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My buy-and-hold strategy has netted me a 100% return currently, and 2017 will be amazing... wait and see!
Happy New Year, indeed!
Surely you must have a link for the information that you base your comments on.
21st Century Cures Act will allow biotech companies to actively advertise off-label use of drugs to payers.
If a drug has already been approved by the FDA, firms can rely on real world evidence to seek approval for additional indications.
Clinical trials are incredibly expensive and the ability to rely on data collected outside traditional drug trials presents an incredible cost savings opportunity.
Acadia Pharmaceuticals is one company that may benefit from the 21st Century Cures Act as CNS drugs are frequently prescribed off-label.
Anavex should hold a silent auction, best and final bid.
I just clicked on the Contacts link, which took me to another (contracted) site; filled in the fields and submitted.
Warning: there's a bug in their software that requires the veteran's and dependent's zip codes, even though one selects a General comment. It seems that in order to submit a comment, you have to make a different selection than General and include a veteran and dependent...odd! I reported it.
I don't have any links to "higher" levels, but might be possible to locate.
Just fyi... I took the opportunity to contact the VA via the website to introduce them to Anavex with a brief summary of progress and results. I requested that they forward the msg to the highest levels within the VA to pursue compassionate use prior to approval. We'll see if I get a response.
People need to understand that placebo-controlled trials are for drugs that have questionable efficacy and improvements compared with placebo. For drugs that have demonstrated higher efficacy, the FDA will determine the trial structure and control arms. It's very reasonable, given the demonstrated efficacy of 2-73, that for the P2b/3 trial, the FDA will only require a few hundred patients with a control arm being donepezil (SoC). No need to compare with placebo, when historical data already can predict those results and it would be rather unethical to not at least put patients on SoC as a minimum.
From what I can gather, it seems that A-beta is also being reduced naturally with 2-73; however, 3-71 is more potent and effective at both.
IMO, doubtful.
As I said, I hope you're right; it would be sensible to make the monotherapy change in an adaptive trial, when the results are indicating so. It will be revealed in due time.
Merry Christmas to you as well, and all fellow AVXL believers!
You may very well be right, as I hope. Why else did they change the weeks of the trial readouts from 38 to 36 and add a 48? However, a previous poster might also be correct in stating that it takes time for the brain to heal and rejuvenate, even when combining donepezil with 2-73. We won't know for sure until the company explicitly reveals the details.
We don't know what's in the works, but my money is on Biogen. Recent divisional spin-off, cancelled partnerships, MTA, Greek CEO (perhaps coincidence). Biogen needs something big to survive; I don't think it's aducanumab.
You should go and re-read the S4. It clearly states 6.7M shares maximum and $100M maximum (which implies $14/sh avg). Not likely to happen since they already sold 3.4M of the shares over the past two months for $11M. Fully diluted MC is currently 45M shares X $4/sh = $180M. Not sure from where you're getting your numbers.
It would seem Biogen is raising funds, and divorcing existing partnerships, to prepare for something bigger in CNS. And I can't imagine they have THAT much confidence in aducanumab.
Shorts and instys need shares and will use scare tactics to shake them loose from weak hands. The only way to combat it is to hold what you have and buy more on every dip.
Shorts are running out of time!
And the plot thickens! Biogen spinning off its Hemophilia division, with the remaining company focusing on CNS disorders. Hmmm...
http://us.rd.yahoo.com/finance/SIG=15o3k7gf4/*http%3A//www.forbes.com/sites/joecornell/2016/12/21/biotech-giant-biogen-to-spin-off-bioverativ/?utm_source=yahoo&utm_medium=partner&utm_campaign=yahootix&partner=yahootix&yptr=yahoo
Being an "investor", I'd think you would know what's been communicated by the company, that restoring homeostasis allows cells to function normally, not only in preventing the misfolded proteins that cause plaque, but also in reducing the plaque that is present.
Roughly a third of the patients on Aducanumab suffer or have suffered brain swelling. It only moderately slows the decline of the disease.
Perhaps the agonistic aspects of 2-73 on M1/M4 are being underappreciated?
http://www.voanews.com/a/new-alzheimers-drug-slows-memory-loss-extends-life-mouse-model/3643150.html
I think Missling realized how long of a process it will be to negotiate the best deal; therefore, raised the additional $11M to keep their trial plans on schedule.
I don't; just saw it on CNBC.
Biogen announces its new CEO. It's not Missling.
There are probably some institutions who don't buy shares of companies, especially young biotechs, with PPS under $5; however, I believe there are more institutions who don't buy biotechs unless they are in at least a Phase 3 trial. I expect with the announcement of P2/3 for Alz, we'll start seeing larger demand and participation from institutions.
Truly is amazing that this can be so heavily manipulated.
Hey FDA! Can we please get a BTD, SPA and/or Fast-track designation?!
Okay, now where was I?
I just now accessed and downloaded from Anavex's home page. If you can't get it, I have a copy.
EDIT: I see you were able to access a copy.
WELL SAID!
You need to revisit the company presentation and pipeline.
LOL! Gimmick? Really...the company puts "gimmicks" in its 10-Ks?
This paragraph about competition is worth pasting...
"Each of our competitors have greater capital resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development, obtaining regulatory approval, and pharmaceutical product manufacturing and marketing than we do. With these additional resources, our competitors will be able to respond to the rapid and significant technological changes in the biotechnology and pharmaceutical industries faster than we can. Our future success will depend in large part on our ability to acquire funding for our research and development. To continue to acquire funding for our research and development, we will likely have to show progress toward our goals and we will eventually be expected to develop a compound that may result in a transaction with another pharmaceutical company."
I especially like the following paragraph taken from the pipeline section...
"Our proprietary SIGMACEPTOR™ Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, both of neurodegenerative nature, including Alzheimer’s disease, as well as of neurodevelopmental nature, like Rett syndrome, a rare disease. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease."
PROPRIETARY!
There are now 39,610,967 shares issued and outstanding as of December 12, 2016.
Here's the most recent... up to $100M (6.7M shares), which would require an avg PPS of $15 to hit $100M.
https://www.sec.gov/Archives/edgar/data/1314052/000161577416007004/s104014_s3a.htm
I thought there was a more recent agreement this year???
Certainly the time remaining this year reduces the probability of a near term PR, but the fact they issued shares to raise funds recently might suggest they're nearing a trial. We'll see...
If my recollection is correct, up to $100M.
What are the probabilities for any of the below announcements happening this year?
1. Rett's P2 trial
2. Parkinson's P2 trial
3. Alz P2b/3 trial
4. Partnership
5. Grant
Anavex would be the last biotech that Cramer would have on his show. He's involved in, or a least knows about, the attacks; their money is elsewhere.
Data are inconclusive? Really? For anyone who can read a chart, the MMSE and ADL graphs are rather convincing. Add to that the super responders and all of the positive comments from caregivers regarding their loved ones' improvements.
Unfortunately, the company didn't PR the CTAD findings and results to the investment community, to increase awareness of progress. Missed opportunity.
Thanks for spreading the word!