Anavex NY TRÅD!!!
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Vi taler kun procenter og ikke absolutte tal
Nu fik Anavex en på hatten og ligger nu på en bund der meget vel kan ryge i dag.
Ihub omtaler en peer review artikel i proces, der i marts skulle være blevet ramt "omfattende rekonstruktion"
Det giver lidt ekstra spænding op til de nok afgørende næste 14 dage.
Aktien kan meget vel blive ramt hårdt hvis shortere eller blackrock, der kummulerer, vil det.
Så er det med at bevare modet undervejs.
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Anavex - Så vidt jeg kan finde ud af har Anavex mulighed for allerede nu, at udstede preferred stocks med mulighed for at kunne opnå stemmeflertal i tilfælde af fjendtligt overtagelsesforsøg.
De nye aktier der er lagt op til at udstede, er således ikke tiltænkt til dette formål. De må efter min bedste overbevisning være tiltænkt til en samarbejdspartner.
Alternativt til en ordinær eller rettet emission for at få penge til at kunne gå selv.
Sidstnævnte mulighed kan være baggrunden for, at vi nok skal længere ned kursmæssigt.
Jeg håber, at det er en partner der er på vej ind. Det kunne løse ressourceknapheden og rumme salgsorganisationen der skal bruges til de store indikationer.
Men jeg ville ikke undre mig, hvis "pengemændene" har overtalt Missling til at sælge dem en stor portion aktier til billig pris og derefter eksploderer værdien på Anavex.
Genmab begik den fejl efter min mening ....
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Anavex. Q2 rapport pr. 31. marts 2021.
CEOen:
This is an exciting time for Anavex and I look forward to advancing our impressive pipeline of mid- and late-stage clinical trials with a commitment to bringing innovative therapies to patients in need around the globe.
75,9 mill. $ på bogen.
Ellers fine ord og forventninger, men ingen af de data/ milepæle vi alle venter på.
Enste spændende kan måske være gode spørgsmål/svar under CC'en kl. 22.30 i aften.
Tålmodighed lidt endnu! -
Han siger at data kommer i dette kvartal:
"Positive momentum continues to build this quarter and affirms the strength of our pipeline and execution capabilities," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "For our lead drug candidate, ANAVEX
2-73 in Alzheimer's disease, we are close to complete enrollment for our Phase 2b/3 study, and we expect a very data-rich current quarter with data readouts from multiple clinical trials and the remainder of 2021 to be a catalyst-rich year for Anavex. This is an exciting time for Anavex and I look forward to advancing our impressive pipeline of mid- and late-stage clinical trials with a commitment to bringing innovative therapies to patients in need around the globe."Saa det ser alt i alt godt ud.
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Anavex Missling forventer nyheder i dette kvartal og "near term" milepæle - ikke en definitiv udtalelse.
Ville ikke være første gang, at han får skubbet nyhederne omkring data længere ud.
Men det er vel begrænset, hvor meget reel indflydelse han har på tidspunkterne - resultaterne/Peer Reviews kommer når de er færdige. Indrulningen i de forskellig forsøg er først færdig, når de forskellige sites har gjort deres - her kan Missling gøre hverken fra eller til.Men igen - intet negativt!!
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Der findes et mindre selskab, Annovis (ANVS) der på mange måder minder om Anavex. De forsker i det samme og har også valgt et alternativ til amyloid behandlings tesen. Det sjove er, at deres markedskommunikation næsten er en tror kopi af Misslings. De holder også deres investorer hen i spænding med jævnlig drops ang. en snarlig offentliggørelse af test resultater
Spændende at se hvem der først får lagt nogle statistisk set signifikante resultater på bordet Jeg selv har en større position i AVXL (som jeg har haft i flere år) og en mindre position i ANVS (som jeg købte i januar). Jeg tror det bedste man kan gøre som investor i disse 2 selskaber er at forsøge at pleje sin tålmodighed. -
Anavex Fonde/investeringsselskaber oppe på 28,98 %.
Tallene er som altid pr. slut sidste kvartal og der er en dag mere til at indberette inden den 15. maj.
