Anavex og CNS
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AVXL - Clint Tomlinson, Anavex Life Sciences Corp. - Executive
Clint Tomlinson plejer at være en del af CC, når Q regnskaber fremlægges.
Her fra Q2 -har endnu ikke kunne finde udskrift fra Q3.
Det er ham jeg har mailet med tidligere.
Ja - markedet har ikke opdaget Anavex endnu, men 2-73 er åbenbart godt nok til, at de austalske myndigheder giver grønt lys for salg under SAS.
Dette betyder pt mere end hvad markedet tillægger af værdi til casen.I Parkinson er der 2 primære endpoints:
1: Bivirkningsprofilen - ( Hvilket alt andet lige må have fået en blåstempling af TGA med SAS godkendelsen )
2: CDR målingen - ( I resultaterne fra AD fase 2a efter 148 uger, så vi tilsvarende resultater, som hvis de bare nogenlunde kan gentages i PD, vil sparke r-v )
Dvs. de primære endpoints burde være så godt som sikret.
Derudover tror jeg på, at mindst 2 eller 3 af de sekundære endpoints også går hjem.
Men det er korrekt vi ved intet før vi ser data!
Der er talrige eksempler på, at markedet kunstig har presset en kurs op på en aktie, for så at falde til jorden med et brag.
Kan godt lide den måde Anavex systematiske på baggrund af løbende tilegnet viden, forsøger at optimere chancen for succes i sidste ende.
Mener dog, at de mangler en stor del på deres kommunikering ud til os trofaste investorer - det havde de mildest talt ofte have gjort mere elegant.I den anden ende ser vi nu Biogen mere eller mindre med magt at forsøg at presse et, efter min og mange andre fagpersoners opfattelse, ubrugeligt og måske direkte sundhedsskadelig komponent igennem.
Ja og Biogen belønnes så af dette finansielle marked, som i bund og grund er ligeglad om stoffet virker, bare der er penge at tjene.
TÆNK BARE HVIS BIOGEN VAR KOMMET MED TILSVARENDE UDMELDING OM EN SAS GODKENDELSE?Håber og tror på, at videnskaben vinder i sidste ende og at skidtet virker.
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Det er så imponerende hvad du kan finde af informationer, Tasso. Igen igen stor tak fordi du deler ud af din viden.
Hvad tænker du om det rejste spørgsmål om de får brug for en partner i en kommende fase?
Jeg fik også lige købt lidt ekstra op under panikken. Var det ikke lidt underligt, at den steg så meget på eftermarkedet?
Nu må vi bare satse på, at der kommer gode resultater i september -
Avxl - Q3 link og udskrift!
Vores gode ven Clint Tomlinson fra IR er med!
Døm selv om CEOen lyder som en, der tvivler på casen eller bare gør det han skal og formidler det faktuelle budskab.
Anavex har nok stadig den tidligere groteske retssag hængende i baghovdet.Tak for de pæne ord elssan, men det er ikke så vanskeligt at holde styr på tingene, især ikke når vi har denne fantastiske Proinvestor hjemmeside.
Har også ønske om, at holde vore lille investorgruppe underrettet.
Vi har iøvrigt ikke solgt en eneste aktie endnu, men har tværtimod frigjort middler til evt. at øge andelen i Anavex ved evt. ny positiv udvikling i casen.Anavex Life Sciences Corp. (AVXL) CEO Dr. Christopher Missling on Q3 2020 Results - Earnings Call Transcript
Aug. 9, 2020 1:38 PM ET ' About: Anavex Life Sciences Corp. (AVXL)
FQ3: 08-06-20 Earnings Summary
Press Release
10-QEPS of $-0.35 misses by $-0.21 Revenue of $0M (-% Y/Y)
Subscribers Only
Earning Call AudioAnavex Life Sciences Corp. (NASDAQ:AVXL) Q3 2020 Results Conference Call August 6, 2020 11:00 AM ET
Company Participants
Clint Tomlinson - IR
Dr. Christopher Missling - President and CEO
Sandra Boenisch - Principal Financial Officer
Conference Call Participants
Charles Duncan - Cantor Fitzgerald
Edward Marks - H.C. Wainwright
Operator
Welcome to the Anavex Life Sciences to announce fiscal 2020 Third Quarter Financial Results Conference Call. My name is Rebecca, and I will be your operator for today's call. [Operator instructions] Please note that this conference is being recorded.
