New customs are finished
2021.12.09 11:08 __Turbo__ New customs are finished
2021.12.09 11:08 Dannosaurusr3x What is the designer appliance wall?
My supervisor and I were going over some projects and saw it listed. We’re just curious what it looks like because we don’t have a single store around us that has one m. Anyone have one willing to take a pic and share it please send it to me. We’re always curious about what cool things we’re missing out on.
submitted by Dannosaurusr3x to HomeDepot [link] [comments]
2021.12.09 11:08 mozaro1 Good day. We got some good news for everyone😍 We are proudly announced that Severe Rise Games is now officially listed in Coin Market Cap https://coinmarketcap.com/currencies/severe-rise-games-token/ This is a another great milestone
submitted by mozaro1 to CryptoMarketsshot [link] [comments]
2021.12.09 11:08 Brilliant_Penalty_91 Ikon pass last day few left get uploaded to your account
Get pass up loaded to your account for the low last day
submitted by Brilliant_Penalty_91 to Ikonpass [link] [comments]
2021.12.09 11:08 anaila01 Mermaid 🧜♀️ NFT GIVEAWAY for next 12 hours 🚀🌙 Join TG To Get A Free RARE NFT
The Mermaid Token was founded to be the number 1 BTC reward token on the Binance smart chain. At the present time there is no token that has achieved as much as Mermaid.
💥NFT giveaway is now live for 12 hour. Join Telegram to enter https://t.me/mermaidtoken
✅ Long term organic marketing plan (We gain holders everyday!)
✅ Did a 1500x in 2 weeks and a 1000x a week later (Check the chart)👇
✅Very active dev (Always in telegram)
✅Own Youtube channel where the dev puts out content and updates
BSC is in need of a token that pays out bitcoins to holders that won't die after a few days. Mermaid is nearly 3 months old and our holders are growing ever single day!
Things to come
🛑Coin Gecko, Delta, FTX listings are still pending. (we are listed on CMC already)
🛑Holder and volume growth
🛑2nd round of NFT giveaways
🛑Staking of the Mermaid token
💎Liquidity Locked (for 1 year)💎 https://mudra.website/?certificate=yes&type=0&lp=0xf509c494a92f2e2884937db0e9902f749edf25e5
📜Contract 📜 0x238c5c0c074126226f4afc5c667ee3c623aa0791
I am sure you have seen our name... join us in our telegram if you have any questions. There is no doubt that even a small percentage of Mermaid in your crypto portfolio will add a lot of long term value.
submitted by anaila01 to CryptoArt [link] [comments]
2021.12.09 11:08 thekookiejar_ Ring Ding Dong in 4K. Go ahead and play it. You know you want to! :)
submitted by thekookiejar_ to SHINee [link] [comments]
2021.12.09 11:08 dicey-dicey Not even Toe is safe from BCEO
2021.12.09 11:08 soubitos OPEN HARDWARE TP5400 DC UPS (design files in link inside)
2021.12.09 11:08 sreekesh_ Aaduthoma nft ( search on opeansea) buy👉 cryptopunki (collection) crypto_gorilla_5802 (a/c)
2021.12.09 11:08 thottyworm Those who finished highschool online, what are the pros and cons? How was your experience?
submitted by thottyworm to AskReddit [link] [comments]
2021.12.09 11:08 apatkarmany A lot of people might question me on this!
This is literally my favorite season. It’s been a while since I really waited to watch every Wednesday to see the episodes, usually I just wait to stream it but this season had it different for me.
I love the new era of Survivor. I love the mass amount of twists because it shows that people need to play the game and people need to expect the unexpected instead of it being the same every season where people know what to expect.
I’m definitely going to get the merge buff for this season!
Fun Fact: my winner pick since preseason has been Erika!!! I love her so much and I can see her taking the title of sole survivor. Her game is different then any other winner and people are going to think she’s low tier cause of that but it’s not!!! Her edit literally matches her story and her strategy so we didn’t need a major screen time from her.
submitted by apatkarmany to survivor [link] [comments]
2021.12.09 11:08 xXTotalHardnessXx Should I go over year 1 content for A level maths?
