Like they say at the state lotto:

You can’t win if you don’t play!

Best of luck to you!

Maybe there is good “ORR” NEWS COMING OUT OF THE CLINICAL TRIALS ON MULTIPLE MYELOMA.

PS:

CLRBZ warrants that expire in 8 days were up About 16% this afternoon. Interesting!

Maybe some insider wants hundred of thousands of warrants to convert into common shares in 7 days?

Splintered:

I see little near term hope for common shares short of huge positive news on CLR130 clinical trials, Phase 2.

Those trials, and their results, should not take so long in that the one or two one hour infusions at a couple of dosing levels can be quickly analyzed, considering the very short half life of radioactive iodine and the immediate effect of it on various cancer cells.

No, the company knows what the results are by now, and I cannot think of any reason the keep the results secret, unless there are plans to sell the company to big Pharma suitor.

The recent decision to dilute with many more shares and raise capital does not support any M&A possibilities. OCICBW

BUT, I really wonder why the old CLRBZ warrants are holding at the high twenty cent level instead of at five cents like much of last year. CLRBZ warrants expire worthless on 4/8/21, right?. What’s up with that at this point?

Why would someone be acquiring hundreds of thousands of these warrants now???

Watching 2/16/21 Pre-Market on this,


...Looking good so far.

But you are right, only around six thousand pre-market shares traded so far.

Doubtful to hold $11 after the market opens at 6:30 am ET.

$9.50 target?

Consensus Rating: Buy
Consensus Price Target: $9.50
Forecasted Upside: 134.57 %
Number of Analysts: 2
Breakdown:
0 Sell Ratings
0 Hold Ratings
2 Buy Ratings
0 Strong Buy Ratings

$4.05 As of 02/10/2021 05:59 PM ET

THIS is the sixth post

in 2021. Quiet board!

IT WILL NOT BE QUIET MUCH LONGER PER MY RESEARCH!

Of course I could be wrong! ??

Good luck Jakkelp!

I hope you recover losses from December to date on this stock/company.

I got out of my CLRBZ warrants by a fat thumb trade a few weeks ago where someone place a buy order 500% above the market price.

That leaves a thousand CLRB shares to dump. This company and it alleged products/technology has been a big disappointment for years.

I now think if the CLR was going to work well, it would have proven itself by NOW.

The special shareholder meeting at the end of this month with DILUTION becoming official will be the mail in the coffin.

Sunofwolf was right, this company is run for the employees pay, not shareholders and potential patients, OCICBW! Just an opinion based on superficial observations!

32 days from now?

More or less??

TLSA looks to have lost a competitor,

in RLFLF... PR says LRFLF failed to meet 28 day survivability goal on Covid lung treatment.

Down over 40% today with billions of shares outstanding. Pain!

That just leaves a yet to be determined 60 day survivability clinical trial milepost.

TLSA will fare better, but it is a lesson learned.

Thanks, XMAN:

Ha! “...Veru will have results by the end of the year. It will help against new variants of Covid...”

Veru will be SOL by then with herd immunity for the currently known variants.**

RDHL IS 9 months ahead of VERU? I think you are right with that opinion!

**I certainly hope so. Demand for OPAGANIB may be down by more than 50% by the end of summer

There are hard charging potential competitors for Opaganib in the wings: For example, TLSA and RLFTF in stage 2- 3 clinical trials for Covid lung damage. CREATIVE methods to reduce lung inflamation!

Cramer better figure out who will hit the finish line before monetization is a lost opportunity in this area of dire need for the time being and for current magnitudes.

RDHL looks promising by early March for conclusive news and early May for production start up....assuming FDA and EU emergency approval. God help us...especially those nations too poor to buy enough Covid vaccines in time to dealt with original & variants.will they at least be able to get treatment if not prevention?

Four horsemen are here with the dark hourse in the lead?

Good to be long here,

Early & long...On another of my Covid-19 treatment investments!

Is this the ground floor of a 6 month flight to the moon and back?

As to new Covid stains,

like the UK strain expected to quickly become dominant in the US by next month, I can document my opinion Opaganib will be equally effective with all strain infections with this headline from the RDHL press release that Frakster’s (post #2783) post was propably based upon:

“...Opaganib targets a human cell component involved in viral replication and is therefore expected to be effective against emerging viral variants with mutations in the spike protein...”

Well that was good for a modest 5% pop up,

but it’s fading some as the stock market discounts the obvious: the lung complications addressed by RDHL’s proposed treatment are really complications in common with all Covid strains.

Now when RDHL announces the CT results in a few weeks, 5% will be a small factorial of the move up which will be sustained as we approach FDA Emergency approval.

