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George what are the highlights or your takeaways ......?
B's FAST TRACKED DESIGNATION 101 Here's why Brilacidin will catch those bottom feeders, the truth about Brilacidin's Efficacy and Safety in COVID-19 will be revealed before long.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. "RIGHT TO TRY"
A drug that receives Fast Track designation is eligible for some or all of the following:[3]
* More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
* More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
* Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
I own some AVXL too.
Longs cashing out today doesn't make a lot of sense or cents unless you absolutely need some cash ... there's a lot more to go "if" you have discipline and patience. Why give away more big gains to come when we've all been waiting for the FDA Approval which eliminates a TON of Future RISK? A buy out will blow the price sky high.
Cant't regret tying up your shares at $50 .... prevent your shares from being used by the day traders and if it hits, who could complain.
Next stock to consider people is IPIX
Conference Call to Discuss LUPKYNIS Approval
JAN 25, 2021 • 8:30AM EST
Webcast
To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada).
This information and more can be found on Aurinia's website.
GREAT DAY TO BE A LONG with lots of shares!!!!
Research IPIX - do your DD... It has extremely exciting possibilities and IMO it Will be a block buster within a couple of months. The share price is affordable NOW to load up, could be that buy of a lifetime.
I invested very big and early into PCYC and AUPH and think IPIX will be the biggest payoff of them all.
Final Score Brilacidin 426, Remdesivir 130 .... a complete BLOW OUT!
Great job Dr. Paddleboarder, Statistical Facts in Medical Science do matter!
BRILACIDIN SI *426*. Some keep babbling about safety.
Government RBLs recently declared BRILACIDIN has a SI of *426*.
Everyone was hoping to at least equal Gileads Remdesivir number of 129.87. A number good enough for FDA APPROVAL and 2 billion in revenues last year.
The higher the SI ratio the more EFFECTIVE and SAFE a drug would be during treatment for viral infections.
SAFE and EFFECTIVE are the key words.
The SI of a compound IS widely accepted parameter used to express a compounds efficacy in the INHIBITION of virus replication.
BRILACIDIN *426* efficiency has a 97% kill rate of the virus in lab testing. When combined with Remdesivir's 129 the kill rate did slightly jump up to 99.85%.
Simply put, peple would being saved at this very moment IF Gilead
was owner of BRILACIDIN *426*.
Seeing is believing. BRILACIDIN did so well that the RBLs STATED that BRILACIDIN should be lab tested against a host of other viruses.
You can believe what the major UNIVERSITIES, Government RBLs and highly honored scientists are saying after testing BRILACIDIN in the labs or you can belive the unsubstantiated claims of the other side. The agenda of the first group is to better society and bring help to the medical community. I can't say what the agenda is of the other side. God only knows..
BRILACIDIN *426* the SAFE ALTERNAIVE to many future ailments...
Love that clip, thank you! I watched it live when it aired and I remember I was a little disappointed, the time lines to approval were indeed accurate but longer than the speculation was at the time. Gave us/me more time to add shares.... now I'm thrilled!!!! Mr. Glickman you were a real gentleman and very knowledgeable and humble at the same time, nice job!
Glad voclosporin will be THE Gold Standard, sorry recent competition ... injections and the higher Adverse Events profile and not as impressive efficacy make you a backup therapy and not patient friendly. Oral medications are much easier (more convenient), safer (infections, and soreness) and less painful (literally) to administer.
GO AUPH $$$$
FDA approval is amazing!!! Aurinia is a well oiled machine based on excellent clinical data and great planning. The Commercial Sales Organization is already in place for an immediate and very successful impact on this disease... LUPKYNIS will be the new gold standard therapy for LN, great for Health Care Providers and their patients.
Any educated guesses what to expect on Monday's close?
AURINIA Monday 8:30 AM Conference Call Information January 25th
Aurinia will host a conference call and webcast to discuss the approval of LUPKYNIS on Monday, January 25, 2021 at 8:30 a.m. ET.
The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada).
Aurinia is proud to announce the FDA approval and availability of our first commercial product, for #lupusnephritis a serious progression of systemic lupus erythematosus (SLE), a chronic, complex and autoimmune disease. Read more here: https://bit.ly/2KFItyB.
FDA APPROVED ... Congratulations Aurinia!!!!
You bury bad news late on a Friday... expecting great news but this is still nail biting.
April 1st is April Fool's ... hope that was just a bad joke! :)
Warren Buffett - "The stock market is a device for transferring money from the impatient to the patient"
THE RINGER: B developer, Dr. William F. "Bill" DeGrado, Ph.D., Professor of Pharmaceutical Chemistry at the University of California, San Francisco (UCSF) [1] and a member of the National Academy of Sciences AND HIS connections!!!!
Warren Buffett - "The stock market is a device for transferring money from the impatient to the patient."
What are the odds or interest for a handsome buyout within Aurinia or do think they want to go it alone?
Who's in it for the long haul if it shoots to $30, sell off, sell some, or are you holding out for a bigger payout???