Resitting my maths a level so I've been going through the year one books, but I can't help but feel I'm wasting my time. Like when I'm going through a chpater, I know most of. There's just a few concepts here or there I've forgotten.
So is it worth going through year 1 content? Or should I just make sure I know the year 2 stuff properly?
Any help would be appreciated.
submitted by xXTotalHardnessXx to 6thForm [link] [comments]
2021.12.09 11:08 jason_ni Yearly interest - is assumption correct?
I have a savings account with a bs, and they give the interest for the account once a year, in May.
If I've had cash in the account from May to now, and were to empty the account today, I'm guessing I'll still get the interest awarded this coming May, on the interest that has been made to this point, before emptying the account, or will removing funds impact the interest made to this point?
Let me know if you need further detail to answer the query!
submitted by jason_ni to UKPersonalFinance [link] [comments]
2021.12.09 11:08 Nickleo02300 Did you knew that
2021.12.09 11:08 edditbot (+7123) Intense Car Chase and Gun Battle in Downtown Seattle Yesterday
submitted by edditbot to eddit6yearsago [link] [comments]
2021.12.09 11:08 peepay Michael will take care
2021.12.09 11:08 Sbenny_Official Heroes of Myth v1.0.2 - Mod APK - Modded Stats & Relationships
submitted by Sbenny_Official to SbennyOfficial [link] [comments]
2021.12.09 11:08 WowpowKerchoo Daily Callie #1144-A Fresh Face
2021.12.09 11:08 CatholicAnti-cap Girolamo Savonarola’s miracles
2021.12.09 11:08 Inevitable-Ad-1836 Good day. We got some good news for everyone😍 We are proudly announced that Severe Rise Games is now officially listed in Coin Market Cap https://coinmarketcap.com/currencies/severe-rise-games-token/ This is a another great milestone
We got some good news for everyone😍 We are proudly announced that Severe Rise Games is now officially listed in Coin Market Cap https://coinmarketcap.com/currencies/severe-rise-games-token/
This is a another great milestone 🏅Successful Play to Earn Launch of NFTale 🏅Officially listed in CMC 🏅SRG price in Trust wallet is showing 📢Coming soon in Coingecko
This made our day and we want to thank everyone for believing and supporting our project. Severe Rise Games had a roller coaster journey but we manage to move forward and "RISE"
Join us and celebrate this day. Let's make SRG trending on CMC!
👉🏻 Follow us on: 📎 Telegram: https://t.me/SevereRiseGamesOfficial 🐦 Twitter: https://twitter.com/SevereRiseGames 📱 Facebook: https://www.facebook.com/SevereRiseGames 📍 Discord: https://discord.gg/nnzGdz8MdQ 🎬 Youtube: https://www.youtube.com/channel/UCCyVbcgN8DJrJJfNk-JWPew
submitted by Inevitable-Ad-1836 to NextBigCryptos [link] [comments]
2021.12.09 11:08 Possible_Abrocoma_22 Starbucks union vote is latest test of resurgent US worker power
2021.12.09 11:08 DangerDave1988 FINALLY! Jesus, I waited so long for you, Bae <3 FK25 takes 7 Minutes…not anymore! Best boosters aside from Maus?
2021.12.09 11:08 pluto00zero my results. i’m from bosnia
2021.12.09 11:08 Zac362 What to read after 'Helsreach' ?
I've just finished 'Helsreach' and thoroughly enjoyed it! It's the first Warhammer book I've read and it's really whet my appetite...
