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Yes, jmkobers and Tony Montana deserve at least one free Daxi treatment each for pushing the raise.
OCUL - one minor technical point that may be confusing to some, the article correctly reports that "On best corrected visual acuity, results looked similar between the two arms: there was a 1.3-letter decrease in the OTX-TKI arm, versus a 1.0-letter drop in the Eylea cohort, at seven months. Execs said that this sort of performance was to be expected, given that patients were being successfully treated with anti-VEGF therapy before enrolling."
It's my understanding that there are three measures of visual accuity, including EDTRS letter score (used in the OCUL trial) and what most of us are more familiar with the Snellen test (where "normal" vision is 20-20). The letter score ranges from 5 (at Snellen 20/800) to 85 (at Snellen 20/20). This website shows the equivalents.
https://www.researchgate.net/figure/Conversions-Between-Letter-LogMAR-and-Snellen-Visual-Acuity-Scores_tbl1_258819613
The point is that if we have patients with, say, 20-40 Snellen or a 70 letter score, a change of 1 or 1.3 is pretty small and it is hard to believe a .3 difference could have any clinical meaning, and in the context of trial this small, it's just noise.
OT - he will raise the Officer Krupke defense (West Side Story): “Hey, I'm depraved on account I'm deprived!”
They want $9000 (used to be $5000) to upgrade our 2018 model S from enhanced autopilot to full FSD. Sounds like a bargain.
Yes, we shareholders voted on it in 2021
https://www.sec.gov/Archives/edgar/data/1479290/000147929021000089/rvncfy20proxystatementdef1.htm
No. 10-q for RVNC says they have 190 million common authorized.
“Common stock, par value $0.001 per share — 190,000,000 shares authorized both as of June 30, 2022 and December 31, 2021; 73,123,363 and 71,584,057 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively”
https://www.sec.gov/ix?doc=/Archives/edgar/data/1479290/000147929022000082/rvnc-20220630.htm#i95a959e23a9c4d189948f4c4848a428f_13
<<She has a point as some doctors will be on the sidelines as they are worried that a side effect will last 6 months.>>
I have no insight into what doctors will actually be worried about, but would they be justified in worrying about a six month side effect? Headaches are common but typically last two days. Ptosis is less common and in fact seems to occur with considerably less frequency than the 3% rate reported in the Botox package insert, I assume because the Daxi formulation makes it more stable and less likely to migrate from the injection site. And when ptosis does occur, it resolves in way less than 6 months, median 43 days according to this article, discussing the combined Sakura 1, 2 and 3 results (which examined 2691 subjects).
<<RVNC underwriters* exercise $30M greenshoe option>>
Isn't it a bit unusual to exercise the greenshoe at the beginning of the 30-day option period? It's like exercising any other option prior to expiration, generally one doesn't do that. I would have thought that it would be typical for the underwriters to short the stock above the offering price (or more likely, just overallot to their customers assuming sufficient interest, which there should certainly be if the stock if trading above the offering price, as here) and then cover later by exercising the shoe or, if the stock trades under the offering price, by purchases in the open market (which has the happy effect of both enriching the underwriters and supporting the price). I suppose if someone was absolutely confident that the stock will trade above the offering price for the next 30 days, it would make sense, but how could that ever be?
I do admit I did not actually research the question or seek actual data, just flapping my gums.
Indeed. Not what I expected but it allows them to move more quickly in commercializing at the cost of relatively modest dilution.
Mostly favorable but the plastic surgeon and Fox news interviewer claim that that some people will avoid Daxxi because the longer lasting effect means that side effects last longer, e.g., drooping eyelid (ptosis) for six months. This misses: (i) Daxxi rate of ptosis is much lower than the Botox rate of ptosis (about 1% for Daxi aggregating all patients in the trial, open and randomized, compared to 3% for Botox) and (ii) ptosis resolves more quickly than the median treatment effect, 58 days according to the report in the Journal of the American Academy of Dermatology.
https://www.jaad.org/article/S0190-9622(19)32459-4/fulltext (see the last footnote to table 1)
And there’s the third $100 million tranche under the 8.5% fixed interest rate loan, available at RVNC’s option, if they meet the conditions (e.g., 50 million of DAXI revenue over trailing 12 months).
No facility inspection this time, I assume.
Remind me, what’s the timing for the cervical dystonia indication, presumably the two successful phase 3 trials in that indication are enough to file.
By the way, Botox has the same warning of danger from toxin spread:
https://www.rxabbvie.com/pdf/botox-cosmetic_pi.pdf
Link to full press release with label description:
https://investors.revance.com/news-releases/news-release-details/revance-announces-fda-approval-daxxifytm-daxibotulinumtoxina
OT: I’m glad that your bouts of periocarditis are asymptomatic to zero but while I think that’s a fine use of the word, an asymptote (and therefore asymptotic) just refers to a curve or line that approaches another line or curve infinitely closely, typically as values approach infinity. So you could have a curve that approaches, for example, the y-axis. See e.g., https://mathworld.wolfram.com/Asymptotic.html. Googling asymptote or asymptotic will produce many definitions of more or less mathematical rigor.
I think the usage you criticize is wrong because it doesn't specify what is being approached, not because it necessarily suggests growth is approaching zero.
Well, there’s the small risk that your Tesla will ignite and incinerate you — ours charges in a garage directly under our bedroom. So in recent years we generally avoid charging during sleeping hours. We can still usually avoid peak charges.
My sister charges her Volt outside her garage. I suppose I could do that. But that increases risk of theft … At least they can’t steal its catalytic converter.
<<If it hasn't been made clear yet, I often don't understand the stock market.>>
If you sold your NVAX a month ago and only bought back 10% of your position, you know something.
