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Starts study. 24 weeks. 100 % enrollment in February. Results Q4 19.
Study finished at the end of July.
But the study has a extension as well.
https://rettsyndromenews.com/2019/02/07/enrollment-complete-study-sarizotan-rett-syndrome-patients/
That study finished at the end of July.
The video happened only a few days ago...
I wanted to say.
After 20 years she has this amazing recuperation and she is a super responder of another trial??
Huge casuality!!
Does anybody know how many Rett trials are with 18+ old patients?
I´m not sure but it has been commented here.
For sure she is not taking Trofinetine because Ph 3 has not started yet and in fact is 5- 20 years old.
I agree 100% with Penny Double. After 20 years she has this amazing recuperation and she is a super responder of another
Huye casuality!!! She has to be one of the first 6 patients , she is taking A- 273 in the extension and maybe with a optimized dose.
Plexrec. No doubt that we are at this level because they can't finish the enrollments.
Once they announce 100% enrollment for Rett and PDD , S.P wil recover.
Meanwhile , Avxl is strong buy!!
Saludos!
It happened the other day, in last days.
The recruitment for Rett in Us has been stopped during last weeks, but if they are enrolled new patients after the preliminary results, she has not had time for such recuperation.
So if she is taking A-273, and very probably she does, she is one of the first six patients, and we are seeing the strong respond taking the drug in the extension. Taking the drug for more than 7 weeks and probably a higher dose of 5 mg.
And most likely what is happening to them. Strongest response in the extension.
Accumulating.I just bought another
3550 shares.
I bought more today at 3.36 $.
Now at 3.61 $.
Someone is in a hurry to buy 14 k shares...
Of course. This is possible.
Anyway , we just need a little more patience..
Why not just do a separate trial in AUS?
This is the main question.
Not separate the trials has no sense ...
A big delay in first results .
Wrong in one month? of course
Wrong in a few months? NO !
Obviously is a conjecture ..BUT..
03/19:
"The follow-up period of the patients is 14 weeks, there are 2 previous weeks called the screening period to see if the patients meet the necessary characteristics to be in the study and the total follow-up is 14 weeks.
And we believe that the OBJECTIVE IS FOR MAY APPROXIMATELY, all the patients necessary to carry out the study are already recruited. "
I've explained my theory a couple of times.
I really think that all the patients have been dosed.
Waiting for patients in Australia.
Part B of Avatar study commences next week, so it means that part A is finished.
After only 6 patients it sounds very optimistic to discuss data with Fda and Ema..so IMO looks like that they have more + data from part A Avatar study...
Biostockclub. Have you had an update in your program for Rett? Chances shoud have increased a few porcentage points.
Thanks for your answer the other time.
Good questions. I have the same doubts.
Although is the same trial, but in different countries, can we have data from Spain soon ? or do we have to wait a few months more until the trial is finished in Australia? I guess that the answer is no, but is there any possibility?
By the way.. after great last news I couldn't resist ,I bought more shares on Thursday at 3,27 , and on Friday at 3,31. I'm going to buy all the shares that I can in the next days/ weeks .
I really think that the 120 patients in PDD in Spain have been dosed , the trial in Spain is finished and just waiting for patients in Au.
From polarbear77:
Rett Syndrome Association of Australia: "Part B of the adult study that will take place at The Alfred in Melbourne will commence in first week in October. "
So Avatar study has part A and B, like Rett in Usa and then probably Pediatric study as well.
Part A at least 6 patients in every study , probably a few more patients because both trials have more patients.
So I would say another 12- 30 patients.
Until now we had the same number of patients in Pdd and Rett, = 120, obviously its not a casualty.
So I suspect that the number of patients Part A Avatar + Part A Pediatric = number of patients In Au in Pdd,
I think that both trials will have the same number of patients, I would say... 140-150..
I think is not inusual to enroll more patients than originally planned, for example NTRP enrolled 8 more patients...LOL !!
In PDD in Spain between the announcement of 50% enrollment and 70%,( new sites we added in Au a week earlier of 70% announcement) during those two months there was a surprising slow progression, but I think that is not correct , the progression was good , because this 70% included the new 20- 30 patients in Au, so 70% of 140-150 patients , not 70% of 120 patients, so with this progression considering 140-150 patients the patient 120 in Spain was enrolled during May/ June .
