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I've slept on this for a long time. I woke back up over the weekend. Bought some tickets today. Now I just need it to take off.
Yes more than viking
Could VERU be the next Viking Therapeutics????
Reason I ask and think an announcement might be incoming on Monday is due to their closing of the Open Market Stock Sale agreement with Jeffries while being involved in current clinical trials which will require cash!!!
Could there be a HUGE announcement incoming on Monday involving
Novo Nordisk A/S?????
I have a sneaky suspicion that VERU has cancelled the Sales Agreement to sell shares on the open market due to an impending deal with a Big Pharma or
Buy-Out announcement. Just my op and Wishful Thinking as a longtime investor and shareholder in here!
Can’t wait to see what VERU announces on Monday!!!!
VERU.............................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783
VERU...........................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783
VERU......................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783
Squeeeeeeeeeeeeeeeeeeeeeeeeeeeeeze baby squeeeeeeeeeeeeeeeeeeeeeeeeeeze!
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?
VERU......................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783
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
Looks like it’s come up off the mat
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.
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.
I believe in the latest VERU filing Blackrock took a 5% or more interest in the company. News can't be all that bad
VERU.................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783
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.
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
No, just investors fed up with the games.
Yea, that didn't help. And it looks shady that he sold all.
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.
Very sad, they could be helping people. But because of money not going their way, it won't happen. It's disgusting.
G-Man,
I totally agree with you. The FDA was most likely paid to not approve the Sabi drug in my opinion.
Is this just another frivolous lawsuit by a typical bottom feeding law firm?
It's ridiculous, that drug should have gotten approved. Probably was a pay off, who knows.
That's our government for you.
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
So, what are we saying ~ all is lost ?
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.
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.
A good chance that VERU will force some shorts to cover today?
Yes, that is very suspicious.
Here Today,
I hope you are somehow correct.
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.
Accumulate here.
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.
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.
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VERU-111 for COVID-19
This past Monday we announced positive results from the Phase 2 clinical trial evaluating VERU-111 for the treatment of hospitalized patients with COVID-19 who were at high risk for acute respiratory distress syndrome (ARDS). VERU-111 is a novel once a day orally dosed small molecule that has both broad antiviral and anti-inflammatory activities which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death. We conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating daily oral once a day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. This trial was conducted in 5 sites across the United States. Patients that were hospitalized with documented evidence of COVID-19 infection with symptoms and who were at high risk for ARDS were enrolled. Subjects received either VERU-111 18mg or placebo as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at Day 29.
For the primary endpoint in hospitalized patients that had >1 dose of study drug, VERU-111 for COVID-19 treatment compared to placebo had a statistically significant and clinically meaningful 81% relative reduction in death or respiratory failure at Day 29. With respect to secondary endpoints, VERU-111 had a statistically significant 82% relative reduction in patient mortality and statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation versus placebo. Furthermore, VERU-111 was well tolerated with a good safety profile.
The Company has been granted an expedited End of Phase 2 meeting with the FDA to discuss next steps including a Phase 3 clinical registration trial design for the VERU-111 COVID-19 program. The Company expects that this confirmatory study will have a similar trial design as the Phase 2 study to evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients that are alive without respiratory failure at Day 29. We expect the Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have COVID-19 and are at high risk for ARDS. The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) has granted Veru a meeting to discuss possible grant funding for the Phase 3 study and manufacturing scale up. We plan to commence the VERU-111 for COVID-19 Phase 3 study in April 2021.
Doctor Dean Presentation
https://www.youtube.com/watch?v=q1toZERkY48&feature=youtu.be
VERU Pharma CEO, Dr. Mitchell Steiner Discusses Clinical Trials and COVID-19 on CEORoadshow
https://www.youtube.com/watch?v=B7w-iWtJQ0g
Edited Transcript of VERU.OQ earnings conference call or presentation 10-Feb-21 1:00pm GMT
https://finance.yahoo.com/news/edited-transcript-veru-oq-earnings-130000522.html
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