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Page 1 of 2 of Article in Forbes by John LaMattina about new Alzheimers Drug.
Only it's not new..it is yet another FAILED REHASH..
AnavexNOW!
http://www.forbes.com/sites/johnlamattina/2016/10/07/a-little-known-drug-company-could-have-the-answer-for-some-alzheimers-patients/2/#3c78b9244a66
A Little-Known Drug Company Could Have The Answer For Some Alzheimer's Patients. By John LaMattina!While many rightfully worry about major health issues such as heart disease, cancer and drug resistant infections, the biggest looming crisis could well be Alzheimer’s disease (AD). As baby boomers get older, more and more will suffer from this disease. Yet, other than palliative treatments such as Pfizer’s Aricept (generic name: donepezil) and Allergan’s Namenda (memantine), which only stave off AD for a relatively brief time, there are no drugs available to halt or reverse this crippling disease.
The dearth of AD drugs isn’t due to a lack of trying. Numerous companies have sought new treatments but greater than 99% of drugs that have entered clinical trials have failed. However, there still are two promising compounds in late-stage development: Lilly’s solanezumab and Biogen’s aducanumab. Solanezumab is an injectable antibody designed to bind to and promote the clearance of the beta-amyloid protein which forms plaques around neurons of people with AD. To date, clinical trials with solanezumab have been disappointing, but Lilly believes that its ongoing late-stage trial will show the benefit of this drug in enhancing cognition in mild AD patients.
Early-stage clinical studies of Biogen’s aducanumab, also an amyloid-targeting antibody given by injection, showed promising reduction of beta-amyloid in the brain in a dose-dependent fashion. Biogen is rapidly moving its drug into late-stage trials. However, both antibodies pose the risk of vasogenic edema (amyloid-related imaging abnormalities or ARIA-E), which could limit their ultimate use and/or effectiveness.
Trying to compete with these large players is Alzheon, a small biotech company in Framingham, Mass. At first pass, it looks like Alzheon has little chance in making a difference for AD patients. It is developing ALZ-801, a prodrug of an old compound, tramiprosate (homotaurine). Tramiprosate was taken into late-stage clinical trials by its originators, Neurochem/Bellus Health. Unfortunately, tramiprosate did not meet the primary outcome goals in phase 3 and the compou
1. Development and approval of amyloid PET imaging–this has shown that clinical diagnosis of AD in mild to moderate AD patients is not accurate in up to 30% of patients (who do not have brain amyloid pathology on amyloid PET imaging).
2. The rate of negative amyloid scans in mild to moderate AD is highest in APOE4/4 non-carriers (40%) and lowest in APOE4/4 homozygotes (5%). Thus, inclusion of APOE4 non-carriers in the earlier pre-PET imaging trials of amyloid-targeting drugs like tramiprosate resulted in trials very unlikely to succeed.
3. With amyloid-targeted agents, it is critical that intervention occurs at the early to mild stage of the disease to demonstrate slowing of disease progression. Intervention later than this is probably too late.
Thus, Tolar believes that a trial can be done to optimize the potential for success. It should be noted that tramiprosate also had issues in terms of variable pharmacokinetics and brain exposure along with poor tolerability in the form of nausea and vomiting. However, these problems seem to have dissipated with a new form of tramiprosate, its valine prodrug, ALZ-801.
Continued from page 1
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So Michael J Fox Foundation should be finished with Treated In Animal Study, Wonder if they will release final data or just announce the recruiting for PHase 2/3?
Agreed that Ariana was most certainly part of Biogen deal. Stock Option s to key employees was part of deal as well. Why give stock options to Material Handling Agreement if no value to Company? Not like Axovant, where it's CEO's Family getting options..
So the pieces to the puzzle are Small Patient Population, rigorous Data Lines redefined and retested. New info on AD Patients also allows for greater Stratification of Patients(perhaps 3 Groups).FDA in on design team..Data continues to flow in to Anavex..You know the problem with Alzheimers..is you forget how precious every extra day is as it's not like Cancer, your family member doesn't just die with failure, they just fade away..We've got to get this drug on the street..NOW.
All this to show a definitive reaction..
However..Playing the Piano and Painting a picture are pretty doogone
definitive to me..and their spouses..
