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VIR gets EUA in 60 days
Cameron mentioned in one of the webcasts that Lenz. could work with
Bispecific T-cell Engager (BiTE ®) technology, and he has friends at Merck,
so multiple possibilities.
Email from IR person about Kite deal:
"Management of HGEN terminated the deal, so they obviously agree that this is the right course of action.
The team wants to control their own destiny and do a fully-powered randomized study across all CAR-Ts that looks at efficacy as well as toxicity. The collaboration was non-exclusive to Kite. That doesn’t mean they would support a study with other CAR-Ts if we were still in ZUMA-19.
Kite have generously done their job to get us to where we now have data that allows us to move ahead.
This shows that lenzilumab does what we thought it would do and at the dose we hoped.
It also creates much more optionality for HGEN, either alone or with all CAR-T players, allo/auto, bi-specifics and even those who don’t have any of those but are in the oncology space."
Alan Lada
Senior Vice President
SOLEBURY TROUT
O. +1.617.221.8006
M. +1.856.313.8206
thanks, Activ-5 shows 48 sites enrolled now,
maybe those interim results could be out soon
https://www.clinicaltrials.gov/ct2/show/NCT04583969?term=Lenzilumab&draw=2&rank=4
Locations
Show 48 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Gritstone Oncology, Inc.
More Information
Go to sections
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04583969 History of Changes
Other Study ID Numbers: 20-0013B
First Posted: October 12, 2020 Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: January 12, 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Adults
COVID-19
Multicenter
Putative
Therapeutics
Any Ideas on when the PH3 secondary endpoints could be announced ?
How long should that take ?
The 2 failures also knockout the FFA theory, that the free fatty acid form is more bio available, total BS
JL, doesn't Matinas Mat9001 depend on DPA, which occurs in very , very small amounts in fish oil, making it much harder and much more expensive to extract from omega 3 fatty acids ?
Could it be an announcement of a settlement on Monday's patents case ? https://www.nasdaqtrader.com/Trader.aspx?id=TradeHalts
T1 right now which is pending news, needs to get to T3 before announced
Gilead's decision to add Vascepa to an ongoing NASH study failed to grab much attention last week. But this development is quite intriguing for several reasons.
https://www.fool.com/investing/2019/11/24/does-amarin-have-a-dark-horse-suitor.aspx
a trial with very small amounts of EPA/DHA to prove lowering of triglycerides - watch this video to better understand krill oil
http://blog.livingfuel.com/?p=6973
Krill Oil – Although krill oil has omega-3s and some antioxidants, it is usually contaminated. Krill are tiny shrimp, approximately one to six centimeters in length, and are a dietary staple for whales, small fish, and seabirds. To extract their oil, they must be soaked in hexane, a chemical found in gasoline and treated with acetone, a chemical found in nail polish remover. Krill oil also has a large amount of what is called free fatty acids, which are short-chain fatty acids that are unstable and oxidize (become rancid) quickly.
ASCT -Not even PH1 , pre-clinical for CVD. They had a PR on Monday making claims in mice, going along with the coordinated attack. Good luck proving that bs 10 years from now vs lowering of SI.
Acasti Pharma Releases Preliminary New Animal Data, and Gains Insights Into CaPre’s Novel Mechanism of Action in Diabetes
GlobeNewswire GlobeNewswire•November 18, 2019
Data from a new preclinical mouse study suggests a unique mechanism of CaPre compared to metformin and icosapent ethyl (VASCEPA®) in a diet-induced obesity animal model
Preliminary, statistically significant findings show that CaPre may promote insulin secretion, and showed a significant increase in plasma levels of 17S-HDHA and PDX as compared to metformin and icosapent ethyl
good info JL on Krill oil thanks,
Krill Oil – Although krill oil has omega-3s and some antioxidants, it is usually contaminated. Krill are tiny shrimp, approximately one to six centimeters in length, and are a dietary staple for whales, small fish, and seabirds. To extract their oil, they must be soaked in hexane, a chemical found in gasoline and treated with acetone, a chemical found in nail polish remover. Krill oil also has a large amount of what is called free fatty acids, which are short-chain fatty acids that are unstable and oxidize (become rancid) quickly.
