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CHMP MEETINGS 2024
Sept 16-19 , Oct 14-17 , Nov 11-14 , Dec 9-12
Correct . Upcoming CHMP MEETINGS: Sept 6-19 , Oct 14-17 .
HERE AGAIN , TIME WILL TELL !
The wheels of Science grind slowly forward ! Comments from 4 years STILL HOLD !
Success is MUCH CLOSER NOW !
Keep believing ( and buying ! ) Longs , Dr. Missling and ANAVEX have this under control ( IMHO ! )
Good Luck and GOD BLESS !
Correct Tred !
“ Ms . Ma is a senior board executive with over 25 years of experience in investing, building , scaling of companies with focus on innovative product launches in DIGITAL HEALTH , TECHNOLOGY - - - “
Hi PsuLion , welcome to the AVXL I hub board . I too am an infrequent poster , but check this and other boards several times a week .
There are several regular posters here who make informed and / or science based contributions — - some of whom I mentioned in my post # 293840 in 2018 . In that brief post I also mentioned my “ guesstimate “ of commercial success for AVXL ( even if only as a safe , non- opioid sleep aid ( 30 - 100 Bio $ growing market ) !
The science in Rett , Parkinson’s Dementia , Alzheimer’s , etc continues to be researched and expanded - - we have yet to see any confirmed failure !
Holding and adding since 2007 and extremely pleased with the growing view of the “ iceberg “ !
Good luck on your DD ! GLTAL !
Nope Power !
First purchase MAY 2007 ( pre Missling )based on poster presentation on A 2-73 murine Alzheimer’s model study presented in France !
Dr. Missling’s foresight and management skills have been largely responsible for our steady progress !
Promised myself ( and wife ! ) to sell when scientific “ failure “ occurs - - However , have not yet SOLD A SINGLE SHARE ( except to convert most shares to ROTH Account ) .
THE BEST IS YET TO COME , time for FDA to wake up and change their paradigm !
GLTAL !
MAY 2007
First Post # 107425
Keep up the great management Dr. Missling !
The BEST IS YET TO COME !
Thank you all Long- Term Believers and Science- Based posters !
When will “ RIGHT TO CHOOSE “ become a reality ?
God Bless and GLTAL !
EXACTLY Falconer !
Great find and comments - - for years you , and several of us on this board , have referred to the belief that poor sleep quality appears to be a significant primary and / or contributing factor in the development of many CNS diseases , and the potential for A2-73 to work “ upstream “ to correct or prevent their development .
Please see my previous posts 128280 and 148418 et al .
Closer to the goal line with each passing week ! Thanks for your continued contributions !
Patience , Good Luck and God Bless to all long term believers !
BOTH !!
Without TGD and TGA we would not be this far along the road to success !
TGD , with his synergistic background of German thoroughness and US risk taking / management & Pharma experience , has put together a talented team which has brought this gem close to a worldwide launch .
Two famous songs / sayings keep flowing through my head : “ I did it My Way “ ( Sinatra / MISSLING ) and
“HOW SWEET IT IS “ ( Gleason/ AVXL LONGS ) .
Thanks to all the many Science- based posters and all the others who keep us all informed and educated ,
We are peeking “ Over the Rainbow “ at last !
GLTAL!
You are right Bas , the Cramer Cabal will be hard at work !
However , our Little gem will soon be RETT-SCUED and PARK-IN -the Sun for all to see and admire !
Lots of self funding , however , Dr. Missling pointed out that in the 120 Parkinson’s Dementia Study “ that without the Michael J Fox Foundation we would not be able to do such a study “ (@ 6:20 of presentation ) .
Also @ ca 7: 44 , we have. “ sufficient cash , including non- dilutive grants and government party support to fund all of our objectives beyond 24 months “ ( I.e. for more than 24 months ).
This ship is in safe , steady hands !
GLTAL !
Am I Missing something ??
Why are so many assuming PRESENTATION has been cancelled ?.
Conference has had WEBCAST PROBLEMS all day Today , and possibly tomorrow .
My bet is AVXL presentation is given as scheduled , and hopefully adds to our fantastic data bank of scientific data .!
GLTAL
AGREE LIMA !
