You seem to be a great investor - making such money

I am a terrible investor and tend to lose money on many of my stocks

I personally like the potential of this product and as such invested r so long

I am more interested in success of the product compared to my profits - if the product is successful - it will make millions of life easier

Listen to this interview - very good
The Q&A are also very good

This interview was given when they started the 1st phase 3 but details on insulin delivery, the background, the lack of side effects - very good

In his words, the Jan results will be one of the biggest events in Insulin and diabetes world in many many years

BTW - Oramed uses traditional insulin and not the powdered one like the university is trying. However it seems the tablets can be stored at room temp

Also they are trying for one tablet per day - this will revolutionize diabetic care. In fact many people on Metformin etc also can take it as it needs very limited insulin to trigger the liver (in short - the injection gives entire insulin as needed by body but oral dose gives just enough to trigger liver)

I know but I am being very conservative.
Also - with my record on Israeli company investment (lost money on every co I invested) I am skeptical

I am not looking at $1000 - I will be satisfied with very good results in Jan 2023 and share price of say $25-30 - this will bring valuation to $1 Billion

I am ok with small wins - in this shit market that will be great returns

If the results are good to great - the insulin giants - Novo or LLY or MRK will go for buy out and it can go for $2-3 B

B.C. researchers make insulin pill 'breakthrough’

https://flip.it/QyENmv

They are calling breakthrough - ORMP will give results in Jan

Alzheimers breakthough -- the mechanisms behind learning and memory identified

Now, researchers have identified the intracellular signal cascade through which ACh regulates aversive learning, a major preliminary test for AD drugs. Researchers also found that donepezil activates this signal cascade to regulate aversive learning. The findings indicate the potential of the signaling cascade as drug targets.


https://flip.it/JVoHLr

The companion diagnostic is just a bs or vapor ware - like the promise of starting a trial for undisclosed indication - he is saying it for 2 years now

M likes to have long list of milestones - seems his fetish

“This study confirms that pridopidine plays an important role in maintaining the health of a neuronal cell by activating the S1R which in turn interacts with specific proteins to initiate the autophagic process”

It may be somewhat different

The last visit of the patient was by end Jun - so they probably have locked the DB and May have unblinded the data.

Once the data is unblinded, while the CRO or a 3rd party appointed for statistical analysis does all data churning - the company clearly can see glimpse of the data - once unblinded the data is no more secret - just remains confidential within a small group to avoid larger leaks.

SAVA posted good results and good update - they are running 2 P3 studies with 750 patients each - they have enrolled 200 patients in each till now - that tells enrollment speed.

Assuming A2-73 results are good in current trial - then FDA is likely to ask for 2 confirmatory P3 studies for A2-73 as well.
If you do simple math starting sometime in 2023 these 2 trials will give results in 2026 or later. So AVXL is nearly 2 years behind SAVA

—-_

Phase 3 Program - Over 400 Patients Are Now Enrolled in Our Phase 3 Clinical Studies.

Open-label Study – Results of an Interim Analysis on the First 100 Patients Who Have Completed at Least 12 Months of Open-label Treatment with Simufilam Follow:

Drug Appears Safe and Well Tolerated.

Overall ADAS-Cog11 Scores Improved an Average of 1.5 Points (S.D. ± 6.6; P<0.05)

63% of the 100 Patients Showed an Improvement in ADAS-Cog11 Scores, and This Group of Patients Improved an Average of 5.6 Points (S.D. ± 3.8).

An Additional 21% of the 100 Patients Declined Less Than 5 Points on ADAS-Cog11, and This Group of Patients Declined an Average of 2.7 Points (S.D. ± 1.4).

Cognition Maintenance Study - Completion of Patient Enrollment is Expected Q4 2022.

This was a very good quarter - achieved big milestone - has developed clear commercialization path - more partners in defense area

The Conf call was very good - mgmt is very confident and clear

O/s shares including warrants - just 7.9 million

@$20 - the market cap will be just $160 million

@$40 - the mc will be $320 million

My view - Looking at the potential - by this time next year, I guess the market cap will cross $350 million (May be earlier)

MRK enter ALZ area

Under the terms of the agreement, Cerevance will receive a $25 million upfront payment and is eligible to receive development and commercial milestone payments totaling approximately $1.1 billion, in addition to potential royalties on sales of approved products derived from the collaboration.



https://finance.yahoo.com/news/merck-enters-alzheimers-r-d-172143518.html

Good progress news today - they are executing well. SP is reflecting the good news.

https://finance.yahoo.com/news/ideal-power-delivers-initial-b-123000228.html


The fast-switching speed of B-TRAN™ solves the slow operating time and electrical arcing of traditional mechanical circuit breakers while also providing more than 50% lower conduction losses compared to solid-state circuit breakers utilizing conventional semiconductor power switches. These benefits position B-TRAN™ to potentially be an enabling technology for circuit breaker applications such as distributed direct current (DC) networks.”

That is another hollow promise by M
- nothing will happen for next 3-5 years and he will keep adding to milestones

Very good post - agree with your points.

On AD, I have reached that conclusion and staying here (and M has been indicating) that AD will need another trial. There is no way FDA will approve AD drug based on one P2 trial with 500+ patients when all other BP are required to carry 2 P3 trials with 1000+ patients.

With the approval path drawn by M, the 1st approval targeted for 2024, I agree that pop up in SP after AD topline results is ‘Sell the News’ event.

Only one unforeseen even - based on AD topline results, a new product hungry BP such as BIIB or LLY or Roche makes a bid for AVXL

The Good news

1. Last patient visit for AD trial completed by Jun end and topline results expected in Fall 2022 - (Sept 21st to Dec end) - at least it is more specific than end of 2022.

