alive and kicking
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Any idea when the Omni shot will be available? My daughter who has health issues is ready for her booster
Based on the data to date, it is inferred that an Omicron-specific monovalent vaccine product administered as a booster dose for those who have already received a primary vaccine series may elicit greater breadth in the immune response. In contrast, an Omicron-specific monovalent vaccine product as a standalone formulation for the primary series is not advised as it is not yet known whether Omicron-specific vaccines will offer similar cross-reactive immunity and cross-protection from severe illness caused by other VOCs in unprimed individuals as the index virus-based vaccines have done.
Although bi- or multivalent products have yet to be approved by regulatory authorities, vaccines containing index virus and Omicron in a single product may be able to achieve similar outcomes as the proposed sequential approach. However, at this time, only limited data are available to assess whether the cross-reactive immune responses in humans using an Omicron-containing bi/multivalent product will be equivalent to those elicited with a sequential vaccine approach.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00941-2/fulltext
double congrats!!
SGEN halted.
I am focused on the Warriors.
I am focused on the Warriors. Curry has ZERO 3 pointers yet the Warriors are up by 13 with 3 minutes left in the game.
Nobody said $300, did you hear that from me?
So you’re basically saying my answer is correct lol.
I don’t use dumb terms like that, but will go higher than where it’s sits now. Easy answer
NVAX - myocarditis. Right, one of the NVAX slides showed the details of the three cases of myocarditis during cross over. and repeated that consistent with background rate claim Since by definition there is no placebo control at that point, I suppose there is no group to compare to other than background rates.
I thought the overall report was good. Bought the dip and we'll see how that turns out.
I only wish my foresight was as good as my hindsight
Here is a link to the FDA document, which was provided by Mouton29 on the Biotech Values board.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169046552
It is depressing. The efficacy was good. The side-effects after the first dose wasn't an issue fine but what is troubling is the jump in grade 3 side effects after the second dose. I sold off 2/3 of my position based on that.
It may be that the FDA wasn't as aware or concerned about side-effect after the low incidence of myocarditis in mRNA vaccines than when they were approved. I looked up the incidence of myocarditis in mRNA vaccines but it is ~1 per 100,000, which is an order of magnitude lower than this reports says for NVAX.
After writing my post I thought again about the side-effect data for the second dose and sold another 1/3 of my initial stake. That means I sold off 2/3 of my shares so took the tax loss. All I have left is what I bought in the mid $40s. I will let that ride.
Here's the link to the NVAX FDA briefing documents: https://www.fda.gov/media/158912/download
Depressing news.
Couldn't believe the opportunity after the 1st Q earnings report. NVAX makes a profit for the first time, confirms guidance, and gets hammered. Great opportunity to add shares.
I'm confident we'll get US approval and gain market share on the MRNA vaccine.
All time high by end of June.
Last Monday while having minor symptoms I tested positive for Covid. Called my Doctor and he said go on Paxlovid that day. Two days later I was testing Negative and feeling good so I stopped the Paxlovid early.
Can anyone believe that we're down on the day we learn the PDUFA date for our drug. Some were trying to create doubt that the FDA would accept the BLA, that doubt is eliminated and while approval is never certain, the FDA is already quite familiar with the drug and I believe Soraya met the criteria the FDA required. I like the chances and believe that if it's to be approved they may do so well prior to the 28 November date.
CBIO—With traditional financing unavailable, some small biotechs are resorting to asset sales:
IMGN has its BLA application accepted with priority review for their single arm trial of mirvetuximab soravtansine in platinum resistant ovarian cancer patients whose tumors express high levels of alpha folate receptor .
https://finance.yahoo.com/news/immunogen-announces-acceptance-biologics-license-103000061.html
Any news flow on why RVNC is being destroyed??
Thanks Dew. The second to last slide (#29) lists the key catalysts for 2022. One of them is to select a third mechanism for combination regimen with EDP-514 for HepB treatment. I will feel better when the candidate(s) are announced and into trials.
