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Avid mentioned as a key player in CDMO services (2021-2026)
CMO and CDMO biotechnology Market Can Become Bigger in Five Years!!
Quote: Key Players of the Global CMO and CDMO biotechnology Market are: Patheon, Catalent, Samsung Biologics, Lonza., Boehringer Ingelheim, Samsung BioLogics, AGC Biologics, WuXi Biologics, AbbVie, Avid Bioservices, Fujifilm Diosynth Biotechnologies, KBI Biopharma (JSR Corporation), Cytovance Biologics, Xpress Biologic, Rentschler Biopharma
Pfizer CEO says two Covid vaccine doses aren't 'enough for omicron' https://www.cnbc.com/2022/01/10/pfizer-ceo-says-two-covid-vaccine-doses-arent-enough-for-omicron.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
VIDEO DISCUSSIONS ON ????CDMO’s contract drug manufacturer s
ttps://youtu.be/mSFPNewg0fA
Avid Bioservices Announces Official Opening of Second Downstream Processing Suite Within Myford North Facility
January 10 2022 - 08:05AM GlobeNewswire Inc.
Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology
and pharmaceutical companies, today announced the official opening of the second downstream processing suite within
the company’s existing Myford North facility. This new downstream processing suite was constructed as the first phase of the company’s two-part Myford facility expansion. Avid has completed its validation of equipment and is now actively scheduling new business into the suite.
“We are pleased to announce the official opening of our recently constructed second downstream processing suite within our state-of-the-art Myford facility. With this milestone, we now have two fully operational downstream processing suites within Myford North, significantly increasing the facility’s capacity and revenue-generating capability,” stated Nick Green, president and chief executive officer of Avid Bioservices. “We’re excited that we will begin work on our first customer project in this newly operational suite in the coming month and look forward to delivering those customers the same reliable, high-quality services that our customers have come to expect from Avid. At the same time, we are continuing to make excellent progress on the second phase of our Myford facility expansion, as well as planning efforts for the construction of our recently announced viral vector facility.”
The second phase of Avid’s Myford facility expansion, for which construction has been initiated, is designed to further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South. Combined, the company estimates that the first and second phases of its Myford expansion will result in a total revenue generating capacity of up to approximately $270 million for the mammalian cell business annually. Avid also recently announced plans for a strategic expansion into the cell and gene therapy market through the construction of a world-class, purpose-built 53,000 square foot viral vector development and CGMP manufacturing facility. It is anticipated that total annual revenue generating capacity will increase to approximately $350 million with the addition of the viral vector business.
About Avid Bioservices, Inc.
Avid Bioservices (NASDAQ:CDMO), an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 28 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization. www.avidbio.com
Humanigen Aligns with FDA on Potential Registration Phase 3 Study for Lenzilumab with CAR-T
January 10 2022 - 05:55AM .. Business Wire
FDA Type C meeting and advice creates alignment on registration pathway for Phase 3 clinical development of lenzilumab for the prevention of CAR-T therapy related toxicities including Immune Effector Cell-Associated Neurotoxicity (ICANS) and Cytokine Release Syndrome (CRS)
Randomized, double-blind, placebo-controlled SHIELD trial to commence in H1 2022, designed to inform a potential label that reflects both the clinical benefit of lenzilumab and the economic benefit (measured by reduction in healthcare resource utilization)
Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ today outlined the next steps for the development of its lead candidate, lenzilumab, in the prevention of CAR-T therapy related toxicities including ICANS and CRS in patients with relapsed or refractory Non-Hodgkin lymphoma (rrNHL).
“Following recent constructive interaction with FDA on the design of the Phase 3 study, known as SHIELD (Study on How to Improve Efficacy and toxicity with Lenzilumab in DLBCL and other NHL patients treated with CAR-T therapy), we believe that we have collaboratively aligned on a potential registration study, recognizing the clinical and economic benefits for patients and healthcare systems,” stated Adrian Kilcoyne,
chief medical officer of Humanigen. “The SHIELD trial will
build on the positive results from the ZUMA-19 study. The primary endpoint of SHIELD will focus on demonstrating a significant improvement in neurotoxicity associated with
both YESCARTA® and TECARTUS®. In agreement with FDA, we will also seek to demonstrate the beneficial impact that lenzilumab may have on healthcare resource utilization.”
CAR-T therapies have resulted in significant advances for patients but the clinical benefit observed often comes at a
cost. In up to one-third of patients, significant toxicities of ICANS and CRS occur1. Currently, the widespread adoption
of CAR-T therapy is limited, in part, by the requirement for treatment in centers that are experienced in managing the common toxicities of ICANS and CRS and by the financial
and health burden that this creates.
