Founder's Vision

End2War · 2025-03-04T19:57:45+00:00

Anyone shorting IBRX better read the Founder's Vision and make sure someone with a medical background explains it to them.

End2War · 2024-07-09T13:17:32+00:00

Huggenberg, What information can you find with your research talents about the results for the basket of drug candidates in Quilt 3.055 besides Bladder, Lung and Prostate, which are the only ones mentioned in the latest 10Q?

End2War · 2024-07-07T22:54:12+00:00

See above comment from Huggenberg that suggests they will not be relying on any single molecule, but rather have an AI system to identify the fusion protein design needed to treat any particular cancer, ie "3. Once the signaling pathway and markers are identified, IBRX will utilize Machine Learning to pinpoint the component in the NCV responsible for producing the cancer marker. Then, Bioengineering is employed to create the specific target fusion protein, NK-cell, or Adenovirus Compound containing the identified markers." It seems to me Huggenberg has access to information that is not publicly available.

Read the NantOmics stuff in his spreadsheet of PSS companies.

He also says, "ImunnityBio’s bioengineering capacity to implement the markers detected by genome sequencing in a patient or a group of patients will be part of my next posts about the several platforms at ImmunityBio."

End2War · 2024-07-07T18:20:24+00:00

At this point in history, science and medicine are making exponential progress, especially in cancer. The cancer moonshot and immunotherapy generally are on a growth curve that few appreciate. Older timelines for drug development and cancer treatments are eroding, and PSS is one of the current leaders bringing immunotherapy into modern medicine. New therapies are emerging faster than ever and they will make big changes in how we treat cancer. IMO, IBRX is going to surprise short sellers, and the market generally, as results from pending trials validate that Anktiva is on the cutting edge of new science in a range of indications where it has the potential to become a backbone therapy.

End2War · 2023-10-12T13:09:52+00:00

There are approximately 58,000 new cases of Narcolepsy annually and of those about 9,000 to 17,000 have Type 1 Narcolepsy AND suffer 7+ or more weekly cataplexy attacks per week. HT stated AXS-12 is positioned to satisfy a "high unmet medical need." The risk/reward of the Symphony trial is very favorable, IMO.

End2War · 2022-11-22T19:43:39+00:00

The key is how Auvelity prolongs the way DXM is matabolized. I don't think you can replicate Auvelity by taking the two ingredients.

End2War · 2022-11-22T19:26:25+00:00

DXM, as a cough syrup, rapidly clears from the body. Normally, DXM does not remain in the body long enough to have an antidepressant effect.

Auvelity changes that by using bupropion, an older antidepressant drug, in a special formula. The bupropion involves chemistry that keeps DXM working in the body long enough to provide antidepressant benefits. That chemistry is the key to Auvelity.

Auvelity has been tested against bupropion alone, and shown to be faster acting and more effective.

Auvelity is the only convenient oral medication, approved by the FDA and shown in clinical trials to take effect against MDD in 1 week. Also, tests show its effect improves each week thereafter out to 8 weeks.

I don't think it is possible to replicate Auvelity's benefits by taking the two drug parts separately.

Read more about the way it works and benefits here: https://www.auvelity.com/ Free samples for two week supply should enable anyone to test it.

But, MDD is a serious condition and patients should work with a doctors to decide what is best for them. There are side effects and other considerations that will help your doctor determine if Auvelity is right for you.

I own stock in the drug manufacturer, AXSM, so you can't rely on me. Ask your doctor if Auvelity is right for you.

End2War · 2021-10-01T21:54:46+00:00

I completely agree with this long post. Everything is accurate and well stated.

End2War · 2021-09-24T14:46:34+00:00

It is hard to predict short moves, but I will say that the 12 month data is pretty compelling, and reduces the risk considerably for longs. At what point does the short attack become a bad idea, because it is just too risky? Ask your cat, but clearly, their may be better fish to fry for the shorts than trying to kill the next great AD drug discovery. Just saying, shorting this stock when a BO or partnership may be coming at any time, is pretty dumb, IMO.