I will now turn the call over to Clint Tomlinson. Please go ahead.
Clint Tomlinson
Thank you, and good morning, everyone. We appreciate you joining us today for Anavex Life Sciences conference call and webcast. Our agenda is to review the company's financial results for its third quarter of fiscal 2020 and provide a clinical study update.
A taped replay of this call will be available approximately 2 hours after the call's conclusion and will remain available for 1 month. The call will also be available for replay on Anavex's website at www.anavex.com.
With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer. Dr. Missling and Ms. Boenisch will make prepared remarks, and then we will take questions from equity analysts.
Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements regarding future events. We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital and maintenance of intellectual property rights.
And with that, I'd like to turn the call over to Dr. Missling.
Dr. Christopher Missling
Thank you. Thank you, everyone, for joining us on today's conference call to review our third quarter financial results and share with you some clinical updates for ANAVEX 2-73 or blarcamesine.
During the last quarter, since our last conference call, we have continued to advance our clinical programs with several key milestones accomplished. Just yesterday, we announced having received compassionate use Special Access Scheme approval for Alzheimer's disease patients' continued treatment with ANAVEX 2-73 by the Australian Government Department of Health, Therapeutics Goods Administration, TGA. This is certainly an important milestone, and we are honored to support medical professionals and their patients seeking treatment for Alzheimer's disease and who have very few medical options.
In June, we received approval from both the Canadian and the United Kingdom health authorities to expand the footprint of the international Phase IIb/III double-blind, randomized, placebo-controlled safety and efficacy trial of ANAVEX 2-73 for the treatment of early Alzheimer's disease into Canada and the U.K., respectively. And in these global regions, it's expected to continue steadfast or even accelerated enrollment of this important Alzheimer's disease trial while also adding international footprint in North America and Europe.
We announced in June the complete enrollment of the ANAVEX 2-73 U.S. Phase II Rett syndrome trial. The enrollment target was surpassed by 50% with 31 patients now enrolled in this trial. We expect to announce top line results from this study in calendar Q4 2020.Furthermore, just last month, we announced that the first pediatric patient was dosed in the third study of Rett syndrome program, the EXCELLENCE trial. This Phase II/III trial will evaluate the safety and efficacy of ANAVEX 2-73 in over 69 patient -- pediatric patients with Rett syndrome aged 5 to 18 over a 12-week treatment period, incorporating ANAVEX 2-73 specific precision medicine biomarkers.
We were also pleased to report in July that the first participant was enrolled in a Phase I clinical trial of ANAVEX 3-71, which focus on the treatment of frontotemporal dementia, FTD, for which ANAVEX 3-71 was previously granted Orphan Drug Designation by the FDA. The Phase I clinical trial is a prospective double-blind, randomized, placebo-controlled study. This study will be followed by longer-duration dosing, including FTD patients and incorporating exploratory efficacy in disease biomarker measures. Top line data is anticipated in the first half of 2021.
Finally, Parkinson's disease dementia top line results from the Phase II study are forthcoming and are expected to be announced during this fiscal quarter.
And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a brief financial summary of the recently reported quarter.
Sandra Boenisch
Thank you, Christopher, and good morning, everyone. We reported a net loss of $6.5 million or $0.11 per share during the quarter as compared to $6.5 million or $0.13 per share in the comparable quarter of fiscal 2019.
Our general and administrative expenses remained consistent quarter-over-quarter at $1.4 million.
Research and development expenses were $6.7 million for the quarter ended June 30, 2020, an increase of $0.9 million over the comparable quarter in 2019. This increase is a result of increased clinical trial activities and the continued advancement of existing clinical trials.
Our cash position at June 30, 2020, was $27.6 million compared to $22.2 million at September 30, 2019.
Thank you. And now I will turn the call back over to Christopher.
Dr. Christopher Missling
Thank you, Sandra. In summary, I want to point out that despite these challenging times, we continue to make steady progress with fiscal responsible work towards reaching several important milestones, and we are poised to an exciting time ahead with multiple data readouts ahead of us. We look forward to providing further updates as advancements continue.
I would now like to open the call for questions. Operator, please go ahead.