Fuerstein, Renauer, et al are Big Pharma Hacks who sold their souls a long time ago..sh well....
Will Volume surge continue in early morning trading?
BIOGEN, Michael J Fox Foundation, FDA grants Co. multiple Orphan Drug Status, Trial Design Experts Engaged right after BIOGEN deal, announcements of up to 4 Phase 2/3 Trials-ALzheimers, Parkinsons, RETT Syndrome, & New IND- A3-71 Developments? Pain Killer Developments? Cancer Developments?
New IND's? Eyes? Heart? In Licensing Agreements?
Maybe the Volume Surge at teh end of yesterday was not that big of a deal..
You know, when you have Biogen and the Michael J Fox Foundation ACTIVELY working with you to treat Multiple Sclerosis and Parkinson's Disease, you get a little more respect. The Whale is going to swim away with a lot of short sellers money..a lot of their money. At least 5 market makers will bite the dust when Anavex is in the belly of the whale, maybe more.
Anavexnow, I am having a hard time sleeping and I don't want to be drowsy.
Thank YOu ,,thank You very much...
http://ir.regenxbio.com/phoenix.zhtml?c=254175&p=irol-newsArticle&ID=2168467
Maybe after the Material Agreement, Biogen has something like this in mind for Anavex..I'm game..
Corey renauer did not disclose Motley Fool's position in Biogen until AFTER he began bashing Anavex.
I am all for suing Motley Fool. They have been despicable.
millstons, eloquently stated..I have been involved in NDA discussions with multi-billion dollar co. and just as you say..to make a Public Announcement,
it's not just ..hey test this for me to see if works..thanks buddy!
like i said earlieer..they have come to terms with success..
CO NOT SELL YOUR SHARES..
oh well
The Dilution Argument is non-existent, period.
end of story. it is effective as short and distort but
at this point, at this price.dilution is irrelevant.
the good dr. has delivered MJFF and Biogen and a
firm to delineate the data from ongoing Phase 2a to craft Phase 3 for
success.
He might be workign around an insomnia quick study as well..
How hard would it be to enroll Insomnia Group?
Guys and Gals the point is simple.
We have a drug that has a CLEAN SAFETY RECORD..
NO SIDE EFFECTS TO SPEAK OF..EASY TO TAKE(Pill Once a day)..
You could use the doggone thing as a Placebo pill.
AND you have all of these positive side effects being observed..
This is a general Population pill..
are you getting it? is this hare to fathom?
it's the new aspirin on steroids..
they are talking you into selling them gold for pennies on the ounce..
Biogen comes in and people are selling because professinal sheisters who don't care about you are telling you to be scared?
reall it's unbearable to watch..
Accumulate
So BIOGEN is in the picture..
Michael J Fox Foundation is givng big preliminary thumbs up..
2 questions for all you brainiacs selling ..
1. Who was selling you the 25 Million Shares on Biogen nes at $4?
2. Who is buying the shares of Anavex at $3.25?
Hey..do you think it's the same people?
this stuff is hard to watch..Accumulate..
the Payoff must be close ..shorts are scared into panic mode..
the dilution scare..it's unbearable.
meaningless announcements? BIOGEN?
IDIOTS!
Accumlate
So BIOGEN is investing millions to test a drug for MS? FACT
MJFF is going to move forward with Hu Testing for Parkinsons.(IMO).
THE FDA is guiding a Phase 2/3 Study..FACT
ALL Billion Dollar markets , ill served..
and Anavex is not worth a risk? hmm..
must be a lot of stupid people at Biogen..
working on it
Scootsmith..100 times is probably not an unreasonable multiple for
many bio stocks..Let's see what EPS Multiple Biogen trades upon ..shall we?
so the average p/e is 24 times..
Biogen is 17.4 times..
so your 100 times is too high..
but ..Biogen did go up in Market Value by 29 BILLION in one quarter over the prospects of an effective Alzheimer drug..
that probably pushed their P/e pretty far up there..For Alzheimers/Parkinson you probably are pretty close on an
100 P/E multiplier.
Thanks once again Dado..I am in for at least the first Trillion..then I am selling half and getting my original money out!
Tirllions spent in ABJECT FAILURE.doing massive Phase 3's ..
