Cassava Sciences Inc (SAVA) News

for a very long period (years), i have cheered on the FDA for standing behind SAVA/SIMU.......starting with the SPA then to the dismissal of the Citizens Petition just months later in 2022.......I have always eluded to the fact that it is extremely prudent to adopt a bullish bias on the FDA/SAVA........Today, this is elevated with yesterday's announcement on the extended trials.......the subtle HINT i take away is the FDA has a sharp interest in Simufilam >>> taking the drug to approval.....yes, yes and YES!

we are on our way to triple digits testing the all time high......PH3 Strong!!

delayed reaction to yesterdays confirmatory news on the extended trials which allows those on simu to stay on simu and even more importantly simufilam WORKS unlike the brain bleeders that do little but compromise the suffering AD patient......this rally on this great news is worth a new 52 wk high....how about triple digits high!!

Simufilam (PTI-125) is a small molecule that targets an altered form of filamin A (FLNA), which is implicated in Alzheimer's disease. By binding to this altered protein, simufilam aims to reduce neurodegeneration and neuroinflammation, and it has shown potential in disrupting the binding of amyloid-beta to neuronal receptors, which is a hallmark of Alzheimer's pathology.
To put it in a plain language - triple digits after P3 readout

SAVA

Nice move today for the bulls!

How would 30% of patients not being helped make for great results? And no 90% isn't unheard of. Does mean it's safe and that's why FDA hasn't stopped trials even with company management stepping down or indicted and is great news compared to MABs for sure

Thanks Doc! Hoping for the best here but 92% is just nuts!

Agree that the chance of success is lower than 92% (imo quite a bit lower). AD is difficult and small cap bio's in this space are very speculative.

The corporate presentation showed 71% of the patients in the two trials are Mild (though table should say MCI or mild). With an average CDR-global of 0.75-0.79, many of the mild are actually MCI (CDR-G 0.5).

We don't know what the SAP actually has as the specifics of primary endpoint analysis but as long as pre-specified before the study is complete, it would be legitimate to have a primary endpoint analysis where the highest hierarchy is analysis of the 71% MCI/mild patients and a supplemental analysis (or secondary) to be the entire cohort. However, given the company's reputation being below that of most politicians, if this is true, they should state it before the trial is complete. Cassava should also release the dated SAP when the P3 results are released (at least IMO), especially if the results are good, to avoid claims of bias.

70% of the P3 patients are mild so extrapolating the P2 results makes for a potentially very favorable outcome in the P3. Also, 90% of the P3 completers are electing to continue taking the drug in the extension study. Unheard of in AZ trials.

The trials were designed before folks realized it doesn't work for moderate patients and included them in these current trials. No one believes there is 92% chance of successful trials. Least of which Wallstreet.

Pentara was responsible for the statistical analysis of the Phase 2 and Phase 2b trials, focusing on cognitive endpoints and overall efficacy of simufilam in patients with mild to moderate Alzheimer's disease. Wang and Burns were not involved in these trials.
Therefore, the Phase 3 trial was designed to have a high probability of statistical significance based on the untarnished Phase 2 results.

Per trial design the probability of either Rethink(0.63) or Refocus(0.80) achieving statistical significance is (1 -(1-0.63) * (1-0.8)) * 100 = 92.4%

Sitrick And Company is Cassava's new PR firm. What do you think about that? Fortune magazine has called our founder and Chairman “one of the most accomplished practitioners of the dark arts of public relations.” The Financial Times called him, “The spin doctor’s spin doctor. https://www.sitrick.com/

Not the right answer but it's OK. It will impact trial results. Folks should be aware of that and with the latest debacle folks may shoot first and ask questions later.

you should know the answer to this, since you claim you did thorough research. The FDA encouraged them to include moderates to open up the possibility of helping patients on the worst end of the spectrum. If FLNA misfolded proteins become too severe, blood flow is cutoff to areas of the brain and cell damage occurs. If too much damage has occurred they will be less likely to respond to treatment. It needs to caught early enough.

They aren't the only ones, no. And if everyone knew it wouldn't work for moderate then why include in the primary results?

Blame the boogeyman but don't respond to facts. Got it. Founding members of the company gone but blame it on the shorts?

You clearly know nothing about me but no nevermind. Keep running AI "research" and pretending to not understand that moderate patients did even worse than expected in P2 and many were included in the current P3. Cross your fingers and don't gamble more than you can afford to lose

Credibility is near zero based on what ? It’s pretty easy to see you’re not an objective person and have some slanted view. Their data has been by far and away the best of any BP or biotech. I see one consistent theme with people like you that make it hard to take your post seriously. Their data is questionable because they didn’t copy the rest of the industry and go after clearing Amyloids.
The irony is now the rest of the industry is copying their misfolded protein theory Mr runcoach.