Mustang - slide 3
https://s3.amazonaws.com/content.stockpr.com/acastipharma/files/pages/acastipharma/db/700/description/WCHD_-July-2017abstract-086_PK_saf_eff-Capre.pdf
and you are correct on Vasepa 960 mg, 1 gram per cap close enough
good point, I took numbers form the ascti website so you are correct then
4 caps of Capre = 1,240 mg of epa/dha
Krill Oil is not more absorbable, EPA ethyl ester is bio-available, all major studies done with the Vasepa form
Capre – Krill Oil - 1,240 mg of epa/dha
EPA/DHA (per g)
310 mg
(EPA/DHA)
Vasepa - 4 caps = 3,500 mg 3.5 grams pure EPA
EPA/DHA (per g)
878 mg
(EPA only)
that's why EPA reduces sudden heart attack death in a way that statins do not, as Dr Sears pointed out in 2011 in the video
other study at AHA points to inflammation as the MOA
Presentation Sa1056, “Purified Eicosapentaenoic Acid Ameliorates Cardiac Fibrosis and Tissue Inflammation on Spontaneously Hypertensive Rats,” – Giselle C. Meléndez, M.D., Danielle Medina-Hernandez, Adam Pflum, M.D., Vivian Xu, David M. Herrington, M.D., presented Saturday, November 16., 1:30 – 2 p.m., Eastern U.S. Time.
https://www.abstractsonline.com/pp8/#!/7891/presentation/28631
JT made a point of saying their technology used to measure was more accurate, plus in Cherry Japanese patients may have had better EPA/AA ratios from the start than USA patients . 18 month review will be interesting to see with with more time to increase EPA/AA levels
the intriguing theory is, if certain resolvins start the end phase, healing phase of the inflammation process, then CV benefit comes from the resolution of chronic inflammation, separate form cholesterol management
read the studies, it's early research, DHA does play a role in resolvins,
seems like EPA is more important, it's early research though, it points to the role of chronic inflammation and how much epa/dha may be needed,
too early research for AMRN to come out and make any claims about resolvins, but very interesting
what exactly do you disagree with,
the only thing Sears disagrees with is DHA's benefit with resolvins and quantity of EPA needed, DR. Serhan who discovered resolvins says more is better, also I did see that Sears is referencing Reduce-It in a positive light in one of his blog posts
Resolvins, derived from EPA, are what reduces CVD.
Discovered at Harvard, resolvins trigger the resolution of chronic inflammation and start the healing process. Chronic inflammation is the root cause of CVD that cholesterol management doesn’t address. The key is getting enough EPA to make a difference, 4 grams EPA at least, more is better.
Resolvins and heart disease https://www.ncbi.nlm.nih.gov/pubmed/28732558
Serhan CN. “Pro-resolving lipid mediators are leads for resolution physiology.” 510:92-101 (2014)
https://www.ncbi.nlm.nih.gov/pubmed/24899309 this guy discovered resolvins Serhan
https://www.jci.org/articles/view/97943
pub med https://www.ncbi.nlm.nih.gov/pubmed/?term=resolvins
similar to eicosanoids like prostaglandins, Leukotrienes
Resolvins are metabolic byproducts of omega-3 fatty acids, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as well as docosapentaenoic acid (DPA) and clupanodonic acid. As autacoids similar to hormones acting on local tissues, resolvins are under preliminary research for their involvement in promoting restoration of normal cellular function following the inflammation that occurs after tissue injury.[1][2] Resolvins belong to a class of polyunsaturated fatty acid (PUFA) metabolites termed specialized proresolving mediators (SPMs).[3][4]
good news - It's a done deal Merger, 8K out - Stockholders approved a reverse stock split of Apricus common stock, at a ratio of one post-split share for every thirty shares outstanding immediately prior to the reverse stock split. The results of the voting included 14,292,620 votes for, 1,618,831 votes against, 79,264 votes abstained and 5,875,069 broker non-votes
Even call to,make sure they have your vote, some were not received and counted
Everyone should vote it's easy -CALL at 1-877-787-9239 Morrow Sodali LLC
thanks oldcoach
oldcoach, did you vote your shares ? anyone still voting Against or not voting ?