“CRS and ICANS remain huge challenges for physicians
and patients treated with CAR-T therapy,” said Dr. Saad Kendarian, Consultant Hematologist at Mayo Clinic and the primary investigator for the SHIELD study. “They result in additional morbidity for patients, as well as significantly increased costs for healthcare providers. Treatments that
can prevent ICANS and CRS could address a critical unmet need.”
The SHIELD study will begin recruitment in H1 2022, with preliminary data potentially being shared at the American Society of Hematology congress in December 2022.
“We are very encouraged with the outcome of our meeting with FDA,” said Dr. Cameron Durrant, Chairman and CEO of Humanigen. “Defining a potential registration pathway across multiple indications is an important next step in our development of lenzilumab. The PREACH-M study in chronic myelomonocytic leukemia has begun dosing patients. Both the SHIELD study in CAR-T and the RATinG study in acute graft vs. host disease are planned to begin enrolling in the first half of 2022. The NIH-sponsored ACTIV-5/BET-B study has reached target recruitment and there are additional COVID studies being initiated in Korea and Australia. Further strengthening the Humanigen pipeline is our Phase 1 program focused on ifabotuzumab in solid tumors.”
Lenzilumab is an investigational product and is not authorized or approved in any country.
Legislation to allow, "...states to direct federal funds toward "supplies to combat the COVID-19 pandemic..."
https://www.yahoo.com/news/ted-cruz-introduces-legislation-allow-150336375.html
Cowtown Joy: I like this idea.
And, considering that the President has concluded that, "...there is no federal solution to COVID..," it only makes sense that states should control the purchase of essential therapeutics.
https://www.usatoday.com/story/opinion/2021/12/28/covid-biden-no-federal-solution-states-control-pandemic/9034179002/
I've learned, the hard way, that "politics" are off-topic to stock specific message boards. I'm not trying to violate TOU with this post.
But, Humanigen needs government stockpile orders at this point in the company's development. They are crucial to our success and survivability. The subject is far from "off topic."
We have been reduced to a micro-cap company, when we really should have been advanced to a large cap company.
"Government" action, not "political" action, is what this post is about. This post actually discusses the views of a Republican senator, and a Democratic president. And their views align.
In addition, we need the full benefit of the governmental help we are already getting from BARDA and CRADA. We need Defense Procurement Orders to help us get lenzilumab manufactured as quickly as possible. Since Regeneron and Lilly mAbs are not effective for this variant, and since there will be more variants, and the government has shelved the billions of dollars worth of mAbs they have bought from those manufacturers, their production capability should be procured to manufacture the variant-agnostic product Humanigen is trying to bring to market.
I look forward to a revenue update as the result of our effort with Clinigen. I would at least like to know that this effort has infused us with the resilience that has made us less vulnerable as a company. And I am aware that the European Commission signed a procurement order for sotrovimab, even before they approved the product.
https://www.instagram.com/reel/CXngIkVFcOG/?utm_medium=copy_link
As the omicron variant of SARS-CoV-2 demonstrates, COVID-19 is here to stay," Emanuel, Osterholm and Gounder wrote in a piece in which they say Biden's national strategy for COVID-19 response must be "updated."
The goal for the ‘new normal’ with COVID-19 does not include eradication or elimination, eg, the ‘zero COVID’ strategy. Neither COVID-19 vaccination nor infection appear to confer lifelong immunity," they wrote. "Current vaccines do not offer sterilizing immunity against SARS-CoV-2 infection. Infectious diseases cannot be eradicated when there is limited long-term immunity following infection or vaccination or nonhuman reservoirs of infection."
The "new normal," they explained, should be "recognizing that SARS-CoV-2 is but one of several circulating respiratory viruses that include influenza, respiratory syncytial virus (RSV), and more." They noted that people have been living normal lives while facing the threat of those other respiratory illnesses, and they must learn to view the threat of COVID-19 as just an additional threat alongside the others.