Rick Barry would not have stepped his toes onto a sinking ship when he made the decision to join SAVAs BOD which was months after the Citizens Petition had tried its success back in the summer of '21......Nor would he take command of a sinking ship today unless the ship was being steered off coarse by (shortsellers) all the while knowing the fundamentals behind simufilam were still in tack full steam ahead PH3.......i believe Barry knows HE'S GOT THIS......

i could not be more pleased with the change of the guard which includes the role Matt N may be assigned with all things SAVA whether it is on X or here @ SAVA or commandeering an alliance with a major potential shareholder (Elon Musk)......go team go,,

from Matt N. on X
"I believe short sellers and big pharma are using the government to stop a promising and safe Alzheimer's drug from getting to patients. Dr. Wang, as a professor and researcher at a small university, is an easy target for the attack and is all alone to mount a fair defense. "
and more..
"Dr. Wang has dedicated his life to curing Alzheimer's disease, but now his safe, twice a day pill, in phase 3 trials at the FDA is coming under attack by short sellers, big pharma competitors, and the DOJ. The DOJ has indicted Dr. Wang 3 months before the first phase three trial finishes in October of this year.
Families on the drug and clinical trial sites that have run the trials have said that the drug does turn around Alzheimer's disease. "

I know the answers. Apparently some don't. AI is useless evaluating a drug for a disease that no one completely understands. Read my post from February 7. It is much more telling than anything AI can spit out IMO. GL

This is all public information, do your own homework. Go to perplexity AI and ask question. It will tell you everything, beats googling.

What mmse scores were allowed in these current trials? What did the bottom range of those score in 2B trials? Scoring range was too broad but not known until too late for current trial recruitment.

P3 excluded vascular dementia and some other conditions. So, the results should be better than P2b. Designed for 80% probability of stat. sig.

There were mistakes with how the current trial was set up that will likely keep the primary endpoints from being met. There will be explanations for the miss, perhaps valid. Problem now will be that wall street will now have an excuse, and so will the FDA for that matter. Now that's just my opinion but for sure based on 2B studies, the current trials recruited patients from too broad of a scoring spectrum.

Believe me I hope the drug works but today was hard for me to believe

You missed the point.
Simufilam binds to and stabilizes filamin A (FLNA), a scaffolding protein in the brain that becomes altered in Alzheimer's disease. Lingering effects of that are to be expected and CMS study confirms that. For the first 3 months there was almost no difference between drug and placebo - simufilam repaired some of the AD damage as was expected. Next 3 months that residual effect gradually disappeared and the study confirmed it. Has nothing to do with stat. significance, that was not the purpose of the study.
P2b data thoroughly reviewed by FDA prior to P3 trial. Board action is a good thing for SAVA, Remi made mistakes. Based on P2b results P3 RETHINK has a great chance of being statistically significant - per study design about 80%. REFOCUS even better, about 90%.

Imo there has never been a more true binary outcome for a pre-revenue biotech than for shareholders here with current trial P3 results. This thing will go to near zero if end of year results don't meet primary endpoints. If results drag out past early January pretty much the same thing is my guess. Credibility is near zero and very fortunate the trials are so far along

What statistical significance level was that?

The Cognition Maintenance Study (CMS) was a Phase II randomized withdrawal trial evaluating simufilam, an oral therapy developed by Cassava Sciences, for the treatment of Alzheimer's disease. Here are the key findings from the study:
Study Design:
The CMS enrolled 157 patients with mild-to-moderate Alzheimer's disease.
All patients first received open-label simufilam 100mg twice daily for 12 months.
Patients were then randomized 1:1 to either continue simufilam or switch to placebo for 6 months.
Primary Endpoint:
The pre-specified cognitive endpoint was mean change in ADAS-Cog11 scores over 6 months, comparing simufilam to placebo.
Key Results:
Simufilam slowed cognitive decline by 38% compared to placebo over the 6-month randomized period.
The placebo arm declined 1.5 points on ADAS-Cog, while the simufilam arm declined 0.9 points.
Patients with mild Alzheimer's disease (MMSE 21-26) who continued on simufilam showed no material decline in ADAS-Cog scores over 18 months, indicating stable cognition.
Safety:
Simufilam 100 mg twice daily was reported to be safe and well-tolerated.
There were no drug-related serious adverse events.
No treatment-emergent adverse events occurred in 5% or more of study participants.

