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Any doubts about Dr. M being in the front end of the new paradigm on clinical trials? He will have plenty of first-hand experience to discuss.
BIO CEO Investor Conference Feb. 12th.
Designing Clinical Trials in a 21st Century Cures Paradigm
The passage by Congress of the 21st Century Cures Act in late 2016 has opened up new opportunities and expectations for the design of clinical trials that the FDA will consider for regulatory review. Real world evidence and the stronger inclusion of patient perspectives on endpoints are two examples of the shifts that will impact therapy development. This session will explain the advantages and complications that drug developers and investors should be aware of as the Cures Act gets implemented.
Moderator: Wade Ackerman, Partner, Covington & Burling LLP
Speakers:
Jeff Allen, PhD, President & Chief Executive Officer, Friends of Cancer Research
Gregory W. Daniel, PhD, MPH, RPh, Deputy Director, Duke-Margolis Center for Health Policy
Steven Kaminsky, PhD, Chief Science Officer, Rettsyndrome.org
Christopher U. Missling, PhD, President and Chief Executive Officer, Anavex Life Sciences Corp.
Raghuram Selvaraju, PhD, Managing Director, Senior Healthcare Analyst, Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC
"Share price is more likely to see $3 than $5 within the next several weeks."
Why not 2,1, or BK?
Thank you!
Good, clear, informative article. One thing, however: seems to conflictive information in the article about start of Ph 2/3 trial. Is it before the end of the year or after extension in 2018?
— Kenneth Dreesen (@Dreesenkl) November 21, 2017
Swallower is a well known poster in stocktwits. Has and would make up anything to discredit Anavex. For those who care, here are the facts about the distinguished Dr. Fadiran:
-----
Dr. Emmanuel O. Fadiran, also known as Tayo, RPh, PhD serves as Senior Vice President of Regulatory Affairs at Anavex Life Sciences Corp. Dr. Fadiran has over 26 years of experience in government service, of which 24 years were dedicated to the Food and Drug Administration (FDA). Prior to Anavex, Dr. Fadiran served as Clinical Pharmacology Team Leader at the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). Dr. Fadiran has been involved in the formulation of significant strategic FDA regulatory initiatives including serving as a member of the Senior Management Teams for the Data Standard (Janus) and Sentinel Initiatives. He was an active member of the FDA Senior Science Council working group for the creation and launching of the FDA’s Strategic Plan for Regulatory Science in 2012. Recently, he has played an active role in the development of the Comprehensive in vitro Proarrhythmia Assay (CiPA) for future replacement of the thorough QT studies. As a long-term member of the FDA Institutional Review Board (IRB) he actively contributed to the development of standard operating procedures (SOP) for the committee. During his 24 years from 1993 to 2017 tenure at the FDA, he reviewed hundreds of NDAs, sNDAs, BLAs, ANDAs and INDs for approval and strategic recommendations for the development of several products across many therapeutic categories. He was also on review teams for several novel therapies including first in class approvals. Dr. Fadiran also led a cross-disciplinary NDA review team and authored the first Cross-Discipline Team Leader (CDTL) review for the Division of the Pulmonary & Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and the implementation of the US FDA Guidance for Industry for population pharmacokinetics. Dr. Fadiran is a recipient of the prestigious Fogarty International Fellowship of the National Institutes of Health (NIH) as well as numerous awards from the FDA, among them the Commissioner’s Award of Excellence, in recognition of his outstanding contributions to regulatory review of applications and development of regulatory guidance and policies. Dr. Fadiran holds a BS (Pharmacy) and MS from Obafemi Awolowo University, Ile-Ife, Nigeria and a PhD in Pharmaceutical Sciences from the University of Strathclyde, Glasgow, UK.
http://www.bloomberg.com/research/stocks/people/person.asp?personId=429395163&privcapId=13580387
Thank you for sharing.
I will sign up to attend the session in San Francisco. Expect significant news at CTAD for Noble to go on the road to sell the story. Huge! or is it biggly?
Added 5k cheap shares today at ~4.06 average. Fully loaded.
Hang in there longs. Our day will come and we will look back to these dog days gratefully for the opportunity to add to our wealth.