Question-and-Answer Session
Operator
[Operator Instructions] And our first question is from Charles Duncan from Cantor Fitzgerald.
Charles Duncan
Good morning and congratulations. I wanted to ask you a couple of questions. First of all, regarding the PD cognition study, what would you look for out of that study to give you confidence to continue to invest in that particular indication? It seems like PD is -- or particularly, cognition in PD is somewhat of a heterogeneous indication. I'm just wondering what you -- how you would define success.
Dr. Christopher Missling
We are doing the study from the background that we had a signal in our Phase IIa Alzheimer's disease cognition study. And we then had, in parallel, a Michael Fox Foundation-sponsored preclinical study in an animal model of disease modification of Parkinson's. So when this data came together, in the outcome, we're considered sufficiently positive to explore these features in one study. That's where the advice from advisers, scientific advisers from Michael Fox Foundation came out to do and execute this study. So it's a combination of looking for cognition, but also looking for features of Parkinsonian disease that can be alleviated with the drug ANAVEX 2-73.
And we decided to shift the focus on the dementia part. So the primary end point is looking at the dementia domain. And the secondary end points are those which are more considered the Parkinsonian impairment, like UPDRS as well as sleep, across data, including in motor impairment features as well as very heavily biomarker -- including biomarker measures, which even goes beyond the classical biomarkers because we're also including the entire genome, including the RNA and the DNA. So I think once we have the data, we'll be able to hopefully be very aware of what's going on in this study.Charles Duncan
Yes. So just if I could follow up. So you -- it sounds like you'd look for a signal in terms of the dementia component or cognition components, so you look for that. And perhaps you'd look for a lack of signal or impact on UPDRS in terms of impairment. And would you hope to see any improvement? I mean I could easily see you seeing some improvement in, for example, sleep parameters.
Dr. Christopher Missling
Right. We don't want to exclude anything. We just really take this as a very objective study to look at what happens in the study when treated with ANAVEX 2-73 versus control. And this is what we really look forward to seeing. .
Charles Duncan
So it's very much a signal-seeking study. You don't have any, call it, biases in terms of effect size or anything that you're thinking about?
Dr. Christopher Missling
Right. We just want to see a signal first, and that could be however it is, and that would be then -- certainly, we can move from there by sharing with the regulatory bodies and take it from there since it's a highly unmet need since now almost 80% of all Parkinson's patients develop dementia.
Charles Duncan
Okay. And I think you mentioned that data should be by the end of September?
Dr. Christopher Missling
We said this quarter. And also, it will definitely be this quarter. I don't want to go in more specifics. We will report exactly when we have the data. .
Charles Duncan
Yes. That's cool. Last question then regarding the first Rett study, the U.S. Phase II. Can you provide any color on the types of patients that were enrolled? Any characteristics that kind of broadly can help us understand that study enrollment and what you look for out of it?
Dr. Christopher Missling
Yes. So we had the benefit of having already a glimpse of the data in the first cohort, which was the PK cohort of 6 patients. And in this cohort, we saw that there was a signal already, which correlated really nicely with the biomarker of a disease-specific biomarker, the glutamate level. And we make sure that, because this is also a complex disease, that we include patients which are able to show an improvement over the various phenotypes of the disease, which is very broad. It ranges from movement impairment to features of cognitive impairment of response, of seizures, of sleep impairment, of startling and breathing impairment. So you want to make sure that you include patients who have some level of dysfunction then to be able to discern an effect with the drug.
Charles Duncan
Sure. And you feel like the enrollment went consistent to the protocol requirements?
Dr. Christopher Missling
Yes. So we have made sure that we have always looked for every patient being specifically matching the inclusion/exclusion criteria.
Charles Duncan
Yes. And beyond just the age restrictions, I know in your other study, you're doing pediatric patients, 5 to 18, which is in itself a big range. But beyond that, when you think about the sample for that first U.S. trial, how does that sample relate to the broader set of patients, Rett patients? Do you think that you've captured a fairly good set or good, broad coverage on the entire population? Are you hitting a certain niche that really can be useful to determining the potential use of 2-73 in that population?