The placebo group did better than expected due to the lingering drug effects, especially for the first 3 months.

Habibi More SAVA red to comE, Come to RNAZ Green tides coming…

Yeah I've just been a follower for a couple years. Glad the trial will run it's course in case the drug does work but what a debacle

Wow! Just saw. What's missing is the motive.
We are left with guessing and that's not a good place to be.
I'm out. Been out.

Quite the corporate shake up. Any thoughts?

I haven't posted in a while. Waiting for results.

there are testimonials from family members of Alzheimer's victims @youtube......search Joe Springer's podcast with Hillary Metz and also search Truthfulhand@you tube.....

“we are flush with anecdotal evidence ‘“

Where can we see these?

in a nutshell,, if Simu didn't work and the data was indeed fake then PH3 would have been long gone years ago and the SAVA ticker would have vanished as well >> the FDA would have halted the trials years ago.......the Biggest short and distort in recent history and i am MAD as blankety blank as i know you are as well.......i hang in there knowing the data and the strong support we get starting with SAVAs largest private investor Matt Nauchtrab (2.2 mil shares deep)......

also of great significance we are flush with anecdotal evidence or the trial participants that are talking upon remarkable cognitive improvement which means many are living their lives again......

when all the fake accusations going back 12 years as spun by the DOJ on this latest round of illegal manipulation become insignificant by PH3 data THEN SAVA can resume trading @its ATH above 145.......until then traders will make piles of loot and then some buying the dips.......enjoy the fun!!

A Playbook from the Presidents Handbook: I am not leaving ditto for SAVA......up 18% is not reflective of ANY short thesis playing out let alone winning......just a kind warning to the shorts who do not want to be greedy right ~~

Isn’t Remi attending something later this month? I can’t remember..

Another round of funding? No, they have more than enough to finish P3 trial. We have to wait till next CC in August to hear more.

<<right before/or in this case after a deal is done>>

that is music to my years.......at any rate sava should be in triple digits this close to the read out on PH3 amidst a backlog of stellar trial data........

Are they getting ready to recycle their old shares? This looks like a move for the crooks and buddies to swoop in and get ready for the “recycling of shares” right before/or in this case after a deal is done.

I wouldnt be surprised either if Anvs announces a financing deal soon, same pattern. The HF sharks are 5 steps ahead of retail.

Is Sava nearing another round of funding? This looks like a move for the crooks and buddies to swoop in and get ready for the “recycling of shares” right before a deal is done.

I wouldnt be surprised either if Anvs announces a financing deal soon, same pattern. The HF sharks are 5 steps ahead of retail.

the White House Press Secretary can spin all she wants while the DNC can deny until they are blue in the face, however; the facts are presenting themselves and in real time as we witnessed the tornado at last thursdays debate which has also been confirmed over the last year perhaps more then once and that is the POTUS has Alzheimer's.......Because of this SAVA stock should be on a tear but as circumstances continue to mimic what is familiar to us which INDEED is outright lying and manipulation by Big Pharma......so the White House lies about the President's condition AND Big Pharma is controlling/manipulating the truth on simu's raw data that is above par......BP is an evil part of the conspiracy we are living today while Professor Wang is a pawn in this evil charade.....This as investors are starring at paper losses in their brokerage account......

Remi has been unable to remedy this evil charade that has taken place over the last years.....what a mess here and @our nations Capitol.

The new SEC filing today
https://www.cassavasciences.com/sec-filings/sec-filing/8-k/0001493152-24-025725
does REVEAL THAT A SECOND EMPLOYEE IS UNDER INVESTIGATION but does not reveal the name.
This seems MATERIAL?
If it is Dr. Burns then real concerns??

Big Pharma's tool ~~ use $$$ and the DOJ to create discourse with SAVA.......this is the same old playbook over the last 3 years while the FDA is steadfast with PH3 witness the 2 SPAs in place.......these sirens will mimic what has occured over the last 3 years and that is; nothing fundamentally has shifted with the science behind simufilam's MOA and PH3 is still just months way from its read out......

the indictment is misrepresented @Professor Wang in the worst way or the bribery BP is using @ the DOJ in the form of American Currency.......

keep in mind; PH3 trials have not been shut down by the FDA after 3 years of the same old recycled hit pieces.......Instead we get 2 SPAs from the FDA while they shut down the Citizens Petition.......

Today, perhaps the Justice Dept has its hands out while BP is fully loaded (deep pockets)....

SAVA new 52 week low

$SAVA taking a hit while RNAZ Going for big gains on FDA Clearance clinical trials on rna cancer miracle treatment