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What do you mean by asking the question: "Wait for what?"?
My response to your original comment was based on your definition of progress...which you stated as follows: "I will agree with you once AVXL files it MAA in Europe and the FDA confirms there is a regulatory path forward for 2-73 in AD toward approval in the U.S."
I responded to your definition of progress thusly: Sheesh...if you're going to wait for those events to happen the SP would probably be north of $30.
Quote: "I will agree with you once AVXL files it MAA in Europe and the FDA confirms there is a regulatory path forward for 2-73 in AD toward approval in the U.S."
Sheesh...if you're going to wait for those events to happen the SP would probably be north of $30.
That chart looks ugly. Clearly showing a downtrend with lower lows and lower highs.
IMO, the MMs are working hard to break down any positive T/A view of AVXL. And mark my words, it was no mistake that AVXL closed at a 3-year low on Friday. They're really shaking the tree hard to get retail holders to sell.
I just added another 4,880 shares at $4.55...and I'll be adding more on Wednesday.
Thanks for the cheap shares!
Wonder what happened to Mike_dotcom? He hasn't posted in awhile.
Here's a link to their newest partner...Velociti
https://www.velociti.com
Check out their investor presentation. Very impressive!
https://d1io3yog0oux5.cloudfront.net/_dd47c7d279e648f1b844bbce5553f870/energous/db/285/3038/pdf/WATT+Investor+Deck+March+2024+2.pdf
Raja...since you're no longer invested in AVXL, I'd like your opinion of another company that I just invested in. Please go to the WATT board and tell me what you think.
Thanks.
Wow...this company has no debt and $16 Million in the bank...and the MC is $11 Million!
The science is incredible: sending power (electricity) using RF technology so you don't need batteries or wires to operate your projects.
Over 200 patents to protect their technology.
Major companies and suppliers are signing up like bees on honey.
Authorized to operate in the U.S., Europe, China, Australia, Japan, India, etc
Just completed a 20:1 reverse stock transaction
Insider buying: President and CEO just bought $100,000 back in November. (First time he's ever done that according to my research)
This seems too good to be true...but my research confirms everything.
I have added it to my portfolio.
Agreed. But if they report positive results, they will get a lot of attention from the media.
There is a silver lining for us though...
If you recall, AVXL shot up to $30/share when SAVA reported positive results. So we could ride their coattails just like we did with SAVA.
Quote: If not us and our science, then who?
There's still one more competitor that is about to release their TLR.
Annovis Bio Provides Data Announcement Update for the Phase II/III Study of Buntanetap in Alzheimer's Disease
March 20, 2024
MALVERN, Pa., March 20, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced successful completion of data cleaning for its phase II/III study of buntanetap in patients with mild to moderate Alzheimer's disease (AD). Topline efficacy data is expected in April.
"We are excited to share that we now move from data cleaning to organization and statistical evaluation of data for our Alzheimer's study, which was completed in February. To clean data this fast is truly a tremendous achievement," said Cheng Fang, Ph.D., Senior Vice President of Annovis. "The team has been working hard to provide trustworthy data, and we look forward to the topline results as we plan to announce it next month."
The phase II/III AD study was a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD. This was a dose ranging study where patients received either one of three doses of buntanetap - 7.5mg, 15mg, or 30mg - or placebo on top of their standard of care for 12 weeks. Over 700 patients were screened with a total of 353 patients enrolled and 327 patients completed the study.
"We are grateful to the participants who enrolled and completed the study as well as their caregivers and families for supporting their loved one's involvement in this trial; we truly couldn't do it without them. We'd also like to thank our study partners whose teamwork and dedication allowed us to complete the study in a timely fashion," said Melissa Gaines, Senior Vice President, Clinical Operations.
AboutBuntanetap
Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by inhibiting the formation of multiple neurotoxic proteins - amyloid beta, tau, alpha synuclein, and TDP43 - thereby improving synaptic transmission, axonal transport and neuroinflammation. Dysregulation of these pathways has been shown to be the cause of nerve cell degeneration and ultimately death. By attacking these pathways, buntanetap has the ability to reverse neurodegeneration in Alzheimer's disease.
About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company's goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor Contacts:
Maria Maccecchini, Ph.D.
maccecchini@annovisbio.com
Does anyone know if WATT receives a royalty after they've sold their technology to a customer?
Been away for awhile. Sold 80% of my shares at $6.16 but am now looking to get back in if things are shaping up.
Would appreciate an update on the P2 Schizo trial?
