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I have some dry powder coming soon....hoping I can catch these low prices before any of the moves you described take place.
I just finished listening to the CC and I agree. I was surprised by the additional detail that was provided indicating that after seeing the Alzheimers data the EMA requested that Anavex submit an application "immediately" and that Anavex was pulled into it (the submittal) as opposed to pushing the application with EMA. I also liked hearing that the cash runway of 4 years does not include the costs associated with marketing/commercialization of A-273 should the EMA offer approval. Rett feedback continues to be strong from the open label extension as well as support for P3 trial and Schizophrenia trial is moving very fast. The next six months should be interesting....
Since there is a significant cash runway, IMO the SP can languish for awhile without dilution perhaps until the EMA filing and other clinical trials are completed. There are other potential catalysts as well that could pop anytime like an FDA signal for AA application or an announcement on a partnership, which seems likely to be needed for EMA approval.
I'm buying at these prices...never know when they will file with EMA or a partnership is announced.
That sounds right. My only thought is if EMA saw the details of the data and suggested Anavex apply for approval, then perhaps BP has seen it as well. Anavex clearly does not have the staff (30-40 employees) to handle marketing, manufactruing and distribution if EMA gives the green light and I cannot imagine they would wait until then to partner up.
Plex....one thing I am not clear on is the need for Anavex to have a big pharma partner before applying to the EMA so that the manufacturing and distribution plan can be considered.....do you know?
Sarepta had the same class action suits when the stock dropped several years ago and now look at it. I bought more today at these low prices considering the EMA application, the FDA draft guidance and the brain atrophy results. I'm not thrilled with the timing of things, but I can certainly wait.
Good point... forgot about FX and Hagerman.
Duchenne prevalence is about 3 time higher than Retts and Sarepta's market cap jumped to the $10B range on accelerated approval for only three exons (about 15% of total exons). Prior to that it was about in the range of AVXL's market cap. If AVXL can get accelerated or full approval for Retts and can generate revenue, this will move.
This is what was on the poster from the European conference:
Fungal infections cause more than 1.5 million deaths a year. Due to emerging antifungal drug resistance, novel strategies are urgently needed to combat life threatening fungal diseases. Here, we identified the host defense peptide mimetic, brilacidin (BRI) as a synergizer with caspofungin (CAS) against CAS sensitive and CAS-resistant
isolates of Aspergillus fumigatus, Candida albicans, C. auris, and CAS-intrinsically resistant Cryptococcus neoformans. BRI also potentiates azoles against A. fumigatus and several
Mucorales fungi. BRI acts in A. fumigatus by affecting cell wall integrity pathway and cell membrane potential. BRI combined with CAS significantly clears A. fumigatus lung infection in an immunosuppressed murine model of invasive pulmonary aspergillosis. BRI alone also decreases A. fumigatus fungal burden and ablates disease development in a murine model of fungal keratitis. Our results indicate that combinations of BRI and antifungal drugs in clinical use are likely to improve the treatment outcome of aspergillosis and other fungal infections.
The link below seems to confirm....
https://www.edisongroup.com/research/spring-into-a-new-strategy/30825/
In a formal or informal recapitalization, shareholders will surrender their stock in order to strengthen the financial picture of the corporation, to induce outside persons to invest in the corporation, or to allow a key employee to acquire stock in the corporation.
Don't you love it when someone can't spell and calls others stupid?
Roche bought into the Sarepta gene therapy as a partnership but it was only outside of the U.S. and they paid them $1Billion. Maybe Roche is offering something similar for a partnership on AD in certain regions and the rumor got twisted....since Anavex already indicated they would go alone on most of the other indications.....or it's just a rumor.
I totally agree with you on the RETTs girls and the fact that A-273 seems to be working is wonderful news for the RETTs community. The RETTS prevalence in girls is roughly 1 in 10,000 whereas DMD is 1 in 3500 male births. Sarepta was seeking to treat exon 51 which is roughly 13% (1 in 27,000) of total DMD and their market cap jumped into the $8Billion range upon accelerated approval from FDA. If A-273 pediatric trial is as successful as the adult trial, there would seem to be a high likelihood for accelerated approval for RETTS.
In previous announcments, AVLX made it clear that they would partner with a BP on AD. We know from Mayo's notes that there is already interest and from the August 2022 PR that they are in negotiations. All of the nonsense about the trial results and data will be closely vetted by any BP looking at this. Even if the SP climbed upon the results, it seems illogical to consider selling until a BP partnership and results from RETT/PDD were announced. I will hold tight until that happens.
