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Yes that does help. I see the same trend in other gold stocks and index/etf's, just not as dramatic. What is your view on owning stock in gold co like NEM vs. an ETF like GLD? I'm thinking I don't have the time or expertise to research this stock, an etf maybe better for me.
Looking to get into gold and I like NEM lately. Can anyone tell me what happened back in 11/2011 taking the pps from $70 to about $15 in 2015? The trend has been good since then, just wondering if there is a significant event that I need to understand. TIA
I agree with Frrol and others re Tom123 TA.
I don't believe TA can predict what will happen after news like today, followed by Wall Street Players returning next week, and more news to follow. Each news event will put more upward pressure on the SP and there is no way to predict how much it will move based on TA alone. The opposition (Tom123) is hearing comes from what seems to be his complete disregard to the news or progress that is expected. 10-20 cents here or there will mean nothing when we go from $2.63 to over $5.00. Time is all we need, and not much at that, IMO
2.63 is a support step.
wheres the resistance steps now?
Not this time if he presents what he said he has.
You and I are saying the same thing; You said it better! No more delays! Anavex may proceed. Expect a PR for FDA approval of trial designs in the coming days. IMO
Quote from FDA Guidelines issued today. "This guideline represents the current thinking of the FDA on this topic." This announcement by the FDA seems to give Anavex and others the ability to move forward with either the old or NEW guidelines right now. No more reasons to wait. IMO. Here's the link for Guidelines announced today:
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585403.pdf
Yes, This FDA press release may be the step we were waiting for...Here is the text of the pr from FDA today:
"FDA announces comprehensive regenerative medicine policy framework
Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy
For Immediate Release
November 16, 2017
Summary
Comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety & efficacy
Release
Today the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.
The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. The suite of guidance documents also defines a risk-based framework for how the FDA intends to focus its enforcement actions against those products that raise potential significant safety concerns. This modern framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible. The policy also delivers on important provisions of the 21st Century Cures Act.
“We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine,” said FDA Commissioner Scott Gottlieb, M.D. “But this field is dynamic and complex. As such, it has presented unique challenges to researchers, health care providers, and the FDA as we seek to provide a clear pathway for those developing new therapies in this promising field, while making sure that the FDA meets its obligation to ensure the safety and efficacy of the medical products that patients rely upon. Alongside all the promise, we’ve also seen products marketed that are dangerous and have harmed people. With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities. This will protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies.”
The framework includes two final guidance documents and two draft guidance documents.
New Final Guidance Documents
The two final guidance documents clarify the FDA’s interpretation of the risk-based criteria manufacturers use to determine whether a product is subject to the FDA’s premarket review.
The first guidance provides greater clarity around when cell and tissue-based products would be excepted from the established regulations if they are removed from and implanted into the same individual within the same surgical procedure and remain in their original form. The second final guidance helps stakeholders better understand how existing regulatory criteria apply to their products by clarifying how the agency interprets the existing regulatory definitions “minimal manipulation” and “homologous use.” As this field advances, the FDA has noted that there are a growing number of regenerative medicine products subject to FDA premarket authorization. These guidance documents will help explain how the FDA will provide a risk-based framework for its oversight. The policy framework defines how we intend to take action against unsafe products while facilitating continued innovation of promising technologies.
To accomplish this goal, the guidance document has clarified the FDA’s view of “minimal manipulation” and “homologous use.” These are two concepts that are defined in current regulation to establish the legal threshold for when a product is subject to the FDA’s premarket approval requirements. By further clarifying these terms in the final guidance, the FDA is applying a modern framework for its oversight. Under the new policy, in order to allow manufacturers of products time to comply with the requirements, for the first 36 months following issuance of the final guidance document the FDA intends to exercise enforcement discretion for certain products that are subject to the FDA’s premarket review under the existing regulations, but are not currently meeting these requirements. The FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern. Going forward, the FDA will apply a risk-based approach to enforcement, taking into account how products are being administered as well as the diseases and conditions for which they are being used. This risk-based approach allows product manufacturers time to engage with the FDA, as to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval.
New Draft Guidance Documents
The two draft guidances provide important information to help spur development and access to innovative regenerative therapies. The first draft guidance, which builds off the regenerative medicine provisions in the 21st Century Cures Act, addresses how the FDA intends to simplify and streamline its application of the regulatory requirements for devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies (RMATs), including combination products. The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.
The second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review, and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation – including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells).
“As a molecular and cell biologist and physician, it has been exciting to witness the approval of the first two gene therapies in the U.S. this year. Given the great opportunities that the field of regenerative medicine presents, we have undertaken a rigorous process to clarify our regulations that included solicitation of public input, and I believe today marks a significant step forward for all stakeholders,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to clarifying some of the more complex areas of the regulations, we have taken meaningful new steps to encourage and expedite the development of innovative therapies. We welcome public comment on our draft guidance documents as we work toward finalizing this framework.”
Both draft guidance documents will have 90-day comment periods.