Dr. Christopher Missling
Yes. So the U.S. study is 18 years and older, and it sounds like very generous, but the reality is there's actually less patient pool for study available in older patients for various reasons. And we basically are happy that we were able to enroll, especially in the last few months, many more patients than we had actually planned for because we just had planned for 21 patients at the beginning, and then we added up 10 more to end up now at 31, which is very beneficial for a calculation of the efficacy. And so we were very pleased about that without having to give up any -- on the quality of the patients or participants in the study.So what we do know from scientific experience is that it is usually harder to find a change of phenotype in the older the patients are, especially in neurodevelopmental diseases. So that means if you treat earlier, it's likely that you are able to find a signal. So the fact that we already saw something in the first 6 patients in adults, in the adult study, but also with the lowest dose, it's kind of very encouraging.
Charles Duncan
Yes, for sure. But it's a heterogeneous patient population, it sounds like and, again, should be viewed with a perspective that it's signal-seeking, not -- certainly not dispositive.
Dr. Christopher Missling
Well, I think we want to, again, see what will be the outcome. We had a very strong effect side in the first 6 patients. I don't know if we can use that as a benchmark for the entire study. It would be great. If so, that would play out in the study. And I think we will see when the study will read out, which is, as I mentioned, by the end of this year, latest.
Charles Duncan
Perfect. Okay. Chris, we'll look forward to data flow over the second half of the year.
Dr. Christopher Missling
Thank you.
Operator
Your next question is from [indiscernible] from H.C. Wainwright.
Edward Marks
This is Marks speaking on behalf of Ram. The first query relates to the Parkinson's, the dementia trial, and then I have a couple of follow-up pipeline questions. But firstly, what do you think in terms of being the most crucial test in the Parkinson's disease dementia trial is? Would you say it's the CDR or the MDS-UPDRS? And if the Phase II trial is positive, would a Phase III trial suffice?
Dr. Christopher Missling
What was the last question? Is the Phase II positive?
Edward Marks
If the Phase II trial is positive, would a single Phase III trial suffice?
Dr. Christopher Missling
I see. So the answer to the first question, the CDR continuity of attention is the primary end point and that is definitely the most relevant signal we are looking at for Parkinson's disease dementia. The UPDRS is a, I would say, a compositive of multiple measures, among them the movement, among them also function and, to a certain extent, activities or daily living. So that's why it's structured in different subscales, like 1, 2 and 3, and 3 being the movement subscale. So we believe the CDR continuity of attention will give us the most important signal for the dementia, Parkinson's dementia domain. But also the other one will be interesting, that's why we included it as a secondary end point.
In terms of your second question, if the Phase II is positive, we would share it with the FDA and then take the steps from there, what would be the right way to approval or the appropriate next step for seeking approval.
Edward Marks
Okay, makes sense. And has the longer-term dosing study using the exploratory efficacy and disease biomarker measures been initiated?
Dr. Christopher Missling
Say that again, please?
Edward Marks
Has the longer-term dosing study using the exploratory efficacy and disease biomarker measures, has that been initiated?
Dr. Christopher Missling
You mean the extension, when you say longer term?
Edward Marks
Yes.
Dr. Christopher Missling
So we have, in all our studies, an extension. So both the U.S. Rett syndrome study as well as the Parkinson's dementia study have an extension. And so the extension for the Rett syndrome study is 12 weeks in the U.S.; 1 year, the AVATAR study; and it will be also 1 year in the EXCELLENCE study in Rett syndrome; and it's 1 year in the Parkinson's dementia study; and it's 2 years in the Alzheimer's IIb/III study. All these extension studies have not only the biomarker, but also the underlying randomized, placebo-controlled studies have the biomarker, including the genetic analysis included. So we don't have to wait for readout of the extension study to learn about that. .Edward Marks
Makes sense. And just finally, in terms of 2-73, are you looking at other CNS result? Or is it just epilepsy?
Dr. Christopher Missling
Right. So when you look at our pipeline, you might have noticed that we have also strong evidence of an animal model confirmatory efficacy for Parkinson's, for infantile spasm, for Fragile X, for Angelman syndrome. And this indication will likely be next in line in case of we have a positive readout on the ongoing studies. So the franchise will expand into this indication since this is something which preclinically has been shown to be already a very strong signal with ANAVEX 2-73.
Operator
[Operator Instructions] And Charles, your line is open.