Agreed....further, if the conversation Mayo had with the exec at a top 5 BP comes to fruition and a partnership happens in 6 months, none of this will matter since a BP team, the FDA, other country medical agencies (AU?) and the SEC will all have access to much more data and likely a peer review paper.
So a physicist just happens to review the AVXL data and publish an article with a title that includes the word "spin". Too funny...if he was just an innocent scientist, would he really be inclined to publish that piece without having reached out to AVXL to double check first.
Absolutely brilliant information Jesse....thanks so much for sharing!
All the noise about the presentation itself is a distraction....AVXL indicated that they would partner with a BP to address A-273 for AD oustide of the U.S. Interested BPs will vett this data to a degree that is well beyond what any poster or article writer could do. At this point in time, waiting for a BP partnership and listening to Dr. Perry over message board posters is probably a wise choice.....
Here's the thing...AVXL indicated all along that they would partner the Alzheimer's and Parkinsons indications with BP and go alone on Retts. Even if the stock soared on the TL results for AD, it made sense to wait for the partnership and the PD and then Retts pediatric results. The platform is significant and will now be extended to Fragile X and other rare diseases which is also worth waiting for. It stands to reason that the scientific advisors at Anavex know many BP execs that will be very interested in pursuing the AD indication with Anavex....that seems like the next step...even before pursuing accelerated approval outside of the US.
https://na.eventscloud.com/ereg/newreg.php?eventid=687700
This link is all you need to know
Good points Falconer....do you think that AVXL will apply for accelerated approval based upn the biomarker that they emphasized today? From what I recall with a ducehenne drug, FDASIA allows FDA to base accelerated approval for drugs for serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint. The results reported today sure seem to support this approach and clearly there is no treatment available today. If AVXL received accelerated approval, it could pave the way for worldwide use....not to mention off-label use. your thoughts?
frrol...I don't see any way around small trials with rare diseases...hence the reason they are rare. FDA had to deal with this issue for a DMD drug that pushed for accelerated approval (AA) and they ultimately approved it. Most of the FDA staff that were trying to stop what little hope the DMD boys had have been removed or moved on from the agency. My hope is that AA would be welcomed by FDA for a terrible disease that has an unmet medical need and a drug with a pristine safety profile and stat sig results. We'll see.
Interesting....I wonder if this could be used in combination with A-273?
https://www.wvnews.com/news/wvnews/historic-breakthrough-wvu-rockefeller-neuroscience-team-first-to-use-ultrasound/article_cfe6fefc-eee9-5add-b853-23642a0a91a7.html?fbclid=IwAR172t5jyF96Pdof6ZbnhRVJxS55OTKqNOXJaWa2iYjSMcFH98UV8Q16_X8
That's hilarious!
Takeda and Zinfandel write off yet another Alzheimer’s PhIII after Actos fails a key interim test
All the B trials are completed and P is done except for results analysis. The K trial is ongoing but it is a relatively small trial....wonder what they are doing these days over at IPIX? Hmmm.....
I was going to ask, but he said "recently" and that the trial could theoretically start before the end of the year if FDA provides approval of the IND. FDA is allowed up to 60 days, but they do not have to take that long. I wonder if there is a way to check which INDs have been submitted and when?
Wow Scott...you have counseled Leo on financial matters related to P? That is impressive....are you counseling Dr. Missling as well?
There is plenty of interest in all the recent successful trials at this company...I think the board is too full of misleading info and negative, so everyone is heading elsewhere...unfortunate.
You are correct unto...I did not realize how far down the most read list we had dropped....everyone is bailing on this board. Even the Alzheimer board is getting more reads that this one...too bad.
I am glad to see you are still here BH. Sure seems like we are approaching that point where patience and this investment might pay off.
Another failed Phase III for AD....do we have the goods with AVXL? I think we may!
"A phase 3 trial of Accera’s Alzheimer’s disease candidate has missed its primary endpoint. The trial aimed to show Accera’s brain metabolism-focused approach to improving outcomes in Alzheimer’s could succeed where beta-amyloid drugs have failed, but instead ended up becoming yet another late-phase failure."
Well that is significant.....the SOC position could be in jeopardy for Aricept....I hope mono therapy with A-273 is as mcmagyar described it....new SOC soon.
I found this quote from the new Biogen CEO....interesting that he does not say "our" when referring to the experimental treatment for Alzheimer's....hmmmmm.
“Our near-term priorities are clear,” Mr. Vounatsos said in a prepared statement, adding that the company intends to “reinvigorate our pipeline in the areas of neurology and neuro-repair” and advance an experimental treatment for Alzheimer’s disease, among other initiatives.
Added today at 3.96....feel like I should add much more...this is being manipulated now, but once the word travels this could get very interesting very quickly.