Største er Black Rock, der har øget til 4.397.565.Har også kig på ANVS og har kun et lille frimærke indtil videre - de er dog noget tidsmæssig efter Anavex, men Anavex har jo også haft sine vilde aktie udsving tidlig i udviklingsfasen.
Håber spørgerne går Missling lidt på klingen i aften og får et eller andet nyt frem. Det vi har fået indtil videre i Q2 var alt sammen positivt, men absolut ikke noget nyt!
Hvis Missling og Anavex skal have sikkerhed for tilstrækkelig opbakning til de potentielle ekstra 100 mill. aktier den 25. maj, så tror jeg han skal komme op med et eller andet inden da - håber dette evt. kommer til udtryk i aften via. spørgerne.
Det irriterer mig f.eks. også, at man den 28. april meldte ud, at Avartar forsøget var færdig i juni - nu er vi en dag over datoen, hvor forsøget skulle være fuld indrullet, så det 7 ugers forsøg teoretisk kan afsluttes i juni.
Dvs. at man på bare på 14 dags tidshorisont ikke har styr på udvikling i sådan en simpel ting, er bare ikke godt nok!Når bare resultaterne er gode i sidste ende, er nuværende kurs og snak ligegyldig - markedet ser kun på de kolde fakta, når alt kommer til alt.
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Ingen tvivl om, at tingene går for langsomt. Derfor er mit håb, at de får en større partner ind meget snart.
Alt for få ressoucer til rådighed og at opbygge et pharma gøres heller ikke med et snuptag.
Håber det er hvad Missling tænke på, da han for nylig udtalte at de undersøger mulighederne for at komme hurtigt på markedet.
Pyt med kursen nu, hvis deres ord fra dagens meddelelse holder vand
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Anavex Husk webcast kl. 22.30!
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Der var ikke meget nyt i dag.
Vi vil stadig få mange data i dette kvartal.
PDD skal gennem fase 3. Men først peer review artiklen i dette kvartal og derefter fda møde.
De har samtaler med big pharma og vil ikke udelukke en aftale på et tidspunkt.
Men tænker selv at markedsføre rett.
Som jeg forstod starter de fragileX efter rett forsøgene.
Lidt tam omgang - synes de virkede trætte...
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Anavex. Udskrift webcast for Q2:
Starten med bl.a indrulningsgraden mangler, men bekræfter at vi får mange data og milepæle inden udgangen af juni.
I Alzheimer fase 2/3 forsøget er der forespørgsel om yderligere ekstension fra patienter og læger - dvs. udover de i alt 3 år!
Vil gå selv i RETT og potentiel partnerskab i Parkinson/ Alzheimer - optimering af værdi for aktionærer.
Forventer at RETT US og RETT 02 vil være tilstrækkelig til markedsgodkendelse fra FDA/EMA - bivirkningsprofilen fra ekstension forsøgene inddrages.Anavex Life Sciences Corp. (NASDAQ:AVXL)
Q2 2021 Earnings Conference Call
May 13, 2021, 2:00 PM ET
Company Participants
Christopher Missling - President and Chief Executive Officer
Sandra Boenisch - Principal Financial Officer & Treasurer
Conference Call Participants
Charles Duncan - Cantor Fitzgerald
Jeffrey Cohen - Ladenburg Thalmann
Raghuram Selvaraju - H.C. Wainwright
Tom Bishop - BI Research
[Abrupt Start]
... recommendation for each of the three studies. The DSMB recommendation is to continue the studies without modifications. This is very good news and indicates we are on the right path with all these studies.
As a reminder of our clinical strategy is to clearly differentiate from other biopharma companies and clinical studies in CNS, Anavex is continuing to pioneer the approach of big data, including all mix [ph] in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analysis of whole genome sequencing and gene expression data in drug development. And in particular, the potential to identify patients' genetic variants and gene expression changes that may predict increased chances of success of Rett syndrome, Parkinson's disease, and Alzheimer's disease treatments.
And now I would like to direct the call to Sandra Boenisch, principal financial officer of Anavex, for a brief financial summary of the recent reported quarter.
