Veru Inc (VERU)

[glenn1919]

VERU................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

[Monksdream]

VERU new 52 hi

[Here Today]

Squeeeeeeeeeeeeeeeeeeeeeeeeeeeeeze baby squeeeeeeeeeeeeeeeeeeeeeeeeeeze!

[glenn1919]

VERU............................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

[Monksdream]

Developing a weight loss novel drug

[Here Today]

I believe Regeneron announced yesterday they were pursuing something to this effect. Wonder if they would be interested in collaborating with VERU with this drug?

[glenn1919]

VERU......................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

[TJG]

struggling to get off the mat, had a good thing going but no staying power... and certainly no interest in it on IHUB.... LOL LOL

[Monksdream]

VERU new 52 week low

[Monksdream]

VERU new 52 week low

[Monksdream]

Looks like it’s come up off the mat

[BostonSportsNut]

Life today?
H.mmmm

[Monksdream]

VERU new 52 week low

[Monksdream]

VERU new 52 week low

[Gman3343]

It surely doesn't look good for him. Now we just wait. However you can all check out xrp on Coinbase. That's my biggest holding out of all my investments. Xrp just got clarity from a federal judge, xrp is not a security.
I'm still holding Veru, long term I like it, but short term not much going on, still many clinicals.
Good luck to all.

[glenn1919]

VERU...............................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

[Jayzp]

Ther meme stock..good nws

https://www.prnewswire.com/news-releases/theralink-acquires-exclusive-landmark-immunotherapy-patent-including-biomarker-from-vanderbilt-university-301787847.html

[Alleyba1]

I still say in my opinion the shareholders should thank Dr. Eisenbarger for the demise of the Veru share price. I wonder when he found out and knew they would not get FDA approval in my opinion. My opinion is when he sold all of his stock the stock tanked shortly thereafter. That is my opinion.

[Alleyba1]

I believe in the latest VERU filing Blackrock took a 5% or more interest in the company. News can't be all that bad

[glenn1919]

VERU.................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

[Alleyba1]

I still say in my opinion the shareholders should thank Dr. Eisenbarger for the demise of the Veru share price. I wonder when he found out and knew they would not get FDA approval in my opinion. My opinion is when he sold all of his stock the stock tanked shortly thereafter. That is my opinion.

[Harbor6460]

Never mess with the FDA. They only approve when influenced with Cash imo. Look at IMGN. Sick approval. Market drops it cause they think they can’t market there own drug. They have another approval coming in less then 3 months

[GlitchMatrix]

No, just investors fed up with the games.

[Gman3343]

Yea, that didn't help. And it looks shady that he sold all.

[Alleyba1]

I still say in my opinion the shareholders should thank Dr. Eisenbarger for the demise of the Veru share price. I wonder when he found out and knew they would not get FDA approval in my opinion. My opinion is when he sold all of his stock the stock tanked shortly thereafter. That is my opinion.

[Gman3343]

Very sad, they could be helping people. But because of money not going their way, it won't happen. It's disgusting.

[Alleyba1]

G-Man,
I totally agree with you. The FDA was most likely paid to not approve the Sabi drug in my opinion.

[cfoofme]

Is this just another frivolous lawsuit by a typical bottom feeding law firm?

[Gman3343]

It's ridiculous, that drug should have gotten approved. Probably was a pay off, who knows.
That's our government for you.

[Alleyba1]

I totally agree with your comments. If this application was made by PFIZER or another BIG PHARMA COMPANY the vote would have been 13-0 in favor. Who knows, in my opinion maybe someone got paid off

[klarino man]

So, what are we saying ~ all is lost ?

[Alleyba1]

I totally agree with you. Statistically the numbers may have been better if the FDA had no concerns about the efficacy of the drug and did not ask VERU to stop the trials. I am afraid the FDA screwed us and wonder who paid them off to give us the denial. Every drug I see on TV indicates the side effects can be death, suicide thoughts, kidney failure, liver disease, COPD , etc. etc. We have a safe drug and it gets shoved up our rear ends.

[Gman3343]

No, why would that happen ? Drug was not approved yet. FDA f-,cked Veru with it's shytty slides show of the drug.
Our government is a bunch of back door dealing scumbags.

[blueazur]

A good chance that VERU will force some shorts to cover today?

[Gman3343]

Yes, that is very suspicious.

[Alleyba1]

Here Today,
I hope you are somehow correct.

[Alleyba1]

I agree with you, but I think, in my opinion, it all goes back to Dr. Eisenbager when he dumped his entire position. In my opinion he must have known the drug would not get approved. He was an insider . This of course is just my opinion.

[klarino man]

Accumulate here.

[Here Today]

Not over yet since the FDA May allow with some provisions. Adcom an advisory and not a final decision. Let’s see what happens since I believe as the Wednesday company PR states:



Veru Provides Update on FDA Advisory Committee Meeting Regarding Emergency Use Authorization of Sabizabulin to Treat Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

