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I would assume the compassionate use people are getting it free
Wouldn't want to muddy the waters with a price just yet. Wait for approval by FDA and formal pricing.
Health Canada Special Access Program (SAP) Authorizes ANAVEX®2-73 (blarcamesine) for patients after successful completion of Open-Label Extension (OLE) study.
Special Access Program (SAP) applications are granted at a physicians’ request on behalf of patients. Based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that the study drug will continue to benefit patients
Nothing wrong with the stock price that couldn't be fixed by:
1. immediate release of full alz data showing efficacy
2. release by sept 30 of top line Rett data
3. NDAs for Rett and alz by year-end
It's time to execute on those goals. PRONTO
not needed: Professional Sales Personnel
if we're the only tablet alz treatment that works, you dont have to hire sales people to push it, as it will sell itself. that said, McKesson has a full suite of solutions for biopharma cos.
NO: Have you got shares in McKesson? but would rather have a specific cost with a distributor than giving away a huge chunk to a partner. Think McKesson would be more cost effective.
Why do you think that one of two Japanese companies, Takeda or Elsa, would allow for easier access to the Chinese market rather than say JNJ, Pfizer, Merck or Roche, etc.?
For China, no difference. For Japan, huge difference. I think Japan is the better market anyway. Can afford to pay up and local manufacturing possible.
24/7 media presence and advertising plus worldwide reach.
the first two are why ad agencies are in business. Think we may need a partner for far east (Japan).
I don't buy the thinking that AVXL will be able to maximize success of a worldwide commercialization effort with just some sort of marketing/distribution agreement.
A distributor like McKesson probably knows more than a BP about getting the product out. A contract manufacturer is already lined up. So what does the BP rpvide if we are already approved that they can't?
Partnership was to be only after 273 approval. So Dr. M doesnt think he needs a BP to get approval.
Since the option expires soon, buying NOW would be a statement that he thinks the stock is undervalued, especially if he ponies up the cash.
If he is going to use proceeds to buy the stock, it would be good to get that alz data released so that the stock price is high and he would lose less shares.
Friday is was over $10, today $8 and change.
What a manipulators paradise. AVXL MMs must all drive Bentleys.
Would love to see Dr. M release full alz data tomorrow and stick it to them.
just like the Fed
[AVXL] requested a block on options.
Please show me data source that says it is possible to request a bloc on options.
Sure would be great to wake up tomorrow to full alz data.
And about as likely as waking up to the Second Coming.
IS AVXL even registered for AAIC?
HArd to release news if you aren't going. Last time I checked they were not.
Yeah govt knows so much about developing drugs and keeping costs down. That is why the value of the dollar is unchanged since 1913....oh wait, the dollar has lost 98% of its value since then. The free market and competition is the best way to keep costs down.
GREAT insight: it only takes ANVS 15 months to run a 600-patient PD p3 trial in the US due to overwhelming US demand and costs only $20M. Let's seize the opportunity to start a US PD p3 trial today
The final lap is like the Belmont, go USA and go big.
NORMAL TIMING: "The study is set to conclude in November, with topline assessment results available by the end of the year, the company said. "
yeah, given Rett is pretty much the same as the previous trial, would like to see Topline data out by end of August.
As for alz, full data dump ASAP
Do we really think that the powerful biopharma industry and their fellow travelers will just step aside, letting tiny Anavex waltz in and be greeted by an unbiased FDA
all the deep state bureaucrat types that frequent this board swear on a stack of Bibles that the bureaucrats are all 100% honest and only care about what is good for DC, er, America.
and with 3 elite FDA bureaucrats on our team, fast track to approval is guaranteed.
ANVS running ahead of AVXL again.
get that PD trial going, Dr. M
get those p3 alz full results out
get the top line Rett excellence data out
by the end of the 3rd quarter.
URGENCY REQUIRED
Brain bleeds vs improvement of patients. The game seens rigged for big pharma
until we file an NDA, no way to know if the game is rigged, or just that the desperation for an alz treatment is high.
right now they are the only game in town
GET IT FILED, Dr. M. This year!
There's like an eight year exemption for new drugs, last time I looked.
so patent protection is now only gong to be eight years, in essence. that will crush the funding for pharma
Wrong. First of all the prices were already negotiated once with Medicare, this is not starting from scratch. This is an attempt to buy votes using merck shareholders money.
And I ready told you why this statement is garbage: """Big Pharma regularly forces Americans to pay many times what they do customers in other countries for the exact same medicines,"
If you lower the returns to pharma cos, you will lower the investment in new breakthough drugs. Period. NO disputing this fact.
So okay, let's gut another great American industry, like we did autos. Soon we will all work for the govt or the defense sector.
I suppose you support rent control also and price controls on home sales. After all, everyone deserves access to cheap housing.
That was a childish response, Gator
I guess we should just give 273 away for free and make AVXL a non-profit then?
Not accurate: "The USA allows big pharma to plunder and price gouge US citizens as compared to the drug pricing globally"
if you study this issue, what the US does is allow BP to get a return on their development costs. Without that, no new drugs. What a small country like Canada does is free ride off the US research, and gets a price based on marginal costs.
The way to get around this would be to have some law that the US price must be the average world price, but this would force up the costs for poor countries that can little afford it.
REPOSTING: “ ANAVEX®2-73 (blarcamesine) had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome. ”
If ever there was a time for an expedited slam dunk approval this would be it should the pediatric results duplicate or exceed the adult trial including safety. Given the two prior trials, 6 months of sitting on the results analyzing every detail by the FDA would be an injustice imo.
Tred says it all!
Brought a tear to my eye.
No doubt 273 was working for that child
Let's get that Rett approval. THIS YEAR!
Make 2023 the start of hope for millions!
End of high pharma prices
https://www.yahoo.com/finance/news/merck-sues-us-government-halt-125209623.html
this would be a disaster for AVXL
Stock can only go down from here. I sold some at 9.15 and parked it in LWLG. Buy back in after the tax loss in end of Nov.
So your serious position, with full alz data forthcoming and and Rett data on the way is that the stock will go down? That is the position to which you are attaching your credibility?
So contracting a firm like McKesson would be a good idea then.
Dont see AVXL on speakers list
I'm suggesting that all those FDA bureaucrats we hired ought to be working on NDA all the time to get it out as fast as possible.
I think it is pretty clear we were discussing distribution. As in, for alz, AVXL would need manufacturing and distrbution capabilities, Make it and get it to customers. Call that marketing, sales, distribution, all the same to me.
NOPE: With the journal article, everything changes.
With the filing of an NDA, everything changes.
The filing starts the clock to either value or not in 6 months max. At that point, big investors will calculate the odds of approval and place their bets. I would expect the stock to double within a week on the filing of an NDA.
A medical journal article wont do anything for the stock price.
GOOD POINT: The good news is the sections they can complete in advance of final trial data are likely to be sections that will equally apply to AD as well as Rett. Things like manufacturing, drug development history, previous trial data.
In that sense Rett is providing a bit of rolling review for AD even though rolling review has not been granted for AD.
That is why I think two filings by YE is not out of the question
Peer -reviewed paper is a distraction. Work on the NDA. If the paper comes out after the NDA is filed, they can just add it. Email still works.
Didn't say that. Try reading it again. I said the reason given that he would skip AAIC becuase he was working on a PARTNERSHIP DEAL was wrong.
Why?
alz data should be ready, Rett data in a month or so. plenty of time to file as the applications should be 75% complete
Right, NDA filing is best use of time, not articles.
No, articles mean nothing. NDA at the FDA is all that matters. Wall Street isnt reading medical journals to pick stocks.