Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Elsa-" Keep us informed
Thank you!
Of course I will do.
Saludos!
Rett Foundation Aus---I sent them a e-mail asking
Well done Plexrec! Keep us informed.
Saludos!
ElsaSara - My Apology. I Screwed Up!
Accepted! Don't worry!
Saludos!
Short interest + 1179057 shares.
7/15/2019 5,236,358
6/28/2019 4,057,301
No sorry.
Thank you very much!!
Saludos!
Andalucia is the biggest region of Spain 8.5 m people. There is only one hospital in Sevilla.
Madrid is in the center of Spain.
In the South and east of Madrid , there are 5 regions , plus the two islands.
Total 21 m people. Total 45 % of the spanish.
There are only 2 hospitals.
I really like the info that you share with us but this time you are not right.
Saludos!!
Bipolar board. Now Missling the villanus. A 273 won't work, Going to 1 $..lol
Can you tell me where is the PR with the bad news? because I can´t find it.
Nothing has changed except the S.P .
No updates of the trials? Only a genius knows that will we have the updates in the ERs ( + when AD trial gets 50% of the enrollment ).
No trial finished? With the info that we have about the first enrollment in Pdd and first dosed in Rett , + the update during last ER in May, we should listen about 100 % enrollment in Rett and Pdd during next week or in two weeks ( based on a simple "rule of three").
Shelf offering? We will see if the use it this year o next year... If they use it before results we can cry as a little girl..for now that have not used it yet. My bet is that they will use it next year.
Do you remember what happened in December? Now the same , great buying opportunity, in fact we couldn't resist and we bought yesterday more shares at this ridiculous S.P.
Can we go lower ? Of course, but I think that Avxl we'll recover like in December-January very soon .
Is the first time in my life that I read a board where there are"longs" complaining all the time about their companies!!!! LOL LOL LOL ..very simple sell and move !!!
By the way... I really think that the trial in Spain could have taken less time.
I don't Know how they chose the hospitals for the trial but for sure it were not well distributed around Spain.
10 hospitals are in Madrid and Barcelona .There are only 2 hospitals in the South. I live in the South of Spain, in one of the biggest Spanish cities and the closest hospital is very far from here.
I don’t know about prostate cancer but I had recurring issues many years ago ith elevated PSA.
I know a little about prostate cancer because I was a shareholder during long time of a little French company that has an amazing device , Focal 1 , that it cures localizaded prostate cancer ( in T1- T2) without side effects .
The device was approved by the FDA a year ago, but is not covered by Medicare yet.,
The main problem with the company is that they have a terrible management.
By the way, Bartemere.. you know the company as well..
Besides very positive S.A articule on friday.
"At this point and at this level, there is probably very little risk in investing in and/or holding the stock, and great rewards if the earlier trial results are confirmed."
I've sold out during this week my Ntrp Oct 5 Call . +300% !
I will buy more Avxl!
Jonjones325. We read in this board about four months ago that Missling was going to ask for the extension for pdd in Spain but he had not asked yet.
The extension in US for Rett was something planned since the beginning ( I guess that it was approved long time ago), but not in Spain and It has to be approved, so it should take some time. For now I don't see as a problem the lack of a PR regarding the extension.
I´m expecting a PR similar to this one in the near future.
https://www.anavex.com/anavex-announces-two-year-clinical-extension-study-of-anavex-2-73-and-presents-phase-2a-dose-response-analysis-at-aat-conference/
I agree with you! Great post!
No , sorry..
Of course I agree. I'm still thinking that she was the first patient dosed. I asked to the IR departament , really I don't Know if they can share this info..if they do it I will share with the board .
Ahhh Ok I understand your point.
Probably the extension is not approved yet in Spain for PDD.
Maybe first we could hear that the extension has been approved.
"today announced that the first patient, who completed the Phase 2 clinical trial ANAVEX®2-73-RS-001 voluntarily moved into the extension study and was dosed in the extension study for the treatment of Rett syndrome."
I think that she should be the first patient dosed on 18th March?
Anavex Life Sciences Announces First Patient Dosed in Extension Study to its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients for Rett Syndrome
GlobeNewswireJune 25, 2019, 1:00 PM GMT+2
NEW YORK, June 25, 2019 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the first patient, who completed the Phase 2 clinical trial ANAVEX®2-73-RS-001 voluntarily moved into the extension study and was dosed in the extension study for the treatment of Rett syndrome.
The open label, 12 week extension study is designed to evaluate long term safety, tolerability, and the effect of ANAVEX®2-73 on Rett syndrome patients following the completion of the Phase 2 study.
Patients who are eligible to be enrolled in the extension study are those who have completed 7 weeks of treatment in the ANAVEX®2-73-RS-001 trial in the U.S.
All eligible patients will be treated with oral liquid ANAVEX®2-73 formulation given once daily for additional 12 weeks. The extension study might be further extended.
ANAVEX®2-73 has already received orphan drug designation from the FDA for the treatment of Rett syndrome.
“We are delighted to provide continuation of ANAVEX®2-73 treatment for Rett syndrome patients. This study is part of an Anavex Rett syndrome program including further studies of ANAVEX®2-73, among them an ongoing Phase 2 study overseas1,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “In addition to Rett syndrome, Anavex has ongoing clinical development programs for ANAVEX®2-73 for the treatment of Alzheimer’s disease2 and Parkinson’s disease dementia3.”
