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Good work in the phone booth, Clark! Probably have a lot of Chinese buyers who listened to that call at 9:00 PM BJT and are putting the squeeze on the shorts.
Right you are, Hoskuld. I agree that many here do meet that threshold but are not institutions. Not only that, but those institutional numbers are misleadingly high because they do include the holdings of many of us who hold the stock "in street name." Look at all the brokerage names on that list. Some may hold AVXL in funds that they run, but for others much (if not most) of their total comes from holding the shares of individual investors who manage their own portfolio. Then, too, whatever the firms hold in their trading accounts on the desks at the end of the quarter also winds up in that "institutional" total, or so I would imagine.
That is a useful reminder, Investor. I expect the PDD peer reviewed paper to come out at the same time as the AD P2b/3 peer reviewed paper. That should be interesting...
Great work, boi. Best post of the week, if not the whole month.
First Purgatory, now Limbo! Are we dealing with biotech or theology today? Just for the record, I will put on my papal mitre (known as the Pope Hat in "Eurotrip") to officially inform the curious that Limbo is out, but Purgatory is still in.
As to the timing of the peer review, this hat does not make me infallible in such matters, let alone omniscient. Staying liturgical, I might guess before Easter. You might try giving up whining for Lent. (That was a bit harsh. I ask for your forgiveness.)
You would have preferred to own SAVA today instead of AVXL? For this trading session I would agree with you. Consider, however, the fate of that poor Congressional soul, Rep. Chris Jacobs (R) NY, who reported that he swapped out of AVXL at 8.67 and purchased SAVA at 42.15 on December 12th...
Waiting in purgatory isn't so bad. You can at least be confident of your final destination.
No surprise in those comments from Clint. They echo what Macfarlane said to Mayo about his experience with patients at his clinic in Australia who were enrolled in the study. While he never had the specific information on who was given placebo and who got Blarcamesine, it was clear from the observed behavioral changes of a significant number that they were benefiting from the drug.
I just took a quick look at the Capitol Trades site, and while I haven't found the Pelosi trade yet, I did see that Chris Jacobs(R) NY actually reported trading both AVXL and SAVA on the same day, December 12th. He reportedly sold AVXL at 8.67 (which seems below the range for that day) and purchased SAVA at 42.15. Ouch!!! That turned out to be one very costly swap...
Thanks, Red! Trading volume in the stock over the last 5 days has been muted, although it as outperformed the market. If this trend continues with only 1 million shares traded daily on average, it may get spooky for the shorts since days to cover at that pace would be 18 days!
In light of the performance of the xbi, as well as the lackluster volume in AVXL, I would say that the '"transfer" of assets from SAVA' has net/net very little to do with today's rise. The theory isn't bad at all, but I suspect it will take days or weeks for it to play out (and perhaps longer if some of the institutional money that exited SAVA today waits for the peer reviewed published data from AVXL).
Really, how did that big XBI day do for other developmental (i.e., pre-revenue) companies targeting neurodegenerative diseases: SAVA, BIVI, or ANVS? All in the red, unlike AVXL. Zig, you better zag and come up with another theory...
A question for board members to ponder. Regardless as to how one feels about Biogen and its product(s) or regulatory tactics, or, for that matter, how one feels about Anavex and the performance of its CEO, I would be interested to know how investors here believe the upcoming (by1/06/23) FDA decision on accelerated approval for Lecanemab will affect the (presumed) subsequent decision on whether to grant approval for Blarcamesine. In other words if Lecanemab is given the green light, does that make it more or less likely that Blarcamesine will also be given accelerated approval (potentially with a Phase 4 trial required)? Obviously we are likely to be getting a fuller data readout from Anavex in the next few weeks, but I am asking the question given what we know now and what we can reasonably infer about the data to come (e.g., subgroup analysis, number/distribution of "super responders," etc.) No need to rehash the current odds of Anavex prevailing short term at the FDA, but just an opinion on whether and how the Lecanemab decision will help or hurt. Thanks to any and all who choose to respond!
Mayo, we look forward to your thoughts in regard to an EMA-focused approval strategy, recognizing that some of the trials were carried out on the Continent and wondering if the very recent appointment of Professor Doktor Grimmer to the Scientific Advisory Board at Anavex was not related to this strategy.
Well, if I were Missling and had finished working on the more detailed results that I was going to release, at this point I would wait until the beginning of the new year rather than put them out in the final five trading days surrounding the holidays, particularly if I was indeed excited about them.
Actually, George, I hope the FDA does approve Lecanemab quickly because subsequent approval of Blarcamesine will then be a no brainer, so to speak...
I hope author is indeed correct about Lecanemab being likely to get approval, and I tend to think he is. Anavex needs a straw man like that to enhance its own chance of early approval.
Yes, I agree, boi, and that would suggest that close to 30% or even 40% of the 50mg patients wound up being super responders.
Boi, please help me here and clarify, is it your understanding (as it is mine) that the 10%-15% super responders that Macfarlane alluded to was the percentage across all of his patients in the study - placebo plus both dosage arms, 30mg and 50mg? (If so, the percentage among the 50% arm is likely to be an extremely impressive number.)
