SAVA scheduled for a flight to Pluto on February 21st (in 45 days). All Abord!!! via /r/wallstreetbets #stocks #wallstreetbets #investing

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My gains.

Associate Professor of Internal Medicine here. I just consulted my green crayons, and I must report my findings. First, they were delicious. Second, I have a disproportionately asymmetric risk-reward opportunity for you smooth brains, and I kept this post brief (relative to my previous post), so focus. Let’s not squander this opportunity.

TLDR:

  1. Five months ago, shorts filed a report with the FDA alleging SAVA manipulated its data leading to a drop in the price. The report demanded halting drug trials to protect patients but forgot to mention a single safety issue (in over 70 pages). LMAO. You can not make this up. The price fell over 66% in the aftermath because we all know how theatrical Mr. Market is. The FDA must respond to the allegations within 150-180 days from the date of the accusations depending on the manner of filing. Because the false assertions cratered the stock price, I believe when the FDA, the principal governing authority of late-stage clinical trials, dismisses irrelevant preclinical claims backed by kindergarten logic, then I anticipate price recovery. In this post, I will explain why the FDA will dismiss the allegations and SAVA will recover its losses (432% gains).
  2. Then I summarize how SAVAge Cassava Sciences Investor base is. We, patients at risk for AD, families of AD patients, Scientists, and Physicians have rallied around historical bulletproof, *clinical* data.

Math Class:

Stock price’s ATH was $147. It fell to 34 = 77% after allegations

Thirty-four back to 147 is an increase of 432%.

Complete recovery means the price will Increase 432%, not 66%.

A quick recap of the data and stock runup:

For this discussion, understand SAVA has had two trials. A 28-day trial (completed) and an ongoing OLE/CMS trial (both in Phase 2). As these trials progressed and respective data released, the stock went parabolic, why? In its entirety, data this robust, to this degree, duration, and consistency has never been seen in the Alzheimer’s space. In summary, A full panel of 17 biomarkers showed a positive response to Simufilam (SAVA’s drug) in the 28-day trial. Then the OLE/CMS trial released Cognitive data at 6, 9, and 12 months, dazzling SAVAges with each release. In this time, the price went from under $5 to over $140 (Market cap of 5 billion+). As a physician and patient advocate, I might be excited about the data, but Mr. Market makes me look relatively dull.

Why did the market value the data at 5 billion? Michael Engelsgjerd, A senior equity research analyst at Bloomberg who specializes in the biotech sector, said it best:

“If you can develop a small molecule pill for Alzheimer’s disease that can definitively improve cognition, that would very likely become the most successful product in pharmaceutical history.”

Put simply, this is precisely what Simufilam accomplished. Definitive cognitive improvement with a small molecule pill. I can not overstate the data’s significance, as Alzheimer’s currently has no effective treatment and is the 6th leading cause of death. Based on the TAM, probability of FDA approval, and similar metrics, the price was expected to appreciate more than $1000 by the approval date (valuation model below for wrinkle-brained investors). Great, right? Well, that’s when all the drama started, and it’s been one hell of a rollercoaster since.

But before we move on, for effect, Here is SImufilam’s data compared to placebo and Donanemab (competition). Aduhelm’s (another competitor) data thus far, is worse than Donanemab’s results.

https://preview.redd.it/4mui1zs60z981.png?width=512&format=png&auto=webp&s=02dc23fb4794b0d2b41878ffeb3ff7f01f21f4be

Short Allegation Destroy Shareholder Value:

On August 2021, a short report was filed with the FDA (called a citizen’s petition) to halt further testing to protect patients. The claims, by Dr. Pitt and Dr. Bredt (more on them later), asked the FDA to stop further research in the interest of patient safety; however, the report 70-page report and five supplements mentioned no significant adverse events. Here is the full report for your viewing pleasure. You might assume the price action signified the|accusations had merit or a chance of succeeding. You would be wholly incorrect. Unfortunately, libel has a real and immediate impact, substantiated or not. Institutions and many investors positively won’t Hodl an already risky/binary biotech play. Pragmatic but unfortunate because, again, the shorts could not point to a single safety issue related to the drug after more than 147,000 dosing events in human trials (Facts). Wait, wait, let me get this correct. Let us illuminate this concept one step at a time:

1) The FDA is the ONLY governing authority for human/clinical trials that will halt trials.

2) The FDA will only halt phase 3 trials to ensure patient safety.

3) Dr. Pitt and Dr. Bredt say they want the FDA to halt Phase 3 because of safety issues.

4) But Dr. Pitt and Dr. Bredt cannot point to a single safety issue after 147,000+ doses? The summary of the number of doses can be found here, and again here is the report filed by Pitt and Bredit.

5) Thus IMO, there is NO chance of the FDA halting trials.

