Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
STO:ACE -70% intra-reader variability of liver MRI P3 contrast agent
Investors are split on what will happen next.
ASCELIA PHARMA PROVIDES CLARIFICATIONS AROUND THE INTRA-READER VARIABILITY IN READ-OUT OF IMAGES IN THE SPARKLE STUDY
2023-08-09
"The two readers with high level of intra-reader variability had variability in all image series. The high level of intra-reader variability was also seen in the unenhanced images. [ . . . ]"
https://www.ascelia.com/mfn_news/ascelia-pharma-provides-clarifications-around-the-intra-reader-variability-in-read-out-of-images-in-the-sparkle-study/
RE-EVALUATION REQUIRED AFTER INTRA-READER INCONSISTENCY IN SCORING OF IMAGES FROM PHASE 3 STUDY SPARKLE
2023-08-07
"Ascelia Pharma completed the global multi-center SPARKLE study in early March 2023 with MRI data from 85 completed patients. Since then, the MRI images have been read and evaluated by three independent radiologists as required by regulatory standards. During the evaluation of headline data, the company identified a high level of inconsistency in the image scoring by some individual readers, i.e., intra-reader variability. [ . . . ]"
https://www.ascelia.com/mfn_news/re-evaluation-required-after-intra-reader-inconsistency-in-scoring-of-images-from-phase-3-study-sparkle/
Guessing if P2 turns out great, it doesn't matter it isn't 2/3? eom
One of the issues with the client computing group is that both Intel and AMD have been primarily doing x86-64 compatible CPUs and have agreements in place for a mutual control of this market. At the same time, many, like Apple, have been doing in-house ARM type of chips that are more power efficient, more integrated, have some exciting virtualization options, and are faster for many workloads. Intel and AMD have stated how they are ready to transition to ARM but it remains to be seen how and when that will happen.
In the EU, a typical mortgage rate is the sum of the base rate and the 6-month euribor rate (which itself is typically reviewed every 6 months). The base rate of 1-2% is not unusual. The euribor rate has been zero or negative for years and the low rate should be still effective. The first big shock should come in 1H 2023 when the combined rate rises from e.g. ~2% to ~5%. The extra interest payment could be the cost of an average appliance. What will be IMO especially affected are various smart home solutions, robotic vacuum cleaners, air and water purifying devices, etc.
VTRS anything going on? Related to RVNC? eom
VTRS anything going on? Related to RVNC? eom
BIOA-B (Bioarctic,Sweden) tripled on P3_Lecanemab(Alzheimer's):
***Nevermind - already posted here***
243962
September 28, 2022 - Regulatory press release
Lecanemab phase 3 Clarity AD study in early Alzheimer’s disease meets primary and all key secondary endpoints with high statistical significance
[---]
Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of Intent-to-treat (ITT) population.
[---]
The Prescription Drugs User Fee Act action date (PDUFA) is set for January 6, 2023.
https://www.bioarctic.se/en/lecanemab-phase-3-clarity-ad-study-in-early-alzheimers-disease-meets-primary-and-all-key-secondary-endpoints-with-high-statistical-significance-5808/
(Tripled between 27th-29th September, I discovered this today. Not listed in US. Thought someone might be interested in this though.)
You were right. I would have thought the placement would at least happen after sBLA submission announcement if it is to happen this year. But it does not seem a bad deal.
I am seeing the last increase over 5M shares outstanding was before March 2021, and tiny steps since then. I have a feeling the management doesn't want to dilute very much from this point on. From what I understand, production and distribution are already in place (unlike many other companies where this is a concern), and R&D cost will be replaced with sales cost, at least for the approved indication.
July Form 483 posted a few days ago: https://www.fda.gov/media/161041/download
The PR has some words that are redacted in the actual 483. There are some dates and additional minor stuff that is present in 483. At first glance, it changes nothing. Anyone notice anything interesting?
I agree. I must admit I myself misread the situation a bit today and expected that the general talk would be at least about a 3-month PDUFA extension or something non-critical of that nature, but it seems people collectively agree on the 8 Sep. Hmm.
I agree. Gas and oil reserves are a couple of orders of magnitude higher in Russia. Though Ukraine in its full borders and in the EU would have been a noteworthy supplier of energy to Europe, I do not think even the denial of these resources was a major cause for starting the war.
If I had to name a single sane reason for this war, it would be the denial of affluence. Putin saw great danger in a large politically stable neighbor possibly approaching double-digit GDP growth upon joining EU. Basically Poland #2. Huge cash inflows would have been guaranteed even from retail investors from the EU and from around the world. This would have been a major threat to an otherwise indifferent public opinion in Russia, especially along the border areas.
Putin has failed to occupy Ukraine quickly, and he has now resorted to the next thing on the list, which is to shell Russia a new buffer zone, blame somebody else for it, and reconstruct the area at any cost. Since the EU and NATO countries largely overlap, it is quite easy for Russian propaganda (domestically) to blame NATO and the US in particular for being the cause of all Russian issues (in particular, the failure to create a proper middle class). Creation of this zone is meant to postpone any even remote thoughts in Russia or in any of its oblasts/regions of doing any meaningful steps to qualify for EU membership.
