음... 역시 미리반등해서 단타나오고
cpi나온뒤 또 단타치고 빠지는군요
여기서 더 올라갈 수 있는건...다우 나스닥 지수뿐?
cpi가 이제 꾸준히 내려갈듯한데, 그러면 당연히 금리인하도 올해 나오겠죠?
예측은 다들 9월부터라곤 하는데...과연 퍼센트지가 100%까지 올라가줄지 기대됩니다
1번정도는 낮춰주고 추이를 지켜보는것도 내쁘지않을듯한데...
닉 티미라오스
연준의 4월 CPI 주요 내용:
- 좋은 지표 하나가 좋지 않은 지표 세 개를 상쇄할 수는 없습니다. 1분기 인플레이션의 외상 후 스트레스 장애를 극복하는 데는 시간이 좀 더 걸릴 수 있습니다.
- 중립적 편향으로 전환될 위험을 줄입니다
CPI와 PPI를 PCE에 매핑하는 예측자들에 따르면 4월 핵심 PCE 지수는 아마도 0.20%에서 0.26% 사이에서 상승했을 것으로 보입니다.
(내일 수입가격 자료에 따라 변동될 수 있습니다)
그러면 12개월 연율을 2.8%로 유지하거나 2.7%로 낮추게 됩니다.
4월 핵심 PCE 지수가 0.24% 상승하면 6개월 연환산 금리는 3월의 3%에서 3.2%로 상승합니다.
3개월 연율은 3월의 4.4%에서 3.3%로 낮아질 것입니다.
또한 주목할 점은 4월에는 주택을 제외한 핵심 PCE 서비스업이 하락할 것으로 예상됩니다.
In the pharmaceutical industry, the FDA will explain the Complete Response Letter (CRL) request.
### ### CRL(Complete Response Letter)이란?
A CRL is an official document issued by the U.S. Food and Drug Administration (FDA) to a pharmaceutical company or medical device company that has requested approval of a drug or medical device. A CRL means that the FDA will not give final approval to a new drug application (NDA) or biological medicine license application (BLA) that has been submitted. Instead, the CRL specifically states what needs to be supplemented, along with reasons that have not been approved.
### Process of CRL requests
1. Application Submission: Pharmaceutical companies or medical device companies submit NDAs or BLAs to the FDA to bring new drugs or medical devices to market.
2. Review Process: The FDA reviews submitted applications thoroughly. The process includes clinical trial data, safety and efficacy data, manufacturing processes, labeling, and more.
3. Issue a CRL: After the FDA completes its review, issue a CRL if it determines it needs any issues or additional information to be resolved before giving approval to the application.
### Components of the CRL
The CRL contains the following information:
- Review Results Summary: The FDA's review of the application summarizes the results.
- Request for supplementation: specify additional information required for approval or what needs to be supplemented. This may vary from adding clinical trials, analyzing data, modifying manufacturing processes, changing labeling, etc.
- FDA Recommendations: They may include FDA recommendations on what steps a drug company should take in the next step.
### Importance of CRL
The CRL is a very important document for pharmaceutical companies and medical device companies. This means that the FDA has thoroughly reviewed the safety and effectiveness of the product, providing an opportunity for pharmaceutical companies to improve their products through complementary work. By addressing the issues posed by the CRL, you can ultimately increase the likelihood that the product will be approved and brought to market.
### How CRL works
Here's what a pharmaceutical company can do after receiving a CRL:
- Submit additional data: Collect and submit additional data requested by the CRL.
- Perform additional clinical trials: supplement the data by conducting additional clinical trials if necessary.
- Request a meeting with FDA: You can request a meeting with FDA to clearly understand the content of the CRL and discuss the supplementary plan.
### Impact of CRL
CRLs can place a time and financial burden on pharmaceutical or medical device companies because additional clinical trials or data analysis take considerable time and money. However, by supplementing the safety and effectiveness of the product through CRLs, it can gain greater trust when it finally hits the market.
CRL is one of the important processes in the pharmaceutical industry, which contributes to ensuring product quality and patient safety.
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