Right?

Answering my own 1/11/21 question: YES!

Wainwright & Co. had good reason to buy 1.8 M shares of RDHL @ the agreed price for the reasons REVEALED a week or two later in RDHL’s 1/29/21 6-K filing with the SEC:


TEL AVIV, Israel and RALEIGH, NC, January 29, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib1 in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.

“Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. The positive and unanimous DSMB recommendation is a significant milestone in the progress of our development program for COVID-19 disease. Taken together with the positive results from the Phase 2 study, this unanimous DSMB recommendation to continue the global Phase 2/3 study suggests we are heading in the right direction from both a safety and efficacy perspective,” said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. “This is a particularly difficult time in the fight against the pandemic, with viral mutations increasing infection rates and impacting many aspects of society’s response to the pandemic. The need for effective therapeutics is clear. Opaganib’s mechanism of action targets the human host cell component SK2, which is involved in both viral replication inside the cell and downstream inflammatory/immune responses. This means that opaganib is expected to maintain its activity irrespective of the worrisome mutations in SARS-CoV-2 spike protein. These mutations underscore the potential of SARS-CoV-2 to develop resistance to direct anti-viral mAbs, and to potentially impact vaccine effectiveness. This is an important advantage of opaganib in the face of the growing multitude of viral strains and provides the promise of a much-needed treatment option to help get patients off oxygen and out of hospital.”

This positive DSMB futility review, which is suggestive that the global Phase 2/3 study is progressing as expected, adds to positive top-line safety and efficacy data from the U.S. Phase 2 study, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms - further adding to the growing safety database for opaganib. Full analysis of the Phase 2 data, including viral and inflammatory biomarker analyses, baseline risk factors and standard-of-care background therapy stratification, is expected in the coming weeks and is planned to be provided for peer review....

My only remaining question is: WHAT TIMEFRAME IS MEANT BY “in the coming weeks”, AND will the results of the FULL ANALYSIS OF THE PHASE 2 DATA, INCLUDING BIOMARKER ANALYSIS, BASELINE RISK FACTORS AND STANDARD-OF-CARE THERAPY STRATIFICATION BE PUBLICLY ANNOUNCED IN THOSE SAME “coming weeks?

The likely answer to this follow up question is more clearly set forth in the conclusion of the Newswire RDHL PR of the same day as the 6-K (1/29/21):

“...Correspondingly, a blind resizing of the study is planned, to approximately 460 patients. There are approximately 30 study sites in 7 countries with additional sites and countries being added in the coming days and weeks. Top-line data, and potential global emergency use authorization applications are expected in the second quarter of 2021.”

Ronjon41:

This biotech stock has been a sleeper for a few years now, holding my money in a lock box. “Dead money”, as Cramer would call it. Since it’s potential products are still all in clinical trial stages, it’s price performance is understandable. Management has not monetized the intellectual property nor helped many patients.

BUT THIS IS CHANGING, NOW!

How do I know this?

Research CLRB’s warrants, trading under the symbol CLRBZ!

I had 10’s of thousands of these warrants in two accounts, with a basis of a few cents. These warrants expire worthless on or about 4/8/21. MY GTC SELL ORDERS ALL TRIGGERED TODAY AT .71 cents- HUGE PROFITS FOR ME IN MY REGULAR IRA AND ROTH IRA. (OF COURSE, I WISH MY SELL ORDERS WERE TWICE AS HIGH, since CLRBZ spiked to $1.50 or so TODAY.)

I believe these most of these warrants are owned by INSIDERS with more information than I have about CLRB & its clinical trial results !!!

I humbly believe that the price action of CLRBZ is a very good indication off the future for the stock CLRB itself- although I could be wrong again!

Everyone, do your own research & Ignore me- and my speculative opinions!

Worth repeating 1/7/21 PR:


“Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced median overall survival (mOS) in Cohorts 1-4 of the company’s ongoing Phase 1 clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM). The results showed mOS of 22.0 months among 15 patients, all of whom were heavily pretreated, averaging five prior lines of systemic therapy. Each patient in Cohorts 1-4 of this dose-escalation study received a single 30-minute infusion of CLR 131.
All patients enrolled in Cohorts 1 through 4 were previously treated with both proteasome inhibitors and immunomodulatory drugs, and experienced disease progression with greater than one-third dual refractory. While no head-to-head studies have been conducted between CLR 131 and other therapies in this heavily pretreated population, for background purposes, a 2016 article published in the journal Bone Marrow Transplantation refractory to both proteasome inhibitors and immunomodulatory drugs achieve mOS of 9 months.1 Additionally, mOS for R/R MM patients receiving treatment in third line averages approximately 12 months of survival, including several recently approved drugs.2,3...”