Intelligence overrules Ingrained Stupidity...
frol..I think this is a result of what you say..
the subgroups are kicking arse..WHY?
Is Aricept the problem? Again..They can go back to
a population group that has stopped taking Aricept due to Reactions
and try doing Mono-A2-73 or try Aricept & A2-73 in dual..
If mono therapy line continuing to show betterment..
the Volunteers of Phase 2a on a 2 Year extension
on Dual Therapy are going to probably stop taking aricept,
the Biogen Testing by previous test estimates may be available
with in-vivo(mice) testing by end of 1st Quarter of 2017..
that is assuming first round of modeling goes well..
there was a post on this earlier.. by another blogger..
Great Point Xena..
I posted an article earlier about there being 3 Subtypes of Alzheimer Sufferers..It was from Elselvier..
Then another posted mentioned starting Aricept and A2-73 at the same time versus already taking Aricept..
Maybe they could find a non-responsive Aricept Group,
Restart Aricept and A2-73..and a Mono of A2-73..
From everything we have seen with Large Trial Failures..
This is yet another brilliant move..
Great Job good Dr.
gud one
Melatonin is meant to reset the body's internal clock — for example, it's appropriate to use the supplement to counter the effects of jet lag, or help someone sleep if they have an unusual work schedule or suffer from a circadian rhythm disorder. It should not be used for general insomnia.
'Nuff said
BLU_1 you rocked THIS! Didn't even think about putting DZP and A2-73 at same time..BRILLIANT!
i thought for sure you were ging to say a photo lab in the Schnucks parking lot..LOL..Maybe Cory Renauer was running the Co. then..
Good thing we ahve the good Dr. in charge now..very good thing..
Admin is ADMINISTERING the resources and getting deals with BIOGEN, MJFF, RETT SYNDROME FOUNDATION, What is WRONG with people?
Oh yeah..they want the value of the Company to go down..
who cares why..
not me.
Go good Dr. Go!
See if you can anser these questions:
What kind of drug may you take that will help you go to sleep at night that is non-addictive, non-drowsy and non-psychotic?
YEP A2-73!
Hey here is another one..What Company recently released preliminary findings that one of their pipeline drugs is Non Addictive, easy to administer, and may be able to replace Opioids as a pain killer and perhaps as an addiction relief drug?
ANAVEX! Man..thank you for allowing me to Administer this Test!
we could have had a V8, and follower Cory Renauer's Advice and bought our own LAB! but of course than we would be broke and Biogen would have gotten our assets out of bankruptcy..
But HEY..don't listen to the good Dr. let's follow what the Genius's of the Web say to do..What coudl go wrong with that Picture?
Where only Fools dare to tread! Don't get Renaured.Accumulate
hence why you spend 1/100 of the money on an Adaptive Phase 2a..find out the PK to the nth degree..then do an effective P2/3..
Anavex did their trials to quickly let Anavex fail..Biogen..apparently not same goal..Anavex is keeping a lot of people up at night..but for Phase 2a participants..they appear to be sleeping like little angels.
go figure
so add a succesful testing of our Pain/Cancer medicine to our BioPharm Arsenal of Goodness! We can not control the price of our stock..but we may certainly understand that the price someone is willing to pay us today in no way represents what someone may be willing to pay us tomorrow..
we have become a multi-faceted, multi-IND co. in 3 years..
A billion Market Cap..puts us around $30/share..
I see many multiples of that $30/per share as our true value..
Accumulate...
that is a non-truth. the value of a test deal with a $60 billion dollar co. in the Biopharm Industry ..i would put at $25 Million..because how many other Company's may even accomplish this testing in any form?
Why $25 Million..well what would you pay someone to open the door for you if you thought you had a drug to treat MS? $25 Million seems like a reasonable door charge to possibly saving millions of lives.
That really doesn't factor in the value of the "relationship" but anyone of intellect knows, that within the Material Testing Agreement is an additional MOU(non-disclosed of course) that depending upon the results..
THIS IS WHAT EACH PARTIES RIGHTS ARE.. I don't know how far Biogen went to locking up Anavex re:MS..but my guess is ..pretty doggone far..
And if YOU are Anavex,,MS is another Population that you may help..
If Biogen wants to in-license A2-73 and combine with other therpies..