"New blood test can identify if a patient has cancer and if it has spread (medicalxpress.com)
"These results make this the first technology to be able to determine the metastatic status of a cancer from a simple blood test, without prior knowledge of the primary cancer type."
https://medicalxpress.com/news/2022-01-blood-patient-cancer.html
CDC declines to add Covid testing recommendation to updated isolation guidance https://www.cnbc.com/2022/01/04/cdc-adds-testing-guidance-to-shortened-covid-isolation-recommendation-after-facing-criticism.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
CDC shortens waiting period for Pfizer Covid boosters to 5 months https://www.cnbc.com/2022/01/04/cdc-shortens-waiting-period-for-pfizer-covid-boosters-to-5-months.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard …. HOW MANY BOOSTERS WILL BE ENOUGH BEFORE PEOPLE COMPREHEND THESE ARE PROPHYLAXIS TREATMENTS NOT VAKXINES …. ???? As Bidenhistime says, C’mon man!!!
Lenzilumab Treatment Response in Hospitalized COVID-19 Patients Correlates with C-Reactive Protein Levels
Multi-variate analysis of LIVE-AIR Phase 3 data demonstrates that elevated baseline C-Reactive Protein (“CRP”) is the most predictive feature for progression to invasive mechanical ventilation (“IMV”) or death and may be a useful biomarker to guide therapeutic intervention
Patients with baseline CRP<150 mg/L who received lenzilumab had a more than 2.5-fold higher likelihood to survive without IMV than patients who received placebo (p<0.001)
Findings suggest hospitalized COVID-19 patients who are early in the hyper-immune response, with lower baseline CRP levels (CRP<150 mg/l), achieve even greater clinical benefit from lenzilumab treatment
Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, announced that a manuscript detailing the results of an analysis of CRP levels from the LIVE-AIR Phase 3 study is available on medRxiv (https://www.medrxiv.org/content/10.1101/2021.12.30.21267140v1) . The results indicate the greatest clinical benefit of lenzilumab treatment may be achieved in hospitalized COVID-19 patients with lower baseline CRP levels, which typically occur earlier in the progression of the disease.
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is an early upstream mediator and orchestrator of the hyperinflammatory immune response following SARS-CoV-2 infection and serves to activate and expand inflammatory myeloid cells. Increases in CRP are driven by elevations of myeloid cell derived downstream cytokines. Highly elevated levels of CRP (>150 mg/L) may indicate a stage of the hyperinflammatory immune response by which sufficient myeloid activation has already occurred, rendering GM-CSF neutralization less adequate to prevent further disease progression.
This analysis and publication provide evidence that a biomarker-driven approach utilizing baseline CRP levels to guide therapeutic intervention and patient selection may improve outcomes in patients hospitalized with COVID-19.
“We are encouraged by these results” said Dr. Dale Chappell, Chief Scientific Officer, Humanigen. “In the context of other GM-CSF targeting therapies having failed to progress in development for COVID-19, these results confirm the importance of patient selection and understanding disease processes when designing clinical trials. Importantly, ACTIV-5/BET-B, a potentially confirmatory Phase 2/3 study, utilizes CRP<150 mg/L to define the primary analysis population.”
Dr. Cameron Durrant, Chief Executive Officer, Humanigen, added, “The PREACH-M study in chronic myelomonocytic leukemia being conducted at 5 centers in Australia has begun dosing patients. Both the SHIELD study in CAR-T and the RATinG study in acute Graft versus Host Disease (aGvHD) are planned to begin enrolling in the first half of 2022, in the US and the UK respectively. Additional COVID studies which will be completed or initiated in 2022 include the NIH-sponsored ACTIV-5/BET-B study in the US and Korea and the C-SMART study being conducted in Australia. All are late-stage, clinical studies. Further strengthening the Humanigen pipeline is our Phase 1 program focused on ifabotuzumab in solid tumors.”
About the LIVE-AIR, Phase 3 Study of Lenzilumab
This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could prevent or alleviate the immune-mediated ‘cytokine storm’ and improve survival without ventilation, or ‘SWOV’ (sometimes referred to as ‘ventilator-free survival’). SWOV is a composite endpoint of time to death and time to invasive mechanical ventilation (IMV) and SWOV is an important clinical endpoint that measures not only mortality, but the morbidity associated with mechanical ventilation. Approximately 94% of patients received dexamethasone (or other steroids), 72% received remdesivir, and 69% received both.
The LIVE-AIR study enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation; and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, with each infusion separated by eight hours. The LIVE-AIR study achieved its primary endpoint of survival without ventilation measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.04) and the results have been published in Lancet Respiratory Medicine.
A new study, which examined 12,000 households, found that omicron is 2.7-3.7 times more infectious than delta among vaccinated individuals.
For the unvaccinated, omicron had only a 1.17 times higher secondary infection rate than delta. But for the fully vaccinated, omicron caused 2.61 times more secondary infections than delta, and for the booster-vaccinated, omicron caused 3.66 times more secondary infections than delta.