For me all other updates like PDD, Rett .. are just side news. Also all the planned initiation of trials and activities are pure B/S as he just keeps repeating. It makes him feel better that he has something to talk about.

The AD topline results - Christmas celebration or AD results stole the 2022 Christmas

4 years and she does not have much to report - whose fault it is

The key word is - an effective treatment - that is not proven yet.

Let’s wait for topline results of the AD trial and then see if it is still true

You say if another P3 is required - I say FDA will ask for another P3 trial and that will be larger to reconfirm the results with larger population.

Your other questions are valid and I do not expect M to give any answers. He clearly has over promise under delivery problem. That is his habit and it will not change. He received big options based on some soft milestones - once the final results come out and if they are not good, he will not get anything further.

Interesting - I have a different view

If AD topline results are not good - this will just tank badly - like 70%

That also means other indications will not do good

Yes - trial results unknown

At this point - everything is dependent on ALZ topline results - it is a binary event

Good or very good results - AVXL flies - no need to know any strategy etc

Not so good results - this tanks by 50%+

Clear results with no benefits - this tanks like 70%+

Lily - interesting approval path
NDA application is completed and accepted by FDA with PDUFA date - however the trial results are known as trial is not completed

————-

https://flip.it/sQeR_l Lilly takes long view on Alzheimer’s drug hopeful as FDA starts expedited review

In between now and when Lilly’s trial is set to read out early next year, results are expected to become available for two other amyloid-targeting drugs: Eisai and Biogen’s lecanemab, and Roche’s gantenerumab. As the drugs belong to the same family of treatments, those results could influence how analysts and investors view the likelihood of a positive Phase 3 outcome for donanemab.

On Thursday’s call, White sought to set expectations. “There’s a chance that we’ll see mixed results in some of these readouts due to the differences in the medicines and their trial designs,” White said. “We won’t be discouraged if others miss their primary endpoints.”

I agree with what you said. Also todays poster is not really that ground breaking.

In my view - SP can go to 3 digits in 1 year based on ALZ result that are likely to come by year end.

AVXL has 77 million o/s shares - @ $100 means marke cap of $7.7 B - not impossible - obviously ALZ results need to be spectacular

There was no PR - we do not know that the last patient last visit has happened - it will start the data lock cycle and we will know that topline results will come

Well - relying on small inconclusive trials and repeating at all places is M strategy.
Not working anymore.

We need to hear that the last visit of last patient ALZ trial is done which will set the clock for topline before year end. That is a binary event - make or break the stock price and heart of large number of investors waiting for the miracle for so many years

Alzheimers breakthough as scientists identify the mechanisms behind learning and memory

https://flip.it/yPwUbV

Evidence is emerging that our understanding of Alzheimer’s is incomplete at best and completely misguided at worst. While Alzheimer’s is clearly linked to age, it appears that abnormal cellular energy management inherent to particular individuals plays a substantial role in the development of disease. The paradigm is shifting.

However, some neuronal mitochondria show signs of metabolic defects and bioenergetic dysfunction during the earliest stages of Alzheimer’s, according to previous studies. Consequently, each unit of lactate provided to a neuron yields less energy. To keep up with the energy demand, neurons with damaged mitochondria reprogram their metabolic processes.

A very nice article (a subject this group liked as it bashed amyloid theory)

https://flip.it/Ef2uLp

We might have Alzheimer's all wrong

Signs of Alzheimer’s in Blood 17 Years Before Symptoms Begin

https://flip.it/RUaGt_

Surprisingly, we found that the concentration of glial fibre protein (GFAP) can indicate the disease up to 17 years before the clinical phase, even though it does so much less precisely than the immuno-infrared sensor.”

Still, by combining amyloid-beta misfolding and GFAP concentration, the researchers were able to further increase the accuracy of the test in the symptom-free stage.

Some you win some you lose - I had a lot of conviction but later lost faith after that time and sold completely.

May be news was leaked to few and it is not good

I am focused on AD trial results only
That is the decider - other trials are just also-ran category. If AD fails, others won’t matter much

We are at Jul 15th - no PR related to last visit by last patient

Knowing how much time M takes for topline - unless this PR comes before Aug 1st, we are unlikely to see topline by end of the year. This will become another big blunder and big Miss by Missling -

We should not be really surprised by this - Miss is in CEO name so he will miss the targets

Charts are post facto and a single event kills charts

Charts may be useful for established predictable companies

For biotech who depend on trial results etc - no chart can predict with decent certainity

The co has 38.6 million outstanding shares
If oral diabetes trial is successful - it can go to $100 before approval and still the market cap will be $3.86 billion

In my view - It cannot go to $1000 as it will mean $38.6 B market cap - unlikely to justify and it will be bought before that

NASH and Covid are hollow efforts - no good results are expected

I am saying that @ that price no one including most of the share holders will be happy as it cannot recover majority of costs - legal - compliance - marketing - supply chain and the big overhead to run such big operations

If pharma industry prices the products based on just recovery of costs - we will not have drugs with yearly costs of $50k to $200k.

If you hear some of the CEOs - they talk about pricing based on affordability and equivalent cost of care giving if drug is not available. If you see they act like groupies - even if a good competition product comes - they do not drop prices - only when generics come the prices get killed

This is my summary of the call from post 1324. So nothing has changed but he just reiterated the same points and stock went up by 40% - we don’t understand market

———

NASH results in Q3-2022
Oral insulin - trial 1 - results in Jan 2023
Oral insulin - trial 2 - 25% behind trial 1
Oravax open label - in coming months
US oral insulin can come to market - early 2025

Strong cash position, no debt

China connection
- $55 million payment - $17 remaining
- 10% royalty on net sales in China
- local partner will manufacture insulin and spend money to conduct trial and development
- he thinks China approval can come before US