GREAT! get a little upfront cash and a percentage of Biogen A2-73 Biz..
and move on..Unless of course..Biogen wants to merge..than we may talk..
America #1 in OPIOIDS and ADDICTION!
So when Tulane announced possible breakthrough in non-opioid new drug, PR was off the hook..Anavex has dropped the PR Ball altogether..
I understand why..but that doesn;t demean the actual excitement or pride thta we as shareholders should feel as our little company tries to make even more lives better.
Keep up the good work good Dr. Rewards come to those who act well and are patient.
http://www.nola.com/science/index.ssf/2016/01/tulane_drug_opioid_addiction.html
thanks Makemy..haven't had the time to follow through on this ..so I appreciate you sharing..so I am thinking 6 months on outside..add a week to set up. a few weeks to go in vivo..check results..April 2017..
you know..two things that I would appreciate..
ONE: what should we think is the TIME FRAME for Biogen to complete MTA regarding MS? One Week, One Month..One year, two YEars?//
someone anyone? we used to have some pretty good input Docs.Have they all gone away?
TWO: What are the ramifications of our Pain Drug being as effective as Morphine as a pain killer? is that no big deal?(which I find IMPOSSSIBLE to believe or is it a HOMERUN! Oxycodone and Heroin be damned...
Come on DOC..help a Polo Shirt out
whatever it takes to keep him! the good Dr.is gold for patients and shareholders!
i don't question it. most whales are told what to buy by little people with small minds. Whales already own billions of BP and would prefer they not lose those Billions whilst Anavex Treats 90% of CNS diseases for pennies on the dollar..Anavex is not good for whales..it is good for baby whales that want to grow up and be big whales..and they are coming..yes sir..Biogen put a little something in the water..and they are a coming..
Jimmy , MS was one of the first IND testings that occurred.You can go back through Anavex news and find the announcement. I called them on it..and they never updated MS good or bad..but we had heard news on multiple others even though MS was first..I think you are on to something..The Biogen deal may be much farther along than thought..and the succesful MJFF In Vivo testing may have pushed Biogen's confidence over the edge.
the good Dr. is probably a little low..personally,
100,000,000,000 seems about right..
Alzheirs, Parkinsons, Epilepsy, Insomnia, MS, Austism, Depression, Anxiety, Preventive is LARGEST MARKET OF ALL! Have not even discussed!
Safe, Easy to deliver, Inexpensive to create...
Really no marketing necessary..PR will cover all of Marketing.
You need to spend money on Marketing when you have
either a drug that barely works or that has competition..
A2-73 only competition is a3-71..
YEAH,,I think the good Dr. could have gone north of 100 Billion.
new one from Microcap:it was a quick read, but they mention Parkinsons but not MJFF?
http://www.microcapdaily.com/?s=anavex
thanks no brainer..feel like I wrote this article myself!
there is very little chance that an MOU has been engaged regarding possible outcomes if testing "Positive". Biogen would be doubly foolish not to lock Anavex into some MOU, first Proving Anavex'x Science(making acquisition cost dramatically higher) and second, letting Anavex go anywhere with that value and Information-to a competitor? No way Jose! There is an MOU and THAT is what got everyone there BONUS STOCK..Flavus & Crew..
no agreement..yeah..WTE
jonjones,
we remain undervalued because Market Makers, Short Sellers and Long Traders continue to sell Momentum Tops and coordinate bottom purchases.
Caveat Emptor! Accumulate.
Until a Whale Buyer buys into 10-20% of the Co. we will continue this brutal repartee. Only in this case the last one to hold the hot potato wins!
so let me get this straight..
Biogen, in your opinion, is going to test A2-73(at it's cost) to confirm
that A2-73 is THE DRUG that allows for Protectan Proregeneration of nerve cells(the Holy Grail for Biogen research on MS) and YOU in your infinite wisdom..say that NO, they have no Agreements IF A2-73 tests positive?
So A2-73 may just take Biogen's efforts and success to another Co.
and let them bid ona A2-73 for MS?
OF COURSE THEY HAVE POST AGREEMENTS! What would be the point of
Biogen testing A2-73's Drug..if there were no POST AGreements?
Really I want to hear this..enlighten me..because I'm not a BP Drug Merger guy..it's just common sense..but maybe BP does it differently..