I agree, and I'll be glad when it's finally over,happy holidays old friend
I agree Lostcoast - thanks
APRI is not a going concern, so they have to sell what they have left, Seelos is buying the Nasdaq listing and needs the Reverse Split to keep the share price up and maintain Nasdaq listing.
Apri shareholders still get 15% of a company with a pipeline with unmet need and 2 late stage candidates. The other thing Apri is selling is Vitaros rights in the USA, which is a PH3 ready drug, not worth much but at least 30 cents a share, before the RS.
Those 2 things create more value for Apri shareholders than letting this fall through. What’s left, selling Vitaros and paying off creditors ? Maybe shareholders get zero. Take the deal, it’s better than nothing IMO.
Pascoe is offering to speak to share holders directly by phone: see link
https://ih.advfn.com/stock-market/NASDAQ/apricus-biosciences-inc-APRI/stock-news/78898944/filing-of-certain-prospectuses-and-communications
I agree, I had to call and ask to get clarification, sometimes things need to be spelled out simply, was not in this case
tell Shareholders you know to vote, I guess they had low retail shareholder participation
In this case the R/S is meant to keep to SEEL over $1 and maintain Nasdaq compliance, and start SEEL out with a low share count, that's a good thing.
Shareholders will still own the same 15% of the new company no matter the share count after the R/S. Share price of SEEL may go down short term but should go up long term. The CVR is what has more value in the short term.
Seelos is really just buying the Nasdaq listing and is trying to sell Vitaros, I’d guess at maybe around $20M, for a PH3 ready drug in the USA. That cash will go to APRI shareholders of record before the merger, based on pre-R/S shares.
I'm thinking 66 cents per share, that's 2.4x the current price. The CVR has value in the short term, IMO
Also studies in China showed DDAIP and alprostadil did work at lower concentrations of DDAIP. The FDA is being overly cautious because they don’t like permeation enhancers. EU approved with no problem and it’s selling there with no issues even at the higher DDAIP concentration
The details on the CVR are in the merger document which is on file. To be clear, the Apricus holders just prior to the merger close will be eligible for the CVR, not as of the record date back in October. So If someone has sold (or sells )their shares prior to the close, they will not be eligible for the CVR. Since 90% of the value of the CVR (after the first $500K) will be split pro rata among those holders based upon the number of shares you hold, the reverse doesn’t really impact what you would receive. The percent of APRI you own is what matters. For example, if you owned 100% of all APRI shares just prior to close, you’d receive the 100% of the payout. If you owned 5% of the shares, you’d get 5%.
I spoke to pascoe directly on this, not that he is a hero, a lot of mistakes have been made, but this really makes sense, most holders are retail and may not be paying attention, this is a good deal
good move Lex, the % ownership in SEEL will be the same, regardless of the number of shares and the CVR will be based on pre- R/S shares, I think it is best, thanks
If anyone still owns and didn't vote, I think we should vote yes on all, and get rid of the POS, and not drag it out, the CVR is based on pre reverse split shares, they need the RS to stay in nasdaq compliance, why drag this turd through the mud any longer
I really don't know oldcoach about what will happen at the FDA meeting,
but I do think the patents are worth more than a dollar a share, especially to ferring, I think someone higher up at the FDA came down on the decision and they don't want to approve a permeation enhancer that comes off patent in 2020 that everyone could use in any way once a product is approved, I don't think a bridge study will cut it, the path forward in the USA for DDAIP/Vitaros is a whole new formula, room temp, enantiomer version less than 2.5%, and trials, Apricus can't do that, who would and risk a restricted label or a 3rd denial, the patent on the DDAIP enantiomer version goes to 2031, so maybe if more safety studies/trials can prove it, and it's exclusive, we just don't know how the FDA is going to handle this, maybe a newer technology is coming down the pike that doesn't open the skin and the FDA doesn't want DDAIP, so that leaves Ferring, would Ferring buy Apri for the room temp device, rayva, new version of DDAIP, I would think so but what the hell do I know at this point, look how wrong I have been here
the only thing to be in for is the sale of the company,
apricus has no future from a business standpoint, imo,
the patents are worth something, we'll see
I really don't know at this point