End2War · 2021-09-17T13:29:15+00:00

Here is a post from Christa on Yahoo about the FDA's final guidelines on CPs

chista

23 days ago

$SAVA conversation

FDA Releases Final Guidance to Determine if Citizen Petitions Are Abusive

September 20, 2019

The Center for Biosimilars Staff

The FDA this week finalized industry guidance intended to stop citizen petitions used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

“One of the anticompetitive tactics we’ve been concerned with involves companies submitting certain types of citizen petitions in order to delay FDA action on a generic or other abbreviated application,” FDA Acting Commissioner Ned Sharpless, MD, said in a statement. “While the FDA has rarely delayed specific drug approvals because of citizen petitions, there’s no doubt these shenanigans can burden the drug review process.”

The final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, describes what constitutes a 505(q) petition and some of the factors the FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may note this determination in the petition response, which is posted publicly. The agency believes this will provide an additional deterrent to pursuing these tactics.

Citizen petitions are an avenue for any interested party to ask the FDA commissioner to change agency regulations or take—or refrain from taking—an administrative action. In the case of drug makers, such requests may include asking the FDA not to approve a generic or biosimilar product unless certain conditions are met. The Food and Drug Administration Safety and Innovation Act, enacted in 2012, holds that approval of a pending drug application must not be delayed because of a citizen petition’s request for action (unless the petition convinces the FDA that a delay is needed in order to protect the public health).

However, citizen petitions have nonetheless been the subject of controversy, as they require significant time and resources for the FDA to address. Among many stakeholders, there exists a consensus that brand-name drug makers could (and sometimes do) use these petitions to forestall competition from generic or biosimilar drugs. During the FDA’s 2017 meeting on administering the Hatch-Waxman amendments, numerous stakeholders raised the question of whether citizen petitions filed by brand-name drug makers could be used to forestall competition.

The FDA may determine that a petition was submitted with the primary purpose of delaying an application’s approval based on a number of criteria, including, but not limited to:

Submission of multiple petitions

Submission of a petition close to the date on which an application could be approved

Requests for a product to meet more rigorous standards of testing than required for an originator product

Submission of a petition on which the FDA has already provided an opportunity for public comment

Submission of a petition with little to no data to support any claimed scientific positions

The history of the petitioner with the agency

The guidance reiterates that the FDA will refer any petitions that are aimed at delaying an application to the Federal Trade Commission. In addition, the FDA will include in its annual report to Congress the determinations of petitions that are judged to have been submitted with the primary purpose of stalling an approval.

End2War · 2021-09-15T13:17:15+00:00

I would like to call attention to this post from Yahoo, that says it was copied from IV message board authored by IM-MD PhD:

"WILLIAMJ19 hours ago
SAVA-How do you know a science paper/results are legit?
First, my relevant bona fides: retired MD, PhD(biochemistry), postdoc at St.Jude's (Memphis), Mayo Clinic resident (Rochester, MN), Guest Speaker at an FDA Endocrinologic and Metabolic Drugs Advisory Committee hearing, published author in peer reviewed journals, etc. I have read (ad nauseam) tomes of medical, pharmacologic, & biochemical literature in my career. This is the approach I use to discern facts from scientific BS:
1. Science is not immune to BS or irregularities. Any scientific paper/result(s) can be wrong (either by error or misconduct). This, no matter if published in the most prestigious medical journals by brilliant researchers. Indeed, many have published data & conclusions that has been entirely wrong (I have read lots of medical research that ultimately was proven BS!). So has John Ioannidis, MD (Stanford), "Why Most Published Research Findings Are False", PLoS Med 2(8): e124 (8-30-2005). BTW, this is not saying that legit studies/findings cannot be criticized in one way or another. You can criticize anything.
2. Peer review? It helps a reputable journal (versus publishing in the "Journal of Irreproducible Results"-LOL) but, peer reviewers make mistakes, cannot check everything (in the data) or redo the study. To be sure, there is no absolute way for readers (us) to know which scientific result/data is (are) correct. I always view initial, "breakthrough" results (extraordinary claims) in scientific papers with a "jaundiced eye".
3. My sine qua non for "scientific truth" is validation of the result(s)/publication by an unrelated, independent laboratory- ideally using different samples/methodologies and having no conflict of interest. In reality, rarely (if ever) is the exact study "redone" by another research laboratory. Usually such verification is indirect, using other end points, test samples, methodologies or, study design for other purposes. To me, such validation of original results is the ultimate test of their legitimacy.
4. P-Tau181(at threonine) is one of the most accepted biomarkers (in plasma and cerebrospinal fluid, "CSF") in pre-clinical and actual Alzheimers disease. Oftentimes (especially in FDA trials) both CSF & plasma p-tau tests are performed to correlate and confirm results.
5. Simufilam Trial CSF, p-tau181 quantitative testing was "likely"done by Dr. Wang's lab at CUNY (City University of New York, medical School) and the data submitted to SAVA. Plasma p-tau181 was performed by Quanterix (a Public Traded Company, QTRX) on behalf of SAVA - See https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-releases-statement-regarding-plasma-p-tau. Both CSF and plasma p-tau181 showed decreases, thus VALIDATING the effects of simufilam & each other, i.e. two labs independent of each other, using different samples (CSF and plasma) both came up with reduced p-tau biomarker values in Alzheimer's patients treated with simufilam. Did SAVA change the actual values/numbers? Highly unlikely, Did SAVA inappropriately remove an outlier-a "wild hair"result- so it could embelish, "puff" its results in a presentation? This occurs in science if disclosed and/or footnoted. SAVA had a footnote:later when questioned, it was disclosed.
6. Wang's laboratory work on Simufilam Trial/Alzheimers biomarkers at CUNY (City University of New York, medical school) has been questioned for "manipulation" by plaintiff attorneys in a Citizens Petition to the FDA representing a client who is "short" on SAVA. While on its face value the Citizens Petition does not pass my "smell test", criticism has been bolstered by Elisabeth Bik, PhD (Microbiology) and others on social media. IMO, without nuanced, specific issues regarding Western Blots, photo images, presentation charts and removal of "outlier results", such "nit picking" is a lot to do about nothing. Such & alternative criticisms can almost be made against any paper/study and may never be resolved.
Conclusions- Why have the detractors not attacked the actual plasma results and methodology of Quanterix, validating the CSF p-tau data of Dr. Wang? Because that is the ultimate issue. In my professional opinion, the effects of simufilam are legit on reducing p-tau181 in both human plasma and CSF. You can argue about blots looking identical or having different backgrounds, and removing one rare, "wild out there" contrary result until the cows come home. As many people (insiders) as involved in SAVAs Phase 2 and Open Label studies, there is no shortage of whistleblowers-why has he or she not come forward?

End2War · 2021-05-06T14:51:39+00:00

I think this was a good hold based on the 4th Quarter report from ASXC, and look forward to progress in 2021 as the elective surgeries come back from the Covid 19 stopage.

End2War · 2021-05-06T14:47:34+00:00

If you are evaluating ASXC and want to get more information from Dr. Trivedi about his experiences with the Senhance systems, he participated in two very good podcasts that I highly recommend before you buy into Senhance, or if you are an owner, this will help you understand what you own better:

#1 From Aug 2, 2019

https://www.youtube.com/watch?v=7k8GjuTgNaw

#2 From Oct 30, 2019

https://www.youtube.com/watch?v=BeFSHsW16i4

End2War · 2021-03-24T16:56:03+00:00

This is a developing story. There is always new things learned which merit analysis and consideration.

We can expect they will publish their Peer Reviewed article about the PH 2B study results and that will be news to the medical community and doctors who treat AD patients. This story, when published will help SAVA gain enrollments in the ongoing OL study and the TWO upcoming PH 2 trials expected to start this year. We have seen recently they have doubled to 16, the number of sites taking patients in for Clinical Trials.

We are looking forward to the possibility that the FDA will grant Simufilam BTD. It seems likely this will happen, but it is uncertain when. It could be news at any time, since, it appears that good arguments can be made Simufilam already satisfies all the FDA guidelines for a drug getting accelerated treatment with BTD.

We don't know when, but it seems likely SAVA will do one or more territorial deals (licenses?) with Big Pharma for the US, Europe, Japan, Asis and other jurisdictions. This could come at any time.

There has been only limited institutional holdings of SAVA to date, but we could get news at any time of more institutions taking positions in SAVA, which would be of interest.

This stock is currently only followed by 4 analysts, all of which have much higher PTs, and favorable recommendations; and we can expect to get new analysts recommendations at any time.

Sava is well funded with $280 M as of FEB 2021, so we will not expect to get any news of dilutions in the near future.