And where do we stand with the EMA for our AD application?
Also, is AVXL going to pursue Rett? (Last I heard, we failed the P3 because of a high placebo response...but we showed strong efficacy with the rest of the patients)
Thanks.
abe
Wonder what happened to Hoskuld? Haven't seen any posts from him in awhile.
Quote: "It's not the first time the FDA has experienced this phenomena... and is why they frequently approve a drug in these circumstances, especially a safe drug. They review the entire package of trial data, OLE and REW information in the approval process... not just the p-values."
Bas2020...although I agree with the premise of your statement, can you give us a few examples for comparison?
Thanks.
abe
1 in 10 FDA-Approved Drugs Miss Primary End Point in Pivotal Trial
February 15, 2023
Kevin Kunzmann
Approximately 1 in 10 drugs approved by the US Food and Drug Administration (FDA) since 2018 were supported by pivotal trial data in which primary efficacy endpoints were missed.
In new cross-sectional research assessing 210 new drug approvals by the FDA from 2018 – 2021, a team of US investigators observed that 10% included pivotal studies wherein at least 1 primary endpoint was null based on findings.1 The new data—which come 2 years following the controversial FDA approval of aducanumab (Aduhelm) for the treatment of Alzheimer disease despite underwhelming trial efficacy outcomes2—highlight the need for improved communication and contextualization by the FDA on their regulatory decision making.
Led by James L. Johnston, MD, of the Department of Medicine at Brigham and Women’s Hospital, the New England-based investigators sought to define the frequency of FDA approvals for drugs based on nullified pivotal trial efficacy endpoints, as well as the agency’s rationale for such approvals. They highlighted aducanumab’s controversial approval in June 2021, as well as a history of inconsistent FDA decisions in instances of uncertain drug or device efficacy, as rationale for the study.
“In June 2021, the FDA granted accelerated approval to aducanumab for the treatment of Alzheimer disease despite both pivotal trials being stopped for futility with respect to the primary trial end point: change from baseline clinical dementia rating score,” the team noted. “Instead, FDA approval was based on an exploratory, surrogate marker: amyloid plaque reduction.”
Johnston and colleagues assessed the Drugs@FDA database for all New Drug Applications (NDAs) eventually approved by the FDA between 2018 – 2021; included in each NDA’s approval package is pivotal trial outcome data. They identified drug, pivotal study and end point characteristics for each drug missing =1 prespecified primary end point.
The team then characterized the FDA’s expressed rational included in the NDA approval packages, as well as details including whether postmarketing studies were prompted by the agency and whether they addressed unmet primary end points.
Of the identified 210 NDA approvals in the observed time period, Johnston and colleagues observed 21 (10.0%) that included null findings for =1 primary efficacy end point; each of the 21 drugs were approved for unique clinical indications. More than half (n = 11 [52.4%]) were first-in-class approvals; 10 (47.6%) previously received an Orphan Drug Designation; 13 (61.9%) received an expedited review pathway from the FDA. Only 3 (14.3%) required an advisory committee meeting prior to FDA approval.
Investigators observed 56 pivotal trials with 74 primary efficacy endpoints supporting the 21 drug approvals—but 5 approvals (23.8%) were supported by a lone pivotal trial. On average were >1 null primary efficacy end point per FDA approval (n = 27).
The team additionally noted 4 drugs were each approved based on a single pivotal study with null results for all its pivotal primary efficacy end points:
Naxitamab for high-risk refractory or relapsed neuroblastoma
Tazemetostat hydrobromide for epitheloid sarcoma
Migalastat hydrochloride for Fabry disease
Asparaginase erwinia chrysanthemi for acute lymphoblastic leukemia and lymphoblastic lymphoma
The FDA had rationalized their approval for 13 of these drugs (61.9%) based on the success of =1 other pivotal trials;they highlighted positive secondary or exploratory end points for 10 approvals (47.6%); and highlighted favorable post hoc analyses in 7 approvals (33.3%).
Investigators noted limitations in their assessment including a singular focus on pivotal trials supporting NDAs, as well as their inability to analyze withdrawn or rejected NDAs due to their unavailability in the FDA’s public database.
However, they concluded their findings “underscore the complexity of regulatory decision-making,” noting the prevalence of drugs approved with null primary end point findings but an overall portfolio evidencing efficacy of the drug.
“For other drugs…the evidence of efficacy was less clear,” they wrote. “Greater transparency regarding FDA decision-making could increase clinician, patient, and payer confidence in novel drugs and improve clinical use.”