So what do I read next?
submitted by Zac362 to Warhammer40k [link] [comments]
2021.12.09 11:08 No_Limit5915 Highly Significant Positive Top-Line Results from its Phase 3 Non-Opioid Injectable SP-102
Scilex Holding Company, a Sorrento Therapeutics, Inc. Subsidiary, Announces Highly Significant Positive Top-Line Results from its Phase 3 Non-Opioid Injectable SP-102 (SEMDEXA™) Pivotal Trial C.L.E.A.R. Program for Sciatica Pain Management Supporting the December 9, 2021 at 9:00 AM EST Download PDF
- Scilex Holding Company, a commercial-stage, non-opioid biopharmaceutical pain management company, announces highly significant positive top-line results from its Phase 3 SP-102 (SEMDEXA™) Pivotal Trial C.L.E.A.R Program for its novel, non-opioid, corticosteroid formulation, injectable dexamethasone sodium phosphate viscous gel product for the treatment of lumbosacral radicular pain (sciatica). SP-102 (SEMDEXA™) has received Fast Track status from the FDA.
- The C.L.E.A.R. Program trial has met the primary efficacy and key secondary efficacy endpoints with highly statistical significance:
- For the primary endpoint of change in average daily pain (as measured by the Numeric Pain Rating Scale) in the affected leg over 4 weeks following the initial injection the LS Mean (SE) group difference of -1.08 (0.17) compared to placebo with a p-value <0.001.
- The two key secondary endpoints assessing Oswestry Disability Index (ODI) and Time to open-label repeat injection have also demonstrated highly statistically significant results for SP-102. The LS Mean (SE) group difference in ODI compared to placebo at week 4 was -6.28 (1.49) with a p-value <0.001. A Cox proportional hazard model showed significantly longer duration of initial SP-102 (SEMDEXA™) treatment compared to placebo Hazard Ratio (95% CI) 0.49 (0.36, 0.65), with a p-value <0.001.
- Scilex expects SP-102 (SEMDEXA™) to be the first FDA-approved non-opioid epidural injection for sciatica with the potential to replace the current 10 to 12 million off-label epidural steroid injections administered each year in the USA, where more than 30 million people suffer from low back and radicular pain. This population is expected to grow as the overall population ages.
PALO ALTO, Calif., Dec. 09, 2021 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), today announced highly significant positive top-line results from its SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program, a corticosteroid injectable dexamethasone sodium phosphate viscous gel for the treatment of lumbosacral radicular pain, or sciatica. SP-102 (SEMDEXA™) has received Fast Track status from the FDA.
C.L.E.A.R. Trial (Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy) was designed to investigate safety and analgesic effects of a single and repeat transforaminal injections of SP-102 (SEMDEXA™) compared to placebo (saline injection). The trial enrolled 401 low back pain subjects with unilateral intervertebral disc herniation in lumbosacral spine resulting in radicular pain symptoms of moderate to severe leg pain. It is the largest known randomized well-controlled trial in sciatica using epidural steroid injections. The primary endpoint of change in average daily pain in the affected leg over 4 weeks following the initial injection had demonstrated LS Mean (SE) group difference of -1.08 (0.17) compared to placebo with a p-value <0.001.
The two key secondary endpoints assessing Oswestry Disability Index (ODI) and Time to open-label repeat injection had also demonstrated highly statistically significant results. The LS Mean (SE) group difference in ODI compared to placebo at week 4 was -6.28 (1.49) with a p-value <0.001. Following the initial 4-week observation period, subjects with moderate to severe radicular pain could receive an open-label repeat injection of SP-102 (SEMDEXA™). Between weeks 4 and 12, repeat injections were administered to 67% of subjects who initially received placebo treatment and 46% of subjects who initially received active treatment. A Cox proportional hazard model showed significantly longer duration of initial SP-102 (SEMDEXA™) treatment compared to placebo Hazard Ratio (95% CI) 0.49 (0.36, 0.65), with a p-value <0.001.
SP-102 (SEMDEXA™) demonstrated a very clean safety profile with no identified safety risks. There were no adverse events of special interest reported (paraplegia, hematoma, injection) associated with epidural steroid injections. There were no SAEs related to the drug or injection procedure.
