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frrol, I might add that the path to approval has likely also been helped by the mixed reception of the three recent mAb treatments at the FDA and EMA, and by lackluster uptake of Leqembi specifically in the marketplace.
Power, I would simply say that if he is setting a target price of roughly 3x the current price, he is quite bullish. Most brokerage firms pressure analysts not to post targets more aggressively than that unless there is an immediate catalyst on the horizon. Like yourself, most holders who understand the dynamics here understand that once an MAA has been filed and accepted, AVXL will be trading comfortably above that $15 level. In response to that move, Summit Roy can claim victory and then set a new target of $45 (or whatever). More trades will be generated on the news and the firm's response. That is how the game is played. Even more importantly for holders, once the milestone of filling at the EMA has been reached (and expectations of a similar filing at the FDA gain in credibility), new sell side analysts will step up to the plate and carry the weight of more substantive firms than Jones Trading.
You go back to it. It said nothing about submitting in the first half of the year.
He never said 1st H24. Everyone knew, at least those who read the board, that it couldn't be in the 1st H24 by the timing of the rapporteur process.
Yes, falconer, I agree that it is extremely unlikely that have not undertaken the anti-aging tests on animals that you suggest. I doubt Missling would have dropped that "potentially anti-aging" comment he made in one of his more recent presentations were they not engaging in that sort of pre-clinical research.
I can't say about the actual submission, nidan, but we know to a fair degree of certainty that Anavex has told the EMA that it plans to file on some specific date within Q3 (and not later than the first week or so in September). Once Missling said they were in the rapporteur selection process on March 4th at the TD Cowen conference, that told us that the projected filing date was a maximum of 7 months subsequent to February 7th, the previous submission date for entry into that process. Obviously as a result of their interaction with the rapporteurs, the date could possibly shift somewhat from that projected.
Perhaps he then should also turn his attention to Remi Barbier at SAVA.
He apparently follows in his father's crusading footsteps (Bill Steiner).
Kenneth Steiner, a "Corporate Watchdog." You can google him and find long lists of various shareholder proposals and their targets.
frrol, if the EMA shared the view that contingent approval would be the more appropriate outcome for 2-73 on its current AD data, would they not have steered Missling to apply for Conditional Approval rather than Full Approval?
In citing the under $5 restriction of the ATM, Hosai, are you alluding to the new vehicle announced last week (and, I believe, put into effect yesterday)?
While I suspect that ultimately there may indeed be some commercial value in buntanetap, I have not been tempted to participate in ANVS because of their weak financial condition. As Langostino said, there will be a lot of dilution in order to float this boat. Furthermore, I had figured the AD TLR might redeem what figures to be an even worse readout on PD, where the company acknowledged data issues at some of the trial sites, and the scrubbing of what it did get has taken months longer than expected (not the mention the endpoint changes requested by the FDA after the trial had started). So the asset may seem cheap, but there is little cash in the corporate till to exploit it, and the PD results may exacerbate the problem.
I am sure there are people here with far more expertise that I, but I believe that Cog-13 is the preferred measure. It is my understanding that the two additional components are memory related, but would be interested in hearing from someone with more knowledge.
It is also worth noting, Ignatius, that they used ADAS Cog-11 versus the ADAS Cog-13 employed in the Anavex trial and the mAb trials.
OK, I was responding to a post about what I thought was your uncertainty on accelerated assessment at the EMA rather than the FDA.
Actually, if you look at the dates to begin the rapporteur process month by month, the actual selection is actually closer to 6 weeks after the submission deadline. Presumably because of the holidays, there seems to no submission deadline (and therefore commencement of the process) in the month of December.
frrol, according to the most recent (monthly) list, donanemab was not granted accelerated accelerated assessment. Its evaluation started on 8/17/23.
Thanks, Hosai. Perhaps because I am also a Gemini?
My understanding is that the second gating factor is when the company files for the rapporteurs. It won't get worked on until 7 months before the targeted MAA date. The EMA also advises against filing for the rapporteurs much later than 7 months prior. If the company also filed that in early/mid-December, then it would have met the January 10th submission deadline for the rapporteur process. It means that when Missling said on March 4th that he hadn't been notified yet on the rapporteur(s), the EMA had waited more than 6 or 7 business days after the published selection days to advise him of the outcome. Certainly possible, but it could also be that the company filed prior to the February 7th deadline (and they would have then been in the process, as Missling said, but were not going to be notified until after March 21st.) So, it seems to me, depending on our interpretation of Missling's comment, that the 7 month minimum until filing for the MAA would mean early/mid July to early September (at the very latest) for the MAA target given to the EMA, assuming the company does prepare it expeditiously, as you say. While mid-June is not inconceivable, I suppose, it seems quite unlikely with only three months left to work with the rapporteurs. I just prefer to expect Q3, leaning toward the first two months.
