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Is this a funny money only bet?
ENTA has a negative EV for all intents and purposes,
without knowing the RSV data.
easily say this is bullish
They may guide down - from 8 Billion - so plenty of meat on the bones
for a given level of viral prevalence, fewer people getting COVID vaccinations leads to more people getting COVID infections,
there are contingency plans on spending if results come in lower in back half of the year but maintaining guidance bc even they don't know yet what covid sales will be like
Kind of surprised that no one has commented on PFE reduced Covid related sales.
https://www.cnbc.com/2023/08/01/pfizer-pfe-q2-earnings-report-2023.html
“The contraction in revenues was driven by the anticipated decline in Paxlovid and Comirnaty sales,” Pfizer CFO David Denton said during an earnings call on Tuesday.
The company’s Covid vaccine raked in $1.49 billion in sales, down 83% from the year-ago quarter. Pfizer’s Covid antiviral pill Paxlovid posted $143 million in revenue, a drop of 98%.
There is this from 2021, lol. ABBV-744 as a potential inhibitor of SARS-CoV-2 main protease enzyme against COVID-19
Just a fast google search. I'm not going to wade through clinicaltrials.gov, someone else can.
https://www.nature.com/articles/s41598-020-79918-3
It looks like old news. Collaboration started last year and papers published. I have not looked at details.
https://pubmed.ncbi.nlm.nih.gov/36537346/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9764278/
https://www.prnewswire.com/news-releases/abbvie-and-scripps-research-announce-collaboration-to-develop-antiviral-treatments-for-covid-19-301502525.html
(or somebody) is manipulating the price lower.
A reminder that it takes more than "data" to have a successful drug. Although lack of data on NDD was a culprit here.
IIRC the China price for Roxa was low and dropping. One contributing factor.
Understandable to pull out under those circumstances. Was there any language on why the opinion was limited to DD?
Also see the note they will not be filing in other markets...
Haven't kept up with Roxa sales in the EU (or anywhere else) but it seems they were slower than astellas was looking for.
Additional from Evaluate Vantage
https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/gsk-admits-anaemia-defeat
If Evrenzo cannot make a success of the anaemia market, what chance does Jesduvroq have? This seems to have been the question that led GSK management to call off its attempts to get the latter approved in new markets, a decision disclosed in its second-quarter results today. GSK had already pulled Jesduvroq’s filing in Europe after the CHMP recommended excluding non-dialysis patients from the project’s label, citing insufficient data to establish its safety in these patients. Withdrawing the filing was probably wise – even Fibrogen’s Evrenzo, with a label covering all patients regardless of dialysis requirements, is not doing well. A year ago, 2028 forecasts that would accrue to Astellas, which has rights in Europe and Japan, sat at $360m. Now they rest at just $99m, Evaluate Pharma consensus shows, possibly because an expensive product that only offers better convenience is struggling to make headway in a market dominated by the well known and now off patent EPO.
Unlikely to be in the final bill? Interesting tho...
Warren Amendment #1 to the Modernizing and Ensuring PBM Accountability Act
Short Title: Addressing Vertical Integration in the Drug Supply Chain
Description of Amendment: The amendment would prohibit a PBM or company that owns a
PBM from also owning a mail-order, specialty, retail, or any other type of pharmacy, and would
require such company to divest its pharmacy within six months
Go to https://investorshub.advfn.com/boards/filters.aspx and check your settings. There is a separate setting for ignoring replies that can be turned on or off.
The like button can be done away with.
But if you keep it please retain the ability to see who did the 'liking.'
No problem.
Part of my comment was actually misdirected, case of mistaken identity, apologies. But your point about the sales force is correct in that it is a different market that needs to be built up. A bear point.
at a disadvantage in the hospital setting,
Pfizer also clarified
Meg Tirrell
@megtirrell
·
1h
Pfizer also clarified that the company as a whole supplies 8% of all sterile injectables used by US hospitals, and the Rocky Mount plant accounts for a quarter of that (so 2%, by my math). Deleted previous tweet for inaccuracy (below for reference)
Looks like BAX caught a bid off of this (sad) news.
A common allele of HLA is associated with asymptomatic SARS-CoV-2 infection
h/t Stat News article
https://www.nature.com/articles/s41586-023-06331-x
Abstract
Studies have demonstrated that at least 20% of individuals infected with SARS-CoV-2 remain asymptomatic1,2,3,4. Although most global efforts have focused on severe illness in COVID-19, examining asymptomatic infection provides a unique opportunity to consider early immunological features that promote rapid viral clearance. Here, postulating that variation in the human leukocyte antigen (HLA) loci may underly processes mediating asymptomatic infection, we enrolled 29,947 individuals, for whom high-resolution HLA genotyping data were available, in a smartphone-based study designed to track COVID-19 symptoms and outcomes. Our discovery cohort (n?=?1,428) comprised unvaccinated individuals who reported a positive test result for SARS-CoV-2. We tested for association of five HLA loci with disease course and identified a strong association between HLA-B*15:01 and asymptomatic infection, observed in two independent cohorts. Suggesting that this genetic association is due to pre-existing T cell immunity, we show that T cells from pre-pandemic samples from individuals carrying HLA-B*15:01 were reactive to the immunodominant SARS-CoV-2 S-derived peptide NQKLIANQF. The majority of the reactive T cells displayed a memory phenotype, were highly polyfunctional and were cross-reactive to a peptide derived from seasonal coronaviruses. The crystal structure of HLA-B*15:01–peptide complexes demonstrates that the peptides NQKLIANQF and NQKLIANAF (from OC43-CoV and HKU1-CoV) share a similar ability to be stabilized and presented by HLA-B*15:01. Finally, we show that the structural similarity of the peptides underpins T cell cross-reactivity of high-affinity public T cell receptors, providing the molecular basis for HLA-B*15:01-mediated pre-existing immunity.