In other words, unvaccinated individuals were just as vulnerable to omicron as they were to delta, but vaccinated individuals were much more likely to be infected by omicron than they were by delta.
New York jury holds drug firm Teva liable in opioid crisis https://www.cnbc.com/2021/12/30/new-york-jury-holds-drug-firm-teva-liable-in-opioid-crisis.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
Lenzilumab, might be the best Covid drug period. And it treats newly hospitalized patients. There are literally zero effective drugs currently authorized for newly hospitalized patients.
The ACTIV-5 trial will prove lenz's worth. The primary endpoint in the ACTIV-5 is for patients with CRP<150mg/L and <85yo. That group represented 336 of 479 patients in the LIVE-AIR trial. That group had 196% efficacy in the LIVE-AIR trial for a p value of 0.0003. That efficacy will be replicated in the ACTIV-5 because GM-CSF is the key to treating Covid.
https://www.bbc.com/news/health-56352128
YES! Because they’re NOT TRUE VACCINES! They are prophylaxis treatments to mitigate the effects of acquired viral infections!!!
True vaccines like for Measles, Mumps, Rubella PREVENT INFECTION!!
WHO warns vaccine-resistant Covid variants could emerge as pandemic drags on https://www.cnbc.com/2021/12/29/who-warns-vaccine-resistant-covid-variants-could-emerge-amid-pandemic.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
PS: With regards to trials, infusing patients with treatments whom are terminal with severe or extreme organ damage and failure is a horrible indicator of efficacy and usefulness as a THERAPEUTIC TREATMENT!!
IF THE VIRAL LOAD IS MITIGATED OR TERMINATED & THE PATIENT DIES FROM ORGAN FAILURE, THEN THE THERAPEUTIC AGENT WAS EFFICACIOUS AND SUCCESSFUL, BUT THE PATIENT STILL DIES WHICH IS WHAT HAPPENED HERE WITH BRILICIDIN ... IMHO as always...
Omicron is 'not the same disease' as previous Covid variants: Oxford scientist https://www.cnbc.com/2021/12/29/omicron-not-the-same-disease-as-earlier-covid-strains-oxford-scientist.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
Omicron infection appears to protect against delta, could displace it, study finds https://www.cnbc.com/2021/12/28/covid-omicron-appears-to-protect-against-delta-could-displace-it-study.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
Wait!! What?? The Therapeutics or Treatment plans would kill the Vaccination plans! So companies that have Therapeutics In their pipelines like Humanigen, IPIX etc are on hold til the big Pharma Companies make their mega BILLIONS on the vaccines that now require multiple booster shots which also do not prevent someone from catching CV19 it rather mitigate the effects of the virus acquired which is more a prophylaxis treatment as I have posting about for well over a year now!
https://www.yahoo.com/news/biden-slow-walking-therapeutics-not-013031594.html
Article regarding mAbs currently authorized.
"Data suggests that two common monoclonal antibody treatments—Eli Lilly’s bamlanivimab plus etesevimab and Regeneron’s REGEN-COV (casirivimab and imdevimab)—are not effective against the Omicron variant of COVID-19. However, preclinical findings have shown that GlaxoSmithKline’s Vir (sotrovimab) works well against Omicron in a lab setting...
Omicron is now the dominant strain of SARS-CoV-2, the virus that causes COVID-19, in the U.S.: It’s responsible for 73.2% of COVID-19 cases in the country, according to data from the Centers for Disease Control and Prevention (CDC)."
https://www.yahoo.com/lifestyle/most-monoclonal-antibody-treatments-dont-143000016.html
Omicron could potentially hasten the pandemic's end, experts say — here's how https://www.cnbc.com/2021/12/22/omicron-could-potentially-hasten-the-covid-pandemics-end-says-expert.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
4 charts show the current state of the Covid pandemic heading into 2022 https://www.cnbc.com/2021/12/23/covid-4-charts-show-current-state-of-pandemic-heading-into-2022.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
WHO says Covid vaccine booster programs will prolong pandemic https://www.cnbc.com/2021/12/22/who-says-covid-vaccine-booster-programs-will-prolong-pandemic.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
WOW, LT COLONEL MD TESTIFIES AGAINST THE VACCINE MANDATES ...
https://l.facebook.com/l.php?u=https%3A%2F%2Ffb.watch%2F9_px1e2Bg5%2F%3Ffbclid%3DIwAR2YAs8GDWR5Pf0Iy6SKD-U_gRqt-RsHjDBpqnmc4JDjwuWjX1EjmJJN9uU&h=AT25jsGL8u-decS1-_-ark_YnvTVeKEV-U9PvlRTTYA-Apf28rXM50yArlHqHxltr-UTT5BnXh9Nnsp0jN0ypi21k69yI_KvF1lV4t8BCpU6pArHsdEcAj_dmV4amajbFjVmIcBQ
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This board is about medical news, medical and medicine advancements from pharmaceutical and biotech companies, as
well as Universities. Company explicit news is welcomed as
well as industry news. This is an information sharing board,
where the latest and newest medical related information can
be posted and disseminated. Enjoy your board...
