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F.4 Planned number of subjects to be included
F.4.1 In the member state 120
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
So.... if results for PDD in Spain goes accordingly, that’s 120 more potential patients continuing to take a-273 for the foreseeable future.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004335-36/ES
Ahhh... the days when I was a health I.T. Tech. The differences between healthpro and eClinicalWorks were like windows xp and win 10.
I would guess that the trial participants for each trial has the option to continue taking the pills after the trial or as an extension is added.
Hence why the extra pills are available. More likely than any commercial use.
Just thinking realistically.
Top line data for PD trial expected sometime these year Missling said on the call.
Over manufacturing of the material is a just in case commercial use or for more studies.
And create a website for said name too.
June 1, 2018 to be specific
Then throw in this, and the stars are staring to align for real medicine that truly improves
https://ehrintelligence.com/news/ehr-data-to-provide-real-world-evidence-for-clinical-trials
Another Amaloid bites the dust and BIIB thinks their Amaloid is different?
LMFAO
https://www.barrons.com/articles/biotech-giants-amgen-and-biogen-fall-on-earnings-alzheimers-news-51548864502?siteid=yhoof2&yptr=yahoo
Another nice read released today.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627760.htm
Right?
Besides, Bruno Mars ain’t having a concert at Maui 3 times in 4 days. Good thing I sold my Maui house and moved to Honolulu during that housing collapse years ago.
They have been assured that they can continue taking a-273, not mattering if they were in the placebo group or not correct?
They need to be told what to do by the “experts”
Additionally, the agency today issued the final guidance, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease, which was issued as draft guidance in December 2017. This final guidance addresses the topic of finding treatments that address the underlying molecular changes (e.g., genetic variants) that often cause or contribute to diseases, including uncommon, or rare molecular changes that are present in a small subset of patients.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm623411.htm
While the fudsters continue posting fud, Gottlieb releases this!!!!!
The FDA announced two new draft guidances for industry on Sept 28. The first document, “Master Protocols—Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics,” addresses master protocol design. This includes a discussion of the information sponsors should submit to the FDA as part of these approaches, and how sponsors should interact with FDA to facilitate efficient review and mitigate risks to patients.
https://www.healthcarepackaging.com/article/fda-modernizes-its-approach-clinical-trials-drugs-and-biologics
Let’s not forget this little doozie biogen shared .
Remyelination may lead to improvements in neurologic function in people #LivingwithMS #MSParis2017 pic.twitter.com/dQddrJ61GB
— Biogen MS (@biogenms) October 27, 2017
I have a question a little off topic. I have over 20,000 shares of Avxl in my 401k. I recently changed jobs. So what would be the way for me to keep these shares even if I have a new 401 with my new company I’m working with.
Am I able to just keep that old 401 with my old company?
And the drum beats on.
Take the lead on cancer to find a cure for Alzheimer's disease (News Release)
Research
Issued by: ICM Institute
08/05/2018
Releases
Anavex Life Sciences Announces New Data Identifying the Response to Biomarker Therapy in Alzheimer's Disease Patients Treated with ANAVEX®2-73 Experimental Drugs at the Alzheimer's Association's 2018 International Conference (AAIC)
An analysis of over 33,000 identified genetic variants that can lead to the development of a precision drug.
Approach to research and treatment of Alzheimer's disease
The study identified 80% of participants as ANAVEX®2-73 respondents.
Notes for Improvement of Cognition (MMSE) and Activities of Daily Living (ADCS-ADL)
The data will inform recruitment for advanced clinical trials ANAVEX®2-73.
Dr. Harald Hampel, professor at the Sorbonne University in Paris, explains that the experimental drug, Anavex 2-73, a candidate in precision medicine from the specialty pharmaceutical company Anavex Life Sciences Corp. activates the Sigma-1 receptor. An experimental drug presented last week at the 2018 International Conference of the Alzheimer's Association in Chicago (AAIC) which takes place every year.
Read the rest of the press release: Towards a treatment for Alzheimer's disease
Press contact
Florence Majri
Sorbonne University Research Project Coordinator
florence.majri@icm-institute.org
florence.majri@sorbonne-universite.fr
Lol, that’s the funniest thing I’ve read in a while. Likening A-273 to saline is better than what BAN would be linked to.
Keep up the rhetoric, doing an awesome job amateur.
