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from link...
Results showed that by the end of the two-year treatment, patients’ scores on the MDS-UPDRS Part IV, assessing motor complications, showed a change of -2.4 units in patients previously treated with placebo, -3.5 units in patients who took amantadine immediate release, and -3.6 units in patients who had deep brain stimulation.
In patients who were already on Gocovri, changes in MDS-UPDRS, Part IV scores were less pronounced — only 0.4 units — confirming the therapy’s effectiveness even before long-term treatment.
“The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI,” said Rajiv Patni, MD, chief medical officer of Adamas Pharmaceuticals. “The large reduction in dyskinesia and OFF, as assessed by the Part IV score of the MDS-UPDRS, was observed by the first visit at Week 8 and was sustained for two years. This durability is noteworthy given the known progression of motor complications.”
Gocovri’s safety profile is in line with previous reports. The most common adverse reactions included falls, hallucinations, peripheral edemas, constipation, and urinary tract infections, but these were generally mild to moderate. During the two-year study, 9% of the patients discontinued the treatment due to adverse effects, and nine patients died, although no death was linked to Gocovri.
Xena..
[if they discuss any aspect of trial structure it may have an impact on price.
/quote]
Agree with this point and would add M.'s appearance and attitude will mean a lot. Since another one of the Amyloid crew spiraled in today, AVXL looks HYUUUGE. I have heard that attitude is everything, such as was reported by Jon from the recent ASM. He cannot be sued for presenting a positive attitude.
Thursday April 26---11:25 AM MD time
Empowered educated patients influencing pre-clinical development and working with industry to optimize drug discovery
Rare Disease Advocacy World
Patient groups role guiding research, disease understanding, supporting pre-clinical development and follow up experiments
Driving translational research and the influence on formulation, routes to delivery and overall clinical development
Effective partnerships between advocacy and industry to expand collaborations that can support enrollment and physician engagement
Christopher Missling,
President and CEO,
Anavex Life Sciences
Steven Kaminsky,
Chief Science Officer,
International Rett Syndrome Foundation
Could it be that new information will be brought forward this week?
AB-E-NORMAL trades
Except.... For a number of Australians who have been popping Anavex 2-73 for up to three years now, with no reported adverse events, no hazardous or debilitating side events. And, for thousands of lab murines, for which not a single well-dosed adverse outcome has been recorded. Simply, Anavex sigma-1 receptor agonists are utterly safe.
xena...
that is why the science is more important than the share price.
OK...thanks ...that's about what I see. Agree, we are due.
basparks...you seem to have a good sense of the AVXL event schedule and the likelihood of news.
Do you think there will be any technical news from next weeks conference? Seems like he has things to say and this would be a perfect time to do so.
TIA.
The review period for the New Adaptive Trials ends 4/29... We are creating the proto types IMO
Thanks Mike...would like to see AVXL pull in any plans...unclear what this (PD,RS,AD) trifecta means in context of new Adaptive Trials rules. When results start to flow then special recognitions (BTD, etc.) may be in order.
“We are excited to progress our program to Phase 2, with a focus on the many patients with Parkinson’s disease dementia, and we remain focused on the discovery and development of potential treatments for neurological diseases with unmet needs, including Alzheimer’s disease and Rett syndrome,” Missling added.
Anavex filed an updated investigational new drug application to the U.S. Food and Drug Administration (FDA) earlier this year for a double-blind, Phase 2 study evaluating Anavex 2-73 in Rett syndrome. If approved, this trial is also expected to open in late 2018.
The company plans to open a Phase 2/3 trial of Anavex 2-73 in up to 300 people with mild-to-moderate forms of Alzheimer’s disease. A Phase 2a dose-escalating study (NCT02244541) involving 32 people with probable Alzheimer’s was conducted at sites across Australia.
Thanks Doc...my horizon is much closer than what is implied by this linking suggests. IMO, AVXL would have been a much better CNS partner.
Any thoughts on what BIIB is planning? Is this as good as it gets?
https://finance.yahoo.com/m/8253574e-55e7-3ea1-9381-9c6de5bf2933/ss_biogen-plunks-down-%241b-in.html
Consider this:
I like the DNA markers for success across all platforms
IMO Anavex will be partnered with Eisai or Takeda
https://www.fda.gov/downloads/Drugs/Guidances/UCM070337.pdf
This FDA guidance doc on Risk Management for compliance w/21 CFR part 210-211 will (at some point) be relevant to all Anavex management, products and processes.
Enjoy.
Jimmy...GREAT MESSAGE:
Anavex has a tough row to hoe but they seem to be doing so methodically and honestly. Let's see what happens and quit wringing our hands about natural and understandable delays. Ignore the Fear Mongers.
the innocent are guilty
CK
We are dealing with a REGULATORY AGENCY folks , this is breakneck speed compared with the old system !
sokol...we are setting a new timeline using real time conversion of newly learned/understood concepts. That by itself is hard enough to do, and we are doing this with CNS diseases which have had no forgiveness nor effective treatment till now.
All of our personal clocks and inference engines must be reset to accommodate the new knowledge and using old cycles we are obligated to follow...or else. Time is something we each have limited amount of. Regulated processes have a way of delaying all cycles even those we normally blow through.