Charles Duncan
I haven't heard anyone. Hopefully, Christopher is still on the line. Just one quick follow-up on the pediatric program. I'm just wondering if you could give us any further indication of the types of patients that you'd like to enroll in that. Obviously, there's a certain age group, 5 to 18. We can read what's on clinical trials. But I'm just wondering if -- when you talk to investigators, if there is a certain phenotype that you would like to see enrolled in that, that could give you confidence in the outcome but also address really the underlying unmet needs.
Dr. Christopher Missling
So the pediatric study from 5- to 18-years old is relatively comparable to the adult study. Once the phenotype shows up in Rett syndrome, it very much stays relatively stable with some variations of that. So you're looking at a similar measure, including the RSBQ, the CGI-I and the sleep parameter or parameter. And the question is actually identical in the adult and in the children because of the phenotype of the Rett population, the adults are still considered children. So we have, in our EXCELLENCE study, because it's a larger study and it's geared towards a pivotal study, that's why it's a Phase II/III, we have more measures included and it's slightly longer. So the adult studies are 7 weeks in duration, and the pediatric study is 12 weeks in duration.
Charles Duncan
Okay. That's helpful. And then just if you could wax poetic, if you will, or speculate on the competitive environment. There are other programs. We did recently see one recommence enrollment around the neuron -- Neuren, Acadia side. We also know GW is doing some work in Rett. And it would seem to me that Rett is a large unmet need, but in an orphan disorder. And I'm just wondering if you could give us a sense of the feedback that you've gotten from the advocacy community on how 2-73 fits within the emerging treatment paradigm, assuming all of these programs are successful, which is a big leap, but the other thing is in terms of competition for patients in the programs.
Dr. Christopher Missling
So, the comment I'd like to give is that from the very beginning, we were fortunate that we were highly supported by the Rett community. The foundation itself actually was instrumental in even getting us where we are. Without them, we wouldn't have had any data in Rett syndrome to begin with. The entire preclinical animal model were supported and financially supported and paid for by the foundation. Without them, we wouldn't have had the data. And then when the data was very positive in the animal model of Rett syndrome, then the decision was made by the Rett foundation to also support our Rett clinical study. So I'd like to thank the Rett foundation for that very much.
We also made something probably very important distinction as we learned also during the COVID time, which was extremely advantageous in hindsight. We just didn't send out the protocol and started the study without feedback from the parents of -- with Rett patients. So, what we did, we basically asked them what is important for you, as a parent, in your respective goal to participate in the study. We learned that visits in the hospital were considered very burdensome. So, I basically decided to then to limit the visits in the hospital and also adding an optionality in the protocol that every visit can also be assessed at the home of the patient. And that was interesting because when COVID came along, we were able to switch to that manifestation or protocol optionality, and that also probably led to our ability to increase our enrollment to -- by 50% instead of stopping the trial entirely, which I understand other trials were forced to do.Charles Duncan
Yes. Certainly, that is -- makes it less complex in terms of interpreting the data, but it also seems like you facilitated progress with the Rett community, and perhaps it will bode well for the future.
Dr. Christopher Missling
And we plan to continue to do that, both with the foundation here in the U.S. very much, but also abroad. In Australia, we're working with the Rett community foundation in Australia as well as in Europe and the U.K. as well. So we are hand-in-hand working towards this goal of making sure that we don't do this in the backroom.
Charles Duncan
Yes. Last question is, do you see, does one see Rett as being a challenge to Asian communities? And is there any corporate strategy to broaden potential access to those countries through maybe partnering or other endeavors?
Dr. Christopher Missling
There is, indeed, the same amount of Rett patients in Asia, especially in Japan and China, but especially in Japan, there's a same amount of patients there than here in the U.S. So it's around about 10,000 to 15,000 patients in Japan alone. And we do plan, after the readout of the U.S. study, which is forthcoming, to then move into the Japanese territory to also continue the study with ANAVEX 2-73 in Rett patients in that regard.
Charles Duncan
And would those be studies you conduct? Or do you think it may be best to do that in collaboration with a partner?
Dr. Christopher Missling
Right. So Japan is a unique market where the entities working has to be local. So there are probably a mix of a local sponsor with us together or to a 0. We have not made a final decision on that yet.
Operator
We have no further questions at this time.