“We are very pleased with the positive outcome and are looking forward to receive a complete data set to further evaluate and characterize efficacy and safety of SP-102 (SEMDEXA™). These top-line results are very remarkable. They will impact greatly the pain management community and will enable us to proceed with our plans for registering SP-102 (SEMDEXA™) with the FDA for the treatment of subacute lumbosacral radicular pain. We plan to present the results from the Phase 3 C.L.E.A.R trial at upcoming scientific conferences and submit for publication in a peer reviewed journal,” said Dmitri Lissin, MD, Chief Medical Officer of Scilex.
Scilex intends to use the results from this pivotal Phase 3 trial to discuss with the FDA in 2022 a licensure application and Breakthrough Designation Status for the high unmet need sciatica indication for which no treatments have been approved in the U.S.
Scilex has extensive clinical and pre-clinical data (including multiple Phase 2 clinical trials) with the novel viscous gel formulation of SP-102 (SEMDEXA™), which was designed to provide extended non-opioid pain relief for sciatica patients. Scilex expects to present the robust data collected over the course of the company’s multi-year clinical development program to the FDA as part of a New Drug Application (NDA).
SP-102 (SEMDEXA™) is the first non-opioid novel injectable corticosteroid gel formulation product in development for the treatment of lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates. If approved by the FDA, the SP-102 (SEMDEXA™) formulation will be available in a pre-filled syringe and will be administered by epidural injection. Based on preclinical and clinical studies, it extends the residency time at the site of injection and does not show the safety concerns that led the FDA to warn against using other injectable steroid formulations by the epidural route of administration.
More than 40% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP)9-11 despite the fact that opioids are associated with serious and potentially life-threatening side effects and have not demonstrated efficacy in the treatment of CLBP.11,12,13 In 2018, more than 67,000 drug overdose deaths occurred in the United States14 of which almost 47,000 (70%) were opioid-related. Over 70% of the 70,630 deaths in 2019 involved an opioid.15 Provisional data release by the Centers for Disease Control and Prevention showed drug overdose deaths rose by nearly 29% over a 12-month period ending in April 2021, to an estimated 100,306.16
“We are anxiously awaiting a new injectable gel formulation of dexamethasone and submission of this data to the FDA for the treatment of radicular pain based on the results of a large, randomized, placebo-controlled, multi-center trial. If approved by the FDA, SP-102 (SEMDEXA™) would be the first corticosteroid with an indication for epidural administration in the U.S. and world, and providing meaningful, extended pain relief. SP-102 (SEMDEXA™) would be a welcome addition to the armamentarium of interventional pain physicians, providing a non-surgical, non-opioid alternative for a condition affecting millions of people,” said Dr. Steven P. Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology, Physical Medicine & Rehabilitation, and Psychiatry & Behavioral Sciences at the Johns Hopkins School of Medicine, and a Professor of Anesthesiology and Physical Medicine & Rehabilitation at Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.
"We are very pleased to have achieved this important milestone and would like to commend the experienced investigators and advisors of the C.L.E.A.R. trial for their persistence and diligence in enrolling sciatica patients through the COVID-19 pandemic and enabling Scilex to achieve a landmark milestone. These highly significant positive clinical results for the pivotal SP-102 (SEMDEXA™) Phase 3 trial may provide encouraging news for the many millions of people worldwide who are confronting painful radicular pain (sciatica) and we look forward to sharing complete Phase 3 results next year. We believe that SP-102 (SEMDEXA™) could be the first FDA-approved epidural steroid gel injection product for patients suffering from this common, very painful condition,” said Jaisim Shah, President and Chief Executive Officer of Scilex.