No, Fitzy, Missling's bogey is not the 1-2 month timeline with which the peer reviewed article was published. The real bogey would be the conclusions of the article: "Lecanemab...resulted in moderately less decline on measurements of cognition but was associated with adverse events." I am confident that the upcoming review of Blarcamesine will be more positive than that.
All decent alternatives, Clark, but it is hard to beat "Red Herring."
So Anavex slowed cognitive decline versus placebo by 45% (which is a blended average of the 30mg dose and the [superior] 50mg dose) compared to an oft quoted 27% by Lecanemab? Is that correct? Am I comparing apples to apples here?
Met primary and secondary endpoints is a nice headline...
No, no haircut...only a slight trim. He is our mad German scientist and program director. We don't have an Elon Musk, but we do have a Wernher von Braun.
That is certainly possible. Without having seen the visual, it sounded like the train of thought was continuing from the first sentence about OLE. Perhaps the "now" indeed changed meaning. Whatever, I agree that those episodic memory results are quite stunning.
I read it as new information, Avx4L. This is how the paragraph begins "We now reading out, I mentioned by the end of the year, the one-year open label extension study and see how the effect is over longer duration. We're now looking at the cognition, we look at episodic memory,..., and all of these were significant. And I like to highlight especially the quality of episodic memory for a reason..." Seems pretty clear to me he has pulled it from the OLE.
I agree, boi, that he stayed on the right side of the line, but most intriguing to me was that he apparently reached into his PDD OLE readout to give us the incredibly positive results on episodic memory at both the 30mg and 50mg dosages. No one seems to have commented on this data being from the OLE, but that is how I interpreted his remarks (and please correct me if I am wrong).
Yes, Treden, at Gugenheim he certainly led us to believe from the data he pulled out of PDD OLE on episodic memory, the correlation of that measure to ADAS-COG, and the pointed remarks about the similar Blarcamesine dosages that the AD P2b/3 would meet its primary endpoint.
In addition, Missling just stated two weeks ago at the Gugenheim conference, "We now reading out, I mentioned by the end of the year, the one-year open label extension study..."
In the Q&A. It is the answer to the first question from Soumit Roy(sp?) on sufficient powering.
Sorry, Leo, my bad. Pass me a (50mg) Blarcamesine.
He said “the high dose group was above baseline” - PRETTY SIMPLE ENGLISH. Did not claim everyone in the group, but indicated the group as a whole. You may not believe it, but that is what he said.
What PDD outcome data on episodic memory are you alluding to? It seems fairly plain to me by the first sentence of that segment ("We (are) now reading out, by the end of the year, the one-year open lable extension study...") that he is picking out something from the OLE study. He mentions that they are "now looking at" a number of things using the CR system battery. He then says "I like to highlight especially the quality of episodic memory for a reason - we noticed that the placebo arm declined,...,in the medium stopped the decline..., but the high dose group was above baseline." No, I don't think he meant every patient in each group, but the reasonable interpretation is the average score for the patients in each group - at least that is my interpretation.
BTW, as others have, I wish to thank you for providing the excellent transcript.
Yes, given that SAVA had traded at more than $44 earlier in the week, the price of $30 was a discount of nearly 33% from where it had been a few days before. No doubt whispers of the deal and the downgrade by B. Riley - guess they weren't invited to participate in the deal - took the air out of that balloon.
That's right, Hoskuld. I've killed women and children. I've killed just about anything that walks or crawled at one time or another. Worse than that, I was a sell side analyst and a hedge fund manager...
sab, SAVA broke down today because B. Riley downgraded the stock from a "Buy" to "Neutral" this morning. Hard for AVXL to hold its ground on a day when our evil twin is down nearly 13%.
No need for PR. Anavex is not attending a conference nor is it making a webcast presentation. Missling is probably meeting with a small group of investors and going over the same material he presented at Gugenheim. If so, he has to be very careful about what he says on the topic of the AD P2b/3 trial.
I think we are going off the track here with this Piper Jeffray discussion. It is extremely unlikely that it has anything to do with investment banking at the moment (although Piper is always hoping that its research efforts with put them in line for that). The snippet from the Fly that I read talked about a meeting being "hosted by Piper Jaffray." That and the simple fact that it leaked to the Fly tells me it is a meeting for Piper's institutional clients who are interested in AVXL (either as current shareholders or at least possible buyers). Let's move along, nothing to speculate on here...
Yes, while this rally in AVXL is very welcome and quite encouraging, some of it has to be attributed to a pharma rally, perhaps giving a particular boost to the more speculative names. SAVA's gains percentage wise over the last three sessions has been close to what AVXL has achieved.
Yes, while this rally in AVXL is very welcome and quite encouraging, some of it has to be attributed to a pharma rally, perhaps giving a particular boost to the more speculative names. SAVA's gains percentage wise over the last three sessions has been close to what AVXL has achieved.
Yes, with Herr Doktor Missling at the helm, you could call it a Teutonic shift…