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This seems pump and dump schema for some people - the letter by CEO is good but nothing to go up by 30%+
Agree - M is following his pattern of over promise under deliver
Very logical
Another company issued shareholder letter and confirmed timing for topline results of their 2 trials - that bump can be justified based on specific information co issued
AVXL has not even told the last visit of last patient - the topline result clock will start from there
Interesting thing - the company has a range of products for CNS diseases but all are pre-clinical except for one being filed for AD treatment approval.
With this - the market cap is $7.1 Billion
This gives AVXL great hope if the current trial results come good to very good - they can also trial for early approval.
One big difference, they have collaborations with 2 major pharma - ESAI and ABBV - that gives them much legitimacy
Interesting - the trial results are still not out
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early AD is ongoing and enrollment of 1,795 patients was completed in March 2021. The readout of the primary endpoint data from the trial will occur in the Fall of 2022.
The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Eisai utilized the FDA's Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab….
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There numbers are just for fun and will become relevant provided the AD trial is successful and then the company still exist and is not taken over.
The company will be bought at around $12-15 B - which could be $120 to $150 if AD trial is successful.
If market or BP had some confidence, they would have invested some money like PFE did take stake in VALN and AKRO
They took 8.1% stake by paying Eur 9.9 and stock is trading at $30
This is great for both companies - PFE already tripled its investment value from $95 million and VALN got the money and SH are happy that SP is flying
Hope we should get such vote of confidence
Agree - Rett readout will not be in 2022 - it will be in 2023
If AD results are good - Rett will not matter as it is much smaller
If AD results are bad - Rett will not matter as it may also fail and it is much smaller
AD results are make or break toss for AVXL
I am optimistic to get data by Christmas but there is 10% chance that we will get it by Thanksgiving
The number of patient ration may be 1/3 USA and 2/3 ROW
Revenue wise - it will be 75% US and 25% ROW (the world that can afford)
Co will not even try to market to countries other than Japan - S Korea and Western Europe - China may be but it will squeeze the balls.
I am focused on topline results - all these responses are just time fillers - does not mean anything
If topline results are bad - the stock is dead anyways
For any company in early days to project such low costs is unrealistic or stupid.
Look at the sales force needed for ACAD and BHVN. Then supply chain people …
So to say that the o/s shares will remain at that low count is stupid - co needs money and they raise th’ issuing shares.
Anyways - if AD topline results are great we will cross $30 even without approval
Read this SAGA of bidding
https://www.fiercepharma.com/pharma/
how-did-pfizer-swat-off-rival-medivation-bidders-price-yes-but-a-ceo-confab-helped
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Check this - a drug that was doing just $2 B worldwide got them $14 B and intense bidding
If AVXL really has an effective AD drug - you can imagine the number of CEOs who will call M?
Biogen - Roche - Lily - Abbie - BMS - JnJ
All trying AD drugs (PFE officially is out of CNS as per their Conf calls some quarters back)
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The short list? Pfizer, of course, plus the $71-per-share bidder and one of the CVR packages, proposed by “Company 4” in the form of $63 per share in cash up front, and up to $5 per share in CVRs.
The two left out of that short list weren’t content to stay out, though; they came back with cash bids of $70 and $70.50 per share, and stayed in the running.
Final bids due August 19. One of the bidders dropped out. The rest of the bids ranged from $72.50 to Pfizer’s $77. The second-highest bid was $75.50.
The lowest bidder then dropped out, leaving three. Best and final offers due August 20. Pfizer’s $81.50 prevailed. The other two companies offered $80 and $80.25.
The projections are stupid at the best.
Look at ACAD or BHVN or any new small biotech - just to reach first $500/700 MILLION - you need to hire a lot more people and there are significant expenses for regulatory, manufacturing (3rd party), IT, marketing, legal … - so typically you add 500-700 people. It requires significant cash to support working capital. So the o/s share count will go much higher than 150 million
Also - if AD is approved - think about $8-10 Billion + BO - you don’t have to calculate EPS etc. at least 3 BP will be at the door fighting for the company.
Read story about Medivation open auction after Sanofi takeover bid BP have money and they will spend it
https://flip.it/VsEbL4
Supplements That Strengthen Your Mitochondria, Says Science
China participation in early days - not good. There is no leverage for negotiation and other small biotechs had sold their product rights for Pennies.
Once you approve the product go there as large market else keep away - your IP will be stolen easily
Hahaha - ‘we got this’
Not even inventor of A2-73 has and will say it till final results are out.