Doc , while stating several facts , you have also seemed to disparage / downplay the validity of a highly respected scientific publication ( Nature Research / Signal Transduction and Targeted Therapy) and the credentials of their equally highly qualified and internationally recognized editorial review boards . It appears that the publication underwent approx 5 MONTHS of peer review before eventual publication under NATURE’s name . My opinion is that the reference to Anavex was vetted and is accurate .
Doc’s third point , while factually accurate , again appears to underplay the HIGH SIGNIFICANCE of a fast track designation, which can have significant benefits in shortening the time line to approval .
Benefit 1 : more frequent meetings with FDA ( and we have strong FDA contact on staff )
Benefit 2 : Rolling Review - - EXTREMELY IMPORTANT — means that Anavex can submit completed sections of its New Drug Application ( NDA ) individually for review by the FDA , rather than having to wait Until all sections are complete and submitting entire application for review , as is the normally the case with a new drug Application .
Benefit 3 : This Fast Track Designation also opens up the opportunity for PRIORITY REVIEW and / or ACCELERATED APPROVAL , provided certain data criteria are met .
With now over 4 years of human trial data from the Australian trials , I believe we have quite a large “ iceberg “ of data to share with the FDA !
God Speed to Anavex in moving forward to providing relief to millions of sufferers of several devastating CNS diseases .
PS : All of above just IMHO ! Looking forward to great news in the coming months !
GLTAL
Agree basparks ,
NIH still stands for “ Not Invented Here “ when BP and Big $$$ are involved !
No problem , the Science is sound , and our time will come .
STUDY START DATE ( date first patient dosed )
JULY 3 , 2018
GLTAL
Nice move Bas , I am also tempted to add more at these bargin prices , but have been moving over 50 K shares from Regular IRA to my Roth since I also feel that confirmation of the science will soon begin to flow in and receive greater attention in the media .
GLTAL
Could be Skyhawk Therapeutics , launched January 2018 : Novel Platform of small molecules that correct RNA expression . Specific areas Alzheimer’s and Cancer research.
Kevin Koch , co- founder , previously with Biogen
Dr. Friedrich Metzger, founding chairman of Skyhawk scientific board , also an advisor to Anavex board and is / was senior Assoc Editor for Journal of Alzheimers and Dementia .
Biogen connection , part of the iceberg ?
2019 , twelve years since start of Anavex growth - - should be a great year , full of lots of “ ahaa “ moments .
Keep up the great contributions and D D longs : Bio , falconer , Talon , Zenia , Nidan , tred , Georgii , et al
GLTAL
FDA s WOODCOCK: “ The clinical trial system is broken “
biopharmadive.com/news/fdas-woodcock
Interesting article from Nov 20 by Andrew Dunn reporting on Janet Woodcocks recent repeated calls for Master Protocols.
Would seem like Anavex 2-73 trials in AD ( Australia) , PD (Spain ) and Rett (. USA) fits the bill for an international Basket Trial for CNS diseases ( one therapeutic drug for multiple diseases ) .
Exciting months ahead as data begin to roll in .
Thanks for all the recent informative posts and summaries Bio , Nidan , Xena et al .
GLTAL
Excellent Post falconer ! A MUST READ for most board members , especially those who are impatient with Anavex’s progress and limited release of data .
Having been involved with many biological research and development projects , involving multiple contacts and discussions with the EPA and / or FDA , and also outside expert consultants , I can assure you that falconers comments are exactly right on all points .
Anavex IS in safe hands and is making steady and exciting progress towards launching breakthrough medical therapeutic advances .
You own shares in a little known company with science which has the potential to be a blessing for millions afflicted with some of the world’s most devastating CNS diseases , IMHO !
Sit back , relax , and watch the future unfold ! Thanks to many other posters such as Bio , Xena , Nidan JJ , power , Tred , and many others who continue to add input and reference links to our growing data pool .
GLTAL
After Hours , two 100 lot sales result in 3.57 percent LOSS ??
Pure Cabal “magic “ !!
EXCELLENT FIND F1ash !
Please review my previous post # 121017 . Dr. Tanzi also appears confident that these types of infections in the brain may well contribute to dementia in many cases .
It is sad to see how a single negative “ reviewer “ can block a valid research proposal , despite several worldwide indications that seem to support the concept that such infections can possibly be significant contributing and / or causal factors in dementia .
He WILL get funding eventually and time will tell whether Drs Muir and Tanzi are on the right track .
Either way , ANAVEX continues to move forward , with each new piece of the puzzle being added BASED On THE SCIENCE !