Related Information
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
Final Guidance: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
Final Guidance: Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception
Draft Guidance: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies
Draft Guidance: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
Framework for the Regulation of Regenerative Medicine Products
Consumer Update: FDA Warns About Stem Cell Therapies
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###"
Agree, the bottom is in. I traded 50% of my IRA, out of ETF's to AVXL @ $4.07 yesterday. The CTAD presentation may not have been obvious enough for new investors, but gave me (long since 2015) the confirmation I needed. Anything close to $4.00 is a long term bottom. Give Anavex a little time, they will change the world as we know it. A good start would be news from the FDA, anytime now!
I don't think Anavex is afraid... they may be setting the Shorts up for a big surprise, keep them guessing. We'll all know in a week.
Is there a PR expected to announce CTAD event this weekend? I only see posts about it here, but nothing mentioned yet by Anavex. If so, when do you expect it based on history?
Lot's of FUD on the board today, we must be getting close to success. What are the expected catalyst in the near term that make you believe the pps will be over $1 in weeks? TIA
Done, and shared, thanks! Let's get'er done AVXL Longs!
Nice buy at the close for 52K. Is that MOC order a sign of short covering?
"IF" is the key word here...
And if Anavex 2-73 is helpful in the remyelination process, MS may be a thing of the past.
Agreed. But I was hoping for a PR about the attendance and maybe the recently approved Patent. I think they want to keep the noise at a minimum for now.
I doubt anything significant is being done at the Bio 2017. I asked IR earlier in the week, they said just yesterday in reply, that nothing has been announced. Today after the market closes they put the info up on their web site. Either they are playing games or the meeting is only for their networking benefit, which I'm OK with. (The later)
I believe the BIO 2017 would be an ideal place to announce the Patent approval and participate in discussions, NDA's in hand....I tried searching the entire site, same results; that's why I asked. We will see. Thanks MC
Anavex is listed at the BIO 2017 conference in San Diego next week. Does anyone know if/when they are presenting? I sent IR an email, will report when I get a reply. I suspect however, I'll get the same ol "Anavex has not announced anything regarding upcoming events."
I've got Ameritrade, mine still shows on my account as CTIX, and when I look up IPIX, it shows @.84, no trading.
Heads up everyone..AVXL on sale AH @5.70 ask, still 465 shares left. Someone either got a call or the're painting the tape.
Yes, please do!
i would like to start a tutorial on options trading and keep it specific to AVXL stock for now. It would be options 101. A 4 or 5 part series.
re: the options crowd. I didn't see any super amount of shares trade in the last few minutes of the trade day. my Etard marketcaster shows 257,594 shares for the day. And with 4 minutes to go it was at 228K shares.
Agree, these things don't add up.
What about the PR that stated the Retts Syndrome Org is providing $.6M in trial funding?
Thanks Frrol, it's interesting to see how different people report different outcomes from the same meeting. The main emphasis on Rett not funded YET! Anyway, as you and others have said, we need a PR and trials to start before we really know what's happening and when.
I guess it would be hard to prove 273 as a preventative to AD in humans...would be a long study. But, if the pre-clinical results can be proven to correlate with human trials, 273 would be something everyone should take. I dream of that day, hope it will be soon enough for me!
Thanks Bourbon, for attending and providing us with a quick update.I don't remember the company ever making this claim with such certainty.
Is this new?
Preclininal testing shows 273 prevents alz from starting. 14 mg is the minimal effective dose in humans.
True, but I still believe there is a real chance for significant NEWS being announced by April 21.
I don't agree
Tom, to answer your question there are over 4,700 April $7.50 calls that expire on April 21st so I would not expect us to get there before then.
Thanks Karen, Xena posted that the order was cancelled, but your assumption makes the most sense as to how it happened.
Generally, the bid/ask thins out in after hours. The seller must have used a market order and the existing bids above the 4.01 were likely for a higher quantity along with being all or none.
It looks like a mistake in reporting to me.
How does a bid/offer @ $5.68/5.74 execute at $4.01? Market order or not, I don't get it.
Bounced again off that $5.65 support, not much retail selling under that floor. I doubt we go lower, expect the day to run higher going into the BLIND weekend. Go AVXL
If there's new data, they would have to PR it in the morning or before its revealed I believe.
I didn't notice it was long until I tried to clip a sentence to quote. lol Keep up the good work; very insightful. Go AVXL
Well done Bio! That is something I thought about but could not make my case as well as you. Your first sentence is LONG, but so am I. LONG AVXL
When I stop and think about the holistic concept of medicine - that which heals the body, I am simply awestruck by the fact that Anavex has developed a hypothesis/theory regarding the nature of all(!) neurodegenerative AND neurodevelopmental diseases which attack the brain and central nervous system and that based upon a single hypothesis, they have gone straight to what they believe is the source of the problem from which so many different indications spring, and, further, they have developed one single compound which, if proven successful, could treat each and every one of a variety of different indications stemming from the same root but traveling on different pathways.
I just voted "FOR" ALL with the AVXL Board recommendations. Now, let's get'er done!
Anyone seeing the price manipulation again this morning? They're trying to take out those "Plato" stops. Retail fighting a good fight. Let's see if we can take over, two options, hold or buy!
I tried to support the price at $5.63, after which the pps went down...almost always happens after I buy. No worries, it's a bargain down here and will be trading higher as the trend continues through the EOM.
What are the important revelations from the new proxy? Any thoughts?