Sandra Boenisch
Thank you, Christopher and good afternoon, everyone. We continue to apply fiscally responsible management of cash utilization with moderate increases within budget. We reported a net loss of $8.2 million for the quarter or $0.12 per share as compared to $7.2 million also $0.12 per share in the comparable quarter of last year.
Research and development expenses were $6.7 million for the quarter compared to $6.1 million for the comparable quarter of fiscal 2020. The increase is primarily attributable to the continued advancement of our ongoing clinical trials. General and administrative expenses were $2.2 million for the quarter as compared to $1.7 million for the prior year period. The increase is associated with the growth of our team. Our cash division on March 31st, 2021 was $75.9 million, which we believe is sufficient cash runway for up to three years.
Thank you. And I will now turn the call back over to Dr. Missling
Christopher Missling
Thank you, Sandra. So, in summary, we expect a very data rich current quarter, with data readouts from multiple clinical trials and also the remainder of 2021 to be a catalyst rich year for Anavex. We look forward to providing further updates as advancements continue.
And I would now like to open the call for questions. Operator, please go ahead.
Question-and-Answer Session
Operator
At this time, we will be conducting a question-and-answer session for equity analysts. [Operator Instructions]
Our first question comes from Charles Duncan, Cantor Fitzgerald. Please go ahead.
Charles Duncan
Hey. Good afternoon, Chris and team congratulations on the progress. Certainly appreciate the update on enrollment in the Alzheimer's program. So, had a quick question regarding the DSMB decision recently to continue this study without modification. I assume that not only did they look at safety, but did they look at any efficacy end points and/or was there an opportunity to change the sizing -- upsize the trial to say data, I'll call it noise or dispersions and that was not done. So, that data is tracking as you would have anticipated on a blinded basis?
Christopher Missling
The Alzheimer study DSMB related question?
Charles Duncan
Yes.
Christopher Missling
Right. So the DSMB has access to all data. And we understand that DSMB made the decision to continue without changes according to their review. We do know also though that the focus on the review was on safety.
Charles Duncan
Okay. So, they're looking at safety adverse events, but were they also considering efficacy? Were there any kind of futility analyses, or did they have the opportunity to recommend upsizing the trial based on data dispersion?
Christopher Missling
The DSMB has usually very independent ability of recommendations, but the DSMB itself -- the priority is on the safety assessment.
Charles Duncan
Okay. So it sounds like in this case, they weren't really looking at efficacy at this point.
Christopher Missling
Again, their access to all the data, so that is the best way I can answer this question. So, there was not a specific request to look into something like futility.
Charles Duncan
Okay. Can you provide some color on the rollover rates for that study into say the Open Label Extension? Can you give us perspective on whether or not patients are going beyond the plan dosing period?
Christopher Missling
Yeah. So, we have a very high rollover rate from the placebo control part of this study into the ATTENTION-AD extension study, which is a two-year 96-week long extension open label. And we happen to reach the -- close to the end of this Open Label Extension study. And we have been received early request for a continuation of patients on this extension study, and we will very likely seek extension of the extension study because of that. And that reminds us of what happened in the Phase 2a, which was also originally limited to a extension period. And then because of requests from participants and caregivers and physicians, investigators, it was extended multiple times to end up a five-year extension in total. And after the five-year, as you know, the participants of the Phase 2a study ended up being allowed to produce a study as a drug on a human terror - the exception procedure. And so, this is the feedback we received from the larger Alzheimer study Phase 2b/3.
Charles Duncan
It seems like the positive relative to the perceived benefit that the patient is getting lack of tolerability issues. But when you mentioned high rollover, could I assume that's like 90% rollover rate or something like that.
And then secondarily in terms of the failure rate within -- or excuse me -- dropout rate within the placebo controlled portion, what were your assumptions and how well did the trial do thus far help patients staying on that?
Christopher Missling
Yeah. Right. So, the percentage is in the range of what you indicated of retention. So, extension into the open label study from what we understand, and we have modeled the dropout rates similar to other drugs in this field at Alzheimer disease. It's a long study. So, there is - in patients with a impairment, like Alzheimer with multiple diseases, not only Alzheimer, also cardiovascular features. So, there is often this phenomenon that the patients do not finish an entire study. So, we have assumed similar rates as in the other studies in comparable length. And I think we are not in any form of passion different than or worse than these numbers.
