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Since Dr. Sabbagh is listed on the front page of the CTAD 2024 Program as being on one of the Organizing and Scientific Committees for this whole event, I would assume that he knows what the phrase "Late Breaking" means -- and it is not a synonym for "rehash!"
I think you may be reading that correctly, frrol. I recall asking him whether it was possible that the trial could be finished by yearend. I didn't specify a readout, so he could have interpreted that as last patient treatment. Safety checks go out about 3 months on this trial, however, as I recall from clinical trials.gov.
And recall, Hosai, that at the Wainwright conference about three weeks ago Missling used the verb "updating" to describe where they were in the process toward MAA submission by yearend. Sounds like additional data to me.
So, frrol, please see if I am interpreting you correctly. Since Anavex went in requesting full approval, it is not open to them to change this during the initial (pre-submission) rapporteur process, and therefore Accelerated Assessment would not typically be open to them. However, if I read you correctly, the CHMP could still grant conditional approval after the normal assessment process, even if the MAA submission was for full approval?
If, as you suggest, the company could yet be steered toward an application for conditional approval, the EMA guidelines indicate that an Accelerated Assessment application may also likely be appropriate.
You “haven’t seen SAVA or ANVS attending these types of conferences,” kunð? Then open your eyes! Both are at Wainwright this week.
John, regardless of who you may think is the best presenter within the organization, people who come to an investment conference want to hear the story (and any updates) from the CEO.
Interesting. Thanks for bringing this Neorocrine Therapeutics schizo trial result to our attention, frrol. It appears that not matching the two rivals, BMY (which bought Karuna) and ABBV (which bought Cerevel), in a Phase 2 study, which suffered from the shortcomings you mentioned, cost NBIX roughly $3 billion in market cap today. It shows again what significant valuation the market is putting on potential Schizophrenia drugs even before a Phase 3 trial was launched.
sab, back in the Spring I said that it was no more than 7 months from the February request for rapporteur assignment -- the latter being confirmed by Missling in early March -- to submission, so the latest they had estimated to the EMA for filing was early September (although it could have been a few weeks earlier). At the ASM Missling said "by the end of the year," although he said that it was likely after September but that yearend was giving them a fair amount of cushion. Q4 submission was confirmed on the August earnings call. So, my best guess after that was (and still is) that it will be submitted in the October-November period.
Do we really know there is no plan to submit to the UK? Until it was announced as a done deal, we didn't know that there was a plan to submit to the EU. The Access Consortium submission would cover three countries in which the AD Ph2b/3 trials were held: Canada, Australia, as well as the UK.
Not only is the timeline in the UK speeded up by this process, but in one fell swoop and with only modest incremental effort Anavex could also use the Access Coordination submission to target Canada and Australia as well (and also Switzerland and/or Singapore).
Good find, Hosai. The rejection of LEQEMBI at the EMA will further reinforce the position of these researchers in the UK who are underwhelmed by the results of the mAb candidates so far.
I agree with you, crescent, about Rett not being dropped but moved to the back burner. Note that a follow up Rett trial doesn't appear in the "near term" column in the company's recent presentation slide. My own gut feeling is that a Fragile X trial comes before another Rett trial.
No, Neal, I think the Dane is closer, and it was still Saturday barely. Reports have him summering at his colonial estate in Ittoqqortoormiit.
It is not just a lot of people who are unaware of the tremendous rate of trial exclusion by the mAb's, it is the vast majority of those who comment on the cognitive results in these studies. Thankfully at least two groups of people are totally aware: the EMA and the FDA...and Missling will forcefully (but diplomatically) remind them of it at every appropriate opportunity in the approval process.
As I recall, even without the mitigation procedures that rate of falls was no higher among the dosed than among the placebo.
Yes, Hosai, if the mAb's are on the sideline in Europe (as Friday's LEQEMBI announcement suggests), it is very hard to imagine only a 10% penetration there with a $10,000 annual price tag, and, yes, I think the chance for approval there is way above 51%, particularly after that ruling. Yet having done this sort of thing in covering another industry, I know that there is no need to have the numbers generate a price target more than 6X the current trading price...