News tomorrow.
Thanks for posting.
Wow!!!
Why would a panel with these credentials agree to present at the premiere Alzeheimer's scientific conference (CTAD) if they had crap to talk about? Illogical!
LB18 - Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease
Mohammad Afshar, MD, PhD(1) - Ariana founder and CEO
Frédéric Parmentier, PhD(1),
Use of network-based cross-species methods for rule/pattern discovery and target/compound prioritisation in neurodegenerative disease
Abstract: One of the major goal in the field of neurodegenerative disease (ND) research and drug discovery is the prioritisation of candidate neuroprotective targets. Over the past years, several models of ND pathogenesis have been generated in yeast, invertebrates and mammals. These models have emphasized multiple disease mechanisms and they have been widely used in genomic screens to search for genes dysregulated by ND-associated protein expression and for modifiers of protein aggregation/toxicity (Willingham et al., 2003;Giorgini and Muchowski, 2006;Bilen and Bonini, 2007). This is notably the case for Huntington’s disease, a dominantly-inherited ND (Zuccato et al., 2010) that is now recognized as a ‘model neurodegenerative disease’ to best understand the mechanisms of more complex NDs such as ALS or Alzeihmer’s disease (Nollen et al., 2004;Kuhn et al., 2007). The goal of my project will be to analyze large datasets for HD and other NDs by using cross-species data integration procedures and target prediction methods which are based on the use of bionetworks. The expected results are conceptual advances in the field of disease modeling and gain of knowledge emphasizing top-priority targets for neuroprotection, which is anticipated to provide unprecedented guidance to target validation and neuroprotective drug profiling/discovery in HD/ND.
Ene I Ette, PhD(2),
President and CEO Anoixis
Dr. Ette has over 26 years of broad experience in academia, drug evaluation and regulation, and the pharmaceutical industry. He has a Ph.D. in Clinical Pharmacology, an MBA, an M.S. in pharmacology, a B.S. in pharmacology, and a B.S. in pharmacy. A prolific author of several original articles in peer-reviewed journals, book chapters, numerous conference presentations and proceedings, Dr. Ette is on the editorial board of many clinical pharmacology / pharmacy journals as well as a referee for many biomedical journals. He is primary the editor of the classic pharmacometrics reference text, Pharmacometrics: the Science of Quantitative Pharmacology. He is also an invited speaker at many international clinical pharmacology/ pharmacy, pharmaceutical science, and statistical meetings.
Dr. Ette is a fellow of the American Colleges of Clinical Pharmacology and Clinical Pharmacy. He is the 2006 recipient of the American College of Clinical Pharmacy’s Therapeutic Frontier Lecture Award for distinguished scientists. He was a consultant to FDA from 1998 to 2001. In 1999 he was the recipient of the American College of Clinical Pharmacy’s prestigious Russell Miller Award for outstanding contributions to the clinical pharmacy literature; and in 1996 the recipient of Excellence in Review Science Award in CDER (FDA). At the FDA he was the major author of the Guidance for Industry: Population Pharmacokinetics.
He is an adjunct professor of applied pharmaceutical sciences at the University of Rhode Island’s College of Pharmacy and the University of the Pacific’s Thomas J. Long School of Pharmacy and Allied Health Sciences. Before now, he was the Senior Director/Head, Clinical Pharmacology, Vertex Pharmaceuticals, Cambridge, MA. where he introduced and championed efforts in the integration of knowledge-based (pharmacometric modeling and simulation) principles into drug development. Before taking up appointment at Vertex he was a leading pharmocometrician in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). He has broad experience academia, drug evaluation and regulation, and the pharmaceutical industry. Moreover, he has broad experience in the evaluation and development of drugs. He is a holder of patents.
Need no further introduction:
Emmanuel O Fadiran, PhD3, Christopher U Missling, PhD3;
(1)Ariana Pharma, Paris, France,
Ariana offers comprehensive and FDA-tested clinical and biomarker data analysis services that guarantee you get the most out of your data
We deliver actionable information that improves disease diagnosis management, advances clinical development, and minimizes risk.
