Cassava Sciences Inc (SAVA)

[runncoach]

Wonder if that will have any significant efficacy data or if it would just be safety measurements

[HANUMAN]

Re my own question:

On-going Open-label Study with Simufilam in Alzheimer's Disease
In March 2020, we initiated a long-term, open-label study to evaluate simufilam in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily over 12 months or more. This study has reached its target enrollment of approximately 200 patients. We expect all patients for this study will complete drug treatment in Q4 2022. We expect to announce top-line clinical results for this study approximately year-end 2022.

[HANUMAN]

When is SAVA due to report further study results?

[runncoach]

Nice

[bandit007]

Liking this runner today. GL

[FooBarAndGrill]

#DuckAndCover $SAVA

[runncoach]

I watched the Megan Kelly podcast today on all the AD fraud and much was talked about regarding SAVA. What the guests could not explain is why anything that was potentially changed in the research (doctored photos or what have you) would have any bearing in the actual results that have been presented. I understand the "where's smoke there's fire" theory and I wouldn't gamble money I couldn't afford to lose here but the fact is the trials march on and one day we will see a result one way or another.

[FooBarAndGrill]

Cassava Director Sanford Robertson Purchased
100,000 Shares At Avg. Price Of $20.69. He paid cash.
Shorties listen up,

[runncoach]

Looks like some significant insider buying just reported and stock is riding quite a bit higher AH.

[McMagyar]

These 60 people are three years at least..
Into an Alzheimers diagnosis…
One year prior to study
One year on study
One year in OLE..

Some of them no doubt were placebo during the trial..

So we have 63 out of 100 who improved
5 points or more??? After three years of Alzheimers?

Without cassava these 63 people would already be walking cadavers in a memory ward..

Instead they have improved???

Wow..

Congrats cassava.. I will take three shots and a chaser

[FooBarAndGrill]

I've also had thoughts about the combo: Simufilam + A2-73. The two are so dissimilar in function ...

Here is a good study of the meaning of ADAS-COG11

[McMagyar]

Yep

[McMagyar]

Still looks like 80% number pos effect..

Would like to know genome of 63%

Hope they different than 80% S1r wildtype that Anavex’s Blarcamesine saves..

Think the combo could be sweet

[runncoach]

So glad these guys already had that 200 million for these 2 trials

[FooBarAndGrill]

Cassava Sciences Reports Second Quarter Financial Results for 2022, Mid-year Corporate Update and Interim Analysis of Open-label Study

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.

Financial Results - Net Loss for Q2 2022 Was $19.3 Million, or $0.48 Per Share.

Cash Position - $197.2 Million of Cash and Cash Equivalents at June 30, 2022.

https://www.sec.gov/Archives/edgar/data/0001069530/000117184322005276/exh_991.htm

[McMagyar]

Don’t worry
Just a shakedown by BP and govt partners

[shajandr]

DOJ opens criminal probe into Cassava over allegations of Alzheimer's drug data manipulation

Months after reports of allegations regarding Cassava Sciences’ lead drug candidate for Alzheimer’s emerged, the DOJ may now be raising its head to investigate the company.

A report from Reuters published this morning said that two sources had confirmed the US Department of Justice opened an investigation into Cassava over allegations that the biotech had manipulated search results related to simufilam, the company’s experimental Alzheimer’s drug.

The sources further told the outlet that the DOJ personnel investigating Cassava “specialize in examining whether companies or individuals have misled or defrauded investors, government agencies or consumers.” The sources did not detail the focus of the probe and if anyone specific was being looked into.

Shares of $SAVA were down approximately 30% in pre-market trading after closing Tuesday at over $21 a share.

The SEC had started investigating the company last November after Cassava revealed that certain unnamed government agencies had asked the company for documentation, going out of its way to say that the requests were not accusations of wrongdoing.

Cassava's problems just got much worse as SEC launches probe into data manipulation claims — report

This saga got its start last August, after law firm Labaton Sucharow filed a citizen’s petition with the FDA on behalf of two doctors asking the regulatory agency to halt all the company’s clinical trials until the company’s data had been audited. The two doctors are neuroscientist and Janssen’s former chief of neuroscience discovery David Bredt, and cardiologist Geoffrey Pitt, director of Weill Cornell Medicine’s Cardiovascular Research Institute.