Editorial Comment:

WHAT WOULD YOU PAY FOR AN EXTRA 22 months of life, if you had the money???

“...The median overall survival of 22 months in this heavily pretreated patient population is very encouraging. These are patients with limited therapeutic options and, unfortunately, face poor prognoses,” said James Caruso, president and chief executive officer of Cellectar Biosciences. “The convenience afforded by CLR 131 delivered in only one or two doses as currently administered in our ongoing hematology studies makes it a far less intrusive regimen than other treatments that must be administered at regular dosing intervals. We believe extending mOS with a more patient-friendly dosing regimen provides both a distinctive product profile and the potential to provide beneficial patient outcomes even in later lines of therapy.”

1. R.F Cornell and A.A. Kassim (2016). Evolving paradigms in the treatment of relapsed/refractory multiple myeloma: increased options and increased complexity. Journal of Bone Marrow Transplantation
2. Jurczyszyn et al (2014). New drugs in multiple myeloma – role of carfilzomib and pomalidomide. Contemporary Oncology
3. Dimopolous et al (2016). Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple...”

Worth repeating 1/7/21 PR:


“Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced median overall survival (mOS) in Cohorts 1-4 of the company’s ongoing Phase 1 clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM). The results showed mOS of 22.0 months among 15 patients, all of whom were heavily pretreated, averaging five prior lines of systemic therapy. Each patient in Cohorts 1-4 of this dose-escalation study received a single 30-minute infusion of CLR 131.
All patients enrolled in Cohorts 1 through 4 were previously treated with both proteasome inhibitors and immunomodulatory drugs, and experienced disease progression with greater than one-third dual refractory. While no head-to-head studies have been conducted between CLR 131 and other therapies in this heavily pretreated population, for background purposes, a 2016 article published in the journal Bone Marrow Transplantation refractory to both proteasome inhibitors and immunomodulatory drugs achieve mOS of 9 months.1 Additionally, mOS for R/R MM patients receiving treatment in third line averages approximately 12 months of survival, including several recently approved drugs.2,3...”

Editorial Comment:

WHAT WOULD YOU PAY FOR AN EXTRA 22 months of life, if you had the money???

“...The median overall survival of 22 months in this heavily pretreated patient population is very encouraging. These are patients with limited therapeutic options and, unfortunately, face poor prognoses,” said James Caruso, president and chief executive officer of Cellectar Biosciences. “The convenience afforded by CLR 131 delivered in only one or two doses as currently administered in our ongoing hematology studies makes it a far less intrusive regimen than other treatments that must be administered at regular dosing intervals. We believe extending mOS with a more patient-friendly dosing regimen provides both a distinctive product profile and the potential to provide beneficial patient outcomes even in later lines of therapy.”

1. R.F Cornell and A.A. Kassim (2016). Evolving paradigms in the treatment of relapsed/refractory multiple myeloma: increased options and increased complexity. Journal of Bone Marrow Transplantation
2. Jurczyszyn et al (2014). New drugs in multiple myeloma – role of carfilzomib and pomalidomide. Contemporary Oncology
3. Dimopolous et al (2016). Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple...”

These warrants (CLRBZ) expire worthless on or about April 8, 2021!

ALL of today’s posts here

are very incisive, honest and informed.

THANK YOU ALL VERY MUCH!

- Crusader

PS:

Also yesterday’s posts, including this one, were very helpful!

“... ARK’s Cathie Wood bought 54,000 shares for her Israel fund in last 2 days not including today yet.
RDHL moved from 32 to 8 on the list
#7 stock if you don’t include the $7 mill in bonds waiting to buy more or for redemptions...”

https://ark-funds.com/wp-content/fundsiteliterature/holdings/ARK_ISRAEL_INNOVATIVE_TECHNOLOGY_ETF_IZRL_HOLDINGS.pdf


https://investorshub.advfn.com/boards/profilea.aspx?user=741182

From COSMO website:


“...Investments in other companies

Cosmo holds stakes in other companies as a result of partnerships and spin-offs. We hold a 46.56% stake in Cassiopea (SIX: SKIN), a 19.6% stake in RedHill Biopharma Ltd. (NASDAQ: RDHL), a 20.52% stake in Acacia Pharma Group plc (EURONEXT: ACPH) and a 7.91% stake in PAION AG (Frankfurt Stock Exchange, Prime Standard: PA8)...

“Something’s happening here, what it is

ain’t exactly clear”...hey now, what’s that sound...Ca-ching $$$

And SEC 10-B-5 et. seq. reads that inside information trading is illegal!