Charles Duncan
Okay. That's helpful. Last question regarding the Parkinson's disease dementia program, were you thinking about going to the agency with say an end of Phase 2 meeting? And if so, can you provide some color on when that might be?
Christopher Missling
Yeah. We said that we would do that. And once the data is completed, we're about to wrap up. You have to understand in the PDD study, there were a lot of measures included. The CDR system, the UPRS, the actigraphy, the sleep paradigms, and most importantly, what have been the most time consuming one, the gene analysis and all this together will be put together in the respected report and that will be shared with the FDA, and then we will be able to get the recommendation for the pivotal study in PDD.
Charles Duncan
Could that be this quarter or in ...?
Christopher Missling
We will do it as soon as we can. We will do it as soon as we can.
Charles Duncan
Okay. Appreciate you taking my questions and the added color.
Christopher Missling
Thank you very much.
Operator
Thank you. Our next question comes from Ram Selvaraju, H.C. Wainwright. Please go ahead. Perhaps your phone is on mute. You may go ahead.
We will go to the next question. It comes from Jeffrey Cohen from Ladenburg Thalmann. Please go ahead.
Jeffrey Cohen
Hi, Christopher and Sandra. How are you?
Christopher Missling
Hello? How are you?
Jeffrey Cohen
Doing fine. Just a few questions. So, first on the income savings. Sandra, can you help us out on the incentive income for quarter and what that might look like for the balance of the year, as far as our modeling purposes?
Sandra Boenisch
What is the question exactly?
Jeffrey Cohen
Wanted to know about the R&D development, Sandra, 1.27 for the quarter and how that may look like for the balance of the year?
Sandra Boenisch
I think it was 960,000 for the quarter, and we expected that will remain consistent throughout the remainder of the year.
Jeffrey Cohen
Okay. Okay. Got it. And for sure, can you give us some insight into the 2-73 trial more specifically as far as any discussion with the agency, as far as fast-track or accelerated approval?
Christopher Missling
Meaning for Rett syndrome?
Jeffrey Cohen
Yes.
Christopher Missling
Yeah. So, we have -- the first study finished, which was the very first study in Rett syndrome, the U.S. Rett syndrome, RS-001 study. And then we had seen a very positive outcome where we were presented top line data recently last year. And we will now be able to share the entire data of the study. And with that data, we will go to the FDA and discuss with them the path forward, given that we have two ongoing studies. One is the RS-002 in the stage age group with higher doses and RS-003, which is also high doses with a younger patient population. And we believe that the first study the RS-002 could be potentially pivotal together with the U.S. study. And that is the discussion we like to have with the agency. We'll explore the approval for younger patient population with the RS-003.
Jeffrey Cohen
Okay. Got it. And any update on the PDD Phase 2 and the AVATAR Phase 2/3 in RTT? Are those timelines still on track?
Christopher Missling
Exactly. So the RS-001 full data will be this quarter and the PDD study will be this quarter in the release of the top line data of the RS-002 is expected by mid of this year.
Jeffrey Cohen
Okay. And that's in adult population, correct?
Christopher Missling
That's the adult population higher dose. That's right.
Jeffrey Cohen
Okay. Perfect. That's all for me. Thanks for taking the questions.
Christopher Missling
Thank you.
Operator
Thank you. And we have Mr. Ram back on line. Please go ahead.
Raghuram Selvaraju
Sorry. Thank you very much for taking my questions. I apologize. I must have had a problem with the signal before. First of all, I was wondering if you could comment on strategic thoughts regarding the potential commercialization of blarcamesine in Rett syndrome versus PDD. And what implications that may have in terms of Anavex's overall positioning? Are you looking at those indications as opportunities to self commercialize entirely, or are you looking at each of them differently in terms of the degree to which Anavex is going to be directly involved in the actual sale of the drug?
Christopher Missling
That's a very good question. I think we are not -- would be not the first company to market a rare disease ourselves, if approved. And that is right now the going plan for Rett syndrome. So, we have put in place steps in order to prepare for that.