My thoughts are based in Dr Freire words, obviously just speculation..
How long is this second phase planned?
"The follow-up period of the patients is 14 weeks, there are 2 previous weeks called the screening period to see if the patients meet the necessary characteristics to be in the study and the total follow-up is 14 weeks.
And we believe that the OBJECTIVE IS FOR MAY APPROXIMATELY, all the patients necessary to carry out the study are already recruited. "
So Avxl will have blinded data from first 120 patients soon, so like is the same trial In Spain and Au I guess that we have to wait until the trial is finished in Au... Just asking?
Saludos!
Excellent news!!!
"This is a remarkable first strong signal for patients with Rett syndrome especially given that the strong effects were seen in adult patients, and we look forward to discussing these results with the FDA and the European regulatory agency as we continue our Rett Syndrome Program including pediatric patients,"
Anavex Life Sciences Announces Preliminary Clinical Efficacy Data of its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients with Rett Syndrome
GlobeNewswireSeptember 16, 2019, 1:00 PM GMT+2
Both global efficacy endpoints, RSBQ and CGI-I, showed significant improvement with respect to baseline after 7 weeks of treatment with ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 (blarcamesine) treatment effect was significantly correlated with changes in two different biomarkers linked to the neurobiology of Rett syndrome, Glutamate and GABA
Detailed Data to be Presented at 6th Annual European Rett Syndrome Conference in Tampere, Finland, September 27-28, 2019
NEW YORK, Sept. 16, 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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced preliminary clinical data of the U.S. Phase 2 Rett syndrome clinical trial.
Preliminary Clinical Data is derived from the ANAVEX®2-73-RS-001 study on the first 6-patient cohort ranging in age from 18 to 36 years who completed the pharmacokinetic (PK) part of the study and who received a low dose of approx. 5 mg daily oral liquid dose of ANAVEX®2-73 (blarcamesine) for 7 weeks. Patients are continuing participation in the ANAVEX®2-73-RS-001 open label extension study.
SCROLL TO CONTINUE WITH CONTENTAd
Both efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) and the Clinical Global Impression – Improvement (CGI-I) showed significant improvement with respect to baseline after 7 weeks of treatment. The RSBQ Total average scores improved from 50 to 34 points (2-tailed Wilcoxon signed rank test, p = 0.027) and the CGI-I scores were positively correlated with RSBQ Total scores at 7 weeks (2-tailed Spearman’s rho = 0.956, p = 0.003).
Supporting the clinical assessments, plasma levels of the biomarker Glutamate also decreased significantly (Week 0 vs. Week 7; 2-tailed Wilcoxon signed rank test, p = 0.046) and levels of Glutamate at Week 7 were directly correlated with CGI-I scores at Week 7 (2-tailed Spearman’s rho = 0.837, p = 0.038) with greater decreases in Glutamate associated with greater improvement in these efficacy scores. Glutamate is the main excitatory neurotransmitter in the brain and is known to be higher in patients with Rett syndrome compared to healthy subjects in the brain, as measured by magnetic resonance imaging spectroscopy (MRS), as well as in cerebrospinal fluid (CSF) and blood plasma.
Additionally, the magnitude of GABA change was inversely correlated with the magnitude of decrease in RSBQ Total scores (2-tailed Spearman’s rho = -0.812, p = 0.050) and GABA changes demonstrated an inverse correlation of the magnitude of Glutamate changes (2-tailed Spearman’s rho = -0.829, p = 0.042).
GABA is the main inhibitory neurotransmitter in the brain, known to be deficient in animal models of Rett syndrome. Excitatory-inhibitory imbalances postulated in many neurologic disorders, including Rett syndrome, have been linked to imbalances between Glutamate and GABA1,2.
An independent DSMB review determined that ANAVEX®2-73 (blarcamesine) was well tolerated, with no SAEs reported and with all patients completing the study. Therefore, the DSMB issued a positive recommendation for the continuation of the Phase 2 Rett syndrome study without any modifications.
“This is a remarkable first strong signal for patients with Rett syndrome especially given that the strong effects were seen in adult patients, and we look forward to discussing these results with the FDA and the European regulatory agency as we continue our Rett Syndrome Program including pediatric patients,” said Walter E Kaufmann, MD, Principal Investigator of the study and Chief Medical Officer of Anavex. “Importantly, we've now observed that the ANAVEX®2-73 (blarcamesine) effect is correlated with changes of Glutamate and GABA levels, objective measures and biomarkers in several neurodevelopmental disorders.”