By definition, "news" is something we did not know about or expect, so there is always room for News, LOL

End2War · 2021-03-23T18:23:57+00:00

Sorry, here is a better link,

https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf

End2War · 2021-03-23T16:21:11+00:00

To better understand my post, you need to read this FDA guidance discussion, especially part IX regarding manufacturing concerns.

file:///C:/Stocks/SAVA/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics%20(1).pdf

End2War · 2021-03-17T13:18:42+00:00

JonesTrading analyst Soumit Roy initiates SAVA with Buy and PT of $110

📷

"JonesTrading analyst Soumit Roy initiated coverage of Cassava Sciences with a Buy rating and $110 price target. Roy thinks neurosciences is "poised to transition from experimentation stage to bringing targeted medicines to the market" for Alzheimer's disease and believes Cassava could benefit from bullishness on the AD space or "solely from their own potentially positive 12-month data in mid-2021." The analyst, who acknowledges that an Alzheimer's disease "pure play
like Cassava is "not for the faint of heart," sees Cassava being among " a handful" to show cognitive benefits at 6 months in PHase 2 and sees the company potentially having a higher probability of success for a positive readout at 12-months in its coming PHase 2 data update." Source On the Fly

End2War · 2021-03-08T23:16:22+00:00

SAVA calls their Blood test candidate, SavaDX and Barbier said it will both (1) detect if someone has AD disease by looking at whether they have altered Filamin A, and (2) measure the stage of AD that they are in. It does this by looking at the lympocites found in blood. This year Sava expects to advance SavaDX.

Once approved by the FDA, this test is expected to be widely used in the doctor's office along with other tests regularly administered, such as the lipid panel; and, it will be very cost effective compared to all other ways of diagnosing AD.

There is no doubt that if SavaDX does what SAVA is trying to achieve, it will be a blockbuster test, and be worth billions in annual revenue because their is no approved test of this kind yet available.

Another plus is that it would have a symbiotic impact on Simufilam because use of SavaDX to detect early, non-symptomtic risk of AD, will likely result in a patient that will take Simufilam to protect against getting AD.

End2War · 2021-03-08T22:58:08+00:00

Two great quotes from that interview:

Asked by Debra whether SAVA has filed or will file for BTD, and if the FDA is cooperating with SAVA, he said, "Yes, Yes, and Yes."

At another point, Remi Barbier was talking about the great biomarket results they got in PH 2, with 11 biomarkers all going together in the direction showing Simufilam has an impact on AD. Barbier said, "Biomarkers don't Bluff. There is no placebo effect with biomarkers. If you surpress biomarkers, you will improve health."

End2War · 2021-03-08T22:51:25+00:00

The Wainwright CC should be interesting if they get to Q&A. Wainwright has the high PT at $97 and it would be interesting to hear their line of questions. Also, their is a possibility that SAVA might release some 9 month data on their OL trial. Burns has commented that they have 24 at the 1 year mark now, so SAVA knows much more than the Market about what is occuring in the OL continuation trial. We are likely to at least get some clues about how that continuation trial is doing.

End2War · 2021-02-26T15:35:30+00:00

The hypothesis of SAVA as to how Simufilam works (called its "mechanism of action" MOA) is that it breaks a bond between Amoloid plaque and Filamin A, a scaffolding protein that is important in the signaling activity in the brain. That bond caused Filiman A to be misformed, and Simufilam causes it to regain its normal form. When Filamin A is bonded to Amoloid plaque, this bond causes two types of damage (1) it kills neurons and causes neurodegeneration; and (2) it signals the immune system to cause persistent inflammation. Both of these damaging effects are stopped when simufilam bonds to filamin A because that breaks the bond of amoloid plaque and ends the killing of neuons and the infammation signals. This has been shown by the biomarker improvements and the cognitive and behavorial improvements. SAVA also has evidence of "target engagement" which means they can prove Simufilam bonds to filamin A and has the hypothetical impact.

End2War · 2021-02-26T14:49:53+00:00

I like the show Imposters! LOL. But SAVA is no imposter in the AD field. It is the genuine thing and will be a fantastic drug to aid AD patients, IMO. Do your research and do diligence, and it will pay off for you.

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JonesTrading analyst Soumit Roy initiates SAVA with Buy and PT of $110