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My options are going to shyt. Unbelievable these screwballs can't pass a drug that saves lives, but pass a vaccine that's killing people
Only our corrupt , paid off POS government. What a damn joke.
Karma, Steiner... KARMA!!
Sorry to hear you got stuck. All the forces at work to bring VERU down made me think twice about holding through the meeting. It was a great swing trader but it was a gamble from the time the meeting got pushed back until today imo. I hope the FDA gives it's approval for longs' sake but not holding my breath. GLTA
$NHHHF
The FDA does not have to follow what the ADCOM says. They can still give EAU based on conditions. I have 2,000 writtten calls that expire November 18th so I am screwed there, I has 3,000 free trading shares, woke up this morning, read report which did not look good and sold 1,000 shares at $14.75.; however, we do not know what FDA will do tomorrow, but I think we got screwed and I wonder if there is any recourse against Dr. Eisenbarger for dumping his whole position. He must have know something in my opinion.
Yea I heard. Not good. Tomorrow will not be fun.
Yea, well bad news . Adcomm voted no 8-5 now it's up to the FDA.
Adcomm can suck a big one.
Yea, well bad news . Adcomm voted no 8-5 now it's up to the FDA.
Adcomm can suck a big one.
$VERU (US) FDA AdComm member: Notes VERU-111 is a new molecular entity with a limited safety database when compared to other products that have been granted EUA (Only 149 subjects received VERU-111 for COVID-19)
— TradeTheNews.com (@Trade_The_News) November 9, 2022
(More at https://t.co/Ql4UFwNI7B)
What's the plan? I do not hold a position currently. $VERU is heavily shorted so an unfavorable recommendation will tank it obviously. If they recommend $VERU be approved for EUA then it could be sell the news and then squeeze to 52 week high. Either way it'll be a big move. good luck to all. I'll probably wait for a dip if it rips then take a long position when it dips and maybe some options. Good luck all.
Yup. I'm listening too
They’re live now
Yes and I think that I am not qualified to say how it's going lol. Exchanges have been civil and questions are being answered fully. That's all I know.
$NHHHF
Have you been watching from before they went on break? How was it going?
Looks like they are taking a break. Have not been able to listen and just turned on the call and they are on break….
$VERU FDA adcom meeting livestream webcast on youtube. Halted pending news.
Nice position. Will be watching the meeting as it happens to see how it goes.
Exactly. I’ve been accumulating myself be it on a slow pace. Every dip below $11, I have added 1,000 shares…. Should be a very nice week if the adcom meeting goes well.
Hmmm. Hadn't thought of that. It's probably getting tough to buy shares to cover as peeps load and hold.
A lot of institutional investors have been holding for some time and adding past 3 months. Should be a fireworks event if Wednesday meeting goes well. Just my opinion.
Could end up being a GME type event if they Short more than the float…..
Shorts have actually borrowed more shares to sell short it seems looking at iborrowdesk.com
$VERU
Could it be that Maybe GILEAD or another Major BP is in talks to Buyout VERU!!!
Approaching the 40 million in volume….
Should be a nice multi day runner as we've seen in the past.
$NHHHF
To me it’s a Huge Short covering start in my opinion… Up over 40% with a load on of volume
I think move up is optimism for Wed meeting. Shorts added positions this morning and I'm watching for a takedown to get back in. This has been a great swing trader but a successful adcom meeting will bring another explosive up move imo. On the sidelines for now. Good luck in all your trades.
$VERU
So in my opinion, either this is all the short covering from the past month of all the shorting or Something has leaked about a possible overseas approval or something big via their oncology drugs is about to be announced…..
A lot of short covering happening right now!!!!!
$VERU Adcom meeting starts Wednesday at 9am EST.
"The committee will discuss the request for Emergency Use Authorization 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. A focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population."
https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-agenda-and-public-participation-information-november-9-2022-meeting-pulmonary-allergy-drugs#event-information
Found on another MB, but s/b of interest to VERU s/holders.
https://theconversation.com/how-covid-19-damages-lungs-the-virus-attacks-mitochondria-continuing-an-ancient-battle-that-began-in-the-primordial-soup-192597
Key Words "Real Drugs".
Paper chasers ~ Kevin Gates last stretch!!!! I wouldn’t like me either, I would love me!!!
Bankhead ~ T.I good for a hundred miles repeat!!! Why y’all so quiet celebrate the cheapies!!!
Where in the world is majorpayne? Looking for that hood stuff!!!!~ UGK let’s ride!!!
Keep it going! Why would you? ~ lil keke In order to beat the market you have to outlast it. Buy the fear!!! Let’s ride
... and the FDA is allowing 7,000 more Americans die who may have been saved.
He cost everyone big bucks non-sequitor.; however, the real drugs are the cancer drugs.
Steiner cost me BIG BUCK$$$$$
with his BIG LIE on Cramers Show.
I could never trust him again!!
I see YOU TUBE took the video of the show private.
The snake most likely got to the guy who made it!
No not for me. How about you non-sequitor?
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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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