Detailed results will be presented at the 6th European Rett Syndrome Conference in Tampere, Finland, September 27-28, 2019 and submitted for publication in a peer-reviewed journal.
Neurobehavioral effects of ANAVEX®2-73 (blarcamesine) previously observed in preclinical studies were also detected in patients with Rett syndrome, pointing to the ability of translation of preclinical to clinical data. ANAVEX®2-73 (blarcamesine) has received orphan drug designation from the FDA and EMA for the treatment of Rett syndrome.
Christopher U Missling, PhD, President and Chief Executive Officer of Anavex, stated, “We are encouraged by the insights gleaned from these first clinical data for ANAVEX®2-73 (blarcamesine) in patients with Rett syndrome and we look forward to both confirm this clinical data and continue the Rett syndrome program with determination. In addition to Rett syndrome3, Anavex has ongoing clinical development programs for ANAVEX®2-73 (blarcamesine) for the treatment of Alzheimer’s disease4 and Parkinson’s disease dementia5.”
About Rett Syndrome
Rett syndrome is a devastating, non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, autistic features, slowed brain and head growth, ataxia, seizures and intellectual disability. There is currently no cure for Rett syndrome. Rett syndrome is caused by mutations in the MECP2gene and strikes all racial and ethnic groups and occurs worldwide in approximately one in every 10,000 to 15,000 live female births.
About ANAVEX®2-73-RS-001 Clinical Study
The Phase 2 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 (blarcamesine) to treat Rett syndrome. Pharmacokinetic and dose-finding elements in a total of 21 patients over a 7-week treatment period will be evaluated incorporating precision medicine biomarkers. Preceding the placebo-controlled randomization of 15 patients, a 6 patient cohort underwent a 7-week pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX®2-73 (blarcamesine). All patients who participate in the study will be eligible to receive ANAVEX®2-73 (blarcamesine) under an open label extension protocol.
About ANAVEX®2-73
ANAVEX®2-73 (blarcamesine) activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. In a Phase 2a Alzheimer’s disease (AD) study, ANAVEX®2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and activities of daily living (ADCS-ADL). Full genomic analysis of ANAVEX®2-73 (blarcamesine) Phase 2a AD patients was performed. The ANAVEX®2-73 (blarcamesine) Phase 2 Rett syndrome study design includes genomic biomarkers identified in the ANAVEX®2-73 (blarcamesine) Phase 2a AD study. Studies of ANAVEX®2-73 (blarcamesine) in a mouse model with a heterozygous Mecp2-null mutation (HET) that causes neurological symptoms that mimic Rett syndrome, ANAXEX®2-73 (blarcamesine) was evaluated in automatic visual responses and breathing tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated HET mice demonstrated fewer automatic visual responses and more frequent expiratory apneas than wild-type mice. Treatment with ANAVEX®2-73 (blarcamesine) for four weeks significantly increased these visual responses in the HET mice (p<0.05). Additionally, chronic oral dosing daily for 3-6.5 weeks of ANAVEX®2-73 (blarcamesine) starting at ~5 weeks of age was also conducted in the HET mouse model of Rett syndrome, and dose-dependent improvements in a variety of sensory and motor deficits, including those involving motor coordination, balance, and learning, were also observed. Notably, one of the strongest effects was on hindlimb clasping, a postural response that resembles the characteristic hand stereotypes present in Rett syndrome. These experiments were sponsored by Rettsyndrome.org.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated 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®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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®2-73 (blarcamesine) 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®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising preclinical 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®3-71 has shown beneficial effects on neuroinflammation and mitochondrial dysfunction. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook 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.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors & Media:
Email: ir@anavex.com
1 Kaufmann et al. Expert Opin Orphan Drugs 4:1043-1055, 2016
2 Banerjee et al. Brain 142:239-248, 2019
3 ClinicalTrials.gov Identifier: NCT03758924; NCT03941444
4 ClinicalTrials.gov Identifier: NCT03790709
5 ClinicalTrials.gov Identifier: NCT03774459
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PDD. Facts.
03/11: 50% enrolment
03/19 : Interview in a radio station of Madrid to dr Freire, main investigator of Elche.