I am not being facetious. This is not hyperbole. It is exactly what Dr. Bredt and Dr. Pitt are saying. LMAO. Every time I review this, Im verbatim am at a loss for words. Worse, I can’t believe Mr. Market overreacted on this ‘news.’ The bottom line is there is NO way the FDA will halt phase 3 trials. I can not illustrate it any clearer for you smooth brains, but for emphasis, please repeat after me; the medication is safe, so trials will continue, and continue they did. The FDA allowed not one but two separate phase 3 trials to begin, and the OLE and CMS Phase 2 trials continue (after reviewing the allegations). Since the allegations were made, the continuation and initiation across four separate SAVA trials SHOULD be enough evidence the allegations will be dismissed; however, Mr. Market can’t stop sniffing crayons. Please give Mr. Market some time. When he realizes he was wrong, he will look like a deer in headlights and drop his crayons as the price recovers leading up to the citizen’s petition dismissal. IMO. More importantly, this is your buying opportunity. If I have to tell you that I don’t have a crystal ball and can not predict the future, you should stop reading. My opinions are based on the above and below evidence. Do your own DD; I could be wrong (but I’m probably not ;)).

Need More Evidence?

Below is a tweet essentially admitting the allegations (CP) will be dismissed.

https://preview.redd.it/a84qpth90z981.png?width=770&format=png&auto=webp&s=e1f1c56cd14553c388e56edd2567abcb10785a9d

You will find exactly ZERO cases of medications with promising clinical data, halted by anyone, FDA/SEC/NIH/IRB when there is no safety issue (let’s throw the DOJ and the FBI in there because that’s what the Adrain et al. are trying). A safety assessment was the entire point of conducting phase 2 trials, and phase 2 confirmed Simufilam is safe. The FDA would not allow SAVA to start Phase 3 (as the FDA did already) if they were worried about safety. A nuanced point for those who thoroughly reviewed the data: Under no circumstance is it acceptable to halt phase 3.

Still More Evidence:

On November 4th, The Journal of Neuroscience (A third-party) responded to the allegations against $SAVA. They stated, “there are no signs of data manipulation.” SAVA price increased 100% in 3 days. I anticipate a similar market reaction when a more significant governing authority (the FDA) dismisses the false allegations.

Remi The Diamond Handed Heathen Barbarian (AKA Chief SAVAge):

SAVA Insiders have been BUYING. Remi (the CEO) has accumulated over a million shares. It’s difficult to overstate how bullish it is for a biotech CEO to go full silverback with his own coin on the open market buying up his own stock and then diamond handing it through trials (when he sees unreleased/ongoing data and knows more than any of us). Sanford (another board member) accumulated over 900,000 shares starting 9/17/20. Both have massive gains on their positions currently, but they still have not sold.

Compare SAVA insider buying to another Alz drug in trials like Cosyntex. Here is their insider trading. Take a look, and then guess whether the trial data that dropped in Q4 ended up good or bad:

https://preview.redd.it/eu4s6wkg0z981.png?width=512&format=png&auto=webp&s=196ed053083cae9e70a8e9bd583f78b84c9a24cf

Ready? Okay, the data readout was “primary endpoints were not met” meaning the study failed. Insiders were selling big time and for a big reason.

Now let’s look at SAVA:

https://preview.redd.it/yxisqrui0z981.png?width=512&format=png&auto=webp&s=b2ee063b74d1266c778ff3760281d3f574e266cf

https://www.marketbeat.com/stocks/NASDAQ/SAVA/insider-trades/

SAVA is sitting on tons of unreleased Phase 2 data (visible to its board), and the final Phase 3 trials are ongoing. The insider trading activity speaks for itself. As Peter Lynch said, “Insiders sell for many reasons, but they buy for only one reason.”

To reiterate, the insiders have only accumulated and held for over two years. The smooth brain market won’t stop its bedwetting until the FDA ultimately dismisses the allegation. IMO, that date will be on/or before February 21st, 2022. In some instances, the FDA may respond by the deadline and say they are extending, but as long as the FDA does not halt trials SAVA is on its way to FDA approval. As discussed above, IMO, the sky will fall before the FDA halts trials.

But Im, an intermediate-term swing trader with erectile dysfunction. What do you have for me, Professor?

There will be another tremendous catalyst for those interested in an intermediate-term opportunity. SAVA collaborated with CUNY School of Medicine to develop this revolutionary drug, Simufilam. When the Shorts attacked the consulting scientist and his work, Remi, the CEO, asked CUNY to investigate the matter to ensure the integrity and offer transparency (because that’s what the guilty do, right? right.) A review of CUNY’s protocol shows that CUNY will announce its conclusion on or before 210 days (March-ish).

