2 Fast 2 VERUious
Alright, you plebs. Sit down and let me tell you a story about $VERU and its little friend, Sabizabulin.
You might be asking, da fu** is Sabizabulin?
Read the results of the study yourself:
A total of 204 patients were randomly assigned to treatment: 134 to sabizabulin and 70 to placebo. Baseline characteristics were similar. Sabizabulin superiority was demonstrated by a planned interim analysis for the first 150 randomized patients. Sabizabulin treatment resulted in a 24.9 percentage point absolute reduction and a 55.2% relative reduction in deaths compared with placebo (odds ratio, 3.23; 95% CI confidence interval, 1.45 to 7.22; P=0.0042). The mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo. For the key secondary end points, sabizabulin treatment resulted in a 43% relative reduction in ICU days (P=0.0013), a 49% relative reduction in days on mechanical ventilation (P=0.0013), and a 26% relative reduction in days in the hospital (P=0.0277) versus placebo. Adverse and serious adverse events were lower in the sabizabulin group compared with the placebo group.
Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo. (Funded by Veru, Inc.; ClinicalTrials.gov number, NCT04842747.)
You: But 👑 Plebs, I'm an idiot. What does this even mean?
“Its demonstrated ability to improve outcomes in those at high risk of acute respiratory distress syndrome (ARDS) and death distinguishes sabizabulin from MRK's Lagevrio and PFE's Paxlovid, indicated for milder disease and for which respective US government procurement contracts worth $2.2B and $5.3B have been awarded,” Gershell commented. “With the global pandemic showing little sign of abating and BARDA to be allocated $9.25B in additional COVID-19 funding, we believe sabizabulin will serve critical roles in the US and abroad.”
To this end, Gershell reiterated an Outperform (i.e. Buy) rating on VERU shares, while boosting the price target from $25 to $36. Think you’ve missed the boat on this one? Think again. Gershell’s target makes room for gains of ~200%.
TL;DR VERU made RONA pills and will go BRRRRRRYou: What about for my homies in the back that only care about squeezes?
Well, good news, you little autists. $VERU currently has 42.84% SI with 80,070,000 outstanding shares.
If only it had some sort of catalyst coming up that could trigger a run on the stock…
The European Medicines Agency's (EMA) Emergency Task Force (ETF) has started a review of Sabizabulin for treating COVID-19.
You: So what?
Me: *slaps you\*
Once the EMA completes its findings, Sabizabulin will be authorized to be used in all member states. That means VERU is going to sell the ever-living shit out of Sabizabulin to the EU running up into flu season. Not only that, approval by EMA also helps FastTrack approval for the US (see above multi-billion dollar contracts.
That's not all!
On June 6th, Veru also submitted Veru has submitted an application seeking emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for a 9mg dose of oral sabizabulin to treat moderate to severe hospitalised Covid-19 patients.
“We have also scaled up manufacturing of sabizabulin 9mg capsules to meet the needs of patients in the US and are building our US infectious disease commercial franchise.”
They already started making enough supply to sell to the US immediately. Just like the EMA, the US also fast-tracked the approval process and should be approving it any day now.
So to recap:
- VERU is making an oral RONA pill that reduces deaths by 25%
- Sabizabulin is getting fast-tracked by the FDA
- Sabizabulin is getting fast-tracked by the EMA
- Over the course of the next 30-days, we will get 2 announcements of Sabizabulin being authorized for emergency use in the US and EU and they have already started making supply to prep for this.
- Oh yeah, they have earnings on August 11th, but more on that later.
You: So who's buying?
FU**ING EVERYONE! And you should be too. Even pharma bro legend /u/martinshkreli got in on it thanks to Huzzies main squeeze, Jupe. Here he is on his Trading Competition: Day 4 stream, buying shares and putting together his own DD.
You: What's the flow?
Me: Here is a snapshot of the order flow from yesterday.
You: How about Dark pools?
Me: Here is a purchase for 1,000,000 shares at 12.34. How do you like them, Dark Pools?
You: Look, this is all a bit over my head. I am a simple autist who plays with crayons in the corner. How high can it even go?
Me: Conservative PT is around $32 dollars, with some bullish cases up to $76.
Me: Here are your crayon drawings, kids.
You: But I'm kind of 🌈 🐻 curious, what's the bear case?