They additionally called for more prioritization and timely completion of postapproval trials addressing uncertain areas of clinical efficacy for approved drugs.
https://www.hcplive.com/view/1-in-10-fda-approved-drugs-miss-primary-end-point-pivotal-trial
Quote: Someone [Bristol Meyers] just paid 14b for a company offering a Muscarinic Receptor Agonist.
Karuna Therapeutics, Inc. is a clinical-stage biopharmaceutical company.
The Company creates and delivers transformative medicines for people living with psychiatric and neurological conditions. Its pipeline is primarily built on the therapeutic potential of its product candidate, KarXT (xanomeline-trospium), an oral modulator of muscarinic receptors that are located both in the central nervous system (CNS), and various peripheral tissues. KarXT combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS.
The Company is developing KarXT for the treatment of acute psychosis in adults with schizophrenia, as well as for the treatment of psychosis in Alzheimer's disease (AD). The Company is also engaged in developing its investigational TRPC4/5 candidate, KAR-2618, for the treatment of mood and anxiety disorders, and plan to provide details regarding the expected development of KAR-2618.
Doc or Raja...either one of you guys taken a larger position in AVXL yet?
If not, would like know your reasons. Thanks
Although I love the price action, I'm nervous as to why it's taking so long for the Rett P3 trial results. One of our competitors (BIVI) had their SP drop almost 80% after reporting problems collecting data from all of their sites. (See below)
BioVie Data for Alzheimer's Treatment Endpoint Misses Statistical Significance
November 29, 2023
BioVie said Wednesday that its Alzheimer phase-3 trial wasn't able reach statistical significance due to too many exclusions to its study.
BioVie said Wednesday that the third trial phase for its drug NE3107, an Alzheimer's disease treatment, showed positive results, but missed its primary efficacy endpoint after excluding much of its data due to protocol violation during the pandemic.
Originally, the trials began with 439 patients across 39 sites during the Covid-19 pandemic, and BioVie later found that it was in violation at 15 sites of protocol and good clinical practice, leading it to exclude all patients from those sites.
The positive data it did collect was from a 57 per-protocol patient pool. While that data found the treatment is biologically active and might have impact on cognitive, functional, and biomarker endpoints, "the data missed statistically significance due to site exclusions."
Shares halted trading at 07:58 ET before releasing the update. The stock was up 3% in premarket trading at $5.12 before being halted. [Now trading at $1.36/share]
By Adriano Marchese
Start at the 2 minute mark.
https://www.kvpr.org/local-news/2023-11-15/congressional-committee-completes-report-into-illegal-reedley-medical-lab
It's my understanding that there are several other illegal bio labs in the U.S.
Got it. Thanks for clarifying.
I disagree. If the SAE was drug-related, they would have to include all of the negatives into the final TLD. If the SAE is not drug-related, then they won't include them into the final TLD. Hence the delay.
Good post, boi.
Getting the EMA to accept our data for pre-submission allows Anavex to complete the full submission when our OLE is finished. The beauty of this scenario is the timing because every company must go through the pre-submission process.
By submitting our data for pre-submission now, allows the EMA to go through their normal evaluation process...which takes 6 - 7 months. By the time they're finished evaluating everything, we will have our OLE data ready to be submitted for full approval.
THAT is good management.
*********************************************************************************************
":...The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council...."
"...We have met the European Agency several times in meetings and we have shared the data which is not yet published, which is the published date of -- the planned published communication of the full data of the Alzheimer Phase 2b/3 study. And we were from this meeting recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly...."
"...Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal..."
Since you come from Carl Icahn's School of Management Accountability, I thought you'd like to see how his company is doing.
Michael Dell mocks the cratering of Carl Icahn's stock
Tech billionaire Michael Dell has let loose with a barbed swipe against his arch-nemesis Carl Icahn, making fun of the famed investor's sinking stock price, in a continuation of a years-long feud between the two magnates.
The #PlayNiceButWin hashtag is a reference to the title of Dell's 2021 autobiography titled, "Play Nice But Win: A CEO's Journey from Founder to Leader." In the book, Dell skewered Icahn as a stooped and shuffling old man focused purely on making life difficult for the companies he was targeting but with few ideas on how to run them.