Keep following Bio , Talon , Doc et al for their many excellent explanatory posts .
Thanks Gentlemen , for your excellent DD and analyses!
We can smell the coffee , or Bourbon ( if you prefer ! )
GLTAL
Is endocyte really worth 10 X Anavex !??
The manipulation will continue until hard results begin to pour in , and that day will come .
As I sit here on the Cancun beach and admire the blue-green Caribbean waters (matching my (pale green “ Anavex investment after a 10 yr wait ) , I remain happy and contented with the growth of our scientific iceberg .
Keep the faith longs and pay attention to the “expert “ posters such Talon , Bio , investor , Xena , power , JJ and many others - - THE SCIENCE is REAL , the noise is FUD .
Ever since 2015 when Shkrelli ( rotting for 7 years in the federal pen on felony convictions ) started texting that “ Anavex sucks and is worthless “ , a mantra that was repeated by Adam “Fartstain “ , I began to realize that big money hedge funds and / BP were “afraid “ of Anavex.’s potential success ( why would they be posting and slamming a tiny penny stock ??
Missing has captained a successful course , and imho he will deliver in less time and money spent than with past BP projects .
I am also of the opinion that Missling has turned away many potential suitors , who are unwilling the pay an acceptable “dowery “ !
This is fun to watch ( but that may just be the tequila talking !)
Cheers , prosit , Chio and GL to all LONGS !
EXACTLY !
AVXL SKEPTICS PLEASE READ TRED’S POST! ( And then repeat together , “ By Jove , I think we’ve got it ! “ )
Nice brief summary of our progress , no question that Anavex \ FDA are working and learning together (IMHO ), and those statements by Dr. Missing will be borne out by the trial data !
Thanks Tred , nice FACT based summary .
GLtAL
Wow Leo , did you really deduce all that from a job posting , or Have you conflated CNS with CNN ?
CORRECT as usual Xena !
And all AVXL believers should be considering transferring some of their AVXL shares held in their IRA account to their ROTH accounts - - - these current low share prices may soon be in the rear view mirror ( IMHO ) !
GLTAL
Congrats Bio , excellent review of the research efforts over the past 30 + years !
Glad to see that you also still have confidence in murine studies !
Concerning Dr.Rudi Tanzi , please review my post # 121017 from Sept 20 ,2017 , in which I outlined some of The statements Dr.Tazi made on data presented at the 2017 AAIC held in July in London , England , and several of Dr . Tanzi’s ongoing lab studies .
It is interesting to note that Dr.Tanz’s research was suggesting that plaque formation was / is actually a defense mechanism , to protect the brain from sources of infection ( bacteria, viruses, etc ) , however he did still feel that an accumulation of plaque can lead to Alzheimers ..
Plaque formation may also occur as a response to inflammation caused by various triggers .
IMHO Anavex remains the current “ World’s Best Hope “ for solving many CNS diseases .
The next 3 to 6 months will be exciting !
Please continue your excellent analyses of evolving research , especially with our currently hidden ( or ignored ) diamond !
GLTAL !
Hi Raja and Bourbon ,
Always enjoy your posts [ and your board names !]
As stated in my first post # 107411 on 6/6/2017 , I have been following Anavex since 2007 and hav e steadily added on every new piece of scientific evidence .
Thankfully I added in 10000 share lots between 2012 and 2015 when share price was between 20 to 35 cents per share and owned ca 350000 share pre split . ( small potatoes compared to your stash Raja !!)
Haven’t added since , have wanted to , but wife says NO ! Our neurosurgeon son is also a strong believer in the science and also owns a bunch !
Over past several years I have transferred 3/4 of our shares to our Roth accounts , so if / when Anavex hits the big time the profits will be largely tax free .
Whatever the outcome , the rides been fun and the future still looks EXTREMELY bright !
Good luck and God Bless to all AVXL believers .
Thanks Tred , but I would need some help from the real Bourbon !
Doc Missling & Co will “ Make all of our days “ sooner than most of us think !
GLTU and all believers !
Ck
A Song For Leo !