42 days into the war, it is expected that Ukraine will remain independent, and join the EU in a few years. There will be a devastated buffer zone annexed by Russia that it needs to quickly prop up to avoid losing it (using for the most part the playbook of Stalin: remove unwanted population, remove signs of war, maintain an external enemy; offer free property, interest-free loans, etc).
To add to my previous comment: Yes, as you have stated, most likely a combo of the two chips. PSVR2 cable looks to be non-removable which some people have complained a bit about, but on the other hand, losing the original cable and using a random low performance cable is bound to generate complaints. If it is non-removable it also saves on the cost of the connector and the socket.
Now to understand what it means in $ terms.
From the info I am seeing it is probably a ~15 ft long USB 3.1 Type C Gen 2 cable operating in Alt Mode with DisplayPort High Bit Rate 3 version 1.3/1.4 for 8.1 Gbps/lane, and that PS5 has been prepared from the start for PSVR2. There seem to be quite a number of re-driver chips compatible with this spec on the market in low single digit dollar range each in bulk for integration, released at different times.
So is that the VR8300 chip from the same series that was also used in nreal
I do lurk on this board and did note the INTC post. I am really not sure about Taiwan. Many compare Russia to China in their geopolitical moves but I don't think the comparison is close to 1:1. PRC might be playing a longer game with Taiwan.
I own no semiconductor stocks at the moment. Last one was AMD and I may be at risk of a fallacy trap that nothing will show the same growth (and risk/reward) in the near future. I am hard pressed to find bargains around. I own some small cap EMS (PCB manufacturing) stocks as speculative but these are growth bets for other reasons.
Any catalysts coming 1H 2022? SGMA on my watch list. EOM
Interesting. Any more info on when the SEV transition to NASDAQ could happen and how that would look like? Guessing seamless from OTC to NASDAQ? Possible extra offering?
Also, after ACC, what are the #2 and #3 things in SEV in the pipeline, even if not in the works yet? TIA
I think almost no additional (emphasis) effect on RVNC at the moment. 2 weeks does not seem long and I think a type A meeting is not strictly an inspection (?). Do you also think the summer (during the low coronavirus tide) has become the best time for inspections, which would mean RVNC needs to hurry?
Type A by_EOY?_Binary$FDA_event_late_'22?eom
TCJA repatriation tax? eom
What about Volvo Cars? 29th Oct IPO on Nasdaq Stockholm. (Quick facts: Free float 16-17.9%, proceeds $2.3b, valued at $18b, still owned by Geely/China which initially wanted to retain ~97% of voting rights but IIs were not happy, so now all shares are equal; energy prices pressure at the moment). I assume the name/legacy is somewhat hot despite Geely. I also assume no TSLA level cowboy stuff.
Thanks. I see how 1 and at least 2(a) could be related. I hope observation 2(b) (included what?) is benign.
I have skimmed through several other 483 Forms issued to other companies (I see some pretty funny things - like a trash pile of handwritten notes on the floor). It seems many are longer than the Revance one. I wager there are probably none with just a single note.
Thanks. From my limited experience with technology patents, our patent lawyer's rule of thumb was that at least one deviation from the first claim makes the patent much less likely to be infringing. Of course, this is very simplified. I have been looking for a common method across all subpoints of the first claim of each patent in the filing, to see that maybe a single substantial difference would have been lucrative to implement.
Having read the filing just once, I understand that a lot is inferred from publicly available information (SEC filings, PRs, marketing materials, statements by the CEO). So probably neither we nor Allergan know for certain all of the exact steps of the process. So some steps are probably different.
I agree that getting the FDA approval without any relatively risky adjustments, and taking the relatively small risk of paying a royalty at some point is (or would have been) the best pathway indeed.
I assume the idea to make a change in the process was not the manufacturing partner's (not sure what other risks to them directly besides bad publicity). Though, it must be quite hard to switch the site that late in the approval process without further delays.
Do we already know that the original manufacturing process in the BLA is already completely different in a substantial way from all of the Allergan claims?
I assume Revance wants the process to be different in a substantial way from Allergan's with the least amount of effort. Ideally it is zero and nothing needs to be done. So that would be close to a self-evident difference.
Is it possible that Revance has made changes to the original manufacturing process described in BLA in order for it to be sufficiently different from the claims in the patents listed by Allergan in the filing, while trying not to go outside of the original manufacturing process scope?
If it needs to do something, what else can Revance do to be different from all of the bulk of patent claims? Is it possible there was a pre-inspection scramble to fix this, e.g. due to pressure like C&D letters and such? I assume it is probably not adding animal protein in order not to be Animal Protein Free (APF) as in [most of] Allergan claims, as I assume APF is required by law, or at least strongly preferred for other reasons.