In December of last year Anavex got approval to use the centralized procedure. There are no submissions taken for Rapporteur appointment in the month of December (and it would have been too late anyway at that point). Perhaps because of the scant time and end of year issues, they didn't hit the early January (6th?) deadline, but did submit for the rapporteur process in the February (the 12th) opening, which was the next available. That much we know for certain, given Missling's remarks on March 4th. That filing date means the actual MAA submission was projected for 6-7 months later. That means mid-August to mid-September. Had the company not asked for an extension during the window in June-July (which they surely must have), they could have gotten the MAA filled by the end of Q3. So, with an extension of a couple of months or so (which is very common), they plan to file in Q4. All in all, it is hard to criticize their level of promptness. Don't just think about the number of months, Bourbon, but think about the process the EMA has laid out. Between the initial filings, the wait for rapporteur assignment, the useful interaction with the rapporteurs, and the compilation of the massive document(s), it takes a lot of time for any filer. Getting the MAA submitted in the October/November time frame would get a good grade for any moderate or smaller company that first got the OK in mid-December of the prior year.
All we really know is that Anavex filed to enter the rapporteur process on or before February 11th (as I recall the monthly openings). It was after the only January opening, since Missling said on March 4th that he was awaiting appointment of rapporteurs, which was scheduled to come later in March if that filing was in February. The LOI was either filed before the request for rapporteurs or at the same time. The projected MAA filing date at that time could have been no later than 7 months away, or September 12th (and I think, as someone here correctly mentioned, the EMA strongly prefers the rapporteur filing not to be less than 6 months from the projected MAA filing, so no earlier than August 12th for the MAA). I asked Missling at the ASM whether there was any issue with changing the projected date (knowing that he had a theoretical window to do so at that time). He said that such requests were made frequently by prospective filers. So, it appears he made such a request and pushed it out another month or two (and possibly three, but I personally suspect it would come in November at the latest.)
Indeed, crescent, approval in Europe should be the expectation, particularly in light of what happened on Friday. The decision by the CHMP to reject the LEQEMBI application (which has a rather minimal chance of being overturned) was a real surprise and a tremendous boon for Anavex, IMO. Aside from keeping that one major potential competitor out of the market (and tarnishing [further] its perception among practitioners here in the US), it also presents a real problem for the other mAb in the EMA hopper, Lilly's Donanemab. I think they will have a difficult time differentiating themselves enough from LEQEMBI to gain approval, since the verdict was that the efficacy in delaying cognitive decline does "not counterbalance the risk of serious adverse effects." Although I would be glad to hear counterarguments from others here, it is my perception that Donanemab may be very modestly more efficacious, but its risk profile is slightly greater. So the "dire need" for any new Alzheimer's treatment options, let alone one that is cost-effective, as you point out, will put even more pressure on the EMA from practitioners and patients' families for a solution. Both the chances for Blarcamesine's approval and the opportunity of a far less competitive market have improved significantly due to the LEQEMBI decision, in my view.
It is "possible" that the Phase 2 Schizophrenia trial (using A3-71) will be completed by yearend, per Missling. If so, I might assume TLR in Q1.
We have known (deductively) since early March that even back then the MAA filing could not likely be projected before September. So, back and forth with the rapporteurs has pushed the original projection back another month or more. Not unusual.
The skeptics have asked whether the slowing of brain atrophy with Blarcamesine is really a meaningful amount. Now we have the numbers, and it is!
I'll tell you what is due in the EU, Leo: a new treatment for Alzheimer's. To their credit, it wasn't Aduhelm; it now isn't LEQEMBI, because of the poor safety/efficacy ratio (and, undoubtedly left unsaid, the cost and the logistical difficulties of infusion and repeated PET scans); and, soon, it would appear, donanemab, for the same reasons as LEQEMBI. There will, nevertheless, be a demand for something from practitioners and patients' families. Their answer at the EMA will be Blarcamesine, as efficacious or more than the mAb's (in a shorter period of time), lower cost than the mAb's, easier administration than the mAb's, safer than the mAb's (with less brain atrophy as well), and more accessible across the entire continent. It is very convenient and powerful when politics and science point in the same direction.