Oppenheimer & Co Inc closes position in VERU / Veru Inc
2022-05-11 – Oppenheimer & Co Inc has filed a 13F-HR form disclosing ownership of 0 shares of Veru Inc (US:VERU) with total holdings valued at $0 USD as of 2022-03-31. Oppenheimer & Co Inc had filed a previous 13F-HR on 2022-02-02 disclosing 19,194 shares of Veru Inc at a value of $113,000 USD. This represents a change in shares of -100.00 percent and a change in value of -100.00 percent during the quarter.
$VERU has $13.03M in Revenue with a Net Profit Margin of -108.82%. Read all of the financials HERE. It doesn't really matter. This is pharma world where small companies make the perfect drug and moon. See MRNA for an example of this. VERU's small/kind-of poor company outlook only increased the SI, which is good for us and bad for them.
That's it. That is the bear case. Sabizabulin is overwhelmingly a positive result and should pass…even according to Oppenheimer, who probably regrets selling 19,194 shares right about now.
"Oppenheimer said that a new analysis conducted by Veru (NASDAQ:VERU) on mortality rates in a phase 3 trial of its COVID-19 therapy sabizabulin assuages concerns and will lead to an Emergency Use Authorization from the U.S. FDA."
You: Okay, okay. This all sounds pretty bullish, but when will this even happen?
The review of sabizabulin was started on 27 July 2022 under Article 18 of Regulation 2022/123, following a request from Germany. EMA’s Emergency Task Force (ETF) will conduct the review in accordance with Article 18 (3) and send recommendations to EMA’s Committee for Medicinal Products for Human Use, which will issue the Agency’s opinion.
You: Yeah, but that could take months!
I read the charter that created the EMA's Emergency Task Force (ETF) Typically, reviews of studies take up to 200 days. However, they established the ETF in 2022, which is authorized to rush COVID-related studies.
Article 15, section 7: The ETF shall perform its tasks as an advisory and support body separate from, and without prejudice to, the tasks of the scientific committees of the Agency as regards the authorization, supervision, and pharmacovigilance of the medicinal products concerned and related regulatory actions to ensure the quality, safety and efficacy of those medicinal products.
Because we are technically in a state of emergency, they are granted special privileges "without prejudice". According to the charter,
Me: Now pay attention. This is the most important part.
Article 16, section 2: Where a developer engages in an accelerated scientific advice process, the ETF shall provide the advice referred to in paragraph 1 free of charge at the latest 20 days after the developer submits a complete set of the requested information and data to the Agency. The advice shall be endorsed by the EU member states.
The EMA meets on a monthly cadence, but because we are in a state of emergency, member states are allowed to hear the ETF's findings and vote via remote meetings. This means that the very latest they will present findings to the EMA is August 16th. EMA has scheduled meetings on August 16th, 17th, 18th, and 19th.
At the very latest, we should know if Sabizabulin will be approved for use by the EMA on August 16th, if not earlier.
You: Is there anything else?
Veru has earnings on August 11th. Because of this, we will see a ramp in IV leading up to that date with a potential drop-off, pending whatever news they drop on that call… All this is, is another opportunity to buy at a lower IV. When the EMA announces the approval of sabizabulin later this month, it won't even matter. Shorts will get squeezed, our dicks will get hard, and we will get paid.
Not to mention the upcoming emergency use of sabizabulin by the FDA. Some rumors have that being approved tomorrow, 60-days from when it was submitted. That is why you see a massive options order flow for 8/5.
You: I am dumb and can't read so good. What is the TL;DR?
This play has something for everyone. High short interest, pharma squeeze with options, and a guaranteed bullish event on the horizon. It's also a value play once Sabizabulin gets approved because it will unlock a potential $9.25 B in funds from BARDA, which "Sabizabulin will serve critical roles in the US and abroad." That is just potential US contracts. It isn't even touching on the contracts it can secure in the very near future from the EU. This baby only has a Market Cap of $985 M right now. There is sooo much room to run. Add a little squeeze juice on top of that, and we have ourselves a perfect storm.
My positions – Just shy under $16k https://imgur.com/a/4eAVuQ7
8/19 $16c x 40
8/19 $26c x 150
9/16 $26c x 15
God speed, you degenerates.
Submitted August 04, 2022 at 04:56PM by King-of-Plebs
via reddit https://ift.tt/BtF03vp