For the PDD, we have to be aware, we have to do another study, which is not -- which we didn't -- we have planned anyway, a pivotal study because the first study was a Phase 2 proof of concept study. And so, we have some more time to think about the second indication PDD in terms of marketing, if we would like to license it or how to structure a partnership, if at all needed going forward. So, this would be something we don't have to decide right now. But Rett syndrome, we would be able to market it ourselves to this content in the U.S.
Raghuram Selvaraju
And pursuant to that, have you made a definitive decision regarding the disposal of the fugitive priority review voucher that you would be eligible for if you won approval of blarcamesine and Rett syndrome, would you, in other words, apply the PRV to something else in your own pipeline, or would it be definitive that you would monetize it?
Christopher Missling
Right? This is the same flexibility we are able to retain given that we are planning to also open another study shortly after the Rett study in Fragile X, where we have very good pre-clinical data. And the drug also is within the family of autism spectrum disorder, like Rett syndrome is as well and where the drug is expected to be also superior to current treatments or symptoms -- or treatments to current opportunities in Fragile X, but also we have another rare disease -- rare disease, which we have not disclosed. So there are different ways to think about that. But we don't have to make the decision yet regarding how to address the voucher.
Raghuram Selvaraju
Okay. Great. And one last question. The clinical development timeline with respect to Fragile X, can you just walk us through what you expect the near term clinical development milestones to be in the Fragile X indication?
Christopher Missling
So for approval, you mean?
Raghuram Selvaraju
Well, start with the near term clinical development milestones, the next clinical study when that is likely -- when it is likely to report data.
Christopher Missling
Right. So the RS-001 full data will be this quarter. The RS-002 top line will be mid of the year. And the RS-003 will be in the second half of this year. And in between discussion with the agency, which will determine how the data can be utilized in order to get approval for the drug for patients which have no therapeutic available for Rett syndrome.
Raghuram Selvaraju
Thank you very much.
Christopher Missling
Thank you.
Operator
Thank you. Our next question comes from Tom Bishop from BI Research.
Tom Bishop
Hey, Christopher. I got a couple of little questions. But I have always assumed that Open Label Extension study means that everyone gets the drug. Is that correct assumption?
Christopher Missling
Everybody who had participated in the study previously, that is Open Label Extension for those who had finished the study, either in placebo or an active drug, they are able to get the drug, not everybody without any association or being not involved in the study.
Tom Bishop
Right. Right. And they get the drug for free still?
Christopher Missling
That's right. Yeah. Nobody has to pay for anything.
Tom Bishop
Okay. Sandra, could you just tell me the number of shares outstanding now, not average for the quarter, but now?
Sandra Boenisch
I think we disclosed in the Q. It should be about 70 million.
Tom Bishop
It should be what?
Sandra Boenisch
70 million.
Tom Bishop
70 million? Okay. And I was wondering if how many Alzheimer's patients still from the original A 2-73 study, which was 32 patients are still on the drug. And there's a famous graphic that I like that shows the number of patients that were on the medium and low dose that showed a sharp decline in MMSE and et cetera. And the -- and those on the high dose showing very little decline. But the total of the two, as I recall, was like 21 or 22 patients. And I'm just sort of wondering where the others went.
Christopher Missling
Yeah. So that was in the three-year interim analysis. We will be able to share the remainder timeframe possibly in the future. But the patients who have been in the study, they have now been switched over to eligibility of a humanitarian device exception -- exemption. That means they're not in a clinical trial anymore because it -- when the trial has completed officially the extension, but they continue to take the drug. And I understand that run about, it's less than 21. I think it's between 10 and 21 patients, if I'm not mistaken. There's a very encouraging number that there's still people after five years taking drug.
Tom Bishop
Yeah. Yeah. That's true. Also with regards to -- I've read some articles where other companies said they are working on the Alzheimer's indication, one guy -- one of them has a partner and the other one's got NIH funding, and of course, Anavex has neither. But I think that there's a good reason for both, but I'd rather hear it from you than me.
