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No not for me. How about you non-sequitor?
Just read Ad-com for stock has been pushed back 1 month until November.
Just read on Stocktwits the following:
rumor is Israel approved VERU as emergency use for critical cases
"The discussion also approved the purchase of a medicine called Sabizabulin, intended for corona patients in serious condition." This is in regard to what the doctors are saying in Israel, perhaps the next country to approve the use of the drug.
Here Today,
Thank you. I happened to find it afterwards. What is you opinion of the upcoming Ad-Com review. As I understand it Steiner said there was nothing wrong with the drug manufacturing facilities and the FDA stopped the clinical trial because the efficacy was sound. So is there any reason in your mind to think we will not get EAU approval, particularly since the drug works and has reduced COVID deaths?
Here Today,
Do you have a copy of that news that you can reprint? So that adds another country interested in the drug. With the plants having no deficiencies and the previous report that they were satisfied with the efficacy, do you think this will happen on October 6th?
Valeo inks contract with Veru for COVID-19 drug sabizabulin
Valeo Pharma (OTCQB:VPHIF) said it signed a commercial services agreement with Veru for COVID-19 drug sabizabulin in Canada.
Sabizabulin is an antiviral and anti-inflammatory drug being developed to treat patients hospitalized with moderate-severe COVID-19 who are at high risk of acute respiratory distress syndrome (ARDS) and death, Valeo said in a Sept. 14 press release.
"Veru plans to pursue an expedited review process with the Canadian healthcare authorities with the objective of making sabizabulin available in Canada at the earliest time possible," said Valeo CEO Steve Saviuk.
Valeo noted that Veru plans to submit an application to Health Canada requesting that the regulator uses the NDS-CV (a prioritized, COVID specific review and authorization submission) through the ACCESS Consortium regulatory pathway.
In June, Veru had submitted a request for emergency use authorization to FDA.
Because news came out that the FDA isn't having a meeting about the drug until Oct 6th.
This will allow shorts to keep shorting.
Many will lose money in their options if they aren't far out.
Haven’t been following this too closely (but interested in it) so why the big drop in pps with a stock that shows a promising positive outlook?
On the heels of unprompted EMA review of Covid drug, FDA schedules adcomm for potential EUA
From Endpoints News. Mentions the trial's early shut-down due to "overwhelming efficiency".
https://endpts.com/on-the-heels-of-unprompted-ema-review-of-covid-drug-fda-schedules-adcomm-for-potential-eua/
HT, too bad the full release did not hit the wires when it went out. Only the headlines were shown on Fidelity; more has been added in the last half hour.
The "rocket" might depend on Covid case count in early October to determine how high.
“The FDA has now completed the audits of selected Phase 3 clinical sites in the United States and now Brazil and Bulgaria and no deficiencies were reported to us.”
To me I believe they have finally realized they are “Short” toast which is why this mornings Seeking Alpha article. Between the actual legit short shares, then all the Dark Pool or “Naked Short” shares, this will rocket once finally approved in my opinion.
Culpher Research and Seeking Alpha - “2 peas in a pod” as they say….
Tweet from May 2022 Culper
@CulperResearch
1) We are short Veru, Inc $VERU, a female condom maker run by a team of alleged frauds and failures who now tout a COVID-19 drug. We find glaring anomolies in the Company's Phase III trial, and think an EUA is a non-starter. Our report is now available at
And finally the company puts out an Official statement which of course differs from what Seeking Alpha has issued today:
Veru Announces Date for FDA Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
Source: GlobeNewswire Inc.
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet to discuss the Company’s request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The meeting is scheduled for October 06, 2022.
“The FDA has now completed the audits of selected Phase 3 clinical sites in the United States and now Brazil and Bulgaria and no deficiencies were reported to us. The FDA informed us today that they intend to convene an Advisory Committee Meeting to discuss the emergency use authorization for sabizabulin,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We are looking forward to advancing the regulatory review process for the use of sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS.”
It’s a Culpher Research / Seeking Alpha tag team event….
Today was the Seeking Alpha article.
Sounds like the tweet is straight from Culper Research.
https://charts.stocktwits.com/production/original_483459038.png
Too high a mortality rate in the placebo group?
Not enough participants in the study?
Location... location... location...