Dr. Christopher Missling
So with that, we thank everybody to participate, and this concludes today's conference. Thank you very much for participating.
Operator
Thank you, ladies and gentlemen. This concludes today's conference. You may now disconnect. -
Biogen/avxl Det må da alt andet lige være et godt tegn for Anavex. De må da også kunne få priority når de ansøger, sikke et marked: https://medwatch.dk/Medicinal___Biotek/article12328652.ece
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Avxl - SAS og medier.
Tak for linket MM - 27 milliarder kr. i omsætning årligt siger lidt om potentialet.
Man kan spørge sig selv om, hvor medieomtalen er henne for 2-73, som rent faktisk nu er tilgængeligt på markedet i Aus under SAS???
Ved flere skribenter fra andre forum har indsendt budskabet til div. medier i Australien, også til dem, der tidligere har dækket flere historier/nyheder fra Anavex.
Men indtil nu har der intet været - total tavshed???
Ved ikke om de er blevet helt lammet af COVID-19 down under!
Men mon ikke lægerne på de 16 Alzheimer sites i AUS. begynder at udskrive 2-73 til nye patienter og langsomt udbreder budskabet.
Men selvom Anavex ikke selv må reklamere med 2-73 fordi det ikke er endelig godkendt, så forhindre det ikke læger og medier i at omtale denne nye mulig behandling i Alzheimer.
Og hvor er de sociale medier - selvom jeg godt ved at f.eks. et ligegyldigt klip med en kattekilling, der falder ned af en sofa bliver set/delt af 1000 gange flere brugere.
Husker her en af de tidlige indslag om en AUS. Alzheimer patient, der tydeligvis viste stor fremgang efter behandling med 2-73 - set af hele 3400!Nå - vi skal nok have de PD fase 2 data for at brænde igennem for alvor.
PS: Eli Lilly skulle iflg. de officelle oplysninger have afsluttet deres lign. PD fase 2 forsøg ca. 3 uger før Anavexs - og de er heller ikke kommet med data endnu.
Som tidligere skrevet bruger de samme CDR primære endpoint som Anavex.
Anavex henviste endda selv til dette ved CC i juni og udtalte ( selvsikkert ), at man så frem til en direkte sammenligning. -
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Avxl - Anavex - Eli lilly Parkinson.
Kyed.
Iflg. ClinicalTrials.gov var Anavexs PD forsøg først afsluttet den 31. juli 2020.
Eli Lillys allerede den 10. juli 2020.
dvs. 3 uger før Anavex - og de har som sagt heller ikke fremlagt data endnu.
PS Eli Lilly har ingen ekstension forsøg i PD, som Anavex.
Det tager nok bare den tid det tager!Anavex:
https://clinicaltrials.gov/ct2/show/NCT03774459?term=Anavex+Life+Sciences&draw=2&rank=6Eli Lilly:
https://clinicaltrials.gov/ct2/show/NCT03305809?term=Eli+Lilly&cond=Parkinson+Disease&draw=2&rank=4TDT.
Tripelbund i 3,8-3,9 $ på få dage, virker umiddelbar som en solid bund.
Hvem ved måske en lille pr. med færdigbehandlet patienter i RETT US i morgen?
Burde være nået i sidste uge. -
Avxl - Bekræftigelse fra TGA om brug af 2-73.
Indlæg fra andet forum, hvor vedkommende spørger TGA om muligheden for udskrivning af 2-73 til andre patienter, udover dem der har deltager i AD fase 2 forsøget!
TGA BEKRÆFTER - JA DET KAN MAN!!!!
I understand the TGA recently gave compassionate SAS approval to use Blarcamesine (please see attached ).
Is compassionate use for those currently in the trial or can my Uncle's doctor request it? In other words, can non-trial participants be eligible for compassionate use if their doctor agrees?
Thank you for responding.
Regards,
Scott
Here is their reply...
Dear Scott
Thank you for your enquiry of 10/08/2020 to the Therapeutic Goods Administration (TGA).
Unless exempt or otherwise authorised by the TGA, therapeutic goods lawfully supplied in Australia must appear as an entry in the Australian Register of Therapeutic Goods (ARTG).