Jake predicted early that ENTA would go down to its IPO price. Nobody else has provided a price estimate. If the price gets close to the IPO price, but does not reach it, then was Jake correct?
For the last six months I would say that Jake's comments on Enanta have been reasonable.
Jake provided an answer that Enanta should have been able to reveal a partnership at the same time that Enanta revealed the phase 2 data. Seems reasonable. Has this occurred with other companies? I do not think Enanta revealed the data publicly at the earliest time possible.
Does anybody other than Jake have a time point that could reasonably be expected for announcement of a COVID partnership?
I don't like to see personal poking between participants, but I do find value in Jake's comments especially as a matter of examining my own bias.
Further up or further down I am happy that I have not purchased more Enanta. If Enanta's greatness is imminent, then let me see it happen.
My point is that at the current price, CD approval and subsequent impact to sales are not appropriately priced in.
Correct me if I'm wrong but I think you're fairly new to RVNC yes?
You raised the idea that the label for CD approval would be narrow. I asked you why you thought that. It is fine with me if you were just talking without any reasons to back that view up.
The only real question is how good the label is - and it should be at least adequate. Yeah, yeah ... stuff has happened and may happen again. Approval is not assured. But absent a best-possible label, CD approval is a sell-the-news event.
It is fine with me if you were just talking without any reasons to back that view up.
I'm a trader it will spike on approval, and I will be out.
have confidence it will sell. If it doesn't I hold and wait until it does.
Why would you think that?
What is it about the data that makes you think the approval may be narrow?
Ramps can definitely be finicky.
30 is better than 20, I agree. But 30 is what I would describe as the minimum for a good launch at this stage IMHO. Just on very oversimplified math, the 11 million sold in Q4 are due for a boost and the 15.4 sold in Q1 with limited access should be replicable in Q2 with new open commercial sales. That's 26.4 million in what should be a favorable Q (Q2/Q4), so rounding down to 25 million and still coming up short doesn't look good no matter what the reason is.
The target for sales should be 30-40 million whether they get there or not. 20 should be punished by the market, and would be. 40 would be nicely rewarded. Just my opinion.
worried about the quarterlies at this stage
When it finally starts gapping up, it will be over fast.
I believe q2 is typically a strong quarter for cosmetic neuromodulator sales
I’m more interested in the trajectory now.
(I would like to see 100M quarterly sales by middle of next year fwiw but I suspect you won’t be along for the ride by then)
they expected a cosmetic lag, and this is the time when sales should start to pick up,
Nothing has happened to explain low 20's.
I keep thinking that I’m missing something…
The market often punishes launches.
I think there is good support around 20 if it gets that far.
Do you know the MOA?
More RSV competition
It's hard to take anything from this company seriously. However, they may actually do something at some point. (NNVC)
07/11/2023 7:20AM
Company's Broad-Spectrum Antiviral NV-387 Has Demonstrated Excellent Effectiveness In RSV In A Lethal Lung Disease Animal Model, Reports NanoViricides
Shelton, Connecticut -- July 11, 2023 -- NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the strong effectiveness of its broad-spectrum antiviral clinical drug candidate NV-387 in an animal model of lethal lung infection with RSV (Respiratory Syncytial Virus).
NV-387 Can Advance Directly into Phase II Human Clinical Trials for RSV Treatment:
NV-387 is the active ingredient of NV-CoV-2, the Company’s drug for the treatment of COVID and possibly long COVID. It is already in Phase 1a/1b human clinical trials for the evaluation of safety in healthy volunteers and of safety and preliminary efficacy in COVID patients as previously reported.
It is expected that NV-387 can be advanced into Phase II studies against RSV once the current Phase I studies of NV-CoV-2 are completed. This will significantly speed up the development of the RSV drug, save costs, and improve return on investments (ROI).
“We are very pleased with the extremely high effectiveness of NV-387 in combatting RSV”, said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “Importantly, both oral administration and intravenous injection of NV-387 were highly effective. This study further establishes the broad-spectrum antiviral effectiveness of NV-387, and further solidifies our novel nanoviricides platform technology.”
RSV is an Important Acute Lower Respiratory Infection (ALRI; includes Pneumonia) : 1
Each year in the United States, an estimated 58,000–80,000 children younger than 5 years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood ALRI and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3·2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.
There are No Effective Treatments for RSV:
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. There are no vaccines currently approved for infants and children.
However, there are no effective therapeutics for RSV to date. Ribavirin is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), an antibody, is approved only as a prophylactic in children and infants at high risk of severe RSV infection, but it is not approved for treatment of RSV infection.
Market Size of RSV Therapeutics is Expected to Hit US$ 8.73 Billion by 2031 : 2
GrowthPlus Reports, in June 2023, says the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
if exercised, owning shares at adjusted cost of ~$20.5 is quite palatable.
August, on the other hand
Thanks, I either missed it or forgot about it.
Still roughly 3 years to approval if there are no further delays. Well out of my time frame, lol.
I did sell a small number of June puts at 25, which worked out much better than selling the 30's. Repeated the exercise for July but at 22.50 so, I may have a small position later this month, lol.