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$Summit Therapeutics(SMMT.US$
Ivonescimab Manuscript for Harmoni-a Clinical Trial Results Published in Jama—-Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant. it is original investigation, just published in JAMA.
Ivonescimab Manuscript for Harmoni-a Clinical Trial Results Published in Jama—-Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant. it is original investigation, just published in JAMA.
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$Summit Therapeutics(SMMT.US$
Summit just in-licnesed the drug from Akeso for US, EU, Japan, etc rights. So far only Akeso annouces a postive H2H trial in China only, exact data to be seen at ASCO. the question is whether to trust a pure China developed novel molecules given China’s credibility issue in medical area
Summit just in-licnesed the drug from Akeso for US, EU, Japan, etc rights. So far only Akeso annouces a postive H2H trial in China only, exact data to be seen at ASCO. the question is whether to trust a pure China developed novel molecules given China’s credibility issue in medical area
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Morning mooers! It is Wednesday May 22, the market is cautiously flat, awaiting Nvidia earnings after market closes.
My name is Kevin Travers, and here are the stories moving on Wall Street Today:
$Target (TGT.US)$'s fiscal first-quarter earnings missed Wall Street's estimates by 3C, and were 1% below last year's $2.05. Shares in the firm fell 8% in early trading, the lowest decline on the S&P 500.
The largest gainer on the S&P 500...
My name is Kevin Travers, and here are the stories moving on Wall Street Today:
$Target (TGT.US)$'s fiscal first-quarter earnings missed Wall Street's estimates by 3C, and were 1% below last year's $2.05. Shares in the firm fell 8% in early trading, the lowest decline on the S&P 500.
The largest gainer on the S&P 500...
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March's nonfarm payrolls report will be released at 8:30 ET this Friday.The consensus estimate polled by Bloomberg shows that nonfarm payroll is expected to increase by 200K, down from 275K in February. The unemployment rate is expected to decrease from 3.9% to 3.8%.
Economists haven't seen signs of a sharp slowdown in the labor market.Continuing Jobless Claims in the United States i...
Economists haven't seen signs of a sharp slowdown in the labor market.Continuing Jobless Claims in the United States i...
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The downgrade from Moody's reflects the financial, risk-management, and governance challenges facing NYCB. Confidence in NYCB has been wavering due to its commercial real estate lending and unexpected losses from its New York office and multifamily property loans.
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Trying to not lose : The FDA's preference for multi-regional trials means SMMT may need to conduct additional trials. This could delay approval and increase costs, creating uncertainty in the short to medium term.
Trying to not lose Jaguar8 : While it's true that the FDA does not universally require MRCTs for all drug approvals, the agency has increasingly encouraged their use, especially for drugs intended to be marketed globally. The FDA’s guidance on MRCTs, particularly the ICH E17 guideline, supports the use of MRCTs to improve the generalizability of trial results across different populations and regions.
Trying to not lose Jaguar8 : And, recent trends and statements from the FDA, including those from key figures like Richard Pazdur, the director of the FDA’s oncology division, indicate a clear preference for multi-regional trials. Pazdur's recent remarks underscore the agency's inclination towards data from MRCTs to ensure broader applicability and relevance of clinical trial findings.
Trying to not lose Jaguar8 : Duh… You can interpret it the way you like, but FDA does what they are supposed to do.
I would take any reliable source such as FDA over an unknown commenter on a broker platform :-)
Trying to not lose Jaguar8 : And , check the latest news posted under MooMoo, which was published by Seeking Alpha like few hours ago
That’s FDA stand as of that latest reliable source
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