Wondering what Texans actually want, the extent to which they want the government to be involved here. Enhancing infrastructure for early warning. Well, I suspect that on July 21, when the special session gavels back in, that the legislature will go back to the bill that was administered this past session but was unsuccessful.It was a half a billion dollar package to create an early detection and warning system with respect to a state that unfortunately is subject to the most amount of natural disasters tha ...

House Republicans called the upcoming “Crypto Week” a step to make the U.S. the “crypto capital of the world.” (Illustration: Chesnot via Getty Images) https://t.co/hz07Nn2ndi https://t.co/3toSEyrcUZ ...

BO HINES: 🇺🇸 "Huge week ahead — it’s Crypto Week in the House!GENIUS heads to the President’s desk. Clarity moves to the Senate.Time to make America the Crypto Capital of the World." https://t.co/LcDfK5OTXK ...

Core Insights - The last analysis on Coca-Cola Company (NYSE: KO) was published in July 2024, focusing on its Q2 performance and strategic positioning [1] - The research emphasizes providing actionable investment ideas based on independent analysis [1] Investment Performance - The service has reportedly helped members outperform the S&P 500 and avoid significant losses during periods of high volatility in both equity and bond markets [2] - A trial membership is offered to assess the effectiveness of the investment strategy [2]

The country’s split with the EU, paradoxically, encouraged the services boom by crushing sterling, making British salaries cheaper for foreigners https://t.co/NiecyDf34n ...

🧠 "The biggest trend of the last 6 to 12 months has been Hyperliquid."FalconX's Global Co-Head of Markets, Josh Lim, on why hedge funds are flocking to protocols with "real revenues," like Hyperliquid and on-chain options. https://t.co/bWBvOjdUyP ...

Herkese merhabalar. Öncelikle hoş geldiniz hepiniz. Ben Osman Çaputçu.Mimar ve girişimciyim. Bu şehirde doğdum. Eee, ilkokul, ortaokul, eee, burada geçti.eee 1999 yılında burada eee doğdum ve aslında eğitim hayatım başladı. Eğitim malum ilk ailede başlıyor. Babamın da aslında eee nasihatiyle ne yaparsam yapayım en iyi şekilde yapmak üzerine gayretim oldu.Hala da devam ediyor. O yüzden burada bu şehirde bu sahnede olmak benim için ayrıca önemli. eee, doğduğum, büyüdüğüm şehirde.Eee, sonrasında tabii ki İstan ...

Değerli konuklar, mutlu bir sabah, mutlu bir gün, mutlu bir gelecek dileyerek konuşmama başlıyorum. Mutlu olma sanatı, mutluluğun tanımıyla başlamaya çalışıyorum. Bütün her şeyde olduğu gibi mutluluğun da bir tanımı var.Bütün özlemler eksiksiz ve sürekli ulaşmaktan duyulan saadet bahtiyarlık diye geçer. Daha kolay bir tanım. Elin erişebileceği çiçeklerden bir demet yapma sanatıdır.Başarı istediğini elde etmek. Bir otor yine bunu güzel özetlemiş. Mutluluk ise elde ettiğini sevmektir.Daha güzel bir özet. Mutl ...

Eee, ben Gizem Girişmen. Türkiye'nin Paralimpik Oyunlar Tarihinde altın madalya kazanan ilk kadın sporcusuyum. Dünya şampiyonu Okçuyum.Eee, bugün karşınızda, eee, bulunma amacım, şunu başardım, bunu yaptım, böyle bir hayat hikayem var gibi bir eee, anlatı yapmak değil aslında. E, aksine, eee, dört kere düştüysem beş kere kalkma mücadelem, eee, hatalarımdan ders çıkartma, eee, vazgeçmeme deneyimlerimle sizlerle paylaşmak için buradayım. Eee, biraz önce de söyledim.E şampiyon bir okçu olarak karşınızda bulunu ...

Summary of Capricor Therapeutics (CAPR) Update Call Company Overview - **Company**: Capricor Therapeutics - **Focus**: Development of Daramyacel, a cell therapy candidate for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) Key Points Regulatory Update - Capricor received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for Daramyacel, indicating that the application does not meet the requirements for substantial evidence of effectiveness and requires more clinical data [4][5] - The review clock has been stopped until a complete response is submitted, and Capricor does not believe a new BLA will be required [5][41] - Capricor is preparing a written response to the CRL and has initiated engagement with the FDA for further discussions [5][10] Clinical Data and Efficacy - The BLA was supported by data from the HOPE-two trial, which demonstrated statistically significant benefits in cardiac function [7][8] - The HOPE-two open label extension study showed significant results in left ventricular ejection fraction with a p-value of 0.0079 [9] - Ongoing Phase III HOPE-three clinical trial is seen as a key opportunity to address the FDA's request for additional clinical data [10] - HOPE-three has completed a twelve-month evaluation of 104 DMD patients, with data expected in Q3 2025 [10] Manufacturing and Quality Control - Capricor is committed to resolving outstanding issues in the chemistry, manufacturing, and controls (CMC) section of the application [11] - The company believes that the issues raised by the FDA are resolvable in a timely manner [11] Industry Context - The FDA's decision is viewed as concerning, especially given the high unmet medical need in DMD and the innovative nature of the therapy [6][12] - Capricor emphasizes the importance of using long-term extension data and real-world evidence in evaluating therapies for rare diseases like DMD [12] Support from Medical Community - A group of leading DMD physician scientists submitted a letter to the FDA expressing support for the Daramyacel clinical program [13] - The letter highlighted their extensive experience in treating DMD and their belief in the efficacy and safety of Daramyacel [13] Future Outlook - Capricor remains committed to working collaboratively with the FDA and is optimistic about the potential for Daramyacel to receive approval [14][15] - The company aims to provide updates as they achieve clarity with the FDA regarding the path forward [69] Financial and Strategic Considerations - Capricor maintains its priority review status and is focused on addressing the FDA's concerns without needing a new BLA [48] - The partnership with NS Pharma remains strong, with continued commitment to commercialization in the U.S. despite the CRL setback [58] Additional Insights - The FDA's cancellation of the Public Advisory Committee meeting without explanation raised concerns about the review process [6] - Capricor's approach to statistical analysis in clinical trials has been a point of contention with the FDA, particularly regarding the use of parametric versus nonparametric models [30][36] This summary encapsulates the critical updates and insights from the Capricor Therapeutics conference call, highlighting the company's current challenges and future strategies in the context of regulatory approval for Daramyacel.