MIAMI, FL, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, announces the results of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC), which reviewed sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS). The advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. However, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. FDA will consider the input of the advisory committee as part of their review of the EUA and render a decision on the Emergency Use Authorization.
“We look forward to continuing to work with the FDA as we continue our efforts to ensure that this product is available to patients in a timely manner,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru.
“In a still evolving COVID-19 pandemic taking the lives of over 300 U.S. citizens a day and with the threat of new virus variants looming that may not be as easily treated with the limited array of presently used therapies, there is an urgent need for newer therapies with much greater effectiveness than what is available. Sabizabulin with its unique action as a microtubular disruptor, both reducing inflammation and viral replication independent of virus variant, shows compelling promise,” said Erik Swenson, M.D. Professor of Medicine, Physiology, and Biophysics, University of Washington, and former Chairman of PADAC. “In a recently published well-executed double-blind placebo-controlled trial of patients with respiratory compromise and at high risk of developing ARDS, sabizabulin reduced absolute mortality at 60 days by 20.5%, compared to 0-6% for all other available drugs. In the long history of drug trials for patients with severe respiratory failure over many decades, there has never been a drug to show such dramatic protection.”
“Adding sabizabulin to the cadre of therapies among hospitalized patients with COVID-19 is crucial in the effort to reduce mortality among a group of patients who have seen the least reduction in death despite newer treatments and approaches,” said Christian Sandrock, M.D. Division Vice Chief of Internal Medicine and Director of Critical Care University of California, Davis, School of Medicine.
Phase 3 sabizabulin clinical study:
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID-19 at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo. In the full study, there were 204 patients enrolled, and for the primary endpoint, there was a clinically meaningful and statistically significant 20.5% absolute reduction and 51.6% relative reduction in mortality at Day 60. In June, the Company submitted a request for Emergency Use Authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence®.
Global regulatory activities:
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin marketing authorization application will receive expedited review. On July 27, 2022, The European Medicines Agency’s Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries. On August 22, 2022, Australia’s Therapeutic Goods Administration (TGA) determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.

[Gman3343]

Veru got screwed by the FDA. They didn't talk about any of the good things the drug does. It sounded like the FDA didn't want this to pass.
The drug has no side effects, doesn't make sense to not approve it and save lives.
The drug also states hospital visits are cut in half, cancer patients get 7 times the dose COVID patients get.
None of this was in the presentation.
The presentation was total Bullshit, it was a setup to say no.
Also the idiots that said no are not informed and hardly know anything about the drug.
It was a total shytshow, as usual our government sticking it to it's people they are supposably trying to protect.
All bullshit.

[frankyahoo]

This seems reasonable. Took a lotto premarket in the 5's. GLTA

$VERU

[rwwest]

Oppenheimer analyst Leland Gershell maintains Veru, Inc. at Outperform with a price target of $36.00, following a recent FDA AdComm vote.
(from a post on yhoo)
Veru (VERU): "See EUA More Likely Than Not " - Oppenheimer Reiterates Stock at Outperform, $36 PT, November 10, 2022 6:30 AM EST
The analyst comments: "At face value, yesterday's advisory committee vote of 5 yes, 8 no to the single voting question of whether sabizabulin's benefits outweigh its risks in those hospitalized with COVID-19 at high risk of ARDS may be taken by some as fait accompli that the FDA will deny VERU's EUA request. Irrespective of their individual votes, all the panel members were favorable on the drug's potential utility and expressed appreciation for the considerably limited amount of efficacy, safety, and mechanistic understanding on sabizabulin, as well as the potential for various aspects of the Phase 3 trial to have biased its outcome. We believe the key distinction between those who voted "yes" vs. "no" was the standard against which this unique case was measured—a standard that may have been unreasonably stringent in the minds of the "no" voters, as the Phase 3 was conducted during a critical/chaotic period of the pandemic in which more ideal trial conditions simply may not have existed.

We believe the most reasonable course of regulatory action will be that which the briefing documents appeared to lay out, that is, for the FDA to authorize sabizabulin for emergency use in the Phase 3 population (WHO 5 and 6, or WHO 4 with comorbidities) and, as a condition of such, stipulate that VERU conduct another randomized double-blind trial in the same population in which patients are fully matched with respect to baseline characteristics and evaluates sabizabulin for superiority to placebo on top of standard of care."

[Alleyba1]

Alleyba1

In my opinion, Dr. Mario Eisenbarger, who was an insider of the company (I believe), sold his entire stake in this company which amounted to $20 million at a time when there may have been a material event pending (before they pushed back ADCOM). In my opinion, the SEC should be looking at this sale of stock. He had owned the stock 5-7 years so why did he sell unless he knew the or heard that the company would not be successful at the meeting and why did Steiner allow the sale at the time? This, in my opinion, is looking very suspicious to me and I was wondering what the thoughts of the other shareholders are?

[Lolo12]

FDA will fuckkk every one ,

[Gman3343]

Blood bath in here now.

[Gman3343]

I'm not a fan either, but I won't let that stop me from making boat loads of money.
This is business and business only .
I really can't stand him, but he's been keeping his mouth shut lately. Maybe he's growing up now lol.
But, you gotta like his plays. at least I do anyways.
Good luck franky

[frankyahoo]

Thank you. I will check it out. Not a fan of GS but will do the DD. Good luck G

[Gman3343]

Damn, if he only waited. I'm not selling. Still a chance our crooked FDA can approve it. Highly doubt it, but I'm holding.
Look at wnft, it's another play of mine.
Penny stock, with a CEO with great history. Going through some legal bs, but it will end soon.
Wnft, of course due your own DD.
I'm not a pumper, there's always risk in any play.
But that's a nice play of mine and two others by same guy George Sharp.
Good luck

[frankyahoo]

My buddy bought $VERU puts on Monday with Friday expiry. He got out with a loss when VERU rallied to $15. Can you imagine how he feels right now? He's done with stocks.

[Gman3343]

Oh, and the FDA let's all the crap pass in our food we eat and gives us cancer. What a damn mess. Colors in food are known to cause cancer as well as aspartame.
But hey, let's put it in the food everyone eats, that's ok to put cancer in people. But a pill that saves lives from COVID they won't pass, oh and no side effects.
Can't make this up.