of his own lab studies .
He reported that the presence of bacteria and viruses in the brain was receiving greater attention , and the formation of plaque may actually be a related defense mechanism . He said :
" We used to think that it took years for plaque to form but it turns out in studies we have done that one bacterium or one virus can trigger a plaque overnight ! "
" We have always thought that this stuff was just junk but it protects the brain against infection Plaque acts like a jail which traps the infection . Instantly this stuff accumulates around the little pathogen and intraps in infection . This is a whole shift in our thinking ! " He further noted that the accumulation of plaque will lead to alzheimers .
However , in my humble opinion , I guess one could also argue that " alzheimers/ insomnia " can lead to plaque accumulation ?!
I believe that our A 2-73 , by promoting Cellular Homeostasis ( at various stages / areas of brain function) will allow " deep sleep " and proper " brain cleansing " . I pray that it may also have a curative effect on already diseased brains !!
GTAL
Subtitle C - Modern Trial Design Section 3021
Excellent posts by many board members ! We are getting closer !
The FDA's Work Plan for Implementation which was issued on JUNE 7 , 2017 , Section 3021 states the following :
" This section directs the FDA to assist sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs and biological products in order to facilitate more efficient product development . To accomplish this FDA must hold a public meeting 18 months after the enactment of the Cures Act and issue guidance on , among other things , how to use such novel trial designs , how they can help to satisfy the substantial evidence standard , and recommended analysis methodologies .
FDA experts staff will plan and conduct the public meeting , further develop novel clinical trial designs and approaches , and draft the required guidance . "
It would appear that our trials are currently being discussed / modified ( together with FDA input ) to meet these objectives AND TO ACHIEVE THE BEST TRIAL OUTCOME ! EXCITING TIMES AHEAD !
Too good to be true ??
Re the excellent posts by gernee20 ( 120461 ) and nidan7500 (120411 ) , all members on this board need to read the FULL text of Dr. Gottlieb's recent speech ( 9/11/17 ) to the Regulatory Affairs Professionals Society 2017 Regulatory Conference . Several comments have been referenced recently by Talon38 , however , many additional statements by Dr. Gottlieb seem to provide a solid reason for the recent quiet period by Anavex and the "delay " in the initiation of the planned trials .
Some quotes from the speech : " FDA continues to advance the use of new tools and clinical trial designs . For example , we are seeing wider use of adaptive approaches , which allow scientists to enrich trials for patient characteristics that correlate with benefits , or that help predict which patients are least likely suffer a certain side effect . "
" As part of these approaches , we're seeing more use of combined-phase studies , what's referred to as seamless trials . Instead of conducting the usual three phases of study , seamless trials encompass one adaptive study where the phases are separated by interim looks . "
" Seamless designs are particularly advantageous for drugs that work in a variety of diseases ,allowing rapid evaluation of the drug and potential approval under our accelerated approval pathway . These new approaches are also highly consistent with the goals of the 21st Century Cures Act .. "
" This approach is well suited to the kinds of drugs that are being developed now , where drugs intervene on common elements found across multiple kinds of disease states . "
" We're also advancing the use of ' Master Protocols ' to enable more coordinated ways to use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient .
This approach is particularly relevant when it comes to targeted drugs . These are drugs that may intervene on markers that are relevant across many different disease subtypes . We may, for example , want to evaluate these different targets simultaneously , as part of one large study . this could give us a better way to understand the comparative benefits of a drug across different settings . to enable these master protocols , it's often important to do molecular patient screening ."
" The Agency also needs to engage in more communication between sponsors , investigators , IRBs , and other stakeholders involved in the development program . This is not a ' business as usual ' approach . It may require a much more iterative process , with greater communication between alll of the stakeholders involved in the clinical trial processes . "
Hmmm ! Working closely with the FDA , Anavex may have the perfect ground - breaking candidate(s)
to test/ implement these new trial procedures .
I , for one , am willing to trust and wait ! GLTA !
Good post JohnJ ! Agree completely !
I am a first time poster , but LONG -TIME believer in Avxl . Bought 3000 shares in May 2007 based on presentation of Alz rat data at a Conf in France ! Got stopped out for small gain in 2008 , but bought back in with 6000 shares at lower price in 2009 .
I have continually added on good news /data over the years , especially between 2012 and 2015 ,at prices as low as 25 cents per share . I choose to ignore the hype and impatience , but also the biased posts /press from the likes of Shkreli ,Adam F who I believe comment to provide "cover " for certain market movers . Having spent over 30 years in R&D with one of the world leading AgChem /Pharma companies , I have a high level of confidence in our phase 1 human study and YES even the RAT / Mouse studies conducted with our AVXL compounds !
I really enjoy and value the input and DD from posters such as Xena , dado , falconer ,Bourbon , johnJ , McMag , Bas Ruby , and yes even tom123 ! Don't criticize his charts folks , he has been "right on " in predicting recent swings . Remember , in today's world it's the computers making the calls not us tiny retail folks . However , the confirmation of our life-saving technology will hopefully begin on Friday ( Jefferies Conf ,) and / or at the AAIC Conf in July .
Don't take my word for it , but don't you think the involvement of the Michael J Fox Foundation , Rhett Foundation , Alz Research , and institutional investors such as vanguard , Blackrock Park west ,etc are strong indicators of tremendous potential ? As a caretaker and PoA for two elderly family members who have been suffering with Alzheimer's for the past 4 years , I pray that our little company can bring a solution to market within the next few years .
Hang in there Longs - - Patience is a Virtue ( and a reward ! ) God Bless and good luck !