Some report that the clinics in the study did not even have a waiting room...
HMMMMMMMMMMMMMMMMMMMMMMMMMMMMM
Meeting finally agreed for October 6th.
$VERU FDA Decision Coming On Oct 6'; Shares Move Higher
BY Benzinga
— 9:06 AM ET 09/07/2022
$VERU adcom on 10/6 pic.twitter.com/bQrP3Ci1Xz
— M (@bio_clouseau) September 7, 2022
Or has the Short Covering prior to News being released started????
Is News imminent or did someone just buy a ton of shares on the ASK???
I guess there is no chart to see that is revealing
Do you want to see the chart? It’s easy to find. Look up your arse since your head is already there!!!
Just my opinion on how these big Institutional Hedge Fund Investors play the game.
Here today.....what makes you think institutional investors are shorting the stock to accumulate additional shares. I thought for sure Dr. Eisenbarger would be in some type of quiet period and not allowed to sell stock as he was an insider. I could have sworn that Mitchell said the decision on the treatment that is under EAU preliminary approval would have been out already. I would like to hear your thoughts.
Additionally I would like to see the chart AD-2 keeps referring to.
Totally false! Nothing posted by Company. Just Institutional Investors Shorting to Accumulate more shares….
Those kinds of emotions are normal for a newbie. They will subside with time!
I’ll post a chart next week after all the SMOKE clears! Don’t let me forget! Smdh
What’s wrong man? Check out my Twitter if you haven’t heard about it already! Lol. Majorpayne001 I’ll post the chart. No FOMO!!!!
This POS is finished, total scam, approval denied for this POS scam
Where is the approval? This is ridiculous, they could be saving thousands of lives by now
Steiner better get his offering out there before the SP goes down any further.
So let’s be clear just because one officer sold some stock doesn’t mean anything. This is a game of patience not panic. He didn’t say it would be done by the end of the month he said the two international sites will be done by the end of the month.
AD2,
What did Mario Esienbarger sell his stake and stop the momentum of the stock in it's tracks? The optics, in my opinion looked very bad, particularly if they do not get the EAU designation which the CEO said on the conference call they would know the decision by the end of the month. So on the assumption that they do get it, no harm no foul. If they do not get it I feel certain with this news expected , out there would have been a blackout period and he would have been unable to do anything with his stock, much less sell it.
What is your take on this . Same question for here today.
Short! That’s insane!
Yes! A guy like that doesn’t come cheap and for no reason. Go on the Veru Pharma website and listen to the earnings call you will hear all of the progress that has been made so far with both the EMA and EUA. This launch will be hot and heavy especially with fall right around the corner. Cases are already on the rise. It’s already done in my opinion. VERU is just getting everything into place!
Yep. Those who have been shorting will eventually have to pay the piper in short order in my opinion.
AD2, are you referring to this PR? If so, it appears to be a positive move.
https://ir.verupharma.com/news-events/press-releases/detail/155/veru-announces-appointment-of-jason-davies-to-lead-emea
Here Today,
Here is my opinion. Blackrock increased their holdings, Morgan Stanley also increased their holdings as well as Goldman Sachs. I think the optics of Eisenbarger were terrible in his selling all shares owned by him. I thought while the EAU decision was pending that this stock was in a black out period. If they DO NOT get EAU approval I think VERU is open to a class action lawsuit. He stopped the momentum of this stock right in it's tracks. We are supposed to get a decision according to Steiner by the end of the month. This I view as a major buying opportunity. Who knows why Dr. Eisenbarger sold? Again, the optics were bad and I will look into filing a lawsuit against VERU if they do not get EAU approval.
Should read Invesco by 2,546.11%
Goldman Sachs increased their stake by 4,643.01% based on disclosures.
BlackRock by 11.77%
Morgan Stanley by 440.12%
Investors by 2,546.11%
Amazing to me. Institutional Investors increased holdings in Q2 by 92.41%…..
I need this puppy to drop to 12.00 so I can get back in. People see one director sell and they think the world is coming to an end lol.
Price was to high, until approval this shouldn't be near 20.00.
Once approval, the sky is the limit.
I just would like one more pull back. Sorry guys.
At least one director was smart enough to sell...
It would be just like him to pull a fast one right now, before it falls too far down the hill....
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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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