I like your enthusiasm and confidence but let the AD topline results come out and then we will see.
As to the R&D day - more like deflated bubble
Wait till EOD - will be lucky if it ends up even 5% up
This is a play stock - when there is no news or content - stock cannot fly high on hot air
So what happened on the big R&D day?
Absolutely nothing
Nothing new - nothing special
So why it was called R&D day?
Who cares - it is a day to forget
Get me AD trial results
In 6 weeks, M cannot even drive to airport from his house - he needs CRO and Ariana to arrange it
https://flip.it/x9bqGK
Blood Vessel Breakthrough Major Step Towards Alzheimer’s Treatment - Neuroscience News
This is a secret event so only some people will get the great news
This is an interesting article
“(Lay Summary: There are thousands of S1R agonists around. Why Anavex2-73 seems to work better. Our modeling studies suggest that Anavex2-73 is unique in that it could also be a potent FKBP12 inhibitor, even Anavex (the company) is not aware of it! Most likely Anavex2-73 will succeed in clinical trial in AD because it works in both pathways!)
(Lay Summary: Upon laboratory confirmation of the modeling studies, Anavex2-73 could change the way we treat or see Alzheimer’s disease. It could restore memory function and completely change the trajectory of disease progression. As a matter of fact, it should work on other diseases as well such as Parkinson’s, ALS, Fragile X syndrome, Rett, and possibly others. As for the ongoing trials, the results could be so spectacular that we would have never expected!)
You are absolutely right
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R and D day could be significant if done right. We shouldn’t have to guess, or question or make an excuse.
It’s on Tuesday for Pete’s sake. Nothing on the website, no additional details. It’s a super secret guessing game!
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He is conducting R&D day as if it is one of the milestones based on which he will get some bonus and options.
Most BP have R&Ad day to showcase their progress, show the focus area, tout some products. They advertise few times before so right people are aware and attend it.
Based on how M is doing, the RDD will be kind of low affair with some analyst who do not any industry standing or those who do not have assignments will join.
I hope we all do not get a feeling that he should not have carried RDD
Topline results by Christmas is my guess based on standard timelines
A sparkly red shiny bicycle (if not car) is my hope - I don’t know how the results will come. If you were to go by all the AD trials - the probability of very good results is like less than 5-10%
The last patient was dosed 48 weeks back - so that time was going normally - Missling does not control time lapse - so I am still hopeful that we will hear about last patient last visit and Christmas topline results
This is why I am awaiting the topline results - this trial is decent size 500+ patients and 48 week. The results will be credible.
Just based on these results - the SP could start flying as there are no big trials this close to results and every other company is dropping - SAVA is in line but their recruitment is so slow that the results cannot come before 2024 end or 2025.
Look today AKRO - PFE bought just 6% of the shares and stock is flying 25% - they are also awaiting NASH phase IIb results in Q3-2022. If some BP shows such confidence in AVXL - SP will start flying
Yes, actually I think that there is 90%+ chance that we will get topline results before Christmas
Whether the results are positive or negative - not sure. But that is part of early biotech investing.
https://flip.it/tXLLqX
Sugary protein could play key role in Alzheimer’s disease
That is what I am doing and saying - wait for AD results - I am optimistic that we will get topline results before year end - more like Christmas
But we need the approval first - I am saying that they will need a larger AD study before approval
Agree with your first part - trial not halted so no dramatic results. A large follow up full P3 trial will be needed
That does not answer my question - show me a single global drug that was approved in Australia first based on Australia trial. - None
So I am right to say that AU is unlikely to approve an important drug like AD in Aus first.
There is nothing happening down under.
I have mentioned for many years - show me a single drug that Australia has approved before any other country? None
There have been many false starts in AU but unless drug trial is done in Europe or US drug does not get approved. China-India approve their own drug but that does not count outside those countries
In fact if anyone who believes that A2-73 is a drug that will help AD, Rett, PDD patients should be worried that such a drug is in hands of such an incompetent CEO who has not been able to move the drug fast enough - Delay is his middle name
Raja - seems you have changed your opinion about M - you have joined my team of being skeptical about M and his inability to move things forward - overpromise and under-deliver
He wants to keep it secret so no one should know that he is developing an AD drug else cabal will attack - haha
That was 6 years away - not relevant anymore - G has recirculated this stale story at regular frequency - no one cares. FDA does not look at it for approval