I´ve listened again the interview . Here is the transcript , in relation to the duration of the trial.
"¿ Qué duración tiene prevista esta segunda fase?
"El periodo de seguimiento de los pacientes es de 14 semanas y hay 2 semanas previas que se llaman periodo de screening para ver si los pacientes cumplen las características para entrar dentro del estudio y el seguimiento total es de 14 semanas .
Estimamos que EL OBJETIVO ES PARA MAYO APROXIMADAMENTE estén ya reclutados todos los pacientes necesarios para poder llevar a cabo el estudio"
Translation from Google:
How long is this second phase planned?
"The follow-up period of the patients is 14 weeks, there are 2 previous weeks called the screening period to see if the patients meet the necessary characteristics to be in the study and the total follow-up is 14 weeks.
And we believe that the OBJECTIVE IS FOR MAY APPROXIMATELY, all the patients necessary to carry out the study are already recruited. "
05/ 01: Two new centers added in Australia. Another two sites were added later.
05/08: 70% enrolment : 84 patients. 24 patients in two months.
With a low estimation in Au in this period of 10 -15 patients enrolled, we have a total of 94-99 , so it means that Spain has been not able to enroll 21- 26 patients in 4 months...
Considering the enrollment until May and the words of dr Freire it sounds impossible.
He could be wrong for 1 month but wrong in 4-5 months???
IMO. I think that the big delay is due to the extension to Au, in fact could be possible that Spain stopped the trial 2- 3 months ago. The question would be if they stopped the trial with the full enrollment of 120 patients, or they stopped with 90- 100 patients.
It´s the only justification that I see for this big delay.
Saludos!
I've sold out during this week my Ntrp Oct 5 Call . +300% !
Easy money. Only speculation position.
Now easy money buying Avxl.
EXCELLENCE study. Why 69 patients...?
I always read all the posts in this board but in last days I couldn't do so I don't know if it has been commented.
Pdd = 120 patients
Rett= 6 + 15 + 30 + 69 = 120
Casuality??? I don't think so. Looks like that we know the number of patients for Avxl to look for approval....
Another trial!!!
Ad p 2a extension in Au
Ad p 2b/ 3 in Au + extension coming soon
Pdd + extension coming soon
Rett in Usa + extension
Rett Avatar in Au
Rett Excellence
0 revenues , and a lot of trials + extensions that it means more expenses and more losses..
so or they are a kamikazes and really I don't think so ..or they are absolutely confidents in what they are doing.....
BioStockclub, if you have a sec. How is
Hello Bio!
There is a difference of 20-26 porcentage points in your model between Rett and Pdd.
What is the main reason?I mean why is so optimistic in Pdd , and less in Rett?
Saludos!
What about the extensions ?
Are they any indication of something good?
The extension in Rett was something planned since the beginning but not in Pdd and Ad.
In reference to the extension in AD or PDD.
The extension is good for both , patients can continue with the treatment if they feel better, and company gets more data, but it means more resources , more expenses for the company.
Although the trial is blinded, Anavex has data about the trial..
Considering the placebo effect, they know that there will be "a few" patients that will feel better in the placebo arm.
So why to do the extension if only" a few" patients are felling better? I think that it has no sense.
Why to spend more money? I think that it has sense if they are seeing a significative number of patients asking for the extension.( feeling better) .IMO
Is the extension a indication that something good is happening..??
Saludos!
Lima, I agree 100%
Lima, Plexrec,georgejjl ...100% agree!!!
Amazing the SP reaction .
Just a little more patience....
Saludos!
Basparks79. Short interest +577 k .
I reafirm my point of view !
Shorts are not going to cover before results.
In fact a increase my bet.
I think that we are not going to hear about the shelf during 2019 , so we will have a big run up in anticipation to the results.. at least 6 m shares short by December.
Saludos!
I agree with your point regarding to the enrollment in PDd.
120 patients in Spain + ¿ X ? in Au , I think it is a real possibiliy.
On 19th March the investigator of Elche said that the enrollment would finish during May or June.
Besides two locations were added in Au on 1st May.
70% enrollment on 8th May.
Finally they are going to finish during Aug/ september...at least strange..
Saludos!
It's worth noting that if you cross reference
Ok. Thanks!!
nct03774459
the update has been today.
2 in Au + 5 in Spain.
Yes. I didn'd realize.
2 in Au and 5 in Spain.