There are situations where special policies have been developed in response to the needs of particular people or circumstances. These policies have resulted in certain therapeutic goods being available without the need to be entered onto the ARTG. Information on some of these policies and the relevant procedures can be found at:
Special Access Scheme
Authorised prescribers
Personal import scheme
Clinical trials exemption schemeThe Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient. Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described by us as 'unapproved'.
Please speak to your Uncle's health professional about accessing Blarcamesine through the SAS for him.
If the publicly available information above does not address your query, please contact the sponsor of the therapeutic goods or consult your health professional regarding:
· availability of, or access to, goods
· manufacturing location or process
· ingredients or contents
· advice on using the good
· suitable alternatives to the good.For more information about the TGA, please refer to the short video on the Role of the TGA.
Yours sincerely
RebeccaRegulatory Assistance Service
Regulatory Guidance, Assistance and SME SectionRegulatory Engagement, Education and Planning Branch
Phone: 1800 020 653 Fax: 02 6203 1605
Email: [email protected]Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia -
God herlig morgen. Nu delt på Yahoo, den fik lov at stå denne gang :-).
har du set nogen steder om Anavex får betaling, eller er det at stramme den, nu det ikke er godkendt.
God dag
MM -
God morgen - betaling og pris på 2-73.
MM - sammenfatter jeg hvad jeg har kunne læse mig frem til betaler patienten af egen lomme. Forsikringen dækker ikke, da det ikke er endelig godkendt. Anavex sætter prisen, men det er ikke kutyme og velset, at man skruer prisen uforholdsvis højt op.
Anavex må ikke reklamerer for 2-73.I princippet svarer SAS til det i US - Right to try.
Man kan kun få det udskrevet via. sin læge og brugen er ellers på eget ansvar.
Lægen skal hver mdr. formel opdaterer SAS ansøgningen for den enkelte patient.Med 16 sites alene i AUS, burde der stille og roligt komme gang i udskrivningen til AD patienter, som i forvejen er tilknyttet en AD læge, men som ikke indgår i selve forsøgene.
Mund til mund princippet mellem lægerne burde hurtig kunne udbrede budskabet i de rette kredse.
Og hvad med presset på de nye AD sites i UK og Holland - og senere Canada, hvis lægerne ser at skidtet virker?
Mon ikke lægerne i disse lande høre om evt. positiv effekt, fra kollegerne i AUS?En ting jeg dog ikke forstår, er den totale manglende dækning fra medierne især i AUS???
2-73 er jo ikke bare en vitaminpille, men en potentiel unik behandling for en af de sværeste og samfundsmæssig dyreste indikationer.PS: Andel shortede aktier er nu på det laveste niveau indenfor det sidste år - lige godt 6.000.000.
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Tak for svar. Så må vi se håbe at Q3 er udformet sådan at vi kan udlæse tal for omsætningen (få et billede af hvor mange som har været interesseret).
I forhold til den manglende mediedækning, som du tidligere har været inde på, har jeg et bud. I og med at vi har set en masse gode indikationer af virkning, ja så har vi ikke fået det endelige bevis. Flere af dine indlæg har indeholdt materiale fra videnskabelige tidsskrifter og andre indlæg fra fagfolk. Hvis vi ser bort fra det faktum at medier jo helst vil svælge i dårlige nyheder, ja så burde der dog kunne spindes en solståle historie over de sidste års flow fra Anavex. Det ER dog et yderst vanskeligt område at forstå endsige skrive om, især uden at det vil blive en afskrivning af omtalte indlæg næsten ord for anden. Det er mit bud på den manglende dækning. Jeg er nu sikker på at når det endelige bevis (forhåbentlig) kommer, ja så bliver Anavex omtalt i de fleste medier verden over.
Jeg vil ikke lægge skjul på at jeg hader shorthandlere. Jeg må trøste mig med at de vil give et ekstra spike på "dagen vi alle venter på". I en anden aktie jeg har (redhill) har de styret gennem de sidste 2 år, hvor der er kommet den ene gode nyhed efter den anden. Der ser det heldigvis ud til at de er ved at tabe kampen, måske bliver imorgen det endelig stød til dem der. Nok om det.Kom nu Anavex
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Avxl - super du holder skanse MM, mens jeg fisker laks i Norge.
Bemærk:
Now Anavex, a drug used to promising effect in treating Alzheimer's patients, is being tested on girls with Rett syndrome.