Dell's tweet, which showed Icahn Enterprises' stock down -80.7% in the last 10 years while the stock market soared, was liked by Nathan Anderson, the activist short seller who runs Hindenburg Research. Earlier this year, Anderson targeted Icahn Enterprises, saying both Icahn and his publicly traded investment vehicle were overleveraged in the face of years of trading losses. Anderson has bet against Icahn Enterprises and the campaign has caused its stock to plunge by more than 60% in 2023.
For his part, Icahn has said Anderson's Hindenburg has launched a disinformation campaign that distorts the financial situation at Icahn Enterprises (IEP) in an effort to make money from the falling stock. A representative for Icahn didn't immediately respond to a message seeking comment.
Dell is not part of the Hindenburg effort, but the bad blood between Dell and Icahn dates back over a decade, when Icahn tried to deep six Dell's $25 billion effort to take his namesake computer company private back in 2013.
After announcing the company's intention, Icahn acquired a sizable stake in the firm in an effort to scotch the deal, saying the proposed buyout offer was too low and amounted to a move by Dell to steal the company from shareholders on the cheap.
Icahn then teamed up with another shareholder to make a counter offer, prompting Dell and his partners to have to raise their price. Dell was ultimately successful in taking the company private, but at a significantly higher price. After losing the fight, Icahn called Dell a dictator.
Dell responded by calling Icahn " a bad guy."
"He lies. He has no ethical boundaries. He will say anything, do anything. I have no time for him," Dell said at a conference the following year.
The contretemps flared up again in 2018, when Dell made a move to buy out investors in DVMT, a holding company that tracked his ownership stake in publicly traded software company VMware (VMW), in an effort to take Dell back into the public markets.
Icahn swooped in and acquired an 8.3% stake in DVMT in an attempt to scuttle the deal, saying Dell and his partners at private equity firm Silver Lake were trying to steal the company.
"You've got two guys that are going to make $11 billion," he said on CNBC in 2018. "Eleven billion dollars for doing nothing. It's unrivaled even on Wall Street's standards."
In a shareholder letter, Icahn declared war.
"I intend to do everything in my power to STOP this proposed DVMT merger," the letter said. "In my opinion, it is better to have peace than war. I still enjoy a good fight for the right reasons, and in the current situation, I do not see peace arriving quickly!" he wrote.
Ultimately, Dell prevailed but was forced to pay a $1 billion settlement to DVMT shareholders who had sued arguing they were short changed. Dell later spun off VMWare and an agreement was reached last year to sell it to Broadcom for $61 billion.
Dell's recent swipe at Icahn Enterprises was directionally correct, but not completely accurate because it did not include dividends. According to FactSet, Icahn Enterprises has returned -46.6% over the last 10 years, compared to a 201.9% return for the S&P 500 SPX.
Meantime, the stock of Dell Technologies (DELL) is up more than 500% since Dell took the company public again in 2018, giving the company a market capitalization of some $53 billion and suggesting Icahn might have had a point a decade ago that Dell was taking the company private on the cheap. Dell has long argued that he could not have initiated the big changes required to make the company successful as a public company.
-Lukas I. Alpert
November 15, 2023 (MarketWatch)
By Lukas I. Alpert
This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.
Because every time he's announced TLR for a trial, AF and other FUD naysayers claim that the FDA will never accept the data. By first submitting all the data to the FDA and waiting for their acceptance, the FUD-sters can't make any false accusations...or at least reduces their opportunity to do so.
It's my opinion that TGD wants to make sure the FDA has accepted our NDA before he announces the TLD for Rett.
I did a quick search and found the company below received a rejection letter from the FDA...but they never informed their shareholders that they applied for a New Drug application. [If you want more examples, you'll have to do your own research]
******************************************************************************************************
Denali Therapeutics Announces The Co. Received A Formal Clinical Hold Letter And Is Moving Forward To Address The FDA's Observations Related To The Preclinical Toxicology Assessment And To Provide The Information Requested To Initiate Clinical Studies
February 14, 2022
As previously announced, Denali Therapeutics Inc. (“Denali”) was informed on January 12, 2022, via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 Investigational New Drug (IND) application to begin clinical testing was placed on clinical hold. Denali has now received a formal clinical hold letter and is moving forward to address the FDA’s observations related to the preclinical toxicology assessment and to provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure. Denali intends to provide an update once a clear path forward has been established.
Agreed. Even Doc328 stated that some companies submit NDAs and don't notify their investors until after they've received acceptance from the FDA of their application. This is exactly what I think Anavex has done.
Let's be real here folks, Anavex has had plenty of time to prepare the TLR for the Rett Excellence trial results.