Truist analyst Asthika Goonewardene said a previous expert call anticipated Exelixis will lose the '776 polymorph patent, but thought that the company should win in their second wave of IP defense for its '439 and '440 patents, which should preserve Cabometyx intellectual property to 2030. In that context, Goonewardene encourages investors to buy the stock amid a dip that follows a Seeking Alpha article citing trader comments that the judge in Exelixis' case with MSN Pharma "telegraphed" a ruling in favor of MSN on the '776 patent.
In day 4 of Cabo patent trial, judge is leaning toward MSN prevailing on the 776 patent (2030 expiry) while EXEL will win on the 473 patent (Aug, 2026 expiry).
EXEL getting hammered today on no news.
On the heels of this disappointing RSV trial, ENTA is riskier now
ENTA’s phase-2b trial in RSV misses primary endpoint:
NIH wants_to_study longer treatment_course for Paxlovid:
NIH wants_to_study longer treatment_course for Paxlovid:
The Paxlovid treatment course under the existing EUA is 5 days. However, this is not because 5 days is necessarily optimal, but rather because 5 days is how long the treatment was in PFE’s phase-3 clinical trial.
see you at $4!
@George Rho
Thanks for reading and for your interesting comment.
I appreciate your insights on its COVID therapy. I seldom discuss early stage projects in my articles, no matter how potentially transformative they may be. This goes doubly for early stage COVID therapies. There are just too many molecules with fabulous potential and intriguing clinical breadcrumbs for me to highlight any one. Every time I think something will break free from the pack, I am disappointed. Most recently Omeros' narsoplimab was my fair hair boy.
As for the reason underlying the spike last year, you sound like you have better insights on that than I do; you played it well selling at $90.
Recent ENTA News
I added last week at about $50.00
....after I swore I wouldn't till there was some hard data or positive catalyst. : )
I rather expect at some point another HBV candidate to combine with EDP 514.
Or the announcement of a partner in covid after the drug shows promise.
ENTA’s enterprise value at the current share price ($51.50) is about $900M.
Yea I thought of that but at this SUB 1B Enter. Value, should Covid program (regardless of results) have such a decimating impact on the valuation?
I guess the market heard your complaints and is offering the opportunity to buy at close to the low point at the open yesterday.
What sucks about being on the West Coast and getting up late is missing early market moves. I would have bought more NVAX on the big drop. I still may. I saw your comments on the cc but haven’t had time to read the entire transcript. While sales of the Covid vaccine in Q1 were lower than Wall Street estimates they finally put NVAX into the plus column. While sales estimates haven’t officially been guided down by NVAX, even a reduction won’t change the fact that revenues will grow substantially this year and the pandemic shows no signs of ending as new variants keep arising so the stock price will rise to some degree with time. What matters most is whether the FDA grants approval as that will be a big price driver. No sure things but I am still hopeful.
Thanks Dew.
We remain committed to developing a combination regimen as a functional cure for chronic HBV patients. EDP-514, our core HBV core inhibitor with Fast Track designation, has demonstrated safe and potent antiviral activity in two phase 1 studies in different chronic HBV patient populations. Those who have high viral load, whom we refer to as viremic patients, and those who are on a treatment with a nucleoside reverse transcriptase inhibitor, whom we refer to as nuc-suppressed patients. These data suggest EDP-514 has the potential to be a best-in-class core inhibitor for HBV.
We remain focused on evaluating internal and external opportunities for additional components with alternative mechanisms to develop in combination with EDP-514 as we believe that a core inhibitor such as EDP-514 will ultimately be an important component of a successful combination regimen.
Essentially I believe there’s no rush. The positions can be built slowly gradually and in pieces over time.
For the foreseeable future the feds will be taking the excess liquidity out of the system and raising interest rates.
Market bloodbath today. Bought more CDMO, IMGN an opened a position in LGND, the latter being a company I have looked at for some quite time. While it can be painful to see things drop across the board, but these are great times for those with patience and a longer investing time frame.