Or, is this just a short squeeze ??

1/27/21: EU grants CLRB orphan drug status on specific blood cancer!

But this is not the U S clinical news on 131 that is promised soon.

Time will tell!

Seeking Alpha article on CLRB:

https://seekingalpha.com/news/3654903-cellectars-clr-131-an-orphan-drug-in-european-for-rare-blood-cancer

FASTEN YOUR SEAT BELTS, Robinhood traders are coming here soon!

Due for clinical trial news?

IR thinks so...good or fluff bad?

Smart!

I hate dead money, but it is going to take awhile for RDHL to recove after doubling down on this financing.

Dilution of the share architecture is rarely good for stock price, but this is what a “shelf” offering is there to do.

It is a mine field to innocent buyers: today’s correction is not the last. “Due to demand” for this offering, they more than double down!

What is the old saying? Paying retail is for .....never mind.

Shady:

Well that is what I was asking. Don’t know the answer.

Was wondering why that old company would/could want to buy by millions of dollars of RDHL stock AT A HIGHER PRICE than Red Hill would trade at if it tanks big time. Why not just wait for it to tank and get it cheaper?

It seems like RDHL is sitting on likely positive news due out shortly (mentioned in last PR)** on their Covid Treatment Trials of Opaganib. RDHL had better FAST TRACK that treatment toward FDA approval to contain pneumonia in those fighting for their lives , especially if the current COVID-19 vaccines prove less effective on the mutations of Covid popping up in South Africa and Japan via Brazil.

Will it tank? I do not know. But I am betting 1,000 shares long that it does not tank.


** 12/31/20 PR:

“...Full analysis of the data, including viral and inflammatory biomarker analyses, baseline risk factors and SoC background therapy stratifications, is expected in the coming weeks. The Company will provide the data for peer review when available.

"We are pleased with these encouraging top-line results from our exploratory Phase 2 study which confirm opaganib's safety and demonstrate promising signals of activity when treating patients with COVID-19 and who require oxygen support. These preliminary results support our ongoing global Phase 2/3 study in severe COVID-19 pneumonia, which is expected to read out in Q1/2021. We continue to work diligently to compile a robust data set to support potential filing of global emergency use applications," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill...”

HCWCO: a Buyer:


https://hcwco.com/services/

The way I read RDHL’s SEC FILING today,


we have 1.8 million shares of “dilution”. This is assuming that H.C. Wainwright & Co. has/ is/will be buying RDHL treasury shares at a price somewhat below market closing price today.

After hours selling of RDHL was immediately evident with DOWN volume of just over 150,000 in the hour after this news.

QUESTION: Does H.C. Wainwright & Co. have reason to believe good news is imminent and its agreement purchase price will not be available at market in the near future??

Just wondering...

Big “D” always hurts

for awhile...if the company is truly growth and earnings orientated.

THEIR (CLRB) FUND RAISING (DILUTION) HAS TO BE USED TO COMPLETE DEVELOPMENT OF A CANCER TREATMENT OR THE PAID BEARS HERE WILL BE RIGHT. IT’s either win/WIN OR lose/LOSE IN THIS MARKET OR ESPECIALLY THE 2021 ONE TO COME!

OBLN...

Clay: stairway to heaven...

??????

I am buying MORE RDHL:

12/22/20 PR:

“...The recommend ation is based on an analysis of unblinded safety data from the first 155 patients treated for 14 days. Top-line data from the 270-patient study is expected Q1 in 2021.

In parallel, the company is conducting an additional U.S. Phase 2 study with opaganib in COVID-19. The trial has completed enrollment of all 40 patients and data is expected shortly”... Seeking Alpha

Short term, we longs will have a Happy New Year, during a very sad health environment that RDHL’s new research may actually help treat back to better Heath the most desperate patients!

TIMING IS EVERYTHING!!!

Agree about NEWS THIS SHORTENED WEEK,

because last PR specific Covid clinical trial update to follow “SOON”.

My year end target is $15.00. I have sell orders closer to $20 pps.

Right, retire, the pre-market was no match,

for the opening bell.

And the ‘23 warrants on this company, rising 400 % on the regular session, Friday, was only on 121,000 units traded. If the Friday volume on those warrants was 10X higher, I might suspect some HEPA news was afoot.

Pre-Market spike $2.64

settling now around $2.30....

https://m.marketscreener.com/quote/stock/HEPION-PHARMACEUTICALS-I-63216091/news/Hepion-Pharmaceuticals-Announces-FDA-Clearance-of-IND-Application-for-CRV431-for-COVID-19-32067969/

Big FDA NEWS today,

clearing CRV431 for Covid “use”?:

LOOKING LIKE BIG OPEN @ 9:30 am ET...hope it holds pre-market gains!!!