Scientific and Medical dedicated Search engine:
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http://www.biologicdrugreport.com/
Naming convention for antibody suffixes:
-ximab = chimeric
-zumab = humanized
-(~z)umab = fully human
FDA and CDC sites:
FDA what's new site: http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
http://www.fda.gov/
http://www.fda.gov/cder/
http://news.google.com/news?q=FDA&hl=en&rls=DGUS,DGUS:2006-15,DGUS:en&um=1&ie=UTF-8&....
http://www.cdc.gov/
Researching sites:
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http://moneycentral.msn.com/investor/home.asp
http://www.superstarinvestor.com/directory.html
http://www.nasdaq.com/
http://www.ddmachine.com/default.asp
http://new.stockwatch.com/
http://www.edgar-online.com/
Educational sites:
http://www.investopedia.com/
http://www.qwoter.com/college/
http://biotech-profits.org/
http://www.hardrightedge.com/wheel/tcrules1.htm
http://www.therapeuticsdaily.com/news/channel.cfm?channelID=28
http://www.medicalnewstoday.com/sections/genetics/
http://www.medicalnewstoday.com/sections/biology-biochemistry/
http://content.nejm.org/current.shtml
http://www.sciencedaily.com/
Some T/A sites:
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http://www.stockta.com/
http://www.stockconsultant.com./
http://www.investorshub.com/boards/read_msg.asp?message_id=297509
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Find out if your stock is on the SHO List
http://www.buyins.net/tools/short_list.php?src=1,7,9
Understanding Level 11-http://www.hotstockmarket.com/forums/showthread.php?t=14938
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Technical Indicators http://stockcharts.com/school/doku.php?id=chart_school:technical_indicators
Screeners:
http://finviz.com/screener.ashx?v=111&f=cap_microover,geo_usa,sh_curvol_o100,sh_insttrans_o20,sh_price_o1,sh_short_u5,ta_rsi_ob70&ft=4&r=21 From Stock Seasonality Site.
http://www.marketscreen.com/c/pcquote/default.asp
http://moneycentral.msn.com/investor/finder/deluxestockscreen.aspx?query=Institutional+Ownership+Up+....
http://www.secform4.com/index.php
http://screen.morningstar.com/StockSelector.html
http://www.stockfetcher.com
http://investorideas.com/
http://www.wallstreettape.com/
http://findarticles.com/p/articles/mi_pwwi/is_200603/ai_n1610669
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SEC FORM EXPLANATIONS
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http://www.briefing.com/GeneralInfo/Features/LearningCenter/edu_SEC_Documents.htm
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To see how and about the SEC rules, regulations and cases involving stock manipulators.
SEC REALTIME FILINGS
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BOARD RULES:
The main objective for this moderated thread is to keep it free of posts which do not add value to the discussion of the stocks, the latest medical news, and information, while keeping the board balanced, clean, on-topic with due diligence kept up to date.
All posts here should stay focused on medical news and information.
Pro and con debate is encouraged as long as the opinions are kept on a mature level, with the omission of personal attacks,
violations of IHUB rules and basic civility.
Personal attacks, personal issues, political innuendo, spamming, duplicate posts of same subject matter, redundancy, obvious bashing, blatant pumping, irrelevant off topic subject matter, advertising, arguing, feeding and promoting bashers of other IHUB sites will be strictly prohibited.
Posts which the moderators feel violate these rules will be removed without question or debate.
If you are willing to cooperate and co~exist with other posters in this environment within the guidelines laid out, then welcome and have a great time posting and learning.
Please Note: Please add links to websites and information whenever they are available for accuracy and informational purposes.
Plus, I am not an MD, but rather a longtime biotech/pharma investor and former Quant analyst. So, if I can answer any questions relating to medical information, I will, and cede to any medical professionals whom are better equipped to answer those inquiries.
Thank you....PL1
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