The two doctors told the Wall Street Journal in a separate report last year that they had shorted Cassava’s stock, betting that the share price would fall once investors recognized the problems the pair found.
Hoau-yan Wang

According to the report, the firm started investigating Cassava after finding results “most unexpected and are probably unique” to two scientists: researcher Hoau-Yan Wang at City University of New York and Cassava’s VP of neurosciences Lindsay Burns. The scientists had published multiple papers detailing the company’s hypothesis about a connection of filamin A protein with Alzheimer’s disease — and that simufilam could address it.

However, the law firm didn’t buy it. The report noted,

This initial analysis suggests a pattern of clear errors and anomalies that are consistent with data manipulation and misrepresentation. These findings undercut the foundational science on which simufilam therapy is based.

Labaton Sucharow then pointed to three types of data it thought might be falsified: clinical biomarker data apparently analyzed by Wang’s lab; Western blot analysis that allegedly bore marks of alteration; and research involving human brain tissue using a methodology that Labaton Sucharow said “defies logic.”

“Cassava Sciences believes the claims made in this post regarding scientific integrity are false and misleading,” a statement from Cassava said at the time. “The Company stands behind its science, its scientists and its scientific collaborators, and is responding to ensure the facts are known and respected.”

The FDA rejected the petition several months later in February earlier this year. However, the federal regulatory agency denied the petition on procedural grounds, replying that the FDA is not permitted to initiate investigations based on citizen petitions

CDER director Patrizia Cavazzoni noted at the time that the FDA was concerned about the issues raised by the short seller.

“We take the issues you raise seriously. Please note that your Petitions are being denied solely on the grounds that your requests are not the appropriate subject of a citizen petition,” Cavazzoni wrote in her response to the firm. “This response does not represent a decision by the Agency to take or refrain from taking any action relating to the subject matter of your Petitions.”
FDA rejects citizen petition claiming Cassava manipulated data, but the biotech's woes are not over

Endpoints News has reached out to Cassava for confirmation and comment — and we will update once we hear back.

[runncoach]

Agreed. Not interested in the investment angle, but lets see what the trial brings

[Steady_T]

Hopefully the DOJ investigation won't stop the ongoing trial or interfere with it.
The drug needs to be evaluated.

[McMagyar]

No one has questioned the 80% response rate of phase 2..

Best I can tell
this is about MOA biogen has been scamming people with for decades out of over $50,000.000,000 being fraudulent..

From 2012..
If I have this right..
One of the benefits of cassava drug is reducing plaque.. but it’s not THE benefit.

THE benefit is making people better
which Biogen’s drug NEVER did..

But.. the phase 2 for cassava is succesful..


I think THAT is really the problem for big govt..

Big govt gets ALL that you have when you are institutionalized with dementia.

Everything.. you are left with nothing.

BP gets the institutional drug dispensary
Gov steals all your assets..

The last thing these sick bastards want

Is a treatment that works..

I am praying for cassava patients and dementia patients all over the world


This dark overhang must be brought into the light and pierced with trillions of
beautiful rays of light from our glorious God.

Prayers

[runncoach]

Not a great headline this morning. Not going to help the trials fill up any quicker. Still hope folks eventually find out if the drug works or not.

[McMagyar]

Shorty and Gov working together
Not a good sign for sick people

[McMagyar]

The point is
2012 is meaningless
when in 2020 you have succesful topline data..

Attack the topline data!!

Oh wait .. you can’t?

80% efficacy and very safe..

So let’s pay some guy $18,000 to review
Inkblots from a decade ago?

Cassava should Pay him $100,000 to review the topline 80% efficacy data.

[McMagyar]

25 years ago.. I drank a lot one night and said some things that were perhaps a little over the top....

25 years later I have two beautiful children..(young adults)

Does that make them.. shortable?

Aren’t my beautiful children enough?