We BELIEVE
We believe for every drop of price the falls,
A stock portfolio grows ,
We believe that somewhere in the darkest night ,
The AVXL candle glows ,
We believe that for every short that goes astray ,
Missling will come to show the way ,
We believe,
We believe,
We believe that above the FAKE NEWS STORM ,
The smallest voice will still be heard ,
We believe that everyone in the great somewhere ,
Hears every word ,
Every time we hear a newborn Rett- baby cry ,
Or touch a leaf ,
Or see the sky,
Then we know why
We believe
When in time ,
We hear a Rett - free baby cry ,
And Anavex has touched the sky ,
And you will then know why ,
WE BELIEVE!
( Apologies to the original “I Believe “ ). !
Oh yes !
Somebody’s getting anxious , somebody wants your shares !
BP , tTutes , Cabal, Shkreli, Fartstain , Martians , Kramer ????
Don’t know and don’t care !
Hold on to your shares and let the traders play .
Dr. Missling has our little gem safely on track , amazing SCIENCE continues to be proven and revealed , and millions of sufferers around the world will finally have real hope .
Too late for many of our loved ones , but they are smiling too !
God Bless , and GLTAL
BAN “ iceberg “ is sinking from accumulating plaque .
YEP , thanks nidan and invester
CID / Anavex / FDA / Rett delay/ etc : Could all be part of the “unseen positive iceberg “ building below the surface .
Interesting months ahead !
GLTAL
Dr. Missslings words at shareholders meeting :
“When people look back and see what we did , and why , they will understand .”
Yep !
Thanks Neiu and TTT ,
This new video update from Australia is well worth watching .
You may also want to look at posts 120931 ( bourbon ) and 121017 ( CkFacts ) , in which insomnia “connection “ is postulated.
GO ANAVEX !
GLTAL and hopefully we start getting some US news coverage soon !
THANKS hebb and TTT ! Great finds !
Media in Australia and Now UK adding coverage !
How long before we begin to get fair coverage in North America ?
The cat is howling in that bag !
GLTAL
Thanks for the condolences talon and Nidan , being a long distance caretaker/ PoA across international borders has been / is a sobering experience !
Re Posts 166293 ( Kevli) and 166295 ( Bio ) , I agree that the addition of Dr. Fredrick Goodsaid is a tremendous plus’for Anavex.
Did you notice that his report “ Regulatory Landscapes for Biomarkers and Diagnostic Tests “ (Mattes & Googsaid , Nov 2017 ) was FUNDED by FDA , with INPUT and REVIEWS by Janet Woodcock ( FDA ) ?
This close cooperation must be helpful for Anavex’s communication with the FDA .
Keep up your good work !
GLTAL
Exactly Nidan / TTT ! The flood gates should open soon !
In the past 10 days this board has posted much excellent information and scientific review — thanks to bio,talon,power ,Xena,jimmy,Sokol, investor, ttt, , bas , bourbon et al .
It has taken me a few days to catch up because I am once again in Canada planning the funeral of another family member who passed early Thursday am after a 4 year battle with Alzheimers . I pray every day that Dr. Missing and Anavex can bring our A 2-73 & pipeline to a successful market launch .
This is not just a hope , but is based solely on the mounting SCIENTIFIC Data which I have been following and investing in since May of 2007 when I first became aware of Anavex . Those 11 years may seem like an eternity for these unfamiliar with the development process , but since the typical development timeline for pharmaceuticals and crop protection chemical can average from 10 to 14 years from discovery to market launch , I am happy with our progress.
As the holder / co- holder of over 150 international patents I have witnessed the “ thrill of victory and the agony of defeat “ on many occasions ( ca 15 commercial product launches and thousands of experimental product “failures” ) . I may be overly optimistic , but I believe our A 2-73 has at least a 75 % chance of commercial success in at least one of its many target areas ( even if only as a safe, non- narcotic sleep aid , as bas has repeatedly posted ! )
The coming months will be exciting , and hopefully rewarding , especially for the millions of dementia sufferers ,including 2 additional family members , who are being robbed of their health and dignity.
Fasten seat belts and prepare for lift-off !
GLTAL !
Thanks for checking hapit !
I still believe that FDA and Anavex both want to have this first “ new regs “ trial done well , hence the time consuming “ back and forth “ .
Additionally , as mentioned almost a year ago ( post 164775 ) , the POSITIVE scientific data
continue to accumulate ( see sokol’s recent excellent summary !} and all true longs are willing to wait !
GLTAL
Deepest sympathies on your recent loss Leo .
CONGRATS !
And the 3 knockdown rule is NOT in effect !