EOLS reports loss, https://finance.yahoo.com/news/evolus-reports-second-quarter-2022-120500215.html
Apparently below expectations, EOLS stock down almost 18 percent, while RVNC is up about 5 percent.
Thanks, all helpful as was Dew's answer. And the slide set. I'm now long.
<<ENTA's EDP-235 is plainly more potent than Paxlovid.>>
Can you, or Dew (the author of the quoted statement) provide a link to comparable data for Paxlovid?
Re ENTA: can you, or someone, provide some explanation or references to help translate this from the press release:
"...provided plasma drug levels that were 6-fold and 12-fold over the plasma protein adjusted EC90 for the Alpha variant and the Delta variant, respectively. "
It seems from this FDA document (https://www.fda.gov/media/71223/download) that EC90 its the effective concentration needed to inhibit viral replication by 90% but I'm not clear on how to apply that to the quoted sentence.
Re apple icar. Expensive, yes, but it will be machined from a single piece of aloo-mini-um.
Maybe the REVB drug could be combined with the Vistagen treatment for a new standard in complex placebos.
I looked at a couple different transcripts before listening but they probably all either copy from each other or use the same software. One — Refinitiv Transcripts — is titled “Edited Transcript…” but I suspect no competent human editor looked at it.
LG’s accent may give the software a harder time.
CLF - quite a typo in the transcripts:
“In addition, we are the only domestic producer of non-oriented electric steel in the United States, where roughly 150 pounds are required per vehicle for using the motor. Because of the growing demand of these steels, we are investing $30 billion in our Zanesville, Ohio facility, a small investment to allow us to add another 70,000 tons of production of non-oriented electrical steels.”
Millions, not billions. If there were any doubt about what LG actually said, note the “small investment” reference.
https://seekingalpha.com/symbol/CLF/earnings/transcripts
When I first read the sentence “Although the trial did not meet its primary endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials” I thought they meant the EFFICACY was consistent with prior results but wasn’t stat sig. But in fact all they are saying is TOLERABILTY is consistent— as would be the case if the treatment were a placebo.
It's also not clear to me that the two rates of severe allergic reaction are measuring the exact same thing
NVAX: I can't claim to have done a comprehensive search but this August 2021 Jamanet article claims "updated" rate of severe allergic reaction of 4.7 per million:
Ended up 21.5 percent. Mr Market is fickle.
Here’s a link to the Seeking Alpha article
https://seekingalpha.com/news/3856915-novavax-shares-plunge-23-after-fda-authorization-amid-severe-allergic-reactions-risk
The article includes these two details:
“….The agency said that "a few cases have been reported spontaneously" following administration of the shot. The frequency category for anaphylaxis will be not known.
Also, paraesthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoaesthesia (decreased feeling or sensitivity, especially in the skin) will be included as a side effect as well”
This appears to be the reason for todays 27 percent plunge. I see a bit more detail in a Seeking Alpha “news article.”
https://www.reuters.com/business/healthcare-pharmaceuticals/ema-adds-severe-allergies-side-effect-novavax-covid-vaccine-2022-07-14/
Putting aside the fact that the daily rate was 60x two weeks ago and clearly fluctuates wildly, these are daily rates. So unless I’m missing something , even a daily rate of .5 per 100,000 corresponds to am annual rate of 182 per 100,000, which exceeds that from cancer.
The upgrade has only a $62 price target, $10 from current price. What’s that, $40 or $50 million increase in market cap? Pfizer predicts $22 billion in Paxlovid revenue, if ENTA’s drug is superior and produces 10 percent of that in revenue (wildly conservative), a 20 percent probability would justify more than $10 upside.
I briefly listened to part of the discussion vaccine advisory panel while multitasking and heard sone favorable remarks about Novavax. I see this in a summary if the meeting at Statnews at https://www.statnews.com/2022/06/28/tracking-an-fda-advisory-panel-meeting-on-updating-covid-vaccines/
“Some fans for Novavax. Two panelists spoke out in favor of the data shown by Novavax indicating that its shot against the original strain might work well as a booster against Omicron strains. James Hildreth, CEO of Meharry Medical Colllege, said the Novavax data were “the most compelling thing I’ve seen today” and that the data seem “more impressive to me than the data for Pfizer and Moderna.” Wayne Marasco of the Dana-Farber Cancer Institute made similar comments, wondering if the Novavax data were showing the limitations of the mRNA vaccines. Hildreth encouraged the FDA to consider Novavax’s emergency use application quickly.”
The market seems to disagree, NVAX down a bit premarket.
What’s special about lug bolts on an EV compared to an ICE vehicle? I have a Tesla and an ICE and sometimes change the wheels (winter to summer) on both and can’t say I’ve noticed a difference.
Re: CLF -- stock has certainly been weak lately, down about 1/3rd since those insider sales barely a month ago I'm looking forward to the CEO complaining about the stupidity of the market on the next quarterly call.
Fibrogen — There are also two fully enrolled phase 3 trials of Pamrevlumab in DMD, with top line data in the earlier of these expected in 1H 2023. My recollection is that previously released results from their DMD phase 2 trial were notable for the lack of detail.
Channeling my inner Vinay Prasad — So when ENTA’s RSV trial fails to meet its primary endpoint because all patients in the placebo arm improved without therapy, we say the trial failed. When Paxlovid can’t show stat sig improvement over the placebo arm — even after excluding previously infected and vaccinated people (basically the population of the US) we get editorials saying it should be handed out by pharmacists to “high risk” people.
Not sure when we will know the results of the UK Panoramic study, which is actually testing Paxlovid in the vaccinated. They have enrolled more than 25 thousand participants. https://www.gov.uk/government/news/thousands-more-patients-to-access-second-ground-breaking-antiviral
<<A long road trip in an electric vehicle is still out of the question>>
In a Tesla it isn’t.