Christopher Missling
I think we're moving very quickly. When you look at those who that get the NIH grants, you have to have published data and then takes a long time to get a grant. And if you get the grant, it takes a long time until you get the money. So that's not a preferred way of moving for the asset. We've been very quick in moving forward the assets and the advantage of happening too early, that you are kept with the upside. So there's a biotech company. You just have not retained the upside for shareholder. And by pushing this out, that is the advantage of having real upside for shareholders of Anavex.
Tom Bishop
Right. And I was just wondering if you've ever had some interest from other people in partnering, or if you just shut them down because you want to keep the 100%.
Christopher Missling
We have always been called upon and knocked on the door to discuss this. And we participate regularly at the conferences like bio regularly. So, we are in discussions with the big pharma companies, but again, it has to be a mutually beneficial structure for striking something. And we are very excited about our projects and our pipeline. And we'd like to retain the upside for that reason. We are proceeding as we speak right now. It does not mean that we will not do -- partnership eventually at the right time, but we are aiming for shareholder value and to maximize it and that requires to have this flexibility of mind.
Tom Bishop
Okay. And last question, the Rett 003 trial, the ANAVEX trial, is that 003 or 004?
Christopher Missling
Tom Bishop
Is that due -- I was wondering how the enrollment's coming on that and what is the size, if you could remind us?
Christopher Missling
Yeah. We increased the size from -- we've said set more than 68, 69. So, it's going to be more than 69 and we have stated that it will be in the second half this year and then enrollment is going well.
Tom Bishop
All right. Fair enough. Thank you, Chris.
Christopher Missling
Thank you.
Operator
Thank you. We have a follow-up question from Charles Duncan, Cantor Fitzgerald. Please go ahead.
Charles Duncan
Hey, Christopher, thanks for taking the follow-up. Had a couple of questions, one back on the PDD and the other is on Rett. Going back to the PDD, your answer before -- I'm just trying to figure it out. First of all, do you intend to present the data or more findings from that study in the near term?
And then, with regard to the genomic analysis, I know that lab function has been a little bit COVID-fied [ph] if you will, in the last year, but would you anticipate, call it days or weeks or months or quarters in which you'd be able to move forward with perhaps end of Phase 2 meeting with the agency?
Christopher Missling
Right. So the PDD data, we'll have a lot of data because the entire CDR system has multiple measures. We're talking about a total of -- it's a lot of the cognitive domains have been captured in the system, very granularly and there is no total CDR system score and they all capture different levels of cognitive domains, like picture recognition, word recognition, picture accuracy, memory, word accuracy, and short-term memory, long-term memory and the reaction time, a short reaction time, memory action time.
So, there are different levels of cognitive tests, which are there, so that is already a lot of measures, which we will present and then comes the entire battery of what were called more participating measures of Parkinsonian disease, not the UPRS, UPRS 1, 2, 3, 4 and then we have the actigraphy, the sleep paradigms, we have two different sleep paradigms. And then on top of it, we have the genomic analysis of how the sigma-1 moves and what it does for patients and regarding sigma-1 status. But despite that, we are now there to finish this up, and we expect this data to be announced, presented this quarter, as we speak. And the discussion with the agency, we'll follow up very rapidly once we have that.
Just understand the agency request a report, the report has to be completed, has to be audited and reviewed and signed. And that's basically requires also some additional time. Business now all done. And this will be all done when we submit to the agency. And so, we expected we need to be -- I would say more question of months, not days, but not too many months. That's part of the best way to describe it.
Charles Duncan
Okay. That's helpful. And then my follow-up on the Rett program. Just quickly on the safety database in terms of its sizing, given the range of age groups that you're studying. What has the agency said to you in terms of what's going to be required for that safety database? It is rare disorders. So I imagine it's not two owners.
Christopher Missling
Yeah. So, we included in all our Rett clinical studies and extension study. So, in the RS-001, it's 36 months -- 36 weeks study of Extension Open Label that was already originally extended before. We have a one year extension in the RS-002, and also the same a one year extension RS-003. And given the history, and we believe these are sufficient timelines for safety, for on safety extension and from the feedback also from the European EU side of the operation, but we believe that what will happen very likely, and that's what Anavex is committing to patients and that's what we're here for is that, those patients who started a study with Anavex will also have always a chance to continue to stay on a study drug or ANAVEX 2 and 3. So it's very likely we'll also extend these extensions beyond the time period anticipated.