Manipulation?? a 174 k order ?! I would say that at least 80% of the times, the last trade is a small sale to the BID that it produces a LOWER CLOSE. how do you call it? is it a maninulation ??.....
Up 18 cents. 3,28-3,46 , too much increase for a limIt order. He/ she wanted to buy Avxl, and he/ she didn't care about the S.P.
I didn't use the correct word in english.
It was a " market order".
One question. When could we have the announcement about the extension in the Pdd trial in Spain?Any ideas?
Last trade 174300 shares at 3.40!!
Big buy at the market. 50 k
Anavex Life Sciences initiated by Janney Montgomery Scott at buy.
Now Bid 3,30 $
https://www.marketbeat.com/stocks/NASDAQ/AVXL/?RegistrationCode=SocialMedia-StockTwits&utm_source=GeneralSocialMedia&utm_medium=Social
Haha. Obviously 3.62$
I saw 60k.
My broker showed 60 k at 2.62 $ a minute ago.
428 k at 3.45! two minutes ago.
300 k total patients with Pd, no 300 K new cases per year, my mistake.
It has no sense like the comment that Australia will speed up the PDD trial, It is absolutely impossible.
1- Spain has 300 k new PD cases per year, Au 150 k ??
Ok the investigator of Elche was wrong about to finish the trial soon very soon, but it doesn't mean that they will have problems to finish the trial.
2- The trial in Spain will finish in about two months?, in Au in two months they will have been dosed 0 patients.
IMO the most logical conclusion if they are doing now the new trial or extension in Au , like we expect is because they want to accelerate the approval without P3 , they will finish the trial in Spain .
So 120 patients in Spain + maybe 60 patients in Au + the extension in Spain, it looks like a good base to look for the approval next year..
Something similar to the 199 patients for whom Acad got FDA approval for PDP.
If I'm not wrong, after two fails Acad knew that Pima worked in certain circumstances.
For example , the patient should have " a very relaxed life" I mean to spend the maximum time at home.
Again If I'm not wrong I think that Fda was "very receptive" with Acad for the develop of the third trial...
If Avxl gets + results for Pdd , I won't commit the same mistake that I had with Acad.
+ results for Pdd = screaming buy not sell.
Acadia got FDA approval for Pimavanserin in PDP with a trial of 199 patients , 6 weeks taking the drug or placebo.
So is enough 120 patients for the approval? Why not?
We can forget the extension , it would be a big plus for the approval.
About the Trial Design
"The pivotal Phase III trial, referred to as the -020 Study, was a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with PDP. A total of 199 patients were enrolled in the study and randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for six weeks.."
http://ir.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&ID=1761922
I do not think that I should have missed the information about phase 3.
it´s what the doctor said, really it is not exactly what we want to listen.
But he doesn´t work for Anavex... and Dr M. has said that he likes the idea about accelerated approval if they get + results, and they will try if it happens.
Like I wrote in other post, nothing new/ important except two points.
- Only Pdd trial In Europe.
- No improvements in last 15 years.
- He explained the trial..trial with placebo.., first step 2 weeks of screening ,14 weeks taking the drug/placebo, nobody knows what the patient is taking..
-He explained Pd/ pdd , ..main problem quality of life.., he mentioned that one of the symptoms associated to Pd is that it affects to sleep.
- Only in Spain about 300 k patients with Pd. He also said that Anavex chose Spain but he didn´t say the reason, but he said that Spain is a top country in the world in investigation.
-Full enrollment for screening he estimated probably by May, first step two weeks of screening, 150 patients for screening. They use test moca( between 13- 23 points) . Main problem for patients that are finally not include is lack of vitamine b12.
- If they get + results, next step a phase 3 with more patients.
Ok. Thank you. I thought that it was the reason . But 70% is too much. The new trial is 20 ug doses but I don't see Ntrp as a good investment going into the results.
Not rumor.It was said for the doctor of a location of the trial ( Elche) in a Spanish radio.
Full enrolment for screening probably by May + 2 weeks of screening.
Total screening 150 patients.
So full enrolment May/June
Sorry. Full enrollment for screening by May
Another 2 weeks for the screening.
Great find! Just explanation about Pdd
Nothing new , except
Full enrollment probably by May
If results are good next step a large phase 3.
Partner? I don't want a partner. At this stage I think that Avxl doesn't need a partner.
Pdd trial probably will finish during September ( plus extension), partner should have come a few years ago.
We will see if they have to conduct a phase 3 but with the extension we have more chances of approval.
With a partner we are thinking in a big appreciation of the share price and not more dilution.
S.P will continue going up in anticipation to the results.
We are not talking about the typical drug with a potencial market of 1-2 b, we are talking about the biggest potencial market in the world, billions in revenues.
Really for this reason, I don't see as a big problem another 10, 15 .. m extra shares, Avxl doesn't need to share the potencial profits. Ok we will have more dilution but if the drug works in pdd we can forget the dilution at 2, 3 ..$..They will be able to sell shares at much higer prices , so the dilution will be much smaller.
All the profits for Avxl.