By 2022, the overall estimated number of epidural steroid injection (ESI) procedures in the U.S. is expected to be 12.1 million across all Medicare and private coverage patients, with lumbar radiculopathy/sciatica procedures comprising approximately 88% of all ESIs administered, according to a proprietary study by Syneos Health Consulting. Despite widespread utilization of ESIs, concerns persist in the market about particulate and solution steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. Opioid prescriptions account for about 40% of the chronic back pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternate pain therapies without the medical and societal challenges.2,5 As a result, a significant unmet medical need exists within the market for a novel, non-particulate ESI formulation that demonstrates safety and effectiveness in controlled clinical trial evaluations.7
In the U.S., more than 30 million people suffer from low back and radicular pain. This population is expected to grow as the overall population ages.1,2 Many patients experience moderate to severe pain with intolerance of and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs).3,4 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.2
Chronic pain affects 116 million Americans and costs the U.S. as much as $635 billion each year, according to a recent report from the Institute of Medicine (IOM) that called for changes in how chronic pain is managed6 and nearly 30 million patients suffer from lower back pain in the U.S.8 Government agencies, physicians, patients, and payers are looking for alternatives to opioids to reduce the risk of dependency or addiction, and serious side effects (such as respiratory depression and constipation), while still offering potent solutions for people living with chronic pain.
Scilex is dedicated to the development and commercialization of non-opioid pain management products for treatment of acute and chronic pain. Scilex’s commercial product ZTLIDO® (lidocaine topical system) 1.8%, a non-opioid prescription lidocaine topical product approved by the FDA for the relief of pain associated with postherpetic neuralgia, shows continued sales growth of 35% year over year despite the continued impact of the COVID-19 pandemic. SP-102 (SEMDEXA™) is the first non-opioid novel injectable corticosteroid gel formulation product in Phase 3 development for the treatment of lumbar radicular pain, containing no preservatives, surfactants, solvents, or particulates. If approved by the FDA, SP-102 (SEMDEXA™) will be available in a pre-filled syringe formulation and will be administered as an epidural injection for the treatment of sciatica. Based on preclinical and clinical studies to date, SP-102 (SEMDEXA™) extends the residency time at the site of injection and has not demonstrated the safety concerns that led the FDA to warn against using other injectable steroid formulations by the epidural route of administration. About Sorrento Therapeutics
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com
. About Scilex Holding
Scilex Holding Company (Scilex) a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE), is dedicated to the development and commercialization of non-opioid pain management products for treatment of acute and chronic pain. Scilex is uncompromising in our focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product in October 2018 and is developing its late-stage pipeline, which includes a pivotal Phase 3 candidate and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a best-in-class prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, or SP-103, a Phase 2, next-generation, triple-strength formulation of ZTlido®, for the treatment of low back pain, and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia in multiple Phase 1 programs to be initiated this year. For further information regarding the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161 - Corticosteroid Lumbar Epidural Analgesia for Radiculopathy - Full Text View - ClinicalTrials.gov
On December 6, 2021, Scilex announced entering into a letter of intent for a proposed business combination with Vickers Vantage Corp. I (Nasdaq: VCKA) (“SPAC”
Scilex Holding Company is headquartered in Palo Alto, California, with operations in both Palo Alto and San Diego, California. For further information please visit www.scilexpharma.com
. About Vickers Vantage Corp. I
Vickers Vantage Corp. I is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. Important Information and Where to Find It
This press release references a proposed transaction between Scilex and the SPAC. This press release does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. In connection with the transaction described herein, contingent upon execution of the proposed merger agreement for the business combination (the “Merger Agreement”), the SPAC would file relevant materials with the SEC, including a registration statement on Form S-4, which will include a proxy statement/prospectus. Investors and security holders of the SPAC are urged to read these materials (including any amendments or supplements thereto) and any other relevant documents in connection with the transaction that the SPAC files with the SEC when, and if, they become available because they will contain important information about the SPAC, Scilex and the proposed transaction.
The preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other relevant materials in connection with the transaction (when and if they become available), and any other documents filed by the SPAC with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov
). The documents filed by the SPAC with the SEC also may be obtained free of charge upon written request to:
Vickers Vantage Corp. I 85 Broad Street, 16th Floor New York, NY 10004 https://investors.sorrentotherapeutics.com/news-releases/news-release-details/scilex-holding-company-sorrento-therapeutics-inc-subsidiary-0
submitted by No_Limit5915
to BANDOFBROTHERSOFSRNE [link] [comments]