Using our KEM® (Knowledge, Extraction, Management) technology, Ariana
– improves the process of identification and validation of biomarker signatures
– increases the power of multi-parametric diagnostic tools
– identifies best patient responder sub-groups and populations at risk of AEs, and improves clinical trial success rates.
Our technology uncovers hidden signals and complex relationships that conventional statistical analyses miss. It’s a unique approach that is both complementary to and supported by statistical analyses, guaranteeing robust, reproducible results. We can easily analyze complex combinations of data including clinical, imaging, metabolic, biochemical and NGS/omics.
(2)Anoixis Corp., Natick, MA,
Pharmacometric Services
Anoixis Corporation helps our partner companies achieve breakthroughs in their drug development process by applying our expertise in pharmacometrics to provide pharmacometrically-guided strategic development plans, innovative study designs, and data analysis. We provide innovative and informative study design and analysis like no other.
Population Modeling
Trial Simulation
Study Design & Analysis
Consulting Services
Workshops
(3)Anavex Life Sciences Corp., New York, NY
Good impersonation.
Old video. Still powerful.
Wrong! And "wrongger"
CTAD Boston - November 1-4, 2017
LBP33: Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease
Mohammad Afshar, MD, PhD1
, Frédéric Parmentier, PhD1
, Ene I Ette, PhD2
, Emmanuel O Fadiran, PhD3
, Christopher U Missling, PhD3
;
(1)Ariana Pharma, Paris, France, (2)Anoixis Corp., Natick, MA, (3)Anavex Life Sciences Corp., New
York, NY
Bas,
You need to do what you believe it is best for you. What surprises me is that you are broadcasting that you are prepared to dump 200k+ shares if no news tomorrow. Not a smart move when selling.
Good luck!
Well said Jimmy. Especially the last sentence.
GLTY too sage.
I believe in the science and the CEO. I expect this investment to be one of the best ever for me. That said, I am prepared for it to go to 0, although I would not wait that long if my believes change due to real news.
Amateur,
This is very old news which has been debunked. I am sure that you will succeed to scare away some of the weak hands that are still around. Most of us have done our DD and know what is real and what is not.
Long-term play not suitable for anxious investors who sweat daily PPS pennies movement.
GLTALongs
Of course. He is one of the key reasons I believe we will succeed.
He is nuts. And I will be the next Pope??
Some times these posters serve as place holders. Based on what the company continues to say about starting Rett clinical soon, there should be an updated version by time of conference, IMHO.
Hard to understand how people get all worked up on this board about speculation (BIIB, Pfizer, shares bought by CEO etc.) and then act upset with the company because the speculation remains just that, speculation.
The only real news we should be expecting is initiation of trials. The CEO needs to deliver on what he has been touting for a while now. My personal expectation is that we will hear about Rett within 2-3 weeks. There are upcoming scientific conferences which will hopefully be the forum for data update from Australia. Everything else is just speculation. Don't blame Missling for that. News will be reported when there is news to report.
Long and strong!
Really?
What do you think?
Tom,
This is not material discussion, hard as you may try to make it so.
The United States Supreme Court has defined "composition of matter" to mean "all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids."
They way I interpret the patent is that it protects 2-73 and the combo with any other substance. Input from those more savvy about patent law and legalese are appreciated.
The door has been opened.
Patent Number 9,750,746 entitled “ANAVEX 2-73 and certain anticholinesterase inhibitors composition and method for neuroprotection.“ This patent provides the Company with intellectual property protection covering composition of matter for ANAVEX™ 2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil. The issued patent offers protection through 2033.
September to remember.
Nice! I got my extra gravy last week.
Again?
Your best post yet.
We know it has been rocky. But the sky's the limit.
Agree. As much as we like to dream of PPS of xxx, I will be static when we get into double digits. Let's get the trials going and with good readouts the market cap will increase accordingly.
Don't get too excited about the patent. A jump into the 6's from patent PR would be a good result. Trials, trials, trials, positive update from Australia, partnership, and we will move into the 10's and never look back.
GLTALongs.
Mr. Plymer,
The lawsuit card has been played and failed. Come up with something fresh.