Baltimore, I have not heard of any new timeline given by the company on the MAA filing beyond the original "as early as possible in 2024." We do know, however, that when the company formally requested the appointment of rapporteurs on (or as much as 4 weeks before) February 7th, they had informed the EMA that the planned MAA submission date was prior to September 7, 2024. We know this because the company had to have an MAA submission date no more than 7 months later before the EMA would initiate the rapporteur selection process. On March 4 (at TD Cowen) Missling told us that he was awaiting notification of the rapporteurs and said that they were in the rapporteur selection process. The most recent filing deadline for the process at that time was February 7. I suppose since he said that they were awaiting notification, they could have met the January 10 deadline and that 6-7 business days after the selection process was theoretically over, the specific notification had not yet been given. I tend to go with February 7, but either way the target for submission was Q3 at that time.
plexrec, our CEO is playing by the pre-submission rules of the EMA, which he must. There are certain timing requirements that has to abide by. You can look it up, as Casey Stengel used to say. From what we have seen of the process so far we can safely say that he has given the EMA a projected filing date for the MAA in calendar Q3 of this year (and more likely in the first month or two).
Actually, Talon, Biogen is holding below $200 because of - not despite - Leqembi. The drug is falling well below sales projections. There are a variety of reasons, of course: physicians are, not surprisingly, quite leery about the possible side effects from a drug that is the first one with a black-box warning to be granted full approval by the FDA in two decades; infusion center capacities also seem to be a problem; getting PET scans signed off by private Medicare Advantage plans is another issue; approval by the EMA has been held up for further review, since the previously cited issues would seem to be even more of a problem in Europe; and Biogen/Eisai have been forced to delay an application for an injectable version after the FDA asked for several more months of immune response data. So, yes, Leqembi is doing no favors for BIIB shareholders.
He remains so.
It was a date in the summer of 2024 that Anavex told the EMA for submission of the MAA, and the EMA does not like to be disappointed on timing.
I found it quite worthwhile.
Fine summary thoughts on the Needham presentation, tschussmann. I, too, noticed the comment on the potential impact of 2-73 on aging. In the past Missling has commented on the potential prophylactic benefits of both 2-73 and 3-71 (presumably through the autophagy process), and I heard him once musing about that effect being something like taking a vitamin. However, I don't ever recall him specifically dropping the anti-aging suggestion. He tries not to be careless with words, and I suspect (like falconer long has) that the company has done clinical research on animals in that regard. Furthermore, since he let out that hint, I would imagine that the results were positive.
Frrol, I would agree that another phase 3 trial for Rett seems more likely than not, and I don't think Missling suggested differently in the last conference call.
However, while we indeed "have to contend with the endpoints' ostensibly successful use by other biotechs," it is worth pointing out that although the trial conducted by Acadia for DAYBUE - presumptively now the SOC - was fully blinded by clinical definition, the closely knit Rett community of parents makes extensive use of social media to share their experiences. The side effect of significant gastric distress (which afflicted over 80% of the patients and caused as many as half to drop out [as I recall]) did not go unreported on social media, thus de facto allowing for some real world unblinding by allowing parents of those who received the placebo to correctly imagine that their child was not receiving the drug.
It is also quite likely that the side effects are causing the rather tepid reception of DAYBUE in the marketplace and the somewhat disappointing subscription renewals. In their Q4 conference call in February Acadia (ACAD) gave revenue guidance for the quarter just ended that was about 15% lower than analyst estimates. The company cited "seasonal effects" from fewer patient office visits in January and early February. One analyst noted that patients taking DAYBUE had dropped from 900 at the end of the year to roughly 860 in late February. The stock fell sharply on the news.
Whether these things help Missling enough in his uphill battle to short circuit the requirement to redo a phase 3 remains to be seen, but they don't hurt.
Correct me if I am wrong, Joseph, but this article "From Autism to Alzheimer's..." seems to be recent (i.e., last week) rather than five years ago. Assuming it is, this is a new support structure for Anavex' case on the MOA. I suspect it will be extremely interesting and useful fodder to be presented with their applications at the EMA and FDA.
No, as far as the impact of an accepted EMA filing goes, you will be wrong. That event will trigger increased sell side coverage and increased ownership by institutions that can accommodate small cap stocks. With rather strong odds that the the EMA will approved, the stock will trade well in excess of $1 billion in market cap within a month or two of that.
Steady, mentioning as you did at the end of your post the long awaited PD trial, my last communication with an executive at the Shake It Up Australia Foundation about a month ago confirmed that they are still fully expecting that trial to commence this year. While the person said they were encouraging patients interested in this trial (or others, I'm sure) to register on their website so they will be available for recruitment when the trial is about to begin, I don't really take that statement to mean the trial is imminent.
Thanks for sharing your thoughts and experience with monoclonal antibodies, sab, and know that our thoughts are with you in your struggle!!!
While most of us roll our eyes when we see the seemingly daily forecasts on imminent AVXL price and volume from George, it is not unusual for him to actually post some useful information or reference worthwhile stories in the media. I am responding to his Saturday post of an article from The Guardian (US) which gives a European view of the monoclonal antibody treatments for Alzheimer's. The researchers cited are suggesting that the benefits cited are proving harder to quantify than the potential harms. You have heard much of it before, but the article is a good read since we know that blarcamesine (A2-73) has gotten over the first hurdle at the EMA and is on its way to an MAA filing.