Yeah they are..

unless you are an aborter

[McMagyar]

Better find a seller before 26?

[McMagyar]

10 years ago
Was when my mdx was first sold

It has 160,000 miles on it..

But I have changed the tires..

Wonder if a succesful phase 2 with efficacy for 80% and safety for 99% count as a tire change?

[McMagyar]

2012 is the best the bad guys got?
Really?
Didn’t cassava just successfully complete phase 2 and is well into finishing up recruiting for phase 3?

And a decade ago.. something was written..
Thank God they now asking to be on Supreme Court and are pro little babies..

Come after the 80% response rate in phase 2 you pieces of human garbage..

Destroy those results..

What the hell

Short Pfizer for killing people with toxin creating mRNA crap

[McMagyar]

Thx..
Biomarkers prove chemistry..
It’s good to show both..

I liked the gaba chemistry in Rett for anavex..

Just shows how powerful our bodies are

[FooBarAndGrill]

Bottom page 17.
PDF

[McMagyar]

Foo what page?

[FooBarAndGrill]

Cassava Poster Presentation at CTAD 2022
Navigation: ---> poster-presentations PDF

[HANUMAN]

Sounds like a very expensive P3. Glad they have the coin to pull it off.

[FooBarAndGrill]

The P3 Clinical trials are UNDERWAY!

70 sites RECRUITING. 1 NOT YET RECRUITING.
Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease (RETHINK-ALZ)

70 sites RECRUITING. 4 NOT YET RECRUITING.
Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease (REFOCUS-ALZ)

[FooBarAndGrill]

I'm sure an 8K is in process. SEC allows 4 business days. Can't speak to market.

[missile_systems]

am I missing something? no pr on the patent awarded ….
only up twelve cents at the moment….
what gives ?
thanks in advance

[FooBarAndGrill]

$SAVA patent granted!
An assay for Alzheimer's disease (AD) pathology in a living patient.

[FooBarAndGrill]

Focus.

[RedShoulder]

FooBarAndGrill, you lost me at the pictures.

[FooBarAndGrill]

We’d Like to Hear from You!
https://www.cassavasciences.com/static-files/49a05fdb-4b2a-4c42-b099-4dac39ee6d07

[runncoach]

Ha ha. Interesting

[FooBarAndGrill]

A Wang research paper was re-published by Springer.com. Wang was not involved in the re-published paper. Research Conclusion: word-for-word identical to the original paper.

OLD: https://link.springer.com/article/10.1186/s13024-021-00438-3
NEW: https://link.springer.com/article/10.1186/s13024-022-00549-5

[FooBarAndGrill]

Filamin A. Poster presented at Neurosymposium 2022.

https://www.researchgate.net/publication/361268287_Increased_insoluble_Filamin_A_concentrations_in_post-mortem_brain_tissue_during_mid-stage_Alzheimer%27s_disease_Neurosymposium_2022_poster

[runncoach]

Just for the record, that's simply publication of the application.

[FooBarAndGrill]

$SAVA new patent:
https://patents.google.com/patent/WO2022098700A1/en?assignee=%22cassava+sciences%22&oq=%22cassava+sciences%22
Think Cytokine Storm. Long Covid. Toxic Shock. ...

[runncoach]

You still trying to steal everyone's shares? Lol

[georgejjl]

One probably should not invest in Cassava Sciences until all investigations are completed.

https://seekingalpha.com/article/4517618-cassava-sciences-and-alzheimers-disease-a-precipitious-path

Good luck and GOD bless,

[HANUMAN]

Just wondering if there is a financial incentive somewhere.

[runncoach]

Just noticed this. If your MOA doesn't fit his "expert" theory on what helps AD then it can't possibly work very well it would seem. My understanding is he doesn't have any training in biology whatsoever. Apologies if that's wrong but it is laughable imo.

[HANUMAN]

What is behind Lame Simian's writing all the SA hit pieces on Cassava? Just curious.

[McMagyar]

Sava had 80% response with little to no adverse events..

Could be a mighty fine combo for moderate to sever ad and for those who don’t signal S1r wildtype..