Fireman02360,
Careful out there, just read a local boy from my state of Hawaii passed fighting a wildfire in Cali.
http://www.staradvertiser.com/2018/08/04/breaking-news/hundreds-attend-memorial-service-for-fallen-firefighter-from-hilo/
Decided to play the game and sold 2k@2.80. Still have enough to be happy and if/when we do get below 2.50, easy free shares.
Tweets from Gottlieb yesterday:
Seamless trials, used in oncology for drugs that might qualify for breakthrough therapy designation, are another novel approach https://bit.ly/2NQy52K . They compress the traditional 3 trial phases into one large, continuous trial that may be able to speed access for patients.
A lot of time and cost is spent between the starting and stopping of the traditional 3 phases. Continuous trials can save time, lower costs and reduce the number of patients. Look for new guidance soon from #FDA on how developers can conduct these “expansion” trials
#FDA is working across our medical product centers to facilitate innovative trial designs and patient-centered endpoints that can make clinical trials more rigorous and efficient.
And FDA has encouraged several pioneering advances in clinical trial design, including Master Clinical Trial Protocols (MAPs), first used in cancer and now used more widely across FDA, in other therapeutic areas
https://endpts.com/weve-scheduled-your-type-t-meeting-with-fda-commish-scott-gottlieb-where-you-can-learn-the-art-of-rapid-fire-rd/
Wasn’t the site up and running the last couple of months already?
Then again, Rett gets misdiagnosed all the time too!!!!, RIGHT?
And Parkinson’s
And depression
And....
AND.....
I seem to have forgotten about MS.
Ahh sugar. Looks like I’m gonna need some A-273 once approved to help with MY memory.
I do believe the pps was above $3, which then means they could have used the agreement they already had in place.
Last I remember, ain’t the IP protected until 2031?
How is that soon?
Second-generation drugs are harder to bring to market, because they are harder to study, Gottlieb said.
“Typically, the subsequent drugs will have to be studied on top of the available therapy and you’ll have to show improved efficacy with combination therapy as opposed to just monotherapy,” Gottlieb said. “It’s hard to run head-to-head comparative studies when already effective therapy is available. People don’t want to forego an effective treatment especially, when you’re dealing with a child with degenerate disease.”
https://cancerletter.com/articles/20180727_4/
Seems like mission accomplished for BIIB. Their goal was:
Take interest away from AVXL and stay on BIIB. Why else would they want to change presentations to AFTER Anavex.
Make bio markers a side topic and keep amyloid on the front burner. Even though the following shows that even analysts are doubting the Amyloid theory
https://www.statnews.com/2018/07/26/biogen-lost-7-billion-overnight-despite-positive-alzheimers-data/
Even if it costs them many Billions in valuation, that’s more shares needing to be sold by Anavex to raise money when it comes time. They have the money and influence to outlast Anavex financially. Curve ball being while we wait for approval for trial start in the U.S. we will start them in the EU and Australia in the mean time.
Cant wait for both trials to start and watch the haves be separated from the have not.
Then there’s A-371 batting cleanup!!!!
Someone’s excited to listen to the presentation
https://mobile.twitter.com/alzgirllori
HH could be the only one raising his hand and I doubt BIIB would have the “fruits” to allow him to ask a question.
Lol dumped on low volume?
The bigger question is what happened to MS on the pipeline path and anything mentioning a-273 being used in ms?
Nice Bio,
The next months/ year will be very intriguing as BIIB, with their grand illusion, is up against a very sharp navigator thats smoothly guiding us through some infested waters.
Lol, for small bios that would pr the exact same things would be called a pr machine, sp pumping even.
What say you about one last attack before AAIC.
Seems different than previous conferences Anavex has attended.
Being realistic and expecting nothing spectacular, just more positive data confirming a p3 is needed.
If something spectacular does get released, awesome.
If not, onward we march into p2 and p2/3 trials.
Translated into English:
Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability and efficacy of ANAVEX2-73 in relation to cognitive deterioration in patients with Parkinson's disease and dementia.
Cognitive impairment in Parkinson's disease with dementia
Not started
Authorization date: 07/03/2018
Imagining that one day, if everything falls into place, Avxl will be more than an ARYC bet from 3 years ago. Still holding strong at a cool 1100% in the green.
Could it be why Anavex went ahead and did even further IP protection as discovered on the board a few weeks ago?