It is not clear to me how BP/big investors and the herd are going to react when they figure our what is going on here(technically/medically) with AVXL. A condition in physics known as thermal runaway comes to mind as an analogy. FWIW I am now sure AVXL has the goods, the science is real. It's the ,"SO WHAT" part I am not sure of.
SOKOL wrote:
And yes, Missling did make mistakes about how long it would be for these trails to be approved and commenced, but that does not change anything about the science, indications and potential for the drug to be a success. Shareholders that sold yesterday at the price of $1.85 are the ones that made the big mistake in my opinion. However, we are all human. We all make mistakes. Being overly optimistic is sometimes a human mistake as is being overly pessimestic, or for capitulating and dumping your investment at precisely the wrong time.
I walked away feeling there is a bright future ahead of us. I also understand that this will take more time than many of us expected. However, they are marching forward with their eyes on the prize.
Like many here, I anxiously awaited news thinking something big was about to happen any minute. Still could but the anxiously waiting has turned more into patiently waiting. These few years have tested our patience to great lengths. News will come when they are ready. He doesn’t want to look back and say. We should have, could have but didn’t.
Juvenile Toxicology: Relevance and Challenges for Toxicologists and Pathologists
Jonjones325...and Bourbon...
Exceptional, above and beyond. Well done, thanks.
Thanks tred...we are both more or less on the same page. we both still believe the science is valid and will pay off big. Time for me is getting shorter after a few years of this I am getting wearier and wearier. It is a marathon.
I was not ready for the big drop today based on no real bad or tech news.
I learned another lesson is the most positive way I can put it.
Highlights of the shareholder meeting
Dr. M knows this, has chose this path for a reason with the BOD and is breaking his way through ice at the FDA to get these trials into smooth sailing water on the other side.
falconer...
Presently, the science of the Anavex molecules plays no role in the AVXL share price.
I can usually find a pony somewhere but today's PR was not well thought out.
IMO, leadership must immediately put out a strong technical paper on RETT clinical prep/trials and exactly where they stand with the FDA. After being told that the FDA were being helpful/working closely w/AVXL today's RETT trial push was inconsistent with expectations.
As long as the science continues to go w/o contradiction we will recover and move on. They must have a strong-positive message from the ASM. IMO, thankfully the YMB is gone for good.
Xena...your assessment on this from todays PR ?
In addition, an updated investigational new drug application (IND) for the double-blind, randomized, placebo-controlled ANAVEX®2-73 Phase 2 study in Rett syndrome was submitted to the FDA in the first quarter of 2018. The Company is currently in dialogue with the agency and anticipates potential initiation of this clinical trial H2 2018. Additional protocol details will be shared at that point.
Top...no debate that today's PR left many questions. My response to ANY news could be easily misunderstood. We need to get clarification on the RETT trial ASAP/TODAY. The PR message today indicated to me they were tired of talking about it. Very confusing considering recent discussions.
Who is buying pre-market - newbies?
understand, but the fact that management put this PR out on the morning of the ASM shows that they do in fact care about the shareholders....they finally threw us a bone.
basparks is BRILLIANT.....called it
Got it..thx
Anyone have details on shareholders session Tuesday? Time-Link for audio? TIA
Jimbo...commendations for a GREAT ATTITUDE
Hope to see a PR in the morning[u]
" we are really close " type of update
I'm not expecting much from the shareholder's meeting...
Thanks Doc for your assessment of these slides. We will need your continuing informed and rational thoughts over the next couple of months. Incomplete or poorly done work serves no one well. Please set the bar along with other qualified posters. The army of unqualified whiners and complainers will be ignored as usual.
By this time next week we will have seen/heard the AVXL..." what's next". The scope and level of detail provided will probably set the bar for the rest of the year at AVXL. We need M. to be detailed and global on RETT trial work (exactly-who/what/when/how/how much)?? Anything less just will not work, IMO. Ambiguity, Smoke and BS will be a big disappointment at this stage.
Based on other information, I am expecting much more detailed information on what has been learned about AUS AD markers. I expect a more restricted Precision protocol trial scope(who) will be treated based on AUS/other findings. We should also hear more about AD trial planning collaboration and any ongoing FDA role with RWE.
We expect M. to provide a strong report. The detail level and the scope of his talk will be picked apart of course, as he should expect that comes with the turf. He needs to present a scientifically powerful report and he needs to do that with thoughtfully intense leadership skill.
This is not about drama it is about recognizing patient lives along notwithstanding the current leadership vacuum at the FDA and BP WW on CNS. Lead, follow or get out of the way. As precision increases we should expect more focus on patients, what is happening with them and how can the learning process benefit those excluded from the currently treated pool. This whole process should be about getting real and not some abstract(SO WHAT) scientific exercise. Like we have said, if you want/expect to be in the room, ACT LIKE IT.
Rett trial announcement will start the rise to a much higher valuation. The tutes know the trial is only 90 days, so they have a definite timelline to trial completion and getting the data. And after just 30 days, it will be obvious that the girls aren't having as many seizures. So tutes will buy in anticipation of Data results as soon as the trial is announced.