Vi falder nok 10 % på den melding på mandag.????
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Avxl - 75 % chance for godkendelse - fra andet forum med forbehold.
I talked with someone at the TGA on Wednesday at in regards to blarcamesine and its 100% the truth = all Alz patients have access , just just need their DR. to fill-out the proper paperwork and submit to the TGA. A bit of paper-work as 2-73 isnt on the approved drug inventory, but people have access. She also told me around 75% drugs eventually get approved after SAS, unless there are safety concerns while under SAS. People failing to realize 2-73 will be approved are kidding themselves and making a petty large mistake.
75 % et gode odds for en godkendt behandling i Alzheimer, når intet andet hidtil har haft en effekt!!!!
Eneste forbehold synes at være bivirkningsprofilen. - Med + 5 år i AD fase 2 patienter og 100 % tilslutning for ekstension forsøg i AD fase 2/3, burde dette ikke være et problem. -
Avxl - RETT historie på MSN og FACE BOOK.
6.475 Aufrufe · 75 Reaktionen | Here it is, with the gorgeous Valentina and her mum Paige Moreno, also featured is Assoc Prof Carolyn Ellaway from the WCH Rett Syndrome Clinic. Not the full story we thought would go to air but none the less great awareness for Rett Australia and resesrch treatments. Big thank you to Valentina and Paige. | Rett Syndrome Association of Australia Inc.- RSAA
Here it is, with the gorgeous Valentina and her mum Paige Moreno, also featured is Assoc Prof Carolyn Ellaway from the WCH Rett Syndrome Clinic. Not the...
(www.facebook.com)
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Avxl - New hope for girls with Rett Syndrome!
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The Sydney Children's Hospitals Network (www.schn.health.nsw.gov.au)
"Our hope is that we will see positive outcomes from this clinical trial fairly soon so we will then be in a position to extend this treatment beyond the extension phase of the trial and provide it to all of our patients," A/Prof Ellaway said.
Hvis ikke AD eller PD giver Provisional Approval af 2-73 i AUS før, så er der gode chancer for, at RETT vil gøre det.
For virker det i RETT piger uden væsentlige bivirkninger, så kan man vel udskrive 2-73 til alle patientgrupper i CNS relaterede indikationer.
Husk - at evt. bivirkninger nok er den væsentlige begrundelse for, at forhindre et SAS godkendt middel at blive endelig godkendt.
Anavex har tidligere udtalt at de nok selv vil kunne håndterer salget i RETT og måske PD - men at de ved AD ( eller hele CNS området ) har brug for en partner.
Hvornår ville Anavex så lave en sådan partneraftale?
Først når de står med en godkendelse i hånden og derved spilde en masse tid eller indgå en betinget aftale, hvis skidtet skulle virke, før - som i meget snart?Vi må se, men tingene kan fra nu af komme til at gå meget stærkt!
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Hej Tasso, er der indikationer på hvor meget 2-73 bremser udviklingen af f.eks Alzheimer, for en kur er det vel ikke? Er der fat i noget med 2-73, der kan give håb om en kur i fremtiden? Jeg forstår naturligvis alle resultater er individuelle, afhængig af hver patients "entry point". På forhånd tak, Steen
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Avxl - Hej Steen
Side 17-20 illustrerer måske meget fint, hvilken respons man kan opnå i patienter i høj dosis 2-73 ( men ikke optimal titrering ).
Tænk at kunne bibeholde sin daglige funktionalitet efter 3 år.
Der er ikke taget forbehold for, at 80 % er genetisk mere modtagelig overfor behandling med 2-73.
Envidere har man ikke i nedenstående givet mere end max 50 mg.
Dvs. en evt. forhøjet og tålelig større dosis i patienter med de rette genetiske forudsætninger, ville muligvis kunne give noget der ligner en kurrende behandling.Bare det, at Alzheimer patienter i Australien med den nu tildelte SAS godkendelse nu på 6. år forsætter behandlingen, fortæller rigtig meget.
PS: Biogen havde deres Accumab ( som de skandaløst nu ansøger FDA om godkendelse af ) kørende i 12 sites i Australien - og de fik ikke lov til forlænge behandlingen med en SAS godkendelse.
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