Thanks, use would be Compassionate Use,

I suppose, without FDA approval?

CLRB UP 2days in a row,

..:With no news that I can find.

$3 inter-day yesterday?

There is no explanation but volume will tell if it is only manipulation of share price.

IT IS CHEAPER AND BETTER LEVERAGE TO USE CLRBZ TO SPECULATE ON THIS COMPANY FOR THE NEXT 30 days ONLY!

JACK, be nimble; JACK BE QUICK!

Trump Dumped Scott?


“...On March 5, 2019, Gottlieb announced his resignation as FDA Commissioner, effective in about a month. He said that he wanted to spend more time with his family.[71] [72] [73]At the time of his resignation, Politico observed, "FDA leaders have typically focused much of their attention on a handful of medical topics, but Gottlieb has been active and aggressive on many issues as commissioner without hewing to a strictly conservative or liberal ideology. It’s an approach that’s won him praise from many in the health sector, while garnering criticism from several of the targeted businesses like tobacco companies and the fast-growing e-cigarette industries."[74]

GOOD FIND, Midas:

Local news has lately emphasized the recent RDHL press releases...

Now, if the FDA green lights this treatment in JANUARY like I think it will, this company and its stock will be one of the very best trades of early 2021. I like the odds here, even though PFE showed us what FDA emergency approval is like.

Operation “Warp Speed” ends JANUARY 21st, 2021, but Biden administration will have an operation to match Trump’s successful (collapsing efforts) , so Dems can take more credit for “beating COVID” and position early for midterm elections.

So, yes, RDHL stands to benefit under both administrations, as do COVID’s critical care patients.

And as a preview all this, WAIT UNTIL YOU HEAR WHO BIDEN APPOINTS AS FDA :

https://www.msn.com/en-us/news/politics/biden-under-pressure-to-name-new-fda-chief-as-public-faith-in-vaccines-falters/ar-BB1aNGSt?fbclid=IwAR2iz4Yf1Q0BczBYrnf08ANpRetW3c2o7zytr09b33lwxhEZfdpjG2fHAlI

OPERATION BREAK NCK SPEED:


The CDC director does not need Senate confirmation, avoiding a hurdle that could slow that process. That is not the case for the FDA commissioner. As a result, even if Biden moves at breakneck speed to replace outgoing Commissioner Stephen Hahn, it could be weeks after Biden is in the White House before his pick could get to work.

In the meantime, the FDA will face critical decisions about vaccines needed to help put the nation on its path out of the pandemic. Biden will have to rely on a temporary head of the FDA to steer the 17,000-employee agency during one of the most challenging times in its history.

“It’s not ideal timing, for sure,” a former FDA official said. “It’s a huge job.”

Positive SEC filing today by HEPA:


“...EDISON, N.J.,?December 10, 2020 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, “Hepion”), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced that, in addition to completing patient dosing in the 75 mg CRV431 cohort of its Phase 2a ‘AMBITION’ clinical trial, it has dosed the first NASH patient in the 225 mg CRV431 dosing cohort.

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. Hepion will also conduct Fibroscans and examine a multitude of candidate biomarkers of NASH resolution and CRV431 efficacy including Pro-C3, Enhanced Liver Fibrosis (ELF) markers, collagens, matrix metalloproteinases, transcriptomics, liver transaminases, and full-scale lipidomic and genomic signatures. Identification of biomarkers will be facilitated by Hepion’s proprietary, machine-learning platform, AI-POWR™.

“We are pleased to complete dosing of all NASH patients in our 75 mg CRV431 cohort,” stated Dr. Robert Foster, Hepion’s CEO. “All patients will now be observed for a 14-day follow-up period, which is scheduled to be completed by December 16, 2020. In parallel with the completion of this dosing cohort, we have now dosed the first NASH patient in the 225 mg cohort. We are delighted with our progress and anticipate that data from this trial will yield important insights that will be applied to our planned Phase 2b clinical trial, which is scheduled to begin in 2021.”


https://www.sec.gov/Archives/edgar/data/1583771/000110465920134049/tm2038218d1_ex99-1.htm

“I continue to look forward to seeing the read-out from the 75 mg dosing cohort,” commented Dr. Stephen Harrison, Hepion's Consultant Medical Director. “Thus far, CRV431 appears well-tolerated in patients. Importantly, we will also be examining fibrosis using multiple non-invasive measures and looking for a dose-response relationship between the 75 mg and 225 mg dosing groups.”