MUST READ... Dr. David Kessler & DR. William DeGrado have a lot in common ... both have strong ties to UCSF!!! Dr. Kessler was named as President Biden's chief science officer of COVID response in charge of vaccine science. YES REALLY!!! Dr. Kessler is a former FDA head and UCSF professor of pedriatics, epidemiology, and biostatistics.
Kessler has been serving as a top pandemic advisor to Biden through the transition, as the Associated Press reports, and he will replace Dr. Moncef Slaoui as the chief advisor to Operation Warp Speed.
Kessler's involvement in the new administration was first reported in early November, when he along with two other UCSF colleagues, Dr. Eric Goosby, and Dr. Robert M. Rodriguez, were named to Biden's pandemic advisory board. Kessler was asked at the time to lead that board.
Previously, Kessler served as FDA commissioner from 1990 to 1997, under the presidencies of George H.W. Bush and Bill Clinton. He also previously served as dean of the UCSF School of Medicine.
Kessler's assignment to the vaccine effort comes at a tense time as COVID infections are raging.
Dr. Kessler LOOK at Brilacidin!!!
We know that Brilacidin is special, a novel therapeutic with no other competitors in the same class. Hat's off to you Dr. DeGrado, Leo and all the LONGS who helped support the company to get us to this monumental achievement! COVID-19 is a serious health threat around the world!
Brilacidin's FDA's FAST TRACK approval gives humanity more hope that we can stop the spread and stop the misery... it could be the tipping point for a high dollar BP or BioTech acquisition to take it world wide within months...
INNOVATIONS B's FDA FAST TRACK Designation approval is a game changer that gives Innovation some real credibility to change the course of this dreaded disease ....(today there are only a few therapeutics approved for this level of urgency and high level of expectation)!!!!
HUGE HUGE HUGE equates to Huge stock appreciation very soon!
Reuters this morning posted that the FDA Granted an IND Approval For Phase 2 Clinical Trial Of Innovation Pharmaceuticals' Brilacidin To Treat COVID-19!!!
EMERGENCY USE / RIGHT TO TRY for COVID-19 can now proceed with Brilacidin vs. the less than stellar and over hyped Remdesivir option.
Wish the Peer Review came out before now???!!!
NOT SO FAST!!! "Pfizer’s promising new COVID-19 vaccine could become a logistical nightmare to distribute to Americans — all because of the ultra-cold temperatures in which it must be stored, experts said."
"The potential coronavirus shot will need to be kept at an astonishing minus 94 degrees Fahrenheit or below to actually be effective."
“It’s unlikely that the average pharmacy or doctor’s office will be able to manage this vaccine,” Dr. William Schaffner, a professor of infectious disease at Vanderbilt University Medical Center, told The Post.
https://nypost.com/2020/11/10/why-pfizers-covid-19-vaccine-will-be-a-nightmare-to-distribute/
Innovation Pharmaceuticals Inc. Demonstrates World-Class Portfolio of Innovative Therapies (IPIX)
November 9, 2020 Stock Day Media
IPIX STOCK BOTTOM LINE
"We remain bullish on IPIX stock. As we said last month, which can readhere, IPIX stock is the cheapest COVID-19 play we have found. Its current market cap is just $83 million compared to $1.5 billion forCytoDynand $1.1 billion forRLFTF, both of which we have covered here at Insider Financial."
"Innovation Pharmaceuticals has been around for so long and its share price depressed that most tend to overlook it, ourselves included. However, we like the data at hand and the potential for the treatment of COVID-19 with Brilacidin and Remdesivir is very compelling. WithGilead, the company behind Remdesivir, sporting a $72 billion market cap, Innovation Pharmaceuticals could be a takeover play as well. The bottom line is that IPIX stock remains a steal at current levels, especially with multiple catalysts coming as the Brilacidin for COVID-19 clinical trial gets underway this quarter."
https://stockdaymedia.com/innovation-pharmaceuticals-inc-demonstrates-world-class-portfolio-of-innovative-therapies-ipix/
From Pre-Print to Peer Review Publication... how long??? Any guesses?
IND approval timelines????
Gilead... Isn't it a Good time to partner with Innovation? Remdesivir has mainly benefited from getting off to a quick start and FDA approval (the SI wasn't outstanding) ....fast forward to 11/09/2020, Remdesivir will soon not be strongly relevant as a single agent. Brilacidin's phase II's has clearly and profoundly outperformed Remdesivir in similar testing. IMO, Gilead needs to have the R+B Combination to be the therapeutic market leader and have a potential blockbuster with additional Brilacidin clinical investments.
FACTS:
· Brilacidin shown in vitro to potently inhibit SARS-CoV-2, the novel coronavirus causing COVID-19.
· In a human lung cell line infected by SARS-CoV-2, Brilacidin achieved a high Selectivity Index of 426.
· The primary mechanism of action of Brilacidin appears to disrupt viral integrity and block viral entry.
· Brilacidin and FDA-approved remdesivir exhibit excellent synergistic activity in vitro against SARS-CoV-2.
Will Gilead Buy Brilacidin to remain relevant. Now more than ever doesn't Remdesivir need Brilacidin combination data to remain competitive? IMO.... YES! They are going to be left in the Vaccine and therapeutic dust/ash bin without the already published combo results.