While Dr. Sebastian Welch, a dementia researcher with the University of Cambridge is not terribly troubled over the ARIA side effect risks for the vast majority of patients (at least for those not on blood-thinning type medications), he is skeptical of selectivity of the trials where 80% percent of the patients were screened out as ineligible. To my way of thinking, he delivers the real "money shot," saying if, when prescribed in the real world, "the drug eligibility is restricted to match the trial eligibility, then very few people will be eligible. If legibility is broader, then the already small effects are likely to be even smaller and the side-effects more pronounced." That no doubt has been pointed out to the EMA (and will be to the FDA, if it has not been already) by the Anavex team in touting the superiority of blarcamesine.
Curious, is it not, abe, that it was only a 12 week study?
I guess you are not talking about their Parkinson's trial...
tschussmann, depending if and how you use leverage in that brokerage account, you should be able to restrict your broker from lending those AVXL shares out. Back in the day, my institutional clients loved to do that with heavily shorted stocks, making it known to their fellow institutional shareholders when they were doing that. The resulting squeeze could not only cause some short term levitation in the price but create outright panic when positive news hit the tape.
"13. Defendant Christopher U.Missling is and was at all material times Board Chair, CEO, President and Secretary of Anavex."
It would suggest better due diligence from the shysters at Levi & Korsinsky if they weren't wrong about Missling being the Board Chair currently and at all material times.
I would imagine, sage, that there was some dialogue with the FDA in the second half of 2023 when he could have brought up that idea you alluded to, AA with the OLE serving as a confirmatory trial. Again if I were guessing, he got some push back on that, so we have the more recent statement from him (in a conference call Q&A?) that the OLE would be part of the NDA package.
By "claimed," frrol, I meant that Missling said those things. As I suggested, I have no idea if they were statistically significant.
So, what can be said about the FDA's move to call in an advisory committee to review Lilly's drug application for Donanemab? First of all, a similar move was made during the Biogen/Eisai application for Lecanemab (LEQEMBI). However, at this late stage it was totally unanticipated by Lilly and the stock market. Predictably, LLY is down sharply today (shedding over $15 billion in market cap) on a day when Big Pharma stocks are up (despite Biden railing against prescription prices in the US last night) and BIIB is outperforming the group. The BIIB move is logical on the theory that it will have quite a few more months to establish LEQEMBI in the market before Donanemab is approved, assuming it actually is.
Beyond that, however, the publicity around this review (as well as the one currently being conducted on LEQEMBI by a Scientific Advisory Group for the EMA) is not helping the cause of monoclonal antibody treatment in the eyes of physicians and caregivers. LEQEMBI is already underperforming the initial targets set by Biogen/Eisai in the marketplace, and in recent special edition I noticed a poll taken by publisher "BioSpace" in which response to the question "Do you believe the current data show a benefit worthy of LEQEMBI's $26,500 price tag?" was 32% Yes, and 68% No.
In answer to sage4's question as to whether this is good timing (for Anavex) I would say it surely is. Both agencies, EMA and FDA, clearly have factions that are skeptical of the benefit to cost ratio - cost including safety, convenience of administration, and expense. Whether they approve LEQEMBI or Donanemab, respectively, or whether they don't, it seems that the outcomes will have been contentious. The physicians who prescribe for Alzheimer's patients by now fully recognize that there are significant limitations to what mAb therapy has offered up so far. The appearance of a drug application for Blarcamesine with a different solution (in a pill) that matches or exceeds the efficacy of mAb's in a shorter period of time, eliminates the risk of serious side effect, and slows brain shrinkage instead of accelerating it, will be taken very seriously at both agencies. (I didn't even mentioned the claimed benefits of better sleep, reduced blood pressure, improved tau levels and reduced inflammation, where we haven't seen the data yet.) So, yes, I think the timing of these calls for advisory groups, which is sparking renewed controversy over the mAb's in the press, coupled with apparently lackluster LEQEMBI sales, is very beneficial for Anavex's cause.
If you hadn't called the presentation a non event, I wouldn't be disagreeing with you, Investor. Whether there is any material information that is new to you or me is irrelevant. What is important is that this, to my knowledge, is the first presentation of the summary information from the Phase 2b/3 trial to an audience in Europe. It is not targeted to institutional investors, as was the TD Cowen presentation on Monday. It is targeted to opinion leaders - researchers and health care providers in the field of degenerative neurological diseases. It is being delivered not by a CEO but by a scientist, Timo Grimmer, well known in his field internationally and particularly in Europe. It is part of the first salvo by Anavex to get approval for Blarcamesine on the continent, and it comes at a time when there is little enthusiasm for LEQEMBI, whether or not that drug gets approved there over the next month or so. In my view it is a real event, not one that should be measured by whether it moves the stock at all on Monday.
Yes, plexrec, you can register for the online version of the conference. If you are not a nurse, student, or citizen of a third world country, you will pay 450 Euros for the privilege (last I checked), or E30 for every minute that Grimmer speaks. If you are good with that, you have to stay up very late tomorrow or get up very early early on Saturday to hear it. Go for it!