Charles Duncan
Okay. Very good. Thanks for taking my follow-up.
Christopher Missling
You're welcome. Thank you.
Operator
Thank you. And at this moment, I would like to hand the call back to Christopher Missling.
Christopher Missling
So, thank you very much. And I want to reiterate, we're very excited about our program. We believe we have a really strong pipeline and a platform which allows us to address multiple unmet needs.
In summary, we expect a very data rich current quarter, with data readouts from multiple clinical trials and the remainder of 2021 to be also a catalyst bridge year for Anavex.
With that, we look forward to providing further updates as advancements continue and stay tuned. And thank you very much and have a good week -- good afternoon. Thank you.
Operator
Ladies and gentlemen, this concludes our call today. You may now disconnect.
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Anavex mener altså, at kunne søge fda m.fl. efter RS-02 data er offentliggjort og peer review på US-trial ligeledes er offentliggjort.
Vel medio H221 med ansøgning om approval i Rett og dermed en evt. voucher, som jeg synes at læse skal være med til at finansiere fragileX studiet
Fragile X skulle efter Ihub være en 8 gange større indikation end Rett. Dette forsøg tager ikke evigheder
En approval i Rett kunne foreligge medio 2022 sammen med data fra alzheimersforsøget.
Hvis Anavex kan ansøge i Rett og få pengene fra voucheren så vil kursen stabiliseres.
Værd at bemærke, at udvanding af Anavex næsten er gået i stå og at en voucher kan stoppe det helt.
Hvad så de 100 mln aktier skal bruges til står så stadig hen i det uvisse og specielt når Missling sagde "license" til et partnerskab - altså ikke co-promote.
De nye aktier kunne komme i spil, hvis fda vil have et stort fase 3 PDD forsøg - hvilket bestemt er muligt.
En partner/licenstager kunne meget vel være interesseret i aktier sammen med en upfrontbetaling. Anavex har næppe ressoucerne til et 1000 personers forsøg med hurtig indruldning.
Tålmodighed som altid og intet sikkert !
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Lidt læsestof til weekenden:
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Rart at se at vi er over 11 igen, vi har næsten indhentet hvad aktien har faldet i værdi over de sidste 5 handels dage.
Har læst Peters Blog (lad os bare kalde ham det for nemhedens skyld), tror lige at jeg skal læse den et par gange mere men han er stadig positiv på 2-73 og placerer den i toppen, BIIB i bunden, SAVA i midten.
Interessant earnings call: Har læst den igennem på Seeking Alpha et par gange og kan ikke rigtigt finde noget at pege fingere på.
Tyder på at den metode de samler data på gir utroligt mange af dem og det tager tid at analysere dem, men de kommer snart (bio Tech tid, ha-ha).Jeg tror de bliver godkendt i RETT, det er jo en orphan sygdom så bare lidt fremgang= godkendt hvis der ingen alvorlige bi-virkninger er.
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Så der en 13f https://fintel.io/so/us/avxl/invesco
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Anavex. Andel institutional steget til 34,44 %!
Flere har øget deres position efter februar poppet.
Pænt øget andel procentvis, trods et større antal aktier pr. 31/3 2021.
Anavex har fra 31/3 til 15/5 kun solgt ca. 85.000 nye aktier - så umiddelbart mangler de jo ikke penge.
Spændende hvad de så vil med de potentielle nye 100 mill. aktier?
Tilslutter mig Solsen, at der er noget samarbejde/partneraftale på vej, hvis resultaterne flasker sig som forventet.
Anavex havde jo været i kontakt med flere BP.I morgen er det tirsdag - en ofte anvendt ugedag til PR.
100 % indrulning i AD kunne være en mulighed - kun 5-8 manglende patienter og 48 aktive sites!
RETT 02 må også være ekstrem tæt på 100 % indrulning.RETT 03 ( under 18 år ) vil blive overindrullet iflg. CEOen - så denne kommer nok lidt senere.
Tror på, at vi får noget rigtig godt ( Peer Review RETT og PDD) inden GF den 25. maj!
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