Since they haven't disclosed the results, I'm assuming that TGD has opted to submit the full data to the FDA and is waiting to hear back for our NDA acceptance. I could be wrong of course...but this is my theory.
Yes. I meant to say webcast and conference call. Thanks for catching that.
Since Anavex has chosen this Monday to release their EOY financials and provide an update on the execution of the Company’s growth strategy, I'm expecting some very upbeat news.
It's common knowledge that companies release good news at the beginning of the week so their SP gains momentum throughout the week. (A good example of this rule was Monday's announcement regarding our EMA relationship)
OTOH...companies will almost always announce bad news at the end of the week on Thursday and Friday; sometimes waiting until the market closes on Friday. This (supposedly) allows the investors to cool off over the weekend instead of dumping their shares throughout the week.
Takes a lot of guts to schedule your EOY financial results on a Monday...with a Q&A video immediately afterwards. Unless of course you feel really confident about the company's future.
Management will host a conference call on Monday November 27, 2023, at 8:30 am ET to review financial results and provide an update on the execution of the Company’s growth strategy. Following management’s remarks, there will be a question-and-answer session.
Quote: The EMA can expedite by 60 working days; they can also delay.
Anavex has the chance to ask for expedition six months from now.
Great. Hopefully we'll hear something around May, 2024 regarding an expedition of our drug with the EMA. Thanks boi
Is it possible that the EMA would expedite their approval process for Anavex since the United States has approved Leqembi?
Seems to me that the EMA has already demonstrated their willingness to find a safe AD drug by accepting our small P2b/3 trial (n= 509) as opposed to the typical double P3 trial.
Wow...that's a powerful video. Thanks.
Excellent post, sokol. Thanks for sharing all of this DD!
Good for you, sab. Having grandchildren sure makes life more enjoyable. Always puts a smile on my face when I talk with them. (I have 3 grandkids too)
Hey Doc.
I was hoping to get your opinion on the recent PR. Pretty impressive, aye?
Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer's Disease to European Medicines Agency (EMA)
NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that representatives of Anavex met with team members of the European Medicines Agency (EMA).
These meetings discussed the debilitating pathology of Alzheimer's disease and Anavex's blarcamesine (ANAVEX(R)2-73) Alzheimer's disease clinical program results, including data obtained in the ANAVEX(R)2-73-AD-004 study.
Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer's disease.
Anavex's goal is to take care of patients in a patient-centric way with the preference for convenient oral treatment options for Alzheimer's disease not requiring complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.
Severe symptoms in relation to Amyloid-Related Imaging Abnormalities (ARIA) is a known risk factor for Alzheimer's patients taking the class of drugs called monoclonal antibodies, and requires constant and repeated MRI examination, for which not all regions in Europe are currently sufficiently prepared and equipped for in addition to the requirement to address affordability and inequalities in patient access within European Union countries.1,2
"We look forward to working together with the team from EMA," said David Goldberger, RPh, MLS, Senior Vice President Regulatory Affairs at Anavex. "We continue to work towards fulfilling our purpose of improving patients' lives with oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer's disease."
There are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030, according to the European Brain Council.3
The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.4,5
"There remains an urgent need for convenient once-daily oral treatment options for Alzheimer's disease, and Anavex is moving forward to potentially addressing the preference for simple patient-centered administrations and shared decision-making," said Christopher U Missling, PhD, President and Chief Executive Officer at Anavex.
In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer's disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.
Data from the blarcamesine in Alzheimer's disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX(R)2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX(R)2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX(R)2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX(R)2-73 for the treatment of Parkinson's disease. ANAVEX(R)3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX(R)3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company's most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
It's my understanding that once you submit your New Drug Application (NDA) to the FDA for approval, they will respond within 30 - 60 days as to whether or not they will accept the application.
If they find something wrong, they will send you a rejection letter and explain why they rejected your NDA...which could vary from a minor correction to a complete failure.
On the other hand, if everything is in order they will acknowledge your NDA within the 30 - 60 day period and the procedural evaluation and approval process begins.
So, I'm wondering if the TGD has already submitted the NDA for Rett syndrome; and is now waiting the 30 - 60 days to confirm that the FDA has accepted our New Drug Application?
Now that would be a great surprise to everyone, no?
SAB...correct me if I'm wrong, but the 6-month chart looks like an inverse Head & Shoulders...which would be very bullish, no?
I did the same thing...so you're in good company. Although I added shares, not options.