SAVA is also expecting to release biomarker data soon. Historically, SAVA has released interim data-keeping investors up to date. As discussed above, SAVA is sitting on a lot of data to be released.

Other potential drivers of price action include:

  • A SI of 40%. (ATH’s)
  • A float of less than 40 million.
  • A dedicated investor base will never sell unless the data changes (The next TSLA, anyone?)

All this information is for short-term/ intermediate-term traders. Long or short, expect massive price swings over the next several months.

I have more wrinkles than these degenerate smooth brains and rock-solid erections, so what do you have, Professor?

The DATA

Why did I invest in this nauseating rollercoaster ride? Because of the cognition data. Dr. Pitt and Dr. Bredt will shift the narrative to preclinical science, but the cognition data eclipses all. The clinical data are the results we see in walking talking patients. Briefly, if a medication kills humans (clinical data), it does not matter what your western blot says (pre-clinical data). The FDA will never ignore dying humans for western blots. The opposite is also true. Simufilam’s CLINICAL data shows cognitive and behavioral improvement. This is all that matters at this stage of testing, and simply put, it is EPIC. Read about why critics shift the narrative here: “Why the Critics are Tuning Out the Cognition Data.”

Simufilam’s data shows it is:

1). Safe

2) Effective

3) Desperately needed by Alzheimers patients.

Before shorts attack the integrity of the Cognition data:

It was collected over sixteen clinical sites, across the US and Canada, by physician principal investigators and their associated staff (unaffiliated with Cassava Sciences). These sites also perform trials for AD drugs by Biogen and Eli Lilly. These clinical sites can be audited by the IRB at any time. Additionally, the chain of custody was made transparent and verified by two independent biostatisticians. The sponsor (SAVA) maintains a master file with all the raw data (including excluded patients and why they were excluded) which can be audited by the FDA at any time. CRA’s, third parties to both Cassava Sciences and the clinical sites, monitor the ADAS scores, review the raw data and adjust scores to ensure consistency and integrity. SAVA uses electronic data capture, which permanently records the data submitted by the independent clinical sites, and the software logs all addendums with time stamps. With that out of the way…

Long-term investors can expect valuation metrics to drive the price over 750-1000 within two years. Here is a full breakdown of TAM and why SAVA is so valuable. A common psychological phenomenon is a disbelief resulting in rejection of simple math. It’s simple math, so look it over with an open mind.

I must always share my favorite summary of how much the market values Alzheimer’s treatment.

On Monday, June 7th, $BIIB announced Accelerated Approval of its Alzheimer’s medication, and the market cap increased by $17 billion in one day. Similarly, the day $LLY and $RHBBY announced FDA Breakthrough Therapy Designation (BTD) of their AD medication, their market cap increased by $15 billion and $13 billion, respectively (on the same day). All three of these medications demonstrated little to no cognitive benefit (SAVA data is vastly superior).

SAVA’s market cap sits at less than two billion dollars currently (get in while you can). The last point is, I invested in the data, the expected data updates are integral to my investment thesis. I’ll be awaiting those, and changes in the data will change my investment.

House cleaning:

I spared the details of the drama surrounding this stock, but to update those that follow me: our group of Scientist investors together we have written a 48-page research report on SAVA here, “A Comprehensive Stock Analysis”.

The Authors include

Clinical and Academic Neurologists,

MDs,

PhDs,

PharmDs,

Successful biotech investors

An Chief Global Strategist and Healthcare Leader

Through my investing career, IMO, the first thing you will notice about successful investors is the amount of data they examine closely to see what others miss. Mr. Market’s “headline hysteria” usually means buying opportunities for them (“overreaction with reversion to the mean”).

SAVA’s YT presence had grown courtesy of the one and only OG Joe Springer (He was a bull when SAVA was $6).

If you have dyslexia and prefer to watch (not read), please watch Dr. Boyers (Academic and Clinical Neurologist) discuss SAVA’s medication with Joe Springer here.

Did I mention SAVA’s historical data and Alzheimer’s patients, families, physicians, and scientists have become a dedicated investor base rallying around the historical data? We are investors that will not sell unless the data changes.

With the allegations expiring and the CUNY investigation ending, our SAVAge group plans to start pitching to tutes.

Lastly:

The clinical data is historical and bulletproof, and I will not let this fact get lost. There is no point in arguing. If you genuinely believe SAVA is a fraud and the FDA will halt trials, then place your (ill-informed losing) bets. What shorts and longs agree on is that SAVA does not know how to go sideways. It will either orbit Pluto or implode to $7 (cash price).

Anyone with genuine questions or who believes my trusted experts and I missed something, I look forward to a civil discussion.

All the above represent my own opinions. This is not financial or medical advice. I have been wrong many times, so do your own DD. Good luck!!!

Submitted January 06, 2022 at 02:35AM by Internal_Ad_1091
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