State of the State... Brilacidin results, SI of 426 (far superior than first hoped for), Free Trials conducted at non-bias RBL's, and the cherry on top ... Dr. William F' DeGrado as your Research and filings and science advocate!!!
findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.
Preprint article details research conducted at George Mason’s Regional Biocontainment Laboratory:
A few Highlights:
· Brilacidin shown in vitro to potently inhibit SARS-CoV-2, the novel coronavirus causing COVID-19.
· In a human lung cell line infected by SARS-CoV-2, Brilacidin achieved a high Selectivity Index of 426.
· The primary mechanism of action of Brilacidin appears to disrupt viral integrity and block viral entry.
· Brilacidin and FDA-approved remdesivir exhibit excellent synergistic activity in vitro against SARS-CoV-2.
· “Preprint: Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2”
http://www.ipharminc.com/new-blog/2020/10/30/preprint-brilacidin-a-covid-19-drug-candidate-exhibits-potent-in-vitro-antiviral-activity-against-sars-cov-2
Effective Brilacidin Prophylactic Use for COVID-19 and others (oral, injections or inhaled) means very high volume of use and huge profits $$$$ and of course GREAT for Humanity! Big Pharma... the risk was just lowered for a buyout????
The President is on his second/third dose of Remdesivir by now, does anyone know what the protocol for dosing was with the RBL Data that shown nearly 100% viral load improvement with the Remdesivir + Brilacidin Combination???
Brilacidin/Remdesivir Combination: In a test at the George Mason University RBL, the Lab combined Remdesivir with Brilacidin which resulted in a 99.85% Viral Load Reduction with insignificant traces of the virus remaining. http://www.ipharminc.com/press-release/2020/9/15/laboratory-testing-of-brilacidin-for-covid-19-in-combination-with-remdesivir-reduces-viral-load-by-nearly-100-percent
On a scale of 1- 10, with 10 being very confident what's your level of confidence of Brilacidin's being approved for COVID-19 and other other high ticket indications based on what has all ready been shown???
You nailed it!
"The principal aim of the pre-IND meetingis to ensure that the drug development plan and future clinical trials are going to be acceptable to the FDA. This is an opportunity for sponsors to gain valuable feedback from leaders in the industry."
Leaders = Dr. Athony Fauci, NIH, CDC ... IPIX will be well represented with William DeGrado there (he probably knows more about Defensin-memetics, and Brilacidin than all of them combined.
Proof of a long over due and a much deserved attention starting to build for Brilacidin! Let me remind everyone what happens (we've seen the public releases) when you combine Remdesivir AND BRILACIDIN.
FACT: A Pre-IND meeting approval, or PIND, with FDA is a CRITICAL MILESTONE for development companies prior to filing the IND, the approval of which allows the conducting of your first in-human clinical trial. 120 patients will be in the Brilacidin COVID-19 Trial.
SO so glad William DeGrado is on this one as probably the #1 advisor in the world to get Brilacidin approved!!! Timing is Great! Expect the stock price to soar unbelievably if the efficacy and safety continue.
the analogy is it's better to lock the barn door than to corral the horses after they left the barn. :)
Better lucky than good sometimes. Let's face it, Many/Most longs are underwater and were not going anywhere, P failed and up until COVID-19 hit it was BLEAK, we were talking/hoping for B-OM to bail out our stock price a little. Innovation was operating on fumes and borrowed money. I felt Absolutely Stuck with this stock, regretted ever buying in and would've loved to get my investment back last November and walk away! We were at .05 cents a share people, we didn't exactly look like rocket scientists for owning this stock.
WHAT EVER GOOD HAPPENS: We were all given Lightening in a Bottle with the urgency of a cure for once in a hundred years world wide Pandemic, COVID-19.... we were dead in the water, let's consider us all infinitely more Lucky and Blessed if Brilacidin hits, and not Wise. Better lucky than good sometimes!!! Super Lucky. That being said, it all fell in Leo's lap! Leo now has the clinical horsepower and clout of William DeGrado to hopefully make Brilacidin a household name and earn William DeGrado at el. the Nobel Peace Prize in Medicine! The clinical data on Brilacidin thus far has been amazing and there is now light.... Longs, let's not pat ourselves on the back in retrospect if it hits, but know we were BLESSED!
Operation Warp Speed in action - August 4th PR... RBL Anticipated academic paper for per review publication with a pre-print in September ... I guess "anticipated" means whenever during Operation Warp Speed?
"At the RBL, ongoing direct inhibition experiments are being conducted with the live virus, including experiments to determine the Selectivity Index—a ratio that compares a drug’s cytotoxicity and antiviral activity—of Brilacidin in human lung cells and also in Vero cells. New in vitro neutralization experiments (with a pseudotyped virus) and binding experiments (using isolated SARS-CoV-2 Spike protein) are helping to further elucidate Brilacidin’s antiviral mechanisms against SARS-CoV-2. The richness of the growing RBL data is informing our planned Phase 2 clinical trial of Brilacidin for COVID-19. Upon completion of in vitro testing at the RBL, an academic paper is anticipated to be submitted in September for peer-review publication, with a pre-print to be made available at that time."