PCRX 113% institution owned with 25% Float sold short Reminds me of SAVA

Buy some out of the money upside calls if there cheap

PCRX is Profitable huge revenues and growth

Income Statement
Revenue (ttm) 690.31M
Revenue Per Share (ttm) 14.88
Quarterly Revenue Growth (yoy) 5.00%
Gross Profit (ttm) N/A
EBITDA 175.34M
Net Income Avi to Common (ttm) 63.59M
Diluted EPS (ttm) 1.34

Company has over 400 Million in Cash

Book Value Per Share (mrq) 19.07 getting it for 11$ back down here all time lows for this stock with 113% institution ownership
Cash Flow Statement
Operating Cash Flow (ttm) 194.36M
Levered Free Cash Flow (ttm) 153.5M Cash flow positive

Stock reminds me of SAVA Dropped down to like 11$ then ran to 42$

Quite the ride here. Smart move

Sold 1/2 from my most recent buy near $10.
GLTA

Smithy...What other diseases has SAVA talked about tackling with their FLNA fix?

Seems like there would be a few. And have they done patent coverage on them if there are any? I'll check out their patents over the weekend, but perhaps someone can give me some motivation?....

Good discussion. Seeing as they are favoring the "Milds" at 71% (even though the mean is right in the middle), they've designed it to make a strong case for a "Milds" approval. The "Moderates" - though there are less of them - will include some pretty advanced cases, and they are probably looking to see some good signs in that group but they are not relying on them to help much overall. I think they'll succeed for what they want and maybe there's a chance they luck out with the "Moderates". But if not, not a deal breaker.

The trial wrapping up 6 months later will possibly show that over more time the "Moderates" start to do better as the corrected proteins come in at higher numbers in their brains compared to the damaged ones. Also there will be data on the differences between the doses to look at.

I think the second trial may help the first trial if it needs it. Between the two trials, there will likely be enough positives to see to warrant approval, it seems reasonable, to me, to expect that approval.

The new seriousness seen in management - (I think Nicaise (Alexion) was brought in at the end of last year to become the CEO....He's been on the Sarepta board with Barry for years) - and the rising stock price and a whole bunch of new "lookers and likers" is going to keep the stock in focus up until the climactic moment at year's end. If ambiguity still ensues and a buying opportunity arises, take it .... The second trial will fix everything.

I bought in on Tuesday at 19. Had bought all the negativity for a year previous and didn't dive in deep until this week. I've been with Anavex for a year and Sarepta for 19 years. I sure wish Anavex had a Robertson, a Barry, a Nicaise, and this Matt N guy routing for it and helping it. Anavex does have the bad press that Cassave has had, so maybe that's one thing going for it! ....It's got the same screwy enemies!

Good day for SAVA longs with all indices in deep red. Up almost 100% last 5 trading days. Should continue next week.

Praying for success and in 5 short months we'll know one way or another. Never bet more than one can afford to lose

EVERYONE wants on board this train before the FDA gives the nod on simufilam AND before the market cap explodes or before simufilam sets fire across the globe.....Suffering alzheimer's victims in need of a treatment that works is the reason for all of the above.......

Big Pharma will be in the crosshairs (BUYOUT)........i am counting on it!!

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

I have followed sava trading closely for years now. Watching order flow and there are a lot of larger buys on green bars. 10k+ share buys. 40%+ of share volume is medium to large orders. Before the recent powerful bounce off of the $9 range I tended to see much more small orders on the buy side.

Matt Nachtrab on X

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?

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..