Great! Less room for Anavex in that bucket.
Actually very little room for Anavex in the same bucket with Eisai, since with Donanemab now likely doomed for the EU as well. They better approve Blarcamesine or they will be coming out of the toilet with just their d*ck in their hand.
Obviously over the last 2 months that MO has worked very nicely. Think of how well it will go over the next two months as he does release some PR's of significance.
Well, to start, there were no fundamental reasons for the stock to go down as low as 3.5. Of course, there was a technical reason: the shorts played the index funds and their rules of rebalancing. The shorts drove the stock down to that level, thereby causing the index funds to sell AVXL stock under the index rules for rebalancing (by market cap, it would appear), allowing the shorts to close their trade at a nice profit by buying from the funds and covering. All that created a stock overhang, which disappeared at the end of June when the rebalancing was complete. Pretty much simultaneously, the market began to experience a fairly sizable rotation out of the big cap tech and into more traditional and interest sensitive names, and biotech was a winner, as one can see by looking at the XBI.
In the midst of that Q2 AVXL downdraft there was one significant fundamental change which wasn't recognized (and even now isn't fully appreciated), but it is starting to sink in with investors. The FDA came out with new guidelines on Alzheimer's endpoints, in particular deemphasizing the relevance of the ADL endpoint in the early/mild stage of Alzheimer's. Anavex not achieving significance on that measure appeared to be the major impediment to approval of Blarcamesine. Now Missling believes, as he stated at the ASM, that "the study is fully approvable." Beyond that, those things "in place already," as you put it, are.much closer on the calendar.
IMO, the above factors, technical and fundamental, have created "the sea change" in market sentiment. (I might also add IMO that if Trump is elected, the odds of FDA approval go even higher and would match or exceed the odds at the EMA.)
Which session/time is that, George?
Boi, I agree that there has been an upward move since the rebalancing overhang was removed, a rotation into small cap stocks began, and the XBI, in particular, started to rebound. However, there is no denying that the EF Hutton report has been an accelerant. The medium is the message.
New brokerage firm. New audience. The medium is the message.
This new guy at E. F. Hutton has industry as well as extensive Street experience, including some time as a portfolio manager. He has covered Anavex for a number of years and has enough confidence in its current situation and its upside potential to make it part of his opening salvo at Hutton. Good for AVXL and good for him, I believe, in terms of timing.
I didn't say you were old, sab. In fact I gave you an out by saying you could have posted from a country which had crossed over into Friday at that point.
Perhaps he is posting from Australia...LOL
Relax, power, the volume is low, so there really aren't many weak hands in this price range. As I suggested at the end of last month, with the overhang of index fund rebalancing gone the stock should be able to regain a fair bit of ground even without much news. There is anticipation of news, of course, and AVXL is helped by some rotation out of tech, strength in the XBI, and a resurgence of small caps generally.
They are all here, John, and more. This is "The Soft Parade" as Jim Morrison would say...
Correct. That is the bad news and the good news. Only those who traffic in microcaps will buy it now. The others will happily buy it at multiples of the current price when it is safer in their eyes and has more liquidity..
Yes, one drug will quite possibly be better than Blarcamesine by 2029: A3-71
Indeed, Ignatius. They opened it again and then had to halt it again down 35%,
Cassava, dropping 20%, has trading halted.
George, I imagine that the last treatment of a patient in the 3-71 schizophrenia trail could occur before the end of summer, but, if I am not mistaken, there are safety check follow-ups thereafter in the range of 3 months or so. What Missling said at the ASM was that it was possible that the trial could be completed by the end of the calendar year.
That said, I would also point out that there was another all cash bidder vying for Karuna against BMS. (As Casey Stengel would say, "you can look it up" in the Karuna proxy.) So, another company has at least $13 billion in change jangling around in its pockets looking for a target in the CNS space (and probably a lot more if the drug[s] in question can treat more than one significant CNS condition.)