Are you sure? I read it in other board and I agreed it was the first time that I saw the 2 locations in Au.
I'll be wrong.
Pdd trial. 2 new centers in Australia.
Last update today.
Locations
AustraliaKaRa MINDSRecruitingMacquarie Park, AustraliaContact: Rosalyn Lai Hammond
HealthRecruitingMalvern, AustraliaContact: Stephen Macfarlane
Let's see if anyone can manage a negative post on this news.
Strong support at 2.50 $..
We need news about 100% enrollment!!
Anavex Life Sciences Reports Recent Data Review by the Independent Data Safety Monitoring Board for its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients with Rett Syndrome
July 31, 2019 07:00 ET | Source: Anavex Life Sciences Corp.
NEW YORK, July 31, 2019 (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 including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Independent Data Safety Monitoring Board (DSMB) for the Company's U.S. Phase 2 Rett syndrome study of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2 study data.
The DSMB reviewed the preliminary efficacy and safety data for the ANAVEX®2-73 Phase 2 Rett syndrome clinical study ANAVEX®2-73-RS-001.
Upon review of the most recent data, the DSMB made the following recommendation:
The DSMB recommendation is to continue the study without modification.
DSMBs are committees commonly used in clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials.
ANAVEX®2-73 has already received orphan drug designation from the FDA as well as a positive opinion for orphan designation from the European Medicines Agency (EMA) for the treatment of Rett syndrome.
About ANAVEX®2-73-RS-001 Clinical Study (ClinicalTrials.gov Identifier: NCT03758924)
The Phase 2 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 to treat Rett syndrome. Pharmacokinetic and dose-finding elements in a total of 15 patients over a 7-week treatment period will be evaluated incorporating ANAVEX®2-73-specific genomic precision medicine and other biomarkers. Preceding the placebo-controlled randomization of 15 patients, a 6 patient cohort underwent a 7-week pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX®2-73. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under an open label extension protocol.
Only 1k in pre market. 2.77 $
Anavex Life Sciences Receives Positive Opinion for Orphan Designation from the European Medicines Agency for ANAVEX®2-73 for the Treatment of Rett Syndrome
GlobeNewswireJuly 29, 2019, 1:00 PM GMT+2
NEW YORK, July 29, 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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on Anavex’ application for orphan designation of ANAVEX®2-73 for the treatment of Rett syndrome. The positive opinion issued by COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.
Under the EMA’s Regulation (EC) No. 141/2000 an orphan medicinal product designation gives companies access to reduced regulatory fees, protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of success at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity in the European Union (EU), hence protecting it from competition from similar medicines, which cannot be marketed during this 10-year exclusivity period for this indication.
The EMA grants orphan medicinal product designation based upon several criteria: the life threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than 5 cases for each 10,000 of population; no satisfactory method of diagnosis, prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that condition.
ANAVEX®2-73 had previously received orphan drug designation from the United States (U.S.) Food and Drug Administration (FDA) for the treatment of Rett syndrome.
“ANAVEX®2-73 has the potential to provide patients and physicians with a much-needed treatment option for Rett syndrome, a rare genetic disorder. The COMP’s adoption of a positive opinion for ANAVEX®2-73 orphan drug designation is another important milestone for this program, which continues to advance rapidly,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “In addition to Rett syndrome1, Anavex has ongoing clinical development programs for ANAVEX®2-73 for the treatment of Alzheimer’s disease2 and Parkinson’s disease dementia3.”
I mean 5 m shorts by december before results expecting results during december.
They are not going to cover before results.
I really hope that you are right , and they cover at 20$..!
Ok 1 m has been covered during 2019..but we have a total of +105 k now since december.
By december we will have 5 m if not hihger!
At this low level we should see some decrease in 15 days by next report.
But no doubt that the majority of the shorts are betting that Avxl will go to Bk in the future, so they are not going to cover until A273 fails.....
The proof is that they didnt cover ( about 300 k that is nothing considering that Avxl crashed) below 2 $.
I think that shorts are not going to cover for now.
They didn't cover below 2 $.
We had a big decrease during May , and a big increase again during last spike to 4$.
Considering that the S.P should go up in anticipation to the results..and I really think that it is going to happen..
I don't see short interest going too much down of the normal report about 5 m